For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

Device Description

The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

AI/ML Overview

The provided 510(k) summary for the "Borrelia burgdorferi IgG/IgM ELISA Kit" details performance characteristics but does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or precision that the device had to meet for clearance. Instead, it presents the device's performance results across various studies and implies that these results were considered acceptable by the FDA for substantial equivalence to a predicate device.

However, based on the presented data, we can infer the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria were not explicitly stated, the reported performance is presented as demonstrated.

Performance Metric	Inferred Acceptance Criteria (Implicit)	Reported Device Performance (Is-EIA)
Clinical Sensitivity (CDC Panel)	Sufficient agreement with characterized sera, particularly for later stages of infection. The predicate device's performance likely served as the benchmark.	70.2% overall agreement (equivocal treated as positive). Specifically: 100% agreement for >1 Yr, 60% for 3-12 Months, 55.6% for 1-2 Months, 60% for <1 Month.
Clinical Sensitivity (Wisconsin Lab)	Sufficient agreement with characterized Lyme sera, particular for later stages of infection.	80.6% overall agreement (equivocal treated as positive). Specifically: 100% agreement for >1 Yr, 100% for 3-12 Months, 76.9% for 1-2 Months, 74.4% for <1 Month.
Clinical Specificity (CDC Panel)	100% agreement for negative samples.	100% agreement for 5 known negative samples.
Prospective Study (WB Positive)	Demonstrated ability to identify Western Blot positive cases among EIA positive/equivocal results, performing comparably or better than existing methods.	78.6% of Is-EIA positive/equivocal results were confirmed by Western Blot (11/14), compared to 38.9% for another commercial EIA (14/36).
Precision (Intra-assay CV)	Consistency (low coefficient of variation) across multiple runs at different sites. Numerical thresholds for CV are not stated but generally, lower CVs are desirable.	Generally low CVs for positive samples (e.g., Site 1: 5.00% to 10.55%; Site 2: 3.51% to 8.80%; Site 3: 3.64% to 7.01%). Higher CVs for negative (e.g., Site 1: 14.78% to 22.30%).
Precision (Inter-assay CV)	Consistency (low coefficient of variation) across different runs and sites.	Generally low CVs for positive samples (e.g., Site 1: 9.62% to 12.52%; Site 2: 8.26% to 11.64%; Site 3: 5.21% to 6.79%). Higher CVs for negative (e.g., Site 1: 19.20% to 20.68%).
Cross-Reactivity	Minimal false positives or equivocal results with potentially cross-reactive sera.	Few positive or equivocal results observed with various cross-reactive conditions (e.g., RPR+, ds-DNA+, Lipemic+, EBV+, CMV+ etc.). Specific counts provided in Table 7.
Automated vs. Manual Correlation	High correlation coefficient between automated and manual testing methods.	Pearson Correlation Coefficient of 0.991 between manual and MAGO Plus results.
Automated Precision (Intra/Inter CV)	Consistency (low coefficient of variation) when performed on the automated platform.	Similar to manual precision, generally low CVs for positive samples (e.g., Intra-assay: 4.39% to 11.53%; Inter-assay: 7.05% to 10.66%). Higher CVs for negative (e.g., Intra-assay: 15.06% to 37.16%; Inter-assay: 26.90% to 35.59%).

2. Sample Sizes and Data Provenance

Clinical Sensitivity and Specificity (Test Set 1 - CDC Panel):
- Sample Size: 47 sera (8 >1 Yr, 20 for 3-12 Months, 9 for 1-2 Months, 5 for <1 Month, 5 Negatives).
- Data Provenance: Obtained from the CDC (Centers for Disease Control and Prevention), tested by Diamedix Corp. Retrospective.
Clinical Sensitivity and Specificity (Test Set 2 - Wisconsin Lab Panel):
- Sample Size: 72 sera (3 >1 Yr, 13 for 3-12 Months, 13 for 1-2 Months, 43 for <1 Month).
- Data Provenance: Obtained from a clinical laboratory in Wisconsin, assayed by Diamedix. Retrospective.
Prospective Sample Study (Test Set 3):
- Sample Size: 173 prospective sera.
- Data Provenance: From patients of various ages and gender from an endemic area, submitted to a clinical laboratory for B. burgdorferi antibody testing. Prospective.
Precision Studies (Manual & Automated):
- Sample Size: 6 sera (4 positive, 2 negative) for each site's manual precision (tested 10 times in 3 runs).
- Sample Size: 6 sera (4 positive, 2 negative) for automated precision (tested 10 times in 3 runs).
- Data Provenance: Not explicitly stated, but likely laboratory-prepared control samples for an in-house study.
Specificity with Potentially Cross-Reactive Sera (Test Set 4):
- Sample Size: Total not explicitly given, but individual groups are: 20 RPR+, 15 ds-DNA+, 5 RF+, 5 Lipemic+, 5 Bilirubin+, 4 Elevated ESR, 5 Elevated CRP, 7 EBV+, 6 CMV+, 4 Rocky MT Spotted Fever (total 76 unique samples, assuming no overlap).
- Data Provenance: Not explicitly stated, likely sourced from clinical laboratories or specialized panels.
Correlation of Manual and MAGO Plus Results:
- Sample Size: 296 sera.
- Data Provenance: Not explicitly stated, but implies concurrent testing of patient samples or a diverse set of samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications for establishing ground truth.

For the CDC Panel and Wisconsin Lab Panel: The sera are described as "characterized sera" or "sera with a clinical diagnosis of Lyme disease." This implies that the diagnosis was established by clinicians or epidemiologists based on clinical presentation and potentially other laboratory tests, but expert qualifications are not detailed.
For the Prospective Study: The ground truth for positive and equivocal EIA results was established by "testing with a Western Blot method." The interpretation of Western Blot results usually involves adherence to standardized criteria, which are often overseen by qualified laboratory personnel, but no specific number or qualifications of experts are given.

4. Adjudication Method for the Test Set

Clinical Sensitivity and Specificity (CDC & Wisconsin Panels): The samples were "characterized." No explicit adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies in these panels. However, a key point is mentioned: "Note that equivocal samples were considered positive for the above calculations due to the fact that all equivocal samples would be tested by immunoblotting in a 2-step system." This reflects a specific decision logic for the primary analysis.
Prospective Sample Study: Positive and equivocal results from both EIAs were "supplemented by testing with a Western Blot method." This acts as the confirmatory or adjudicating test for initial EIA findings. No human adjudicators for the Western Blot results are mentioned; it's implied that the Western Blot itself serves as the definitive test in a two-step algorithm.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is an ELISA kit, which is a laboratory assay for detecting antibodies, not an imaging or diagnostic AI algorithm that humans interact with to make decisions. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this type of device.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire clinical sensitivity and specificity evaluation, prospective sample study, precision study, and cross-reactivity study demonstrate the performance of the "Borrelia burgdorferi IgG/IgM ELISA Kit" as a standalone diagnostic assay. The results presented are exclusively based on the device's output. The "correlation of Manual and MAGO Plus Results" section also shows the device's performance in both manual and automated standalone modes.

7. Type of Ground Truth Used

Expert Consensus/Clinical Diagnosis/Reference Method (with further confirmation):
- Clinical Sensitivity/Specificity Panels (CDC & Wisconsin): "Characterized sera" with a "clinical diagnosis of Lyme disease" and "normal sera." This implies a ground truth established by clinical diagnosis and possibly backed by other diagnostic markers.
- Prospective Study: The primary ground truth for confirmation for an EIA result was a standardized Western Blot procedure. This is a commonly accepted reference method for Lyme disease serology in a two-tier testing algorithm.
- Specificity with Potentially Cross-Reactive Sera: Ground truth was based on the "laboratory results" for specific conditions (e.g., RPR+, ds-DNA+), meaning a confirmed diagnosis of those conditions or positive results on tests for those conditions.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. As this is an ELISA kit (a chemical/biological assay), the concept of a separate training set as used in AI development is not directly applicable.

However, if "training set" is implicitly referring to the samples used during the development and optimization of the assay before formal clinical validation, that information is not provided in this 510(k) summary. The presented data falls under validation and verification studies.

9. How the Ground Truth for the Training Set Was Established

As no explicit "training set" distinct from the validation/test sets is mentioned for an AI/machine learning context, the method for establishing ground truth for such a set is not detailed. The ground truth for the validation sets (as described in point 7) was established through clinical characterization and standardized Western Blot testing.

Summary

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K98365

510k Summary of Safety and Effectiveness

s summary of 510(k) safety and effectiveness information is being submitted in accordance with the . Juirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Applicant Information:

Date Prepared:	Oct 11, 1998
Name:	Columbia Bioscience, Inc.
Address:	8775 M Centre Park Drive, #559
	Columbia, MD 21045

Contact Person:	Norman Jenkins
PhoneNumber.	410-995-0450
Fax Number.	410-995-0448

Device Information:

Trade Name:	Borrelia burgdorferi IgG/IgM ELISA Kit
Common Name.	Borrelia burgdorferi EIA Test
Classification Name;	Borrelia Serological Reagent

livalent Device: Jus Lyme Elisa

Device Description: The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

Intended Use: For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia bargdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

Principle of Procedure:

The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzymelinked immunosorbent assay to detect IgG/IgM to Borrelia burgdorferi in human serum. Partially purified Borrelia burgdorferi antigen is attached to a solid phase (microtiter well). Diluted test sera an added to each well. If antibodies which recognize the, Borrelia burgdorferi antigen are present in the patient sample they will bind to the antigen in the well. After incubation, the wells are washed to remove unbody. An enzyme labeled anti-human immunoglobulin (conjugate)

the to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme

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is present from prior step, the reaction is stopped and the, color intensity is measured photometrically producing an indirect detection of the specific antibody present in the patient sample.

rformance Characteristics

1. Clinical Sensitivity and Specificity :

The lollowing information is from a panel of characterized sera obtained from the CDC (Centers for Disease Control and Prevention) r no toned by Diamedix Corp. using the Is-anti B.burgdorferi IgG/IgM Test Kit. The panel consists of 5 normal sera with . clinical diagnosis of Lyme disease and obtained at different times from onset of disease. The results are means to convey further information on the performance of the assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC. Table I illustrates the performance of the assay with this serum panel.

Elapsed TimeFrom Onset	Positive	Equiv.	Negative	Total	% Agreement
> 1 Yr	8	0	0	8	100.0%
3 - 12 Months	9	3	8	20	60.0%
1 - 2 Months	4	1	4	9	55.6%
<1 Month	3	0	2	5	60.0%
Negatives	0	0	5	5	100.0%
Total	24	4	19	47	70.2%

Table 1 : Results of the CDC Serum Panel Stratified by Time After Onset

Note that equivocal samples were considered positive for the above calculations due to the fact that all equivocal samples would be : ested by immunoblotting in a 2-step system.

: following information is from a panel of characterized sera obtained from a clinical lab in Wisconsin and assayed by Diamedix o using the Is-ani B.burgdorferi IgG/IgM Test Kit. The panel consists of 72 sera with a clinical diagnosis of Lyme disease and otained at different times from onset of disease. Table 2 illustrates the performance of the assay with this serum panel.

Table 2 . Results of the Characterized Lyme Sera Stratified by Time After Onset

Elapsed TimeFrom Onset	+	E	-	Total	% Agreement
> 1 Yr	3	0	0	3	100%
3 - 12 Months	11	2	0	13	100%
1 - 2 Months	8	2	3	13	76.9%
<1 Month	24	8	11	43	74.4%
Total	46	12	14	72	80.6%

Note that equivocal samples were considered positive for the above calculations due to the fact that all equivocal samples would be tested by immunoblotting in a 2-step system.

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2. Prospective Sample Study

^ ye hundred and seventy three prospective sera from patients of various ages and gender from an endemic area that were submitted to Inical laboratory for B. burgdorferi antibody testing were assayed using the Is-anti-B. burgdorferi IgG/IgM test kit and another nmercially available EIA kit. Positive and equivocal results from both assays were supplemented by testing with a Western Blot method. Table 3, and the summary that follows, shows the prevalence of positive and equivocal results obtained in both EIAs (firststep) and percentage of these sera positive by the Western Blot method (second-step).

		Western Blot
		Pos	Neg
Is-EIA	Pos	7	2
	Equiv	4	1

OtherEIA	Pos	11	12
	Equiv	3	10

Table 3 : Prospective Sample Study Results

The results from Table 3 are summarized as follows :

Result	Is-EIA	(95% CI)	Other EIA	(95% CI)
EIA Pos. or Equiv.	14/173 = 8.09%	(3.95-12.20%)	36/173 = 20.8%	(14.6-27.0%)
Pos. or Equiv.Western Blot Pos.	11/173 = 6.36%	(2.65-10.07%)	14/173 = 8.09%	(3.95-12.24%)
% Western Blot Pos.among EIA Pos. or Equiv.	11/14 = 78.6%	(56.6%-100%)	14/36 = 38.9%	(22.64-55.14%)

3. Precision

To determine the precision of the Is-ani-B burgdorferi IgGllgM Test Kit, four positive and two negative sera were assayed ten times each in three different runs at three different sites. The intra- and interassy precision obtained at each site is shown in Tables 4, 5 and ().

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TABLE 4 : Is-anti-B. burgdorferi IgG/IgM Precision Site 1

RUN 1			RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	1.31	6.03%	1.38	10.55%	1.20	6.80%	1.29	9.80%
2 (POS)	1.40	6.86%	1.49	5.03%	1.24	6.31%	1.38	9.62%
3 (POS)	1.34	8.17%	1.42	6.07%	1.19	4.49%	1.32	9.69%
4 (POS)	2.26	5.00%	2.36	5.98%	1.82	7.53%	2.15	12.52%
5 (NEG)	0.20	16.26%	0.24	22.30%	0.20	14.76%	0.21	20.68%
6 (NEG)	0.16	14.78%	0.17	21.19%	0.20	15.81%	0.18	19.20%
						CAL	0.97	12.81%
						PC	1.29	11.06%
						NC	0.29	11.95%

$11 = 30$
PC and NC	$n = 3$
CAL	$n = 9$

TABLE 5 : Is-anti-B. burgdorferi IgG/IgM Precision Site 2

RUN 2

RUN 1

RUN 3

INTER ASSAY

SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
(POS)	1.34	6.19%	1.24	6.18%	1.19	8.13%	1.25	8.26%
2 (POS)	1.52	8.80%	1.36	3.51%	1.33	5.18%	1.40	8.55%
3 (POS)	1.50	8.56%	1.28	7.50%	1.26	9.53%	1.35	11.64%
4 (POS)	2.60	4.81%	2.30	7.27%	2.27	6.56%	2.39	8.66%
5 (NEG)	0.21	18.40%	0.20	12.31%	0.20	8.72%	0.20	13.38%
6 (NEG)	0.15	9.21%	0.14	14.02%	0.15	16.87%	0.15	13.51%
						CAL	1.00	3.22%
						PC	1.42	8.54%
						NC	0.33	6.34%

n = 30 PC and NC n = 6 (`AL n = 9

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TABLE 6 : Is-anti-B. burgdorferi IgG/IgM Precision Site 3

	RUN 1		RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	1.27	5.54%	1.31	3.64%	1.35	4.86%	1.31	5.21%
2 (POS)	1.42	4.55%	1.44	6.30%	1.49	6.84%	1.45	6.18%
3 (POS)	1.36	7.01%	1.40	6.80%	1.42	6.69%	1.39	6.79%
4 (POS)	2.26	5.64%	2.29	5.58%	2.31	6.77%	2.29	5.91%
5 (NEG)	0.22	15.92%	0.22	12.49%	0.23	18.81%	0.23	15.45%
6 (NEG)	0.18	6.84%	0.16	5.67%	0.17	8.49%	0.17	8.70%
						CAL	1.00	8.04%
						PC	1.39	7.19%
						NC	0.33	12.37%

n = 30 PC and NC n = 3 CAL n = 9

4. Specificity with Potentially Cross-Reactive Sera

To evaluate the performance of the Is-anti-B.burgdorferi IgGl1gM Test Kit with potentially cross reactive sera, a group of sera with laboratory results that may cross-react or interfere with the assay were tested. Table 7 summarizes the results obtained.

ﺳﺴﺴﺴ

Laboratory Test	Lab Results	N	# equivocal	# positive
RPR +	1:2 - 1:32	20	7	1
ds-DNA +	52 - 1072 IU	15	0	1
RF +	245 - 338 IU	5	0	0
Lipemic +	+++	5	1	1
Bilirubin +	2.8 - 11.2 mg/dl	5	0	0
Elevated ESR	43-78	4	0	0
Elevated CRP	4.2-22.2 mg/dl	5	0	0
EBV +	+	7	1	1
CMV +	0.72 - 2.31 OD	6	2	1
Rocky MT Spotted Fever	1:64 G	4	0	0

Table 7 : Results with Potentially Cross-Reactive Sera.

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5. Correlation of Manual and MAGO Plus Results

s ls-anti-B.burgdorferi IgG/IgM Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence ne manual and MAGO Plus procedures, the results of 296 sera tested by both methods were plotted. Figure 3 illustrates the correlation between manual and MAGO Plus results. The data indicate good correlation with a Pearson Correlation Coefficient of 0.991.

Image /page/5/Figure/2 description: This image is a scatter plot comparing Mago Plus Index Values to Manual Index Values. The x-axis represents Manual Index Values, ranging from 0.00 to 8.00, while the y-axis represents Mago Plus Index Values, also ranging from 0.00 to 8.00. The data points are clustered tightly along a diagonal line, indicating a strong positive correlation between the two sets of index values. The correlation coefficient, r, is given as 0.991, further supporting the strong positive relationship.

Image /page/5/Figure/3 description: The image shows the title of a figure. The title is "Figure 3 : Correlation of Mago Plus and Manual Results". The title is written in a bold, sans-serif font.

Mago Plus Precision 6.

The precision of the assay when performed on the Mago Plus Automated EIA Processor was determined by assaying 6 sera 10 times each in three different runs. Table 8 shows the intra-and interassay precision obtained using the MAGO Plus.

	RUN 1		RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	1.11	6.65%	1.15	8.45%	1.30	8.11%	1.19	10.32%
2 (POS)	1.31	9.82%	1.39	6.30%	1.51	5.80%	1.41	9.26%
3 (POS)	1.24	11.53%	1.28	4.94%	1.47	5.60%	1.33	10.66%
4 (POS)	2.13	5.88%	2.29	5.39%	2.40	4.39%	2.27	7.05%
5 (NEG)	0.14	36.89%	0.19	16.64%	0.21	15.06%	0.18	26.90%
6 (NEG)	0.11	28.75%	0.13	37.16%	0.18	23.42%	0.14	35.59%
						CAL	0.98	9.67%
						PC	1.23	4.68%
						NC	0.3	0.00%

TABLE 8 : MAGO Plus Is-anti-B. burgdorferi IgG/IgM Precision

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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 6 1998

Norman Jenkins President Columbia Bioscience, Inc. 8775 M Centre Park Drive #559 Columbia. MD 21045

Re: K983605

Trade Name: Is-Borrelia burgdorferi IgG/IgM ELISA Test Regulatory Class: II Product Code: LSR Dated: October 11, 1998 Received: October 14, 1998

Dear Mr. Jenkins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: not known

Device Name: Borrelia burgdorferi IgG/IgM ELISA Test

Indications For Use: For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot Positive supplemental results are supportive evidence of exposure to B. procedure. burgdorfer i and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Y (Per 21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

Woody Dubois

on of Clinical Laboratory Devices 510(k) Number

Regulation Number and Section

§ 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).