PLATELIA LYME IGM

K081362 · Bio-Rad · LSR · Jun 26, 2008 · Microbiology

Device Facts

• Record ID: K081362
• Device Name: PLATELIA LYME IGM
• Applicant: Bio-Rad
• Product Code: LSR · Microbiology
• Decision Date: Jun 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

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.

Device Story

Platelia™ Lyme IgM is an enzyme immunoassay (EIA) for qualitative detection of human IgM antibodies to Borrelia burgdorferi in serum or plasma. Device uses microplate wells coated with anti-human μ-chain antibodies; conjugate consists of Borrelia B31 antigen mixed with peroxidase-labeled monoclonal anti-Borrelia antibody. Performed in clinical laboratory settings by trained personnel. Output is qualitative antibody detection; results used alongside clinical history, symptoms (e.g., erythema migrans), and other laboratory data to support Lyme disease diagnosis. Positive/equivocal results require confirmatory second-tier testing. Device aids clinical decision-making by identifying potential infection, though negative results do not exclude disease.

Clinical Evidence

Performance evaluated using CDC Lyme Disease Serum Panel (n=43). Overall agreement with clinical diagnosis was 74.4% (29/43 positive/equivocal). Intra-assay precision demonstrated CV < 5% for positive samples. Cross-reactivity tested against various conditions (e.g., Syphilis, EBV, CMV, HIV, ANA, Rheumatoid Factor); some cross-reactivity observed with EBV IgM and Mumps IgM. Interfering substances (hemoglobin, bilirubin, triolein, albumin) showed no significant impact on assay performance (correlation coefficients > 0.99).

Technological Characteristics

Enzyme immunoassay (EIA) using microplate solid phase. Solid phase coated with anti-human μ-chain antibodies. Conjugate: Borrelia B31 antigen and peroxidase-labeled monoclonal anti-Borrelia antibody. Sample types: serum or plasma (K3 EDTA, sodium heparin, or sodium citrate). Qualitative detection. Standalone laboratory assay.

Indications for Use

Indicated for presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma. Intended for patients with history and symptoms of B. burgdorferi infection. Positive/equivocal results require second-tier testing (e.g., Western blot). Not for excluding Lyme disease.

Regulatory Classification

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Predicate Devices

• Mardx Lyme Disease EIA (IgM) Test (K894293)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K081362

| Date of Summary | May 13, 2008 | JUN 2 6 2008 |
|---------------------------------|---------------------------------------------------------------------------------------------------|--------------|
| Product Name | Platelia™ Platelia™ Lyme IgM | |
| Sponsor | Bio-Rad<br>3 Boulevard Raymond Poincaré<br>92430 Marnes-la-Coquette<br>France | |
| Correspondent | MDC Associates, LLC<br>Fran White, Regulatory Consultant<br>163 Cabot Street<br>Beverly, MA 01915 | |
| Substantially Equivalent Device | The Platelia™ Lyme IgM Assay is substantially equivalent<br>to the Mardx B. burgdorferi EIA. | |
| | Manufacturer: Mardx Diagnostics, Inc. | |
| | Product: Mardx Lyme Disease EIA (IgM) Test - | |

K894293

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<br>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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#### 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<br>Criteria | Hemoglobin | Bilirubin | Triolein | Albumin |
|----------------------|------------------------|------------|-----------|----------|---------|
| Slope (a) | $0.85< a <1.15$ | 0.907 | 0.916 | 0.889 | 0.893 |
| Y axis intercept (b) | $<0.10$ | 0.071 | 0.050 | 0.061 | 0.073 |
| Correlation coeff | $>0.975$ | 0.999 | 0.999 | 0.997 | 0.999 |
| a+b | $0.85< a+b <1.15$ | 0.978 | 0.966 | 0.950 | 0.966 |

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Image /page/5/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 a rounded rectangle shape with the words "BIO-RAD" in white letters on a black background. The font is bold and sans-serif.

:

### CDC Lyme Disease Serum Panel

| Time<br>from<br>onset | Platelia™ Lyme IgM | | | | Western Blot IgM | | | |
|-----------------------|--------------------------|----------|--------|--------------------------------------------------|------------------|----------|-------|--------------------------------------------------|
| | Positive or<br>equivocal | Negative | Total | %<br>agreement<br>with clinical<br>diagnosis (1) | Positive | Negative | Total | %<br>agreement<br>with clinical<br>diagnosis (1) |
| Normals | 1 | 4 | 5 | 80.0%<br>(4/5) | 0 | 5 | 5 | 100.0%<br>(5/5) |
| 0-1<br>Month | 4 | 1 | 5 | 80.0%<br>(4/5) | 3 | 2 | 5 | 60.0%<br>(3/5) |
| 1-2<br>Months | 6 | 2 | 8 | 75.0%<br>(6/8) | 7 | 1 | 8 | 87.5%<br>(7/8) |
| 3-12<br>Months | 14 | 3 | 17 (2) | 82.4%<br>(14/17) | 6 | 12 | 18 | 33.3%<br>(6/18) |
| > 1 Year | 4 | 4 | 8 | 50.0%<br>(4/8) | 3 | 5 | 8 | 37.5%<br>(3/8) |
| Total | 29 | 14 | 43 (2) | 74.4%<br>(32/43) | 19 | 25 | 44 | 54.5%<br>(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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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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Page 2 -

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 [phone] or [phone] 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

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#### 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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