(251 days)
No
The description details a standard enzyme immunoassay with automated steps and fluorescent detection. There is no mention of AI or ML in the device description, intended use, or performance studies. The results are calculated based on the measured fluorescence intensity, not through learning algorithms.
No.
The device is an in vitro diagnostic (IVD) device used to detect antibodies, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that this assay is for "presumptive detection of human IgM antibodies to Borrelia burgdorferi," and should be used to "test patients with a history and/or symptoms of infection with B. burgdorferi." This indicates its purpose is to aid in the diagnosis of Lyme disease.
No
The device is an in vitro diagnostic (IVD) assay that includes physical reagents (SPR, reagent strips) and is run on a specific instrument family (VIDAS). While the instrument performs calculations and generates a report (software functions), the core of the device is a chemical/biological assay with associated hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum... or plasma...". This clearly indicates that the device is used to perform tests on biological samples (serum or plasma) taken from the human body to provide information about a person's health status (presence of antibodies to a specific pathogen).
- Device Description: The description details a laboratory assay that uses reagents and an instrument to analyze a biological sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document describes various performance studies, including sensitivity, method comparison, analytical specificity, and cross-reactivity, all of which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in a laboratory setting.
- Predicate Device: The mention of a "Predicate Device" (K081362; Platelia™ Lyme IgM) is a strong indicator that this device is being compared to another legally marketed IVD device, a common practice in the regulatory submission process for IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM 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 IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
Product codes
LSR
Device Description
The VIDAS Lyme IgM 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. Anti-human IgM 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-Methyl-umbellifery) 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 proportional to the quantity of anti-B. burgdorferi IgM antibody present in the sample.
At the end of the VIDAS Lyme IgM assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests (Precision, Reproducibility, Interfering Substances, Cross-Reactivity) and Clinical Testing (Sensitivity, Method Comparison).
Precision: 4 serum samples were tested in duplicate in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 1 site (n = 80).
Reproducibility: 4 serum samples were tested in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 3 sites (n =240).
Interfering Substances: Specimen-related interference (hemolysis with 5 g/L hemoglobin, lipemia with 30 g/L triglycerides, bilirubinemia with 0.3 g/L bilirubin, human albumin up to 60 g/L) and Exogenous Interferents (15 commonly used drugs).
Sensitivity testing: 202 retrospective samples from patients meeting a case definition of LD and confirmed positive for B. Burgdorferi infection.
Method Comparison: A prospective study was performed on 975 fresh or frozen prospectively collected sera submitted for routine Lyme disease testing from an endemic area of the United States. Testing was performed in three laboratories.
Analytical Specificity: 100 sera from apparently healthy subjects from an endemic population (New York) and 100 sera from a non-endemic population (Texas) with no known history of Lyme disease were run on the VIDAS Lyme IgM assay and the predicate Lyme IgM assay.
CDC Reference Panel: A serum panel obtained from the CDC (n=39).
Key results:
Precision and Reproducibility studies showed acceptable variability.
No significant interference was observed from common interfering substances or drugs.
Clinical Sensitivity:
Stage I: VIDAS 52.1%, Predicate 54.6%
Stage II: VIDAS 91.9%, Predicate 91.9%
Stage III: VIDAS 76.2%, Predicate 61.9%
All stages: VIDAS 66.8%, Predicate 66.8%
Method Comparison: Positive % Agreement = 51.0% (107/210); Negative % Agreement = 88.6% (678/765).
Second-Tier Testing with Western Blot: 1st Tier PPA = 51.0% (107/210); 2nd Tier PPA = 80.8% (84/104).
Concordance with IgM Western Blot: Predicate device: 49.5% (104/210); VIDAS Lyme IgM: 49.0% (95/194).
Analytical Specificity: Endemic Population - VIDAS Positivity 12.0%, Predicate Positivity 19.0%; Non-Endemic Population - VIDAS Positivity 14.0%, Predicate Positivity 3.0%.
CDC Reference Panel: Total Agreement with clinical status - VIDAS 69.2% (27/39), Western blot IgM 59.0% (23/39).
Cross-Reactivity: Cross-reactivity observed for various infections/diagnoses, with Human Immunodeficiency Virus showing the highest (35.00%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
Stage I (early localized, single lesion; 1 – 30 days): VIDAS Lyme IgM 52.1% (62/119), Predicate Lyme IgM 54.6% (65/119)
Stage II (early disseminated, multiple lesions; 1 – 30 days): VIDAS Lyme IgM 91.9% (57/62), Predicate Lyme IgM 91.9% (57/62)
Stage III (late disseminated): VIDAS Lyme IgM 76.2% (16/21), Predicate Lyme IgM 61.9% (13/21)
All stages: VIDAS Lyme IgM 66.8% (135/202), Predicate Lyme IgM 66.8% (135/202)
Positive % Agreement (PPA): 51.0% (107/210) [44.0 - 57.9]%
Negative % Agreement (NPA): 88.6% (678/765) [86.2 - 90.8]%
Analytical Specificity (Positivity):
Endemic Population: VIDAS 12.0%, Predicate 19.0%
Non-Endemic Population: VIDAS 14.0%, Predicate 3.0%
Cross-reactivity:
Anti Nuclear Antibodies: 5.00%
C Reactive Protein: 6.55%
Cytomegalovirus: 17.64%
Epstein Barr Virus: 10.76%
Helicobacter pylori: 6.99%
Hepatitis A Virus: 14.37%
Herpes Simplex Virus: 15.30%
Human Immunodeficiency Virus: 35.00%
Human Anti-mouse Antibodies: 6.45%
Leptospirosis: 10.18%
Measles: 13.15%
Mumps: 4.34%
Rheumatoid Factor: 8.19%
Rickettsiosis: 5.35%
Rubella: 10.52%
Syphilis: 9.25%
Systemic Lupus Erythematosus: 7.14%
Toxoplasmosis: 19.23%
Varicella Zoster Virus: 6.89%
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
VIDAS® Lyme IgM Assay
510(k) SUMMARY
JUN 0 4 2013
1
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
VIDAS® Lyme IgM
A. Submitter Information
| Submitter's Name: | bioMérieux SA |
|---|---|
| Address: | Chemin de l'Orme |
| 69280 Marcy-l'Etoile - France | |
| Contact Person: | Catherine FRITSCH |
| Phone Number: | +33 4 78 87 23 98 |
| Fax Number: | +33 4 78 87 20 75 |
| Date of Preparation: | August 2012 |
B. Device Name
| Trade Name: | VIDAS® Lyme IgM |
|---|---|
| Common Name: | Lyme IgM Assay |
| Classification Name: | 21 CFR 866.3830 - Treponema pallidum treponemal test reagents |
C. Predicate Device Name
Trade Name: Platelia™ Lyme IgM
D. Device Description
The VIDAS Lyme IgM 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. Anti-human IgM 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-Methyl-umbellifery) 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 proportional to the quantity of anti-B. burgdorferi IgM antibody present in the sample.
At the end of the VIDAS Lyme IgM assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
1
E. Intended Use
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM 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 IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the assays is presented in the table below.
| Item | VIDAS® Lyme IgM (LYM) Assay | Platelia™ Lyme IgM (K081362) |
|---|---|---|
| Intended Use | The VIDAS Lyme IgM (LYM) assay | |
| is an automated qualitative enzyme | ||
| immunoassay intended for use on | ||
| the instruments of the VIDAS family | ||
| in the presumptive detection of | ||
| human IgM 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 | ||
| IgM positive and equivocal | ||
| specimens should be further tested | ||
| with a Western Blot IgM assay to | ||
| obtain supportive evidence of | ||
| infection with B. burgdorferi. | The Platelia™ Lyme IgM Test is a | |
| qualitative test intended for use in | ||
| the presumptive detection of | ||
| human IgM antibodies to Borrelia | ||
| burgdorferi in human serum or | ||
| plasma (K3 EDTA, sodium | ||
| heparin or sodium citrate). The | ||
| EIA system should be used to test | ||
| serum or plasma from patients | ||
| with a history and symptoms of | ||
| infection with Borrelia burgdorferi. | ||
| All positive and equivocal | ||
| specimens should be re-tested | ||
| with a specific, second-tier test | ||
| such as Western-Blot. Positive | ||
| second-tier results are supportive | ||
| evidence of infection with Borrelia | ||
| burgdorferi. The diagnosis of | ||
| Lyme disease should be made | ||
| based on history and symptoms | ||
| (such as erythema migrans), and | ||
| other laboratory data, in addition | ||
| to the presence of antibodies to | ||
| Borrelia | ||
| burgdorferi. Negative results | ||
| (either first- or second-tier) should | ||
| not be used to exclude Lyme | ||
| disease. | ||
| Specimen | Serum or plasma | Serum or plasma |
| Analyte | IgM antibodies to Borrelia burgdorferi | IgM antibodies to Borrelia |
| burgdorferi | ||
| Automated | Yes | No |
| Assay | ||
| Technique | Enzyme-linked fluorescent assay | |
| (ELFA) | Enzyme immunoassay (EIA) |
2
G. Nonclinical Tests
A summary of the non-clinical results is presented below.
Precision
For the precision study, 4 serum samples were tested in duplicate in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 1 site (n = 80). The precision was calculated following the recommendations of the CLS10 document EP5-A2. The total precision data in the table reflect the 80 values generated per sample for Site 1 and takes into account replicate, run, day, calibration, and lot as potential sources of variation. The total precision for controls include within-day, between-days and between-calibration variability and is lot specific.
| Panel Member | N | Mean
Index | Within-run | Within-day | Between-days | Total | | | | |
|------------------|----|---------------|------------|------------|--------------|--------|------|--------|------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Sample 1 | 80 | 0.19 | 0.01 | 3.9 | 0.01 | 2.7 | 0.00 | 0.0 | 0.01 | 5.2 |
| Sample 2 | 80 | 0.27 | 0.01 | 4.7 | 0.01 | 2.8 | 0.00 | 1.4 | 0.02 | 9.1 |
| Sample 3 | 80 | 0.38 | 0.01 | 2.6 | 0.01 | 3.0 | 0.00 | 0.3 | 0.02 | 4.7 |
| Sample 4 | 80 | 1.31 | 0.03 | 2.1 | 0.02 | 1.6 | 0.01 | 0.9 | 0.09 | 6.9 |
| Positive Control | 40 | 0.74 | NA | NA | 0.04 | 5.3 | 0.00 | 0.0 | 0.07 | 10.1 |
| Negative Control | 40 | 0.00 | NA | NA | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
Reproducibility
For reproducibility, 4 serum samples were tested in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 3 sites (n =240). The reproducibility was calculated following the recommendations of the CLSI® document EP5-A2. The total reproducibility data in the table reflects the 240 values generated per sample for all sites and takes into account replicate, run, day, calibration, lot, and site as potential sources of variation. Out of the 240 total values, 2 Low Positives (Sample 3) gave an equivocal value ( 1 year | 3 | 4 | 42.9 %
(3/7) | 3 | 4 | 42.9 %
(3/7) |
| Total | 24 | 15 | 69.2%
(27/39) | 18 | 21 | 59.0 %
(23/39) |
Cross-Reactivity
Cross-reactivity is based on the study of samples that are negative with the test being evaluated and positive for the potentially interfering disease. The results of the samples tested according to the disease are shown in the table below:
| Infection or Diagnosis | N | VIDAS Lyme
IgM
Equivocal or
positive
results | % Cross-
reactivity |
|------------------------------|-----|----------------------------------------------------------|------------------------|
| Anti Nuclear Antibodies | 60 | 3 | 5.00 |
| C Reactive Protein | 61 | 4 | 6.55 |
| Cytomegalovirus | 34 | 6 | 17.64 |
| Epstein Barr Virus | 65 | 7 | 10.76 |
| Helicobacter pylori | 143 | 10 | 6.99 |
| Hepatitis A Virus | 153 | 22 | 14.37 |
| Herpes Simplex Virus | 98 | 15 | 15.30 |
| Human Immunodeficiency Virus | 20 | 7 | 35.00 |
| Human Anti-mouse Antibodies | 31 | 2 | 6.45 |
| Leptospirosis | 216 | 22 | 10.18 |
| Measles | 38 | 5 | 13.15 |
| Mumps | 46 | 2 | 4.34 |
| Rheumatoid Factor | 61 | 5 | 8.19 |
| Rickettsiosis | 112 | 6 | 5.35 |
| Rubella | 19 | 2 | 10.52 |
| Syphilis | 270 | 25 | 9.25 |
| Systemic Lupus Erythematosus | 28 | 2 | 7.14 |
| Toxoplasmosis | 26 | 5 | 19.23 |
| Varicella Zoster Virus | 58 | 4 | 6.89 |
7
7
510(k) SUMMARY
8
The effect of Babesiosis, Erhlichiosis and Rocky Mountain spotted fever pathologies on the VIDAS Lyme IgM performance is not known.
l. Conclusion
The results from the nonclinical and clinical studies submitted in this premarket notification are complete and demonstrate that the VIDAS® Lyme IgM is substantially equivalent to the predicate device identified in Item C of this summary.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
bioMerieux SA c/o Catherine FRITSCH Regulatory Affairs Director 5 rue des Aqueducs 69290 Craponne, France
June 4, 2013
Re: K122979
Trade/Device Name: VIDAS® Lyme IgM Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: May 6, 2013 Received: May 7, 2013
Dear Ms. FRITSCH:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
9
Page 2 - Catherine FRITSCH
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the 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 regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/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
10
Indications for Use
510(k) Number (if known): K122979
Device Name: VIDAS® Lyme IgM
Indications For Use:
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM 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 IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
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)
| John Hobson-S |
|---|
| --------------- |
| Division Sign-Off | |
|---|---|
| -- | ------------------- |
| 2013.06.03 13:35:34 |
|---|
| -04'00' |
| Office of In Vitro Diagnostics and Radiological Health |
|---|
| -------------------------------------------------------- |
| 510(k) | K122979 |
|---|---|
| -------- | --------- |
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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