(310 days)
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IgG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (< 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy.
VIDAS TOXO IgG Avidity assay performance has not been established for prenatal screening, for newborn testing, for use in immunocompromised patients and in cases of endogenous or exogenous reinfection by Toxoplasma gondii. This assay has not been cleared or approved by the FDA for blood/plasma donor screening.
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IqG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IqG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (< 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy.
The addition of a dissociating agent (such as urea) which disrupts the Ag-Ab link during an ELISA test has little effect on the high avidity Aq-Ab link, but great effect on that of weak avidity Ab. Comparison of results obtained with and without a dissociating agent corresponds to one measure of avidity.
The assay principle combines a two-step enzyme immunoassay sandwich 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. VIDAS TOXO IgG Avidity uses a dual strip comprising one reference strip and one test strip. The sample to be tested, after dilution, is dispensed into both sample wells of the dual strip: reference and test.
Anti-toxoplasma IgG present in the sample forms complexes with antigen coated to the solid phase. In the reference strip, non-specific antibodies are eliminated by washing, whereas specific antibodies remain coated to the solid phase. In the test strip, washing with the dissociating agent changes antibody links: high avidity antibodies remain bound to the solid phase, whereas low avidity antibodies are eliminated.
Alkaline phosphatase labeled with human anti-IgG antibody (conjugate) is then cycled in and out of the SPR, and binds with any human IgG coated on the interior of the SPR. Unbound conjugate is removed by washing.
All of the assay steps are performed automatically by the instrument. The reaction medium is cvcled in and out of the SPR several times. 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. Fluorescence is measured twice in the Reagent Strip's reading cuvette for each dual reagent strip. The first reading is a background reading of the substrate cuvette before the SPR is introduced into the substrate. The second reading is taken after incubating the substrate with the enzyme remaining on the interior of the SPR. The RFV (Relative Fluorescence Value) is calculated by subtracting the background reading from the final result. The RFV for the two assays (reference and test) appear on the result sheet. The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument and then printed out.
The ratio between the quantity of high avidity antibodies (test strip) and the quantity of total antibodies (reference strip) provides an index that indicates antibody avidity in the tested sample.
The provided document describes the VIDAS® TOXO IgG Avidity Assay, an automated qualitative test for determining anti-toxoplasma IgG avidity in human serum. It is intended to aid in the presumptive exclusion of a recently acquired (≤ 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy, in conjunction with other laboratory and clinical findings.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as clear numerical targets. Instead, it presents several analytical performance metrics for the VIDAS® TOXO IgG Avidity Assay, which inherently serve as the data demonstrating its performance. For comparison, the document also includes data for the predicate device, VIDAS® TOXO IgM Assay.
| Performance Metric | VIDAS® TOXO IgG Avidity Assay Reported Performance |
|---|---|
| Within-run Precision | Low avidity: Mean avidity index = 0.1196, CV = 7.9% |
| Low avidity close to clinical decision point (C5): Mean avidity index = 0.2620, CV = 7.8% | |
| High avidity close to clinical decision point (C95): Mean avidity index = 0.3209, CV = 5.7% | |
| High avidity (medium): Mean avidity index = 0.5352, CV = 6.1% | |
| High avidity (high): Mean avidity index = 0.6843, CV = 7.1% | |
| Between-Run Precision | Low avidity: Mean avidity index = 0.1196, CV ≤ 0.1% |
| Low avidity close to clinical decision point (C5): Mean avidity index = 0.2620, CV ≤ 0.1% | |
| High avidity close to clinical decision point (C95): Mean avidity index = 0.3209, CV = 4.3% | |
| High avidity (medium): Mean avidity index = 0.5352, CV = 3.1% | |
| High avidity (high): Mean avidity index = 0.6843, CV = 2.1% | |
| Total Precision (within-run, between-run, between-day, between-lot, and between site) | Low avidity: Mean avidity index = 0.1196, CV = 8.4% |
| Low avidity close to clinical decision point (C5): Mean avidity index = 0.2620, CV = 9.7% | |
| High avidity close to clinical decision point (C95): Mean avidity index = 0.3209, CV = 7.4% | |
| High avidity (medium): Mean avidity index = 0.5352, CV = 7.0% | |
| High avidity (high): Mean avidity index = 0.6843, CV = 7.4% | |
| Cross-Reactivity | No clinically significant interference from samples with Rheumatoid Factors, Antinuclear antibodies, Epstein Barr virus, CMV, HAMA, HAV, HBV, HSV-2, Rubella, VZV (except 1 of 12 HSV-1 samples showed interference). |
| Interfering Substances | No interference from Hemoglobin (up to 300 µmol/L), Triglycerides (up to 30 mg/mL), Bilirubin (up to 510 µmol/L), Human albumin (up to 5 g/dL). |
| Drug Interference | No interference from Sulfamethoxazole, Sulfapyridine, Sulfasalazine, Spiramycin, Clindamycin, Trimethoprim, Sulfamethoxazole + Trimethoprim, Pyrimethamine (at specified concentrations). |
2. Sample Size for the Test Set and Data Provenance
The document refers to "non-clinical (analytical) comparison" data, which typically represents testing done for analytical performance rather than clinical validation of diagnostic accuracy with patient samples.
- Precision Studies:
- Within-run Precision: n = 80 replicates at each of 3 sites (total 240 replicates per avidity level).
- Between-Run Precision: n = 40 runs at each of 3 sites.
- Total Precision: n = 120 runs (2 runs per day, for 10 days with 2 reagent lots, at 3 sites).
- Cross-Reactivity: Number of samples varies by condition (e.g., 12 samples tested for HSV-1 disease, others are not specified with counts beyond "samples from patients with...").
- Interfering Substances: Not specified with sample counts but indicates testing was done up to certain concentrations.
- Drug Interference: Not specified with sample counts but indicates testing was done at specific drug concentrations.
Data Provenance: The document does not explicitly state the country of origin for the samples or if the data is retrospective or prospective. It is clinical laboratory data, generated during the analytical validation of the assay.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document describes analytical performance studies (precision, cross-reactivity, interference). For these types of analytical studies, the "ground truth" is typically defined by controlled experimental conditions (e.g., known concentrations, spiked samples, well-characterized panels) rather than expert clinical consensus. Therefore, expert involvement for establishing ground truth in this context is not applicable.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies to establish a consensus ground truth from multiple expert readings of patient cases. Since this document focuses on analytical performance rather than diagnostic accuracy with expert-adjudicated clinical cases, no such adjudication method is mentioned or relevant to the data presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies detailed are analytical performance evaluations of the assay itself, not studies comparing human reader performance with or without AI assistance. The device is a diagnostic assay, not an AI-powered image analysis tool or decision support system for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies presented are standalone performance evaluations of the VIDAS® TOXO IgG Avidity Assay. The assay is an automated qualitative test that provides results directly. The analytical performance data (precision, cross-reactivity, interference) are all measures of the algorithm's/device's performance without human intervention in the result determination. The document states, "All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. During the final detection step... results are automatically calculated by the instrument and then printed out."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the analytical studies presented, the "ground truth" was established by:
- Known Characteristics of Controls/Samples: For precision studies, standardized controls or characterized samples with known avidity levels were used.
- Known Presence/Absence of Interferents/Cross-Reactants: For cross-reactivity and interference studies, samples were either known to contain specific cross-reactants/interferents or were spiked with them at defined concentrations.
This type of ground truth is based on the intrinsic properties of the test materials and the controlled experimental setup, which is standard for analytical validation of in vitro diagnostic devices. Clinical ground truth (e.g., confirmed toxoplasmosis infection status based on pathology or long-term clinical outcome) would be established in a clinical performance study, which is distinct from the analytical studies described here.
8. The Sample Size for the Training Set
The document describes pre-market analytical performance data for a diagnostic assay. It does not mention a "training set" or "test set" in the context of machine learning or AI development. The data presented are from validation studies of the finished device. Therefore, information on a training set size is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" for an AI or machine learning model is not applicable to the analytical validation of this in vitro diagnostic assay.
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MAY 1 8 2011
510(k) SUMMARY
VIDAS® TOXO IgG Avidity Assay
A. Submitter Information
| Submitter's Name:Address: | bioMérieux, Inc.595 Anglum RoadHazelwood, MO 63042 |
|---|---|
| Contact Person: | John Albright |
| Phone Number: | 314-731-8546 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 2010 |
| B. Device NameTrade Name: | VIDAS® TOXO IgG Avidity Assay |
| Common Name: | TOXO IgG Avidity Assay |
| Classification Name: | 21 CFR 866.3780 Product Code LGDToxoplasma gondii serological readents |
C. Predicate Device Name Trade Name:
VIDAS® TOXO IgM Assay
D. Device Description
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IqG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IqG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (< 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy.
The addition of a dissociating agent (such as urea) which disrupts the Ag-Ab link during an ELISA test has little effect on the high avidity Aq-Ab link, but great effect on that of weak avidity Ab. Comparison of results obtained with and without a dissociating agent corresponds to one measure of avidity.
The assay principle combines a two-step enzyme immunoassay sandwich 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. VIDAS TOXO IgG Avidity uses a dual strip comprising one reference strip and one test strip. The sample to be tested, after dilution, is dispensed into both sample wells of the dual strip: reference and test.
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Anti-toxoplasma IgG present in the sample forms complexes with antigen coated to the solid phase. In the reference strip, non-specific antibodies are eliminated by washing, whereas specific antibodies remain coated to the solid phase. In the test strip, washing with the dissociating agent changes antibody links: high avidity antibodies remain bound to the solid phase, whereas low avidity antibodies are eliminated.
Alkaline phosphatase labeled with human anti-IgG antibody (conjugate) is then cycled in and out of the SPR, and binds with any human IgG coated on the interior of the SPR. Unbound conjugate is removed by washing.
All of the assay steps are performed automatically by the instrument. The reaction medium is cvcled in and out of the SPR several times. 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. Fluorescence is measured twice in the Reagent Strip's reading cuvette for each dual reagent strip. The first reading is a background reading of the substrate cuvette before the SPR is introduced into the substrate. The second reading is taken after incubating the substrate with the enzyme remaining on the interior of the SPR. The RFV (Relative Fluorescence Value) is calculated by subtracting the background reading from the final result. The RFV for the two assays (reference and test) appear on the result sheet. The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument and then printed out.
The ratio between the quantity of high avidity antibodies (test strip) and the quantity of total antibodies (reference strip) provides an index that indicates antibody avidity in the tested sample.
E. Intended Use
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IqG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (< 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy.
VIDAS TOXO IgG Avidity assay performance has not been established for prenatal screening. for newborn testing, for use in immunocompromised patients and in cases of endogenous or exogenous reinfection by Toxoplasma gondii. This assay has not been cleared or approved by the FDA for blood/plasma donor screening.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the assays is presented in the table below.
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| Item | Device[VIDAS TOXO IgG Avidity Assay] | Predicate[VIDAS TOXO IgM Assay] |
|---|---|---|
| General Comparison | ||
| Intended Use | The VIDAS® TOXO IgG Avidity assay is anautomated qualitative test for thedetermination of anti-toxoplasma IgGavidity in human serum using the ELFAtechnique (Enzyme Linked FluorescentAssay). The VIDAS® TOXO IgG Avidityassay is intended for use in conjunctionwith results from the VIDAS TOXO IgG IIand must have a positive titer (≥ 8 IU/mL);other laboratory findings and clinicalinformation to aid in the presumptiveexclusion of a recently acquired (< 4months) Toxoplasma gondii infection inpregnant women and patients withlymphadenopathy.VIDAS TOXO IgG Avidity assayperformance has not been established forprenatal screening, for newborn testing, foruse in immunocompromised patients andin cases of endogenous or exogenousreinfection by Toxoplasma gondii. Thisassay has not been cleared or approved bythe FDA for blood/plasma donor screening. | VIDAS® TOXO IgM Assay is intended foruse with a VIDAS (VITEK®ImmunoDiagnostic Assay System)instrument as an automated enzyme-linked fluorescent immunoassay (ELFA)for the presumptive qualitative detection ofanti-Toxoplasma gondii IgM antibodies inhuman serum, as an aid in the diagnosis ofacute, recent, or reactivated Toxoplasmagondii infection. This assay must beperformed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.VIDAS TXM assay performance has notbeen established for prenatal screening ornewborn testing. This assay has not beencleared by the FDA for blood/plasma donorscreening. |
| Specimen | Serum | Serum |
| Analyte | Anti-toxoplasma IgG avidity | Anti-toxoplasma IgM |
| Assay Principle | Immunoassay based on sandwich principle | Immunoassay based on sandwich principle |
| Automated | Yes | Yes |
| Assay Technique | Enzyme-linked fluorescent assay (ELFA) | Enzyme-linked fluorescent assay (ELFA) |
G. Performance Data
A summary of the non-clinical results is presented in the table below.
| Non-clinical (Analytical) Comparison | ||
|---|---|---|
| Item | VIDAS® TOXO IgG Avidity Assay | VIDAS® TOXO IgM assay (K923166) |
| Within-runPrecision | n = 80 replicates at each of the 3 sitesLow avidity:Mean avidity index = 0.1196CV = 7.9%Low avidity close to the clinical decisionpoint (C5):Mean avidity index =0.2620CV = 7.8% | n = 22 replicatesHigh positive:Mean test value = 1.93CV = 4.8%Low positive:Mean test value = 1.10CV = 6.7%Negative:Mean test value = 0.08 |
| Non-clinical (Analytical) Comparison | ||
| Item | VIDAS® TOXO IgG Avidity Assay | VIDAS® TOXO IgM assay (K923166 |
| High avidity close to the clinical decisionpoint (C95):Mean avidity index =0.3209CV = 5.7%High avidity (medium):Mean avidity index = 0.5352CV = 6.1% | CV = 6.1% | |
| High avidity (high):Mean avidity index = 0.6843CV = 7.1% | ||
| n = 40 runs at each of the 3 sitesLow avidity:Mean avidity index = 0.1196CV ≤ 0.1%Low avidity close to the clinical decisionpoint (C₅):Mean avidity index = 0.2620 | n = 3 replicates for 12 daysHigh positive:Mean test value = 1.96CV = 3.7%Low positive:· Mean test value = 1.03CV = 7.5% | |
| Between-RunPrecision | CV ≤ 0.1%High avidity close to the clinical decisionpoint (C95):Mean avidity index = 0.3209 | Negative:Mean test value = 0.07CV = 6.4% |
| CV = 4.3%High avidity (medium):Mean avidity index = 0.5352CV = 3.1%High avidity (high):Mean avidity index = 0.6843CV = 2.1% | ||
| Total Precision(within-run,between-run,between-day,between-lotand between site) | n = 120 runs (2 runs per day, for 10 dayswith 2 reagent lots (10 days per lot), at 3sites)Low avidity:Mean avidity index = 0.1196CV = 8.4%Low avidity close to the clinical decisionpoint (C₅):Mean avidity index = 0.2620CV = 9.7%High avidity close to the clinical decisionpoint (C95):Mean avidity index = 0.3209CV = 7.4%High avidity (medium): | No claim |
| Mean avidity index = 0.5352CV = 7.0%High avidity (high):Mean avidity index = 0.6843CV = 7.4% | ||
| Cross-Reactivity | No clinically significant interference wasobserved for:• Samples from patients withRheumatoid Factors | No cross-reactivity was observed for:• Samples from patients withRheumatoid Factors |
| Non-clinical (Analytical) Comparison | ||
| Item | VIDAS® TOXO IgG Avidity Assay | VIDAS® TOXO IgM assay (K923166) |
| Samples from patient with Antinuclear antibodies Samples from patients with Epstein Bar virus infection. Samples from patients with CMV Samples from patients with HAMA Samples from patients with HAV Samples from patients with HBV Samples from patients with HSV-2 Samples from patients with Rubella Samples from patients with VZV However, a clinically significant interference was observed with 1 of the 12 samples tested for HSV-1 disease. | Antinuclear antibodies Samples from patients with Epstein Bar virus infection. | |
| InterferingSubstances | No interference from: Hemoglobin up to 300 µmol/L Triglycerides up to 30 mg/mL Bilirubin up to 510 µmol/L Human albumin up to 5 g/dL | No claim |
| Drug Interference | No interference with Sulfamethoxazole was observed at a concentration of 1.58 mmol/L (400 µg/mL) No interference with Sulfapyridine was observed at a concentration of 1.20 mmol/L (300 µg/mL) No interference with Sulfasalazine was observed at a concentration of 754 µmol/L (300 µg/mL) No interference with Spiramycin was observed at a concentration of 15.0 µg/mL No interference with Clindamycin was observed at a concentration of 89.1 µmol/L (45 µg/mL) No interference with Trimethoprim was observed at a concentration of 138 µmol/L (40 ug/mL) No interference with Sulfamethoxazole and Trimethoprim was observed at a concentration of 1.58 mmol/L (400 µg/mL)and138 µmol/L (40 µg/mL), respectively No interference with Pyrimethamine was observed at a | No claim |
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| Non-clinical (Analytical) Comparison | ||
|---|---|---|
| Item | VIDAS® TOXO IgG Avidity Assay | VIDAS® TOXO IgM assay (K923166) |
H. Conclusion
The VIDAS® TOXO IgG Avidity Assay is substantially equivalent to the bioMérieux TOXO IgM Assay.
The 510(k) summary includes only information that is also covered in the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 8 2011
bioMérieux, Inc. c/o John Albright Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042-2320
Re: K101946
Trade/Device Name: VIDAS® Toxo IgG Avidity Assay Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: May 13, 2011 Received: May 16, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 - John Albright
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sakazym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: VIDAS® TOXO IgG Avidity
Indications For Use:
The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IgG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (≤ 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy.
VIDAS TOXO IgG Avidity assay performance has not been established for prenatal screening, for newborn testing, for use in immunocompromised patients and in cases of endogenous or exogenous reinfection by Toxoplasma gondii. This assay has not been cleared or approved by the FDA for blood/plasma donor screening.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddi E. Poole
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K 16 1946
§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).