(434 days)
No
The document describes an automated immunoassay system using established ELFA technology for various diagnostic tests. There is no mention of AI, ML, or any learning algorithms used in the device's operation or result interpretation. The performance studies focus on standard analytical validation metrics like method comparison, precision, and linearity, not on the performance of a learning model.
No.
This device is an in vitro diagnostic (IVD) medical device, used for the detection of various markers in human samples to aid in diagnosis, not for direct therapy.
Yes
Many of the assays performed on the VIDAS system are explicitly stated as "an aid in diagnosis" of various conditions (e.g., H. pylori infection, Lyme disease, Toxoplasma gondii infection, thyroid disorders, DVT/PE). The device is also referred to as an "in vitro diagnostic medical device."
No
The device description explicitly states it is an "automated multiparametric immunoassay system" and describes the hardware components and technology used (ELFA, fluorescence reading, enzyme, substrate). It is an in vitro diagnostic instrument, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section for each of the listed VIDAS assays explicitly states: "This device is an in vitro diagnostic medical device for professional use only."
Furthermore, the "Device Description" for the VIDAS 3 system also states: "This device is an in vitro diagnostic medical device for professional use only."
These statements clearly indicate that the VIDAS system and the associated assays are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELF A technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.
Product codes (comma separated list FDA assigned to the subject device)
LYR, JJE, LSR, LFX, LGD, DHA, KLI, CDZ, JLW, DAP
Device Description
The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). All of the assay steps as well as the assay temperature are controlled automatically by the instrument. The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. After preliminary wash and sample dilution steps, the sample is cycled in and out of the SPR for a specified length of time. IgG antibodies to H. pylori present in the specimen will bind to the H. pylori antigen coating the interior of the SPR. Unbound sample components are washed away. Anti-human IgG antibodies conjugated with alkaline phosphatase are cycled in and out of the SPR and will attach to any human IgG bound to the SPR wall. A final wash step removes unbound anti-human antibody conjugate. During the final detection step, the substrate (4 Methylumbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methylumbelliferone), the fluorescence of which is measured at 450 nm. The intensity of fluorescence is measured by the optical scanner in the instrument. At the assay, results are automatically calculated by the instrument, a test value is generated and a report is printed for each sample.
The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.
The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.
The VIDAS Lyme IgG II assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA) (see User's Manual). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. After a preliminary wash step and a sample dilution step, the antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi specific recombinant proteins coating the interior of the SPR. Unbound sample components are washed away. Antihuman IgG antibodies conjugated with alkaline phosphatase, will attach to the immunocomplex bound to the SPR wall. A final wash step removes unbound conjugate. During the final detection step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methylumbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of anti-B. burgdorferi IgG antibody present in the sample.
At the end of the VIDAS Lyme IgG II assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
The VIDAS® RUB IqG (RBG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that consists of a two step enzyme immunoassay sandwich method and a fluorescent detection. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR®), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and are provided in sealed reagent strips. All assay steps are automated by the instrument. The assay reactions take place by pipetting up and down with the SPR through the wells of the reagent strip. The sample is initially diluted, and follows a first incubation step in the SPR, where anti-Rubella IgG antibodies present in the sample bind to the rubella antigen coating the interior of the SPR. After a wash step to eliminate any unbound component, a second incubation is performed using a monoclonal anti-human IgG alkaline phosphatase conjugate. Following another wash step, the detection substrate (4-methyl-umbellifery) phosphate) is added to the SPR. The enzyme conjugate catalyzes the hydrolysis of the substrate into a fluorescent product (4-methylumbelliferone), and its fluorescence is measured by the intensity of the fluorescence is proportional to the concentration of rubella antibodies present in the sample. Results are automatically determined by the instrument based on the stored calibration curve and according to the CLSI® I/LA6-A recommended cut-off of 10 IU/mL. The assay is calibrated against the WHO 1st International Standard for anti Rubella Immunoglobulin, Human (1997).
The VIDAS TOXO IgM (TXM) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR®), serves as the solid phase as well as the pipettor for the assay. The SPR is coated with goat anti-u chain antibodies. The VIDAS TOXO IgM (TXM) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are in the sealed TXM Reagent Strips. After a sample dilution step, the sample is cycled in and out of the SPR for a specified length of time. IgM antibodies present in the specimen will bind to the anti-u chain antibodies coating the interior of the SPR. Unbound sample components are washed away. An immunocomplex of T. gondii antigen and mouse monoclonal anti-P30 antibodies conjugated with alkaline phosphatase is cycled in and out of the SPR and will attach to the human anti-T. gondii IgM bound to the SPR wall (Note: P30 is a major surface protein of the T. gondii tachyzoite, with molecular weight of 30,000 (5)). A final wash step removes unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is introduced into the SPR. Enzyme remaining on the wall of the SPR will catalyze the conversion of the fluorescent product, 4-methylumbelliferone. The intensity of the fluorescence is measured by the optical scanner in the instrument. When the VIDAS TOXO IgM (TXM) assay is completed, the results are analyzed automatically by the instrument, a test value is generated, and a report is printed for each sample.
The VIDAS HCG (HCG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. The SPR is coated at the time of manufacture with mouse monoclonal anti-hCG antibodies. The VIDAS HCG (HCG) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing anti-hCG antibody conjugated with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR and the hCG will bind to antibodies coated on the SPR and to the conjugate forming a "sandwich". Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is cycled through the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The intensity of fluorescence is measured by the optical scanner in the instrument ; it is proportional to the hCG concentration present in the sample. When the VIDAS HCG (HCG) assay is completed, the results are analyzed automatically by the instrument and a report is printed for each sample.
The VIDAS T4 (T4) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPRs are coated with mouse monoclonal anti-T4 antibodies. The VIDAS T4 (T4) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are in the sealed T4 Reagent Strips. The sample is transferred into the well containing the T4 antigen conjugated with alkaline phosphatase. The conjugate solution also contains ANS and sodium salicylate, which liberate bound T4 from the carrier proteins in the sample. The sample/conjugate mixture is cycled in and out of the SPR and the T4 in the sample competes with the T4-alkaline phosphatase conjugate for binding with the mouse monoclonal anti-T4 antibodies coated on the SPR. Wash steps remove unbound conjugate. A fluorescent substrate, 4methylumbelliferyl phosphate, is cycled in and out of the SPR. Enzyme remaining on the SPR well will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone (450 nm). The intensity of fluorescence is measured by the optical scanner in the instrument. It is inversely proportional to the T4 concentration present in the sample. When the VIDAS T4 (T4) is completed, the results are analyzed automatically by the instrument, and a report is printed for each sample.
The assay principle combines an enzyme immunoassay competition method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®), serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. The sample is taken and transferred into the well containing the conjugate which is an alkaline phosphatase-labeled testosterone derivative. The testosterone present in the testosterone derivative in the conjugate compete for the antitestosterone specific antibody sites coated to the inner surface of the SPR. Unbound components are eliminated during the washing steps. During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is inversely proportional to the concentration of testosterone present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
The VIDAS TSH (TSH) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR®), serves as a solid phase for the assay as well as a pipetting device. The SPR is coated at the time of manufacture with mouse monoclonal anti-TSH antibodies. The VIDAS TSH (TSH) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing anti-TSH antibody conjugated with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR and the TSH will bind to antibodies coated on the SPR and to the conjugate forming a "sandwich". Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is cycled through the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4methylumbelliferone. The intensity of fluorescence is measured by the optical scanner in the instrument ; it is proportional to the TSH concentration present in the sample.
When the VIDAS TSH (TSH) assay is completed, the results are analyzed automatically by the instrument, and a report is printed for each sample.
The VIDAS D-Dimer Exclusion II (DEXII) assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. The SPR is coated at the time of manufacture with anti-Fibrin degradation product (FbDP) monoclonal antibodies. The VIDAS D-Dimer Exclusion II assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing an alkaline phosphataselabeled anti-FbDP monoclonal antibody. The sample/conjugate mixture is cycled in and out of the SPR and the antibodies coated on the SPR and to the conjugate forming a "sandwich". Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is cycled through the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The intensity of fluorescence is measured by the optical scanner in the instrument; it is proportional to the D-Dimer concentration present in the sample. When the VIDAS D-Dimer Exclusion II assay is completed, the results are analyzed automatically by the instrument, and a report is printed for each sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult symptomatic population (for VIDAS H. pylori IgG)
Intended User / Care Setting
Trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).
Professional use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Method Comparison (VIDAS H. pylori IgG): 250 serum samples including positive, equivocal and negative samples were used, and results were evaluated according to CLSI EP12-A2 quideline "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline".
Method Comparison (VIDAS Lyme IgG II): 220 serum samples including positive and negative samples were used, and results were evaluated according to CLSI EP12-A2 guideline "User Protocol for Evaluation of Qualitative Test Performance; Approved quideline".
Method Comparison (VIDAS RUB IgG - Quantitative): 112 serum samples (ranging from 0 to 225 IU/mL) were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS RUB IgG - Qualitative): 220 serum samples including positive, equivocal and negative samples were used, and results were evaluated according to CLSI EP12-A2 quideline "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline".
Method Comparison (VIDAS TOXO IgM): 198 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS HCG): 113 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS T4): 105 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS Testosterone): 172 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS TSH): 179 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Method Comparison (VIDAS D-Dimer Exclusion II): 219 plasma samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples".
Precision studies for various assays: Serum/plasma samples (number varies per assay, generally N=72 or N=108) were tested in triplicates or duplicates, twice a day, over 6 days on 1 reagent lot using 3 instruments at 1 site. Evaluated according to CLSI EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods" and CLSI EP12-A2 "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline - Second Edition".
Linearity studies for various assays: Sample pools were serially diluted (number of samples varies per assay) and tested in triplicate to evaluate linearity according to CLSI EP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach".
Detection Limits studies for various assays:
For LoB determination: 6 blank samples were each tested in 4 replicates in a single run per day for 4 days with 1 VIDAS 3 instrument and 2 assay lots.
For LoD/LoQ determinations: 6 low-level samples were each tested in 6 replicates, 2 runs per day, for 5 days, with 1 VIDAS 3 instrument and 2 assay lots.
Evaluated per CLSI EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline, Second Edition".
Assay Performance Testing using a CDC Panel (VIDAS RUB IgG):
CDC low-titer rubella antibody standard: Vials of CDC low-titer reference standard were reconstituted water as preconized by CDC and then pooled as MSN (Master Stock Neat). A ½ dilution solution was prepared. Both neat and 1/2 dilutions were tested in triplicate in the same run on VIDAS and VIDAS 3 instruments using the same VIDAS RUB IgG reagent lot.
CDC reference panel: 100 specimens, 50 pairs of sera titered by Hemagglutination Inhibition (9 negative sera resulting in 18 negative specimens and 41 positive sera resulting in 82 positive specimens). A single replicate of each of the 100 CDC reference panel samples was tested on VIDAS and VIDAS 3 instruments using the same VIDAS RUB IgG reagent lot.
Carry-over (VIDAS HCG): One high HCG positive sample was tested with one HCG batch analyte negative sample and one carry-over analyte negative sample during 7 runs on 3 VIDAS 3 instruments until 84 replicates of each sample was obtained.
Dilution (VIDAS HCG): Four samples (human serum pool) with approximate HCG concentrations of 6 000, 25 000, 75 000, and 150 000 mUllmL, were tested on two VIDAS 3 systems using an automated dilution sequence and a manual dilution sequence. For automated dilutions, eleven (11) dilution levels ranging from 1/1 to 1/1000 were tested per sample. For manual dilutions, two dilution levels were defined and tested per sample.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison (VIDAS H. pylori IgG):
Study type: Method Comparison, qualitative.
Sample size: 250 serum samples.
Results:
Contingency Table:
VIDAS 3 Positive, VIDAS Positive: 122
VIDAS 3 Equivocal, VIDAS Equivocal: 6
VIDAS 3 Negative, VIDAS Negative: 113
Percent Agreement: Negative 96.6% [91.5 ; 98.7] %, Positive 100% [96.9 ; 100.0] %
Precision (VIDAS H. pylori IgG):
Study type: Precision.
Sample size: 3 serum samples (N=108 for each).
Results: Repeatability (Within-RUN CV%) ranged from 5.2% to 7.7%, Total Between-CALIBRATION CV% ranged from 6.4% to 9.8%, Total Between-INSTRUMENT CV% ranged from 6.8% to 10.1%.
Method Comparison (VIDAS Lyme IgG II):
Study type: Method Comparison, qualitative.
Sample size: 220 serum samples.
Results:
Contingency Table:
VIDAS 3 Positive, VIDAS Positive: 109
VIDAS 3 Negative, VIDAS Negative: 110
Percent Agreement: Positive 99.09% [95.04;99.98] %, Negative 100.00% [96.70;100.00] %.
Precision (VIDAS Lyme IgG II):
Study type: Precision.
Sample size: 3 serum samples (N=108 for each).
Results: Within-run CV% ranged from 3.4% to 5.4%, Total Between CV% ranged from 6.2% to 8.2%.
Method Comparison (VIDAS RUB IgG):
Study type: Method Comparison, quantitative and qualitative.
Sample size: 112 serum samples (quantitative), 220 serum samples (qualitative).
Results (Quantitative):
Weighted Deming: Slope 0.9791, Intercept -0.2245, Correlation coefficient 0.9776.
Passing Bablock: Slope 1.00, Intercept 0.00, Correlation coefficient 0.9821.
Results (Qualitative):
Contingency Table:
VIDAS 3 Positive, VIDAS Positive: 111
VIDAS 3 Equivocal, VIDAS Equivocal: 8
VIDAS 3 Negative, VIDAS Negative: 96
Percent Agreement: Negative 99% [94.4;99.8] %, Positive 97.4% [92.5;99.1] %.
Precision (VIDAS RUB IgG):
Study type: Precision.
Sample size: 5 serum samples (N=72 for each).
Results: Within-RUN CV% ranged from 5.7% to 15.2%, Total Between-CALIBRATION/INSTRUMENT CV% ranged from 6.5% to 18.9%.
Linearity (VIDAS RUB IgG):
Study type: Linearity.
Measured range: 0 - 250 IU/mL.
Key results: The VIDAS RUB IgGa assay on VIDAS 3 is linear across the measuring range.
Detection Limits (VIDAS RUB IgG):
Study type: Detection Limits.
Key results: LoB = 0.389 IU/mL; LoD = 0.595 IU/mL; LoQ = 0.608 IU/mL.
Assay Performance Testing using a CDC Panel (VIDAS RUB IgG):
Study type: Reference panel testing.
Results (CDC low-titer standard): For VIDAS 3, mean values were -11.0% (neat) and -11.4% (1/2 dilution) compared to theoretical concentration. For VIDAS, mean values were -15.7% (neat) and -7.6% (1/2 dilution).
Results (CDC reference panel): The VIDAS RUB IgG (RBG) assay identified 80/82 (97.6%) positive tests on 82 positive sera and 18/18 (100%) negative tests on 18 negative sera.
Method Comparison (VIDAS TOXO IgM):
Study type: Method Comparison, qualitative.
Sample size: 198 serum samples.
Results:
Contingency table:
VIDAS 3 Positive, VIDAS Positive: 93
VIDAS 3 Equivocal, VIDAS Equivocal: 6 (symbol ্ব)
VIDAS 3 Negative, VIDAS Negative: 98 (symbol রিক)
Percent Agreement: Negative 100% [96.2;100.0] %, Positive 96.9% [91.2;98.9] %.
Precision (VIDAS TOXO IgM):
Study type: Precision.
Sample size: 4 serum samples (N=108 for each).
Results: Within-RUN CV% ranged from 2.7% to 3.0%, Total Between-CALIBRATION CV% ranged from 2.9% to 3.9%, Total Between-INSTRUMENT CV% ranged from 3.1% to 3.9%.
Method Comparison (VIDAS HCG):
Study type: Method Comparison, quantitative.
Sample size: 113 serum samples.
Results: Weighted Deming: Slope 0.9265 [0.9043, 0.9488], Intercept 0.0828 [-0.1242, 0.2898], Correlation coefficient 0.9848 [0.9779, 0.9895].
Precision (VIDAS HCG):
Study type: Precision.
Sample size: 6 serum samples (N=72 for each).
Results: Within-RUN CV% ranged from 4.0% to 6.7%, Total Between-CALIBRATION CV% ranged from 4.8% to 7.5%, Total Between-INSTRUMENT CV% ranged from 4.8% to 7.6%.
Linearity (VIDAS HCG):
Study type: Linearity.
Measured range: 2 - 1500 mIU/mL.
Key results: The VIDAS HCG assay on VIDAS 3 is linear across the measuring range.
Detection Limits (VIDAS HCG):
Study type: Detection Limits.
Key results: LoB = 0.242 mlU/mL; LoD = 0.571 mlU/mL; LoQ = 1.280 mlU/mL.
Carry-over (VIDAS HCG):
Study type: Carry-over.
Key results: Average carry-over observed on VIDAS 3 compared to a
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOMERIEUX JOHN ALBRIGHT REGULATORY AFFAIRS MANAGER 595 ANGLUM ROAD HAZELWOOD MO 63042-2320
July 9, 2015
Re: K141133
Trade/Device Name: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR, JJE, LSR, LFX, LGD, DHA, KLI, CDZ, JLW, DAP Dated: June 15, 2015 Received: June 16, 2015
Dear Mr. Albright:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141133
Device Name
VIDAS H. pylori IgG, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO IgM, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
Indications for Use (Describe)
For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
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This device is an in vitro diagnostic medical device for professional use only.
For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.
For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELF A technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.
For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle with a half-moon design on the left side. A green and yellow line runs vertically through the center of the circle. The word "BIOMÉ" is written in black, sans-serif font above the word "RIEUX".
510(k) SUMMARY
According to the 21 CFR 807.92, this 510(k) summary aims to provide an understanding of the basis for a determination of substantial equivalence.
Assigned 510(k) number: K141133
A1. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B1. Device Name
| Trade Name: | VIDAS® H.pylori IgG |
|---|---|
| Common Name: | H.pylori IgG |
| Classification name: | Campylobacter fetus serological reagents |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3110 |
| Device Classification: | Class I |
| Product code: | LYR |
C1. Predicate Device
VIDAS H.pylori IgG (K001460)
D1. Device Description
The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). All of the assay steps as well as the assay temperature are controlled automatically by the instrument. The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. After preliminary wash and sample dilution steps, the sample is cycled in and out of the SPR for a specified length of time. IgG antibodies to H. pylori present in the specimen will bind to the H. pylori antigen coating the interior of the SPR. Unbound sample components are washed away.
Anti-human IgG antibodies conjugated with alkaline phosphatase are cycled in and out of the SPR and will attach to any human IgG bound to the SPR wall. A final wash step removes unbound anti-human antibody conjugate. During the final detection step, the substrate (4 Methylumbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a
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fluorescent product (4-Methylumbelliferone), the fluorescence of which is measured at 450 nm. The intensity of fluorescence is measured by the optical scanner in the instrument. At the assay, results are automatically calculated by the instrument, a test value is generated and a report is printed for each sample.
E1. Intended Use
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.
F1. Technological Performances Summary
A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.
| Item | New Device
VIDAS H. pylori | Predicate (K001460)
VIDAS H. pylori |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | VIDAS® H. pylori IgG (HPY) is an automated
qualitative test for use on the instruments of the
VIDAS family, for the detection of anti-Helicobacter
pylori IgG antibodies in human serum or plasma
(EDTA) using the ELFA technique (Enzyme Linked
Fluorescent Assay). The VIDAS HPY assay is
intended as an aid in diagnosis of H. pylori infection
in an adult symptomatic population. | Same |
| Sample type | Serum or plasma | Same |
| Analyte | H.pylori IgG | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay (ELFA) | Same |
| Kit Composition | 30 Strips, 1x30 SPRs, 1 Standard (liquid), 1 Positive
Control (liquid), 1 Negative Control (liquid) | Same
(no change to assay). |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |
G1. Performance Data
Method Comparison
A study was conducted to verify the correlation of the VIDAS H. pylori IgG assay on the VIDAS 3 to the VIDAS H. pylori lgG assay on the VIDAS. One reagent lot, one of each instrument and 250 serum samples including positive, equivocal and negative samples were used, and results were evaluated according to CLSI EP12-A2 quideline "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline".
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Contingency Table:
| VIDAS | |||||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | ||
| VIDAS 3 | Positive | 122 | 3 | 0 | 125 |
| Equivocal | 0 | 6 | 4 | 10 | |
| Negative | 0 | 2 | 113 | 115 | |
| Total | 122 | 11 | 117 | 250 |
Associated percent agreements and their 95% two-sided score confidence intervals (CI) are calculated in the table below :
| Category | Samples of
interest/Total | Percent Agreement
2-sided 95% CI |
|----------|------------------------------|-------------------------------------|
| Negative | 113/117 | 96.6%
[ 91.5 ; 98.7 ] % |
| Positive | 122/122 | 100%
[ 96.9 ; 100.0 ] % |
Precision
Three serum samples with samples close to the assay cut-off and moderate positive samples were tested in triplicate (3 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 108). The repeatability (within-run precision), between-day, between calibration, between instrument, total between calibration, and total between instrument precision were calculated according to CLSI EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods" and CLSI EP12-A2 "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline - Second Edition". The results were as follows:
| | Sample 1
N = 108
Mean Test Value (TV)
0.76 | | Sample 2
N = 108
Mean Test Value (TV)
1.26 | | Sample 3
N = 108
Mean Test Value (TV)
2.23 | |
|-------------------------------|-----------------------------------------------------|--------|-----------------------------------------------------|--------|-----------------------------------------------------|--------|
| | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Within-RUN
(Repeatability) | 0.06 | 7.7 | 0.08 | 6.2 | 0.12 | 5.2 |
| Between-RUN | 0.04 | 5.7 | 0.04 | 3.0 | 0.04 | 1.7 |
| Between-DAY | 0.00 | 0.0 | 0.00 | 0.0 | 0.05 | 2.4 |
| Between-
CALIBRATION | 0.01 | 2.0 | 0.03 | 2.0 | 0.05 | 2.1 |
| Between-
INSTRUMENT | 0.02 | 2.4 | 0.00 | 0.0 | 0.05 | 2.3 |
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| Sample 1 | Sample 2 | Sample 3 | ||||
|---|---|---|---|---|---|---|
| N = 108 | N = 108 | N = 108 | ||||
| Mean Test Value (TV) | ||||||
| 0.76 | Mean Test Value (TV) | |||||
| 1.26 | Mean Test Value (TV) | |||||
| 2.23 | ||||||
| SD | CV (%) | SD | CV (%) | SD | CV (%) | |
| Total Between- | ||||||
| CALIBRATION | 0.07 | 9.8 | 0.09 | 7.2 | 0.14 | 6.4 |
| Total Between- | ||||||
| INSTRUMENT | 0.08 | 10.1 | 0.09 | 7.2 | 0.15 | 6.8 |
H1. Conclusion
The results for the performance testing submitted in this premarket notification are complete and demonstrate that the VIDAS H.pylori Assay is substantially equivalent to the predicate device identified in Item C1 of this summary. The addition of the VIDAS 3 instrument to the VIDAS Family does not affect the safety and effectiveness of the Reagent kit.
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A2. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B2. Device Name
| Trade Name: | VIDAS® 3 |
|---|---|
| Common Name: | VIDAS 3 |
| Classification name: | Analyzer, chemistry (photometric, discrete), for clinical use |
| Classification panel: | Clinical Chemistry |
| Governing Regulation: | 21 CFR 862.2160 |
| Device Classification: | Class I |
| Product code: | JJE |
C2. Predicate Device Name
Trade Name:
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
D2. Device Description
The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.
The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.
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E2. Intended Use
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).
This device is an in vitro diagnostic medical device for professional use only.
F2. Technological Performances Summary
| Component | New Device
VIDAS 3 | Predicate (K891385)
VIDAS Instrument |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | VIDAS 3 | VIDAS |
| Indications for
Use | The VIDAS 3 system is a complete standalone
immunodiagnostic system intended for trained
and qualified laboratory technicians (daily
routine use) and laboratory administrators
(application configuration).
This device is an in vitro diagnostic medical
device for professional use only. | The VIDAS® is a compact automated
multiparametric immunoanalyzer that
using predispensed disposable reagent
strips and specially coated Solid Phase
Receptacles (SPRs), can pipette, mix,
incubate, control and analyze samples
for in vitro diagnostic purposes.
The VIDAS is only dedicated to be used
in combination with VIDAS reagents
range, designed and produced by
bioMérieux.
The technology used, which is
adaptable to a wide range of assays,
combines the EIA method with a final
fluorescence reading: this technology is
known as ELFA (Enzyme Linked
Fluorescent Assay). The enzyme used
in the VIDAS product range is alkaline
phosphatase, which catalyzes the
hydrolysis of the substrate 4-methyl
umbelliferyl phosphate (4-MUP) into a
fluorescent product 4-methyl
umbelliferone (4-MU) the fluorescence
of which is measured at 450nm.
The immunological methods are either
indirect EIA, immunocapture, sandwich
or competition, all involving a conjugate
using the alkaline phosphatase.
This device is an in vitro diagnostic
medical device for professional use
only. |
| Technology | Automated multiparametric immunoassay
system which uses ELFA (Enzyme Linked
Fluorescent Assay) technology. | Same |
| # Sections | 4 | 5 |
| Reagent slots
per section | 3 | 6 |
| Component | New Device
VIDAS 3 | Predicate (K891385)
VIDAS Instrument |
| Total # samples
that can be run
simultaneously | 12 | 30 |
| Monitor | Peripheral (Attached) | Peripheral |
| Computer | Peripheral | Peripheral |
| Keyboard | Peripheral | Peripheral |
| Printer | Peripheral | Peripheral |
| Instrument
Components | All unique or updated components are verified
to not affect reagent performance. | All unique or updated components are
verified to not affect reagent
performance. |
| Components
(Scanner head) | The scanner head is an instrument sub-system
that's primary function is to perform the optical
reading of the fluorescence as generated by the
immunoassay reaction. | Same |
| Components
(Software) | The user Software functions include: entry of
patient data; run execution; data reduction and
interpretation through a computation engine;
edition of results; system supervision;
management of calibrations and controls;
validation of results; management of patient
records. | While the VIDAS 3 software is unique
to the VIDAS 3, it offers the same basic
functions as the VIDAS software and
uses the same computation engine. |
| Components
(Reagents) | VIDAS reagents are comprised of predispensed
disposable reagent strips and specially coated
Solid Phase Receptacles (SPRs). | Same |
| Reagent
(Principle of
Operation) | Each VIDAS assay has been designed to be
run on any of the three VIDAS family
instruments. Each assay has a unique protocol
(volumes, sequence of steps, incubation times,
etc) that is independent of the instrument. | Same |
| Reagent | The assay intended use, clinical utility, principle
of operation, kit composition, kit stability, kit
storage conditions, calibration type, calibration
frequency, sample type, sample volume,
calculation of results, and interpretation of
results are all independent of the instrument. | Same |
| Reagent Loading | Manual | Same |
| SPR/Strip
synchronization | Automated confirmation | Manual |
| Sample Pipetting | Manual or automated | Manual |
| Sample dilutions | Manual or automated | Manual |
| Execution of the
assay protocol | Each assay has its own pre-defined protocol
that defines the sequence of assay steps (e.g.
volumes, incubation times, order of steps). | Same |
| Enzymatic
Reading | The reading made by the scanner head is
based on the 4-methylumbelliferone (4-MU)
fluorescent product located in the optical
cuvette of the reagent strip after the enzymatic
reaction has occurred. | Same |
| Component | New Device
VIDAS 3 | Predicate (K891385)
VIDAS Instrument |
| Calculation and
Interpretation of
results | Data reduction of the fluorescence
measurement is based upon computation
engine and a knowledge base including assay
and lot specific information. | Same |
| Unload Strips /
SPRs | After completion of the run, the user manually
removes the reagent Strips and SPRs. | Same |
| Unload other
reagents and
waste | Manual | Not applicable |
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G2. Performance Data
The VIDAS 3 performance testing was demonstrated through assay performance testing, using VIDAS D-Dimer Exclusion II, VIDAS H. pylori, VIDAS Human Chorionic Gonadotropin, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS T4, VIDAS Testosterone, VIDAS TOXO M, and VIDAS TSH assays as the representative assays. This assay performance testing, which included method comparison, precision, detection limits, and linearity, demonstrated equivalency of the VIDAS 3 to the VIDAS and that running a VIDAS assay on either the VIDAS instrument or the VIDAS 3 instrument has no significant impact on the assay results.
H2. Conclusion
The results for the performance testing submitted in this premarket notification are complete and demonstrate that the VIDAS 3 is substantially equivalent to the predicate device identified in Item C2 of this summary.
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A3. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B3. Device Name
| Trade Name: | VIDAS® Lyme IgG II |
|---|---|
| Common Name: | Lyme IgG |
| Classification name: | Treponema pallidum treponemal test reagent |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3830 |
| Device Classification: | Class II |
| Product code: | LSR |
C3. Predicate Device
VIDAS® Lyme IgG (K122986)
D3. Device Description
The VIDAS Lyme IgG II assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA) (see User's Manual). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. After a preliminary wash step and a sample dilution step, the antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi specific recombinant proteins coating the interior of the SPR.
Unbound sample components are washed away. Antihuman IgG antibodies conjugated with alkaline phosphatase, will attach to the immunocomplex bound to the SPR wall.
A final wash step removes unbound conjugate. During the final detection step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methylumbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of anti-B. burgdorferi IgG antibody present in the sample.
At the end of the VIDAS Lyme IgG II assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
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E3. Intended Use
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi.
This device is an in vitro diagnostic medical device for professional use only.
F3. Technological Performances Summary
A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.
| Item | New Device
VIDAS Lyme IgG II | Predicate (K122986)
VIDAS Lyme IgG |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | The VIDAS Lyme IgG II (LYG) assay is an
automated qualitative enzyme immunoassay
intended for use on the instruments of the VIDAS
family in the presumptive detection of human IgG
antibodies to Borrelia burgdorferi in human serum
(plain or separation gel) or plasma (sodium
heparin or lithium heparin). It should be used to
test patients with a history and/or symptoms of
infection with B. burgdorferi. All VIDAS Lyme IgG
II positive specimens should be further tested
with a Western Blot IgG assay to obtain
supportive evidence of infection with B.
burgdorferi. | Same |
| Sample type | Serum or plasma | Same |
| Analyte | Lyme IgG | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay (ELFA) | Same |
| Kit Composition | 60 Strips, 2x30 SPRs, 1 Calibrator (liquid), 1
Control (liquid) | Same |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |
G3. Performance Data
Method Comparison
A study was conducted to verify the correlation of the VIDAS Lyme IgG II assay on the VIDAS 3 to the VIDAS Lyme IgG II assay on the VIDAS. One reagent lot, one of each instrument and 220 serum samples including positive and negative samples were used, and results were evaluated according to CLSI EP12-A2 guideline "User Protocol for Evaluation of Qualitative Test Performance; Approved quideline".
14
Image /page/14/Picture/1 description: The image shows the logo for bioMérieux. The logo features the company name in a sans-serif font, with the letters spaced out. Above the name is a blue globe-like design with curved lines, bisected by a green and yellow curved line that extends upwards.
Contingency Table
| VIDAS | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| VIDAS 3 | Positive | 109 | 0 | 109 |
| Negative | 1 | 110 | 111 | |
| Total | 110 | 110 | 220 |
Associated percent agreements and their 95% two-sided score confidence intervals are presented in the table below:
| Category | Samples of Interest/Total | Percent Agreement with 2-sided 95% CI |
|---|---|---|
| Positive | 109/110 | 99.09% |
| [95.04;99.98] % | ||
| Negative | 110/110 | 100.00% |
| [96.70;100.00] % |
Precision - VIDAS 3
Three serum samples were tested in triplicate (3 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 108). The results were calculated according to CLSI EP5-A2 and were as follows:
| Panel Member | N | Mean Index | Within-run | | Between-run | | Between-day | | Total
Between | |
|--------------|-----|------------|------------|--------|-------------|--------|-------------|--------|------------------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Sample 1 | 108 | 0.17 | 0.01 | 5.4 | 0.00 | 0.0 | 0.00 | 1.8 | 0.01 | 8.2 |
| l Sample 2 | 108 | 0.23 | 0.01 | 4.0 | 0.00 | 0.9 | 0.00 | 1.0 | 0.02 | 6.9 |
| Sample 3 | 108 | 0.64 | 0.02 | 3.4 | 0.00 | 0.0 | 0.00 | 0.0 | 0.04 | 6.2 |
H3. Conclusion
The results for the performance testing submitted in this premarket notification are complete and demonstrate that the VIDAS Lyme IgG II Assay when used on VIDAS 3 instrument is substantially equivalent to the predicate device identified in Item C3 of this summary. The addition of the VIDAS 3 instrument to the VIDAS Family does not affect the safety and effectiveness of the Reagent kit.
15
Image /page/15/Picture/0 description: The image contains the logo for BIOMÉRIEUX. The logo features a blue globe-like symbol with curved lines on the top half and a green line running vertically through the center. Below the symbol, the company name "BIOMÉRIEUX" is written in capital letters with a sans-serif font.
A4. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B4. Device Name
| Trade Name: | VIDAS® RUB IgG |
|---|---|
| Common Name: | Anti-Rubella IgG |
| Classification name: | Rubella virus serological reagents |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3510 |
| Device Classification: | Class II |
| Product code: | LFX |
C4. Predicate Device
VIDAS® RUB IgG (K080766)
D4. Device Description
The VIDAS® RUB IqG (RBG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that consists of a two step enzyme immunoassay sandwich method and a fluorescent detection. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR®), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and are provided in sealed reagent strips. All assay steps are automated by the instrument. The assay reactions take place by pipetting up and down with the SPR through the wells of the reagent strip. The sample is initially diluted, and follows a first incubation step in the SPR, where anti-Rubella IgG antibodies present in the sample bind to the rubella antigen coating the interior of the SPR. After a wash step to eliminate any unbound component, a second incubation is performed using a monoclonal anti-human IgG alkaline phosphatase conjugate. Following another wash step, the detection substrate (4-methyl-umbellifery) phosphate) is added to the SPR.
The enzyme conjugate catalyzes the hydrolysis of the substrate into a fluorescent product (4-methylumbelliferone), and its fluorescence is measured by the intensity of the fluorescence is proportional to the concentration of rubella antibodies present in the sample. Results are automatically determined by the instrument based on the stored calibration curve and according to the CLSI® I/LA6-A recommended cut-off of 10 IU/mL. The assay is calibrated against the WHO 1st International Standard for anti Rubella Immunoglobulin, Human (1997).
16
Image /page/16/Picture/0 description: The image contains the logo for bioMérieux. The logo features a blue circle with a half-moon design on the left side. A green and yellow curved line runs vertically through the center of the circle. The word "BIOMÉRIEUX" is written in a sans-serif font below the circle.
E4. Intended Use
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.
F4. Technological Performances Summary
A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.
| Item | New Device
VIDAS RUB IgG | Predicate (K080766)
VIDAS RUB IgG |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Intended Use | The VIDAS® RUB IgG (RBG) assay uses Enzyme
Linked Fluorescent Assay (ELFA) technology on
the instruments of the VIDAS family for the in vitro
quantitative and qualitative measurement of IgG
antibodies to rubella virus in human serum. The
VIDAS® RUB IgG (RBG) assay is intended as an
aid in the determination of immune status to rubella.
The performance of this device has not been
established for screening of cord blood, or for
neonatal
samples. Likewise, performance
characteristics of the assay have not been
established for immunocompromised or
immunosuppressed individuals | Same |
| Sample type | Serum | Same |
| Analyte | Anti-Rubella IgG | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay (ELFA) | Same |
| Kit Composition | 60 Strips, 2x30 SPRs, 1 Calibrator (liquid), 1
Positive Control (liquid), 1 Negative Control (liquid) | Same
(no change to assay). |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |
17
Image /page/17/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized globe above it. A green and yellow line bisects the globe vertically.
G4. Performance Data
Method Comparison - Quantitative
A study was conducted to verify the correlation of the VIDAS RUB IgG assay on the VIDAS 3 to the VIDAS RUB IgG assay on the VIDAS. One reagent lot, one of each instrument and 112 serum samples (ranging from 0 to 225 IU/mL) were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples". The results were as follows:
| Analysis | N | Slope | Intercept | Correlation
coefficient |
|-----------------|-------|--------|-----------|----------------------------|
| Weighted Deming | 91* | 0.9791 | -0.2245 | 0.9776 |
| Passing Bablock | 112 | 1.00 | 0.00 | 0.9821 |
| Weighted Deming | 89** | 0.9640 | -0.2343 | 0.9805 |
| Passing Bablock | 111** | 1.00 | 0.00 | 0.9840 |
- 21 samples had an average concentration equal to zero for VIDAS 3 and/or VIDAS, and were excluded from the Weighted Deming analysis.
** After removal of outliers.
Method Comparison - Qualitative
A study was conducted to verify the correlation of the VIDAS RUB IgG assay on the VIDAS 3 to the VIDAS RUB IgG assay on the VIDAS. One reagent lot, one of each instrument and 220 serum samples including positive, equivocal and negative samples were used, and results were evaluated according to CLSI EP12-A2 quideline "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline".
Contingency Table:
| VIDAS | |||||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | ||
| VIDAS 3 | Positive | 111 | 0 | 0 | 111 |
| Equivocal | 3 | 8 | 1 | 12 | |
| Negative | 0 | 1 | 96 | 97 | |
| Total | 114 | 9 | 97 | 220 |
Associated percent agreements and their 95% two-sided exact confidence interval are calculated in the table below:
| Category | Samples of
interest/Total | Percent Agreement 2-
sided 95% CI |
|----------|------------------------------|--------------------------------------|
| Negative | 96/97 | 99%
[94.4;99.8] % |
| Positive | 111/114 | 97.4%
[92.5;99.1] % |
18
Image /page/18/Picture/1 description: The image shows the logo for bioMérieux. The logo features the company name in a sans-serif font, with the "bio" portion in a darker, bolder font. Above the name is a blue globe-like graphic with curved lines, bisected by a green line that extends upward like a plant stem.
Precision
Five serum samples (with 2 samples close to the clinical decision points) were tested in duplicate (2 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 72). The repeatability (within-run precision), between-day, between calibration, between instrument, total between calibration, and total between instrument precision were calculated according to CLSI EP5-A2. "Evaluation of Precision Performance of Quantitative Measurement Methods". The results were as follows:
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N = 72 | N = 72 | N = 72 | N = 72 | N = 72 | ||||||
| Mean (IU/mL) | Mean (IU/mL) | Mean (IU/mL) | Mean (IU/mL) | Mean (IU/mL) | ||||||
| 2.69 | 5.81 | 12.82 | 28.93 | 132.88 | ||||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Within-RUN | ||||||||||
| (Repeatability) | 0.41 | 15.2 | 0.55 | ರಿ.5 | 0.74 | 5.7 | 2.39 | 8.3 | 10.24 | 7.7 |
| Between-RUN | 0.29 | 10.7 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
| Between-DAY | 0.00 | 0.0 | 0.00 | 0.0 | 0.19 | 1.5 | 0.43 | 1.5 | 0.00 | 0.0 |
| Between- | ||||||||||
| CALIBRATION | 0.00 | 0.0 | 0.10 | 1.8 | 0.33 | 2.6 | 0.75 | 2.6 | 5.25 | 4.0 |
| Between- | ||||||||||
| INSTRUMENT | 0.09 | 3.5 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
| Total Between- | ||||||||||
| CALIBRATION | 0.50 | 18.6 | 0.56 | 9.7 | 0.83 | 6.5 | 2.54 | 8.8 | 11.51 | 8.7 |
| Total Between- | ||||||||||
| INSTRUMENT | 0.51 | 18.9 | 0.56 | 9.7 | 0.83 | 6.5 | 2.54 | 8.8 | 11.51 | 8.7 |
Linearity
Two sample pools (VNH1 and VNH2) were serially diluted into a total of 11 samples and tested in triplicate in order to evaluate the linearity according to CLSI EP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach". The VIDAS RUB IgGa assay on VIDAS 3 is linear across the measuring range 0 - 250 IU/mL.
Image /page/18/Figure/7 description: The figure is a scatter plot titled "VN H1" that shows the observed concentration of RBG (IU/mL) on the y-axis versus the expected concentration of RBG (IU/mL) on the x-axis. The plot includes data points for observed concentrations, observed concentration means, a straight regression line, and a third-order polynomial. The x and y axis range from 0 to 40, and the data points appear to follow a linear trend.
19
Image /page/19/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a stylized font, with the "bio" part in a larger font size than the "Mérieux" part. Above the company name is a blue globe-like symbol with curved lines, and a green line that extends from the top of the globe down through the middle of the logo.
Image /page/19/Figure/2 description: The image is a scatter plot showing the relationship between the expected concentration and observed concentration of RBG in IU/mL. The x-axis represents the expected concentration of RBG, ranging from 0 to 300 IU/mL. The y-axis represents the observed concentration of RBG, ranging from 0 to 400 IU/mL. The plot includes data points representing observed concentrations, with a straight regression line indicating the trend between the two variables.
Detection Limits
The detection limits of the VIDAS RUB IgG assay on the VIDAS 3 were evaluated per CLSI EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline, Second Edition''. For LoB determination, 6 blank samples were each tested in 4 replicates in a single run per day for 4 days with 1 VIDAS 3 instrument and 2 assay lots. For LoD/LoQ determinations, 6 low-level samples were each tested in 6 replicates, 2 runs per day, for 5 days, with 1 VIDAS 3 instrument and 2 assay lots. The LoB, LoD and LoQ determinations were based consequently on 912 results, including 192 results from blank samples and 720 results from low-level samples both assay lots combined. The LoB, LoD, LoQ of the VIDAS RUB IgG assay on the VIDAS 3 are as follows: LoB = 0.389 IU/mL; LoD = 0.595 IU/mL; LoQ = 0.608 IU/mL.
Assay Performance Testing using a CDC Panel
A CDC low-titer rubella antibody standard and a CDC reference panel (CDC RUB IgG serum panel) was tested using the VIDAS RUB IgG assay on the VIDAS 3 system and on the VIDAS system.
CDC low-titer rubella antibody standard results:
Vials of CDC low-titer reference standard were reconstituted water as preconized by CDC and then pooled as MSN (Master Stock Neat). According to the CDC information, the theoretical dose of the neat solution was 21 IU/mL. A ½ dilution solution was then prepared from the MSN solution and had an expected dose at 10.5 IU/mL.
The neat and 1/2 dilutions solutions of the CDC low titer standard (MSN & MS1/2 solutions) were then tested in triplicate in the same run on the VIDAS and the VIDAS 3 instruments using the same VIDAS RUB IgG reagent lot.
The mean result (IU/mL) obtained with the neat and 1/2 dilutions of the CDC low-titer standard and the difference in % compared to the theoretical/expected concentration of CDC low-titer standard were calculated for the VIDAS and the VIDAS 3:
- for VIDAS 3, the mean value of the neat and ½ dilution were respectively -11.0% and -11.4% compared to the theoretical concentration.
- for VIDAS, the mean value of the neat and ½ dilution were respectively -15.7% and -7.6% compared to the theoretical concentration.
20
Image /page/20/Picture/0 description: The image contains the logo for bioMérieux. The logo features the company name in a sans-serif font, with the "bio" portion in a darker shade. Above the name is a circular graphic with blue lines on the left side and a green line that curves through the center. The overall design is clean and corporate.
CDC reference panel testing, data analysis and results:
The CDC reference panel consisted of 100 specimens, 50 pairs of sera titered by Hemagglutination Inhibition (9 negative sera resulting in 18 negative specimens and 41 positive sera resulting in 82 positive specimens). A single replicate of each of the 100 CDC reference panel samples was tested on the VIDAS and the VIDAS 3 instruments using the same VIDAS RUB IgG reagent lot.
The number of positive and negative sera detected are identical between VIDAS 3 systems: The VIDAS RUB IgG (RBG) assay identified 80/82 (97.6%) positive tests on 82 positive sera and 18/18 (100%) negative tests on 18 negative sera. One of the pairs of HI positive sera was reported as VIDAS equivocal (both results).
21
Image /page/21/Picture/0 description: The image contains the logo for bioMérieux. The logo features a blue and white globe-like symbol with vertical lines, bisected by a green and yellow line. Below the symbol, the company name "BIOMÉRIEUX" is written in a simple, sans-serif font, with each letter separated by a space.
A5. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B5. Device Name
| Trade Name: | VIDAS® TOXO M |
|---|---|
| Common Name: | Anti-TOXO IgM |
| Classification name: | Toxoplasma gondiiserological reagents |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3780 |
| Device Classification: | Class II |
| Product code: | LGD |
C5. Predicate Device
VIDAS® TOXO M (K923166)
D5. Device Description
The VIDAS TOXO IgM (TXM) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR®), serves as the solid phase as well as the pipettor for the assay. The SPR is coated with goat anti-u chain antibodies. The VIDAS TOXO IgM (TXM) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are in the sealed TXM Reagent Strips. After a sample dilution step, the sample is cycled in and out of the SPR for a specified length of time. IgM antibodies present in the specimen will bind to the anti-u chain antibodies coating the interior of the SPR. Unbound sample components are washed away. An immunocomplex of T. gondii antigen and mouse monoclonal anti-P30 antibodies conjugated with alkaline phosphatase is cycled in and out of the SPR and will attach to the human anti-T. gondii IgM bound to the SPR wall (Note: P30 is a major surface protein of the T. gondii tachyzoite, with molecular weight of 30,000 (5)). A final wash step removes unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is introduced into the SPR. Enzyme remaining on the wall of the SPR will catalyze the conversion of the fluorescent product, 4-methylumbelliferone. The intensity of the fluorescence is measured by the optical scanner in the instrument.
22
Image /page/22/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of the company name in a stylized font, with a blue sphere above it. A green and yellow line bisects the sphere and the company name. The sphere has a series of curved lines on the left side.
When the VIDAS TOXO IgM (TXM) assay is completed, the results are analyzed automatically by the instrument, a test value is generated, and a report is printed for each sample.
E5. Intended Use
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent (VITEK® immunoassay (ELFA) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening.
This device is an in vitro diagnostic medical device for professional use only.
F5. Technological Performances Summary
A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.
| Item | New Device
VIDAS TOXO IgM | Predicate (K923166)
VIDAS TOXO IgM |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | The VIDAS® TOXO IgM (TXM) assay is intended for use
on the instruments of the VIDAS family (VITEK®
ImmunoDiagnostic Assay System) as an automated
enzyme-linked fluorescent immunoassay (ELFA) for the
presumptive qualitative detection of anti-Toxoplasma
gondii IgM antibodies in human serum, as an aid in the
diagnosis of acute, recent, or reactivated Toxoplasma
gondii infection. This assay must be performed in
conjunction with an anti-Toxoplasma gondii IgG antibody
assay. VIDAS TOXO IgM (TXM) assay performance has
not been established for prenatal screening or newborn
testing. This assay has not been cleared by the FDA for
blood/plasma donor screening. | Same |
| Sample type | Serum | Same |
| Analyte | Anti-Toxo IgM | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay (ELFA) | Same |
| Kit Composition | 60 Strips, 2x30 SPRs, 1 Calibrator (liquid), 1 Control
(liquid) | Same
(no change to assay). |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |
G5. Performance Data
Method Comparison
A study was conducted to verify the correlation of the VIDAS TOXO IgM assay on the VIDAS 3 to the VIDAS TOXO IgM assay on the VIDAS. One reagent lot, one of each instrument and 198 serum
23
Image /page/23/Picture/1 description: The image shows the logo for bioMérieux. The logo features the company name in a sans-serif font, with the "BIO" portion in a bolder font. Above the name is a blue globe-like symbol with curved lines on the left side. A green line curves over the globe and extends downward, creating a visual element that suggests growth or movement.
samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples". The results were as follows:
Contingency table:
| VIDAS | |||||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | ||
| VIDAS 3 | Positive | વેરૂ | O | 0 | ત્ત્વે ઉત્પત્તર તે ઉત્પત્તર તે જે જે જે જે જે જે જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયે |
| Equivocal | 2 | ব | 0 | 6 | |
| Negative | 1 | 0 | ರಿಕ | 99 | |
| Total | 96 | র্ব | ರಿ8 | 198 |
Associated percent agreements and their 95% two-sided score confidence intervals are calculated in the table below :
| Category | Samples of interest /Total | Percent Agreement 2-sided 95% CI |
|---|---|---|
| Negative | 98/98 | 100% |
| [96.2;100.0] % | ||
| Positive | 93/96 | 96.9% |
| [91.2;98.9] % |
Precision
Four serum samples were tested in 3 replicates twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 108). The repeatability (within-run precision), between-run, between-day, between calibration, between instrument, total between calibration, and total between instrument precision were calculated according to CLSI EP5-A2. "Evaluation of Precision Performance of Quantitative Measurement Methods". The results were as follows:
| | Sample 1
N = 108 | | Sample 2
N = 108 | | Sample 3
N = 108 | | Sample 4
N = 108 | |
|-------------------------------|---------------------|-----|---------------------|-----|---------------------|-----|---------------------|-----|
| | Mean Index
0.47 | | Mean Index
0.60 | | Mean Index
0.79 | | Mean Index
1.07 | |
| | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Within-RUN
(Repeatability) | 0.01 | 3.0 | 0.02 | 3.0 | 0.02 | 2.7 | 0.03 | 2.7 |
| Between-RUN | 0.00 | 0.0 | 0.00 | 0.7 | 0.00 | 0.0 | 0.00 | 0.0 |
| Between-DAY | 0.00 | 0.0 | 0.00 | 0.5 | 0.01 | 0.9 | 0.01 | 1.1 |
| Between-
CALIBRATION | 0.01 | 2.4 | 0.00 | 0.0 | 0.01 | 0.8 | 0.00 | 0.0 |
| Between-
INSTRUMENT | 0.00 | 0.0 | 0.00 | 0.8 | 0.01 | 0.7 | 0.02 | 1.7 |
| Total Between-
CALIBRATION | 0.02 | 3.9 | 0.02 | 3.2 | 0.02 | 3.0 | 0.03 | 2.9 |
| Total Between-
INSTRUMENT | 0.02 | 3.9 | 0.02 | 3.3 | 0.02 | 3.1 | 0.04 | 3.4 |
24
A6. Owner information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |
B6. Device Name
| Trade Name: | VIDAS® Human chorionic gonadotropin |
|---|---|
| Common Name: | HCG |
| Classification name: | Human chorionic gonadotropin (HCG) test system |
| Classification panel: | Clinical Chemistry |
| Governing Regulation: | 21 CFR 862.1155 |
| Device Classification: | Class II |
| Product code: | DHA |
C6. Predicate Device
VIDAS® HCG (K921302)
D6. Device Description
The VIDAS HCG (HCG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. The SPR is coated at the time of manufacture with mouse monoclonal anti-hCG antibodies. The VIDAS HCG (HCG) assay configuration prevents nonspecific reactions with the SPR. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing anti-hCG antibody conjugated with alkaline phosphatase.
The sample/conjugate mixture is cycled in and out of the SPR and the hCG will bind to antibodies coated on the SPR and to the conjugate forming a "sandwich". Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbelliferyl phosphate, is cycled through the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The intensity of fluorescence is measured by the optical scanner in the instrument ; it is proportional to the hCG concentration present in the sample. When the VIDAS HCG (HCG) assay is completed, the results are analyzed automatically by the instrument and a report is printed for each sample.
25
Image /page/25/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle with vertical lines on the left side, resembling a globe. A green and yellow curved line runs vertically through the center of the circle. Below the circle, the word "BIOMÉRIEUX" is written in a sans-serif font.
E6. Intended Use
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.
F6. Technological Performances Summary
A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.
| Item | New Device
VIDAS HCG | Predicate (K921302)
VIDAS HCG |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VIDAS® HCG (HCG) assay is
intended for use on the instruments of the
VIDAS family as an automated quantitative
enzyme linked fluorescent immunoassay
(ELFA) for the determination of human
Chorionic Gonadotropin (hCG)
concentration in human serum or plasma
to aid in the early detection of pregnancy. | The VIDAS HCG (HCG) assay is intended
for use on the instruments of the VIDAS
family (VITEK ImmunoDiagnostic Assay
System) as an automated quantitative
enzyme linked fluorescent immunoassay
(ELFA) for the determination of human
Chorionic Gonadotropin (hCG)
concentration in human serum or plasma
for use in the early detection of pregnancy. |
| Sample type | Serum or plasma | Same |
| Analyte | HCG | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay
(ELFA) | Same |
| Kit Composition | 60 Strips, 2x30 SPRs, 1 Calibrator
(lyophilized), 1 Control (lyophilized), 1
Diluent Buffer (liquid) | Same
(no change to assay). |
| Measuring Range | 2 - 1500 mIU/mL | Same |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |
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G6. Performance Data
Method Comparison
A study was conducted to verify the correlation of the VIDAS HCG assay on the VIDAS 3 to the VIDAS HCG assay on the VIDAS. One reagent lot, one of each instrument and 113 serum samples were used, and results were evaluated according to CLSI EP9. "Method Comparison and Bias Estimation Using Patient Samples". The results, and the 95% Confidence Intervals (CI) were as follows:
| Analysis | N | Slope | Intercept | Correlation
coefficient |
|-----------------|-----|----------------------------|-----------------------------|----------------------------|
| Weighted Deming | 113 | 0.9265
[0.9043, 0.9488] | 0.0828
[-0.1242, 0.2898] | 0.9848
[0.9779, 0.9895] |
Precision
Six serum samples were tested in duplicate (2 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 72). The repeatability (within-run precision), betweenrun, between-day, between calibration, between instrument, total between calibration, and total between instrument precision were calculated according to CLSI EP5-A2. "Evaluation of Precision Performance of Quantitative Measurement Methods". The results were as follows:
| | Sample 1
N = 72 | | Sample 2
N = 72 | | Sample 3
N = 72 | | Sample 4
N = 72 | | Sample 5
N = 72 | | Sample 6
N = 72 | |
|-------------------------------|-----------------------|-----|-----------------------|-----|-----------------------|-----|------------------------|-----|-------------------------|-----|--------------------------|-----|
| | Mean (mIU/mL)
4.46 | | Mean (mIU/mL)
6.46 | | Mean (mIU/mL)
9.48 | | Mean (mIU/mL)
74.43 | | Mean (mIU/mL)
311.52 | | Mean (mIU/mL)
1109.32 | |
| | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Within-RUN
(Repeatability) | 0.30 | 6.7 | 0.35 | 5.4 | 0.41 | 4.4 | 3.16 | 4.2 | 12.48 | 4.0 | 56.36 | 5.1 |
| Between-RUN | 0.12 | 2.7 | 0.20 | 3.1 | 0.13 | 1.4 | 0.73 | 1.0 | 0.00 | 0.0 | 0.00 | 0.0 |
| Between-DAY | 0.00 | 0.0 | 0.00 | 0.0 | 0.19 | 2.0 | 0.32 | 0.4 | 5.75 | 1.8 | 0.00 | 0.0 |
| Between-
CALIBRATION | 0.08 | 1.7 | 0.26 | 4.1 | 0.12 | 1.3 | 2.36 | 3.2 | 5.59 | 1.8 | 32.71 | 2.9 |
| Between-
INSTRUMENT | 0.08 | 1.7 | 0.00 | 0.0 | 0.23 | 2.4 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
| Total Between-
CALIBRATION | 0.33 | 7.4 | 0.48 | 7.5 | 0.49 | 5.2 | 4.02 | 5.4 | 14.84 | 4.8 | 65.16 | 5.9 |
| Total Between-
INSTRUMENT | 0.34 | 7.6 | 0.48 | 7.5 | 0.54 | 5.7 | 4.02 | 5.4 | 14.84 | 4.8 | 65.16 | 5.9 |
Linearity
Three sample pools were serially diluted into a total of 11 samples and tested in triplicate in order to evaluate the linearity according to CLSI EP06-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach". The VIDAS HCG assay on VIDAS 3 is linear across the measuring range 2 - 1500 mIU/mL.
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Image /page/27/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized globe above it. The globe is blue and has curved lines on the left side, and a green and yellow line runs vertically through the center of the globe and the company name.
Detection Limits
The detection limits of the VIDAS HCG assay on the VIDAS 3 were evaluated per CLSI EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline. Second Edition", For LoB determination, 6 blank samples were each tested in 4 replicates in a single run per day for 4 days with 1 VIDAS 3 instrument and 2 assay lots. For LoD/LoQ determinations, 6 low-level samples were each tested in 6 replicates, 2 runs per day, for 5 days, with 1 VIDAS 3 instrument and 2 assay lots. The LoB, LoD and LoQ determinations were based consequently on 912 results, including 192 results from blank samples and 720 results from Iow-level samples both assay lots combined. The LoB, LoQ of the VIDAS HCG assay on the VIDAS 3 are as follows: LoB = 0.242 mlU/mL; LoD = 0.571 mlU/mL; LoQ = 1.280 mlU/mL.
Carry-over
One high HCG positive sample was tested with one HCG batch analyte negative sample and one carry-over analyte negative sample during 7 runs on 3 VIDAS 3 instruments until 84 replicates of each sample was obtained. The average carry-over observed on VIDAS 3 and its 95% confidence interval were calculated and compared to a