(42 days)
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No
The summary describes a standard qualitative EIA assay for antibody detection, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is a qualitative test used for the detection of human IgM antibodies to Borrelia burgdorferi, which aids in the diagnosis of Lyme disease. It does not provide any treatment or therapy.
Yes
The device is a qualitative test intended for the presumptive detection of human IgM antibodies, which means it helps in identifying a medical condition (Lyme disease) by detecting specific biomarkers. This process of identifying a disease or condition is the definition of a diagnostic device.
No
The device description clearly states it is an "EIA test system" and a "qualitative assay," which are laboratory-based tests involving reagents and physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma". This involves testing biological samples (serum or plasma) in vitro (outside the body) to provide information about a person's health status (presence of antibodies related to Lyme disease).
- Device Description: The description reinforces this by stating it's a "qualitative assay for the detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma".
- Performance Studies: The performance studies describe testing of serum samples for various characteristics like precision, cross-reactivity, and interference, all of which are typical evaluations for an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device (Mardx Lyme Disease EIA (IgM) Test) with a K number (K894293) strongly suggests that this device is being compared to a previously cleared IVD.
The core function of the device is to analyze a biological sample in vitro to aid in a medical diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Platelia™ Lyme IgM Assay is a qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma. The EIA system should be used to test serum or plasma from patients with a history and symptoms of infection with B. 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 B. 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 B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
Product codes
LSR
Device Description
The Platelia™ Lyme IgM Assay is a qualitative assay for the detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma. The Platelia™ Lyme IgM Assay is an enzyme immunoassay with capture of the IgM on the solid phase. Anti-human u-chains antibodies are coated on the solid phase (wells of the microplate). A mixture of the Borrelia B31 antigen and the monoclonal anti-Borrelia antigen antibody labeled with peroxidase is used as the conjugate.
Mentions image processing
Not Found
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Intra-Assay Precision:
- Study Type: Precision study
- Sample Size: Three samples close to the cut-off value tested 20 times each, various samples spanning the assay range tested 30 times each.
- Key Results:
- Samples close to the grey zone (20x):
- Cut-Off: Mean OD 0.30, SD 0.005, CV 1.7%; Mean RATIO 0.99, SD 0.02, CV 1.8%
- Grey Zone min: Mean OD 0.27, SD 0.009, CV 3.3%; Mean RATIO 0.87, SD 0.029, CV 3.3%
- Grey Zone max: Mean OD 0.36, SD 0.009, CV 2.4%; Mean RATIO 1.19, SD 0.029, CV 2.4%
- Various samples (30x):
- Negative: Mean OD 0.08, SD 0.013, CV 15%; Mean RATIO 0.24, SD 0.04, CV 15.2%
- Low positive: Mean OD 0.42, SD 0.019, CV 4.4%; Mean RATIO 1.17, SD 0.052, CV 4.4%
- Medium: Mean OD 0.67, SD 0.025, CV 3.7%; Mean RATIO 1.88, SD 0.070, CV 3.7%
- High: Mean OD 1.57, SD 0.038, CV 2.4%; Mean RATIO 4.23, SD 0.104, CV 2.5%
- Samples close to the grey zone (20x):
- Conclusion: The coefficient of variation was less than 5% for positive samples.
Cross Reactivity:
- Study Type: Cross-reactivity study
- Sample Size: Varies by disease condition (e.g., 34 for Syphilis, 5 for CMV IgM, etc.)
- Key Results:
- Syphilis: N=34, 1 Positive / Equivocal
- CMV IgM: N=5, 1 Positive / Equivocal
- EBV IgM: N=5, 5 Positive / Equivocal
- HSV IgM: N=10, 0 Positive / Equivocal
- Toxoplasmosis IgM: N=10, 0 Positive / Equivocal
- Rubella IgM: N=10, 0 Positive / Equivocal
- Measles IgM: N=10, 0 Positive / Equivocal
- Mumps IgM: N=10, 2 Positive / Equivocal
- VZV IgM: N=6, 0 Positive / Equivocal
- HIV: N=10, 0 Positive / Equivocal
- Antinuclear Antibodies (ANA): N=10, 1 Positive / Equivocal
- Heterophile Antibodies (HAMA): N=10, 0 Positive / Equivocal
- CRP: N=5, 2 Positive / Equivocal
- SLE: N=2, 0 Positive / Equivocal
- Rheumatoid Factor: N=9, 0 Positive / Equivocal
Interfering Substances:
- Study Type: Interfering substances study
- Key Results:
- Hemoglobin: Slope (a)=0.907, Y axis intercept (b)=0.071, Correlation coeff=0.999, a+b=0.978
- Bilirubin: Slope (a)=0.916, Y axis intercept (b)=0.050, Correlation coeff=0.999, a+b=0.966
- Triolein: Slope (a)=0.889, Y axis intercept (b)=0.061, Correlation coeff=0.997, a+b=0.950
- Albumin: Slope (a)=0.893, Y axis intercept (b)=0.073, Correlation coeff=0.999, a+b=0.966
- All results met acceptance criteria: 0.85 0.975 for Correlation coeff, 0.85 1 Year:**
- Platelia™ Lyme IgM: 4 Positive/equivocal, 4 Negative, 8 Total; 50.0% agreement with clinical diagnosis (4/8)
- Western Blot IgM: 3 Positive, 5 Negative, 8 Total; 37.5% agreement with clinical diagnosis (3/8)
- Total:
- Platelia™ Lyme IgM: 29 Positive/equivocal, 14 Negative, 43 Total; 74.4% agreement with clinical diagnosis (32/43)
- Western Blot IgM: 19 Positive, 25 Negative, 44 Total; 54.5% agreement with clinical diagnosis (24/44)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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510(k) SUMMARY
| Date of Summary | May 13, 2008 | JUN 2 6 2008 |
|---|---|---|
| Product Name | Platelia™ Platelia™ Lyme IgM | |
| Sponsor | Bio-Rad | |
| 3 Boulevard Raymond Poincaré | ||
| 92430 Marnes-la-Coquette | ||
| France | ||
| Correspondent | MDC Associates, LLC | |
| Fran White, Regulatory Consultant | ||
| 163 Cabot Street | ||
| Beverly, MA 01915 | ||
| Substantially Equivalent Device | The Platelia™ Lyme IgM Assay is substantially equivalent | |
| to the Mardx B. burgdorferi EIA. | ||
| Manufacturer: Mardx Diagnostics, Inc. | ||
| Product: Mardx Lyme Disease EIA (IgM) Test - |
Bio-Rad Platelia" Lyme Substantial Product Attribute Mardx Lyme Disease Test IgM Assay Equivalent The Platelia™ Lyme IgM Intended use The MarDx B. burgdorferi ﮯ ﮨﮯ Assay is a qualitative test Disease Enzyme intended for use in the Immunoassay (EIA) IgM presumptive detection of Test Systems is a human IgM antibodies to qualitative test intended for Borrelia burgdorferi in use in the presumptive human serum or plasma. detection of human IgM The EIA system should be antibodies to Borrelia used to test serum or plasma burgdorferi in human from patients with a history serum. This EIA system and symptoms of infection should be used to test with B. burgdorferi. All serum from patients with a positive and equivocal history and symptoms of specimens should be reinfection with B.
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| tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. 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 B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease. | burgdorferi. All positive and equivocal specimens should be re-tested with a highly specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. 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 B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease. | ||
|---|---|---|---|
| Sample | Plasma or serum | Serum | √ |
| Test | |||
| methodology | ELISA | ELISA | √ |
PRODUCT DESCRIPTION
The Platelia™ Lyme IgM Assay is a qualitative assay for the detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma.
INTENDED USE
The Platelia™ Lyme IgM Assay is a qualitative test intended for use in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma. The EIA system should be used to test serum or plasma from patients with a history and symptoms of infection with B. 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 B. 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 B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
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SUMMARY OF TECHNOLOGY
The Platelia™ Lyme IgM Assay is an enzyme immunoassay with capture of the IgM on the solid phase. Anti-human u-chains antibodies are coated on the solid phase (wells of the microplate). A mixture of the Borrelia B31 antigen and the monoclonal anti-Borrelia antigen antibody labeled with peroxidase is used as the conjugate.
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Image /page/3/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white and features the text "BIO-RAD" in a bold, sans-serif font. The text is enclosed in a rounded rectangle.
PERFORMANCE DATA
Bio-Rad confirms that any/all data provided in this submission may be released upon request.
Intra-Assay Precision
To confirm the intra assay precision of the Platelia™ Lyme assay two studies were run.
- Three samples close to the cut off value were tested 20 times during the same run, O according to the assessed kit's protocol.
- Various samples spanning the assay range were tested 30 times during the same run, o according to the assessed kit's protocol.
Samples close to the grey zone (20x)
| Sample | OD | RATIO | ||||
|---|---|---|---|---|---|---|
| Mean | SD | CV | Mean | SD | CV | |
| Cut-Off | 0.30 | 0.005 | 1.7% | 0.99 | 0.02 | 1.8% |
| Grey Zone min | 0.27 | 0.009 | 3.3% | 0.87 | 0.029 | 3.3% |
| Grey Zone max | 0.36 | 0.009 | 2.4% | 1.19 | 0.029 | 2.4% |
Various samples (30x)
| Sample | OD | RATIO | ||||
|---|---|---|---|---|---|---|
| Mean | SD | CV | Mean | SD | CV | |
| Negative | 0.08 | 0.013 | 15% | 0.24 | 0.04 | 15.2% |
| Low positive | 0.42 | 0.019 | 4.4% | 1.17 | 0.052 | 4.4% |
| Medium | 0.67 | 0.025 | 3.7% | 1.88 | 0.070 | 3.7% |
| High | 1.57 | 0.038 | 2.4% | 4.23 | 0.104 | 2.5% |
Conclusion:
The coefficient of variation was less than 5% for positive samples.
Cross Reactivity
The following potentially cross-reactive sera were run on the Platelia Lyme IgM assay.
Platelia™ Lyme IgM
| Disease Condition | N | Positive / Equivocal |
|---|---|---|
| Syphilis | 34 | 1 |
| CMV IgM | 5 | 1 |
| EBV IgM | 5 | 5 |
| HSV IgM | 10 | 0 |
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| Disease Condition | N | Positive / Equivocal |
|---|---|---|
| Toxoplasmosis IgM | 10 | 0 |
| Rubella IgM | 10 | 0 |
| Measles IgM | 10 | 0 |
| Mumps IgM | 10 | 2 |
| VZV IgM | 6 | 0 |
| HIV | 10 | 0 |
| Antinuclear Antibodies (ANA) | 10 | 1 |
| Heterophile Antibodies (HAMA) | 10 | 0 |
| CRP | 5 | 2 |
| SLE | 2 | 0 |
| Rheumatoid Factor | 9 | 0 |
Interfering Substances
The following potentially interfering substances were tested on the Platelia Lyme IgM.
Platelia™ Lyme IgM
| | Acceptance
Criteria | Hemoglobin | Bilirubin | Triolein | Albumin |
|----------------------|------------------------|------------|-----------|----------|---------|
| Slope (a) | $0.850.975$ | 0.999 | 0.999 | 0.997 | 0.999 |
| a+b | $0.85 1 Year | 4 | 4 | 8 | 50.0%
(4/8) | 3 | 5 | 8 | 37.5%
(3/8) |
| Total | 29 | 14 | 43 (2) | 74.4%
(32/43) | 19 | 25 | 44 | 54.5%
(24/44) |
Performance of Platelia™ Lyme IgM Assay on Lyme CDC panel
(1) Equivocal samples considered as positive; 10 One sample not tested due to insufficient sample volume
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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 features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Fran White Regulatory Consultant Bio-Rad 163 Cabot Street Beverly, MA 01915
JUN 2 6 2008
K081362 Re: Trade/Device Name: Platelia™ Lyme IgM Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagent Regulatory Class: Class II Product Code: LSR Dated: May 14, 2008 Received: May 15, 2008
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the we have feviewed your bookers a determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices the increations for abo bannerce prior to May 28, 1976, the enactment date of the marketed in meerstate oominered prob wies 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 approval of a promation applicans of the Act. The general controls uevice, subject to the general convirements for annual registration, listing of devices, provisions of the Free ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (I MA), it may be subject to sam adallitie 21, Code of Federal Regulations (CFR), Parts arrecting your act 1100 cc, 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 I lease be advisod that I 27 b issueser ination that your device complies with other from that FDA has made a leveral statutes and regulations administered by other requirements of the Precess of the Act's requirements, including, but not I cacrai agencies: "Four mass compey 1 CFR Part 807); labeling (21 CFR Parts 801 and minted to: registration and nothing (2) == == ================================================================================================================================ (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally attaym
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
8
Indications for Use
510(k) Number (if known):
KO81362
Device Name:
Platelia™ Lyme IgM
Indications for Use:
The Platelia™ Lyme IgM Assay 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 test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. 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 B. 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 B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ludlow M. Cook
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD81362
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