For the qualitative presumptive detection of 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.

The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Borrelia burgdorferi IgM ELISA Kit, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative or numerical format (e.g., "Sensitivity must be >X%"). Instead, it presents performance data for comparison against other methods or expected clinical behavior. For example, it provides agreement percentages with characterized serum panels and precision values.

Therefore, the table below will summarize the provided performance characteristics rather than predefined acceptance criteria. The implied acceptance is that these performance characteristics are adequate for the intended use and comparable to similar devices (as suggested by the substantial equivalence to "Zeus Lyme Elisa").

Performance Metric	Reported Device Performance
Clinical Sensitivity (CDC Panel)	40.4% agreement (equivocals considered positive) overall
> 1 Yr from onset	12.5% agreement
3 - 12 Months from onset	45.0% agreement
1 - 2 Months from onset	33.3% agreement
< 1 Month from onset	20.0% agreement
Clinical Specificity (CDC Panel)	100.0% agreement in negatives (5/5)
Clinical Sensitivity (Wisconsin Panel)	81.9% agreement (equivocals considered positive) overall
> 1 Yr from onset	66.7% agreement
3 - 12 Months from onset	84.6% agreement
1 - 2 Months from onset	69.2% agreement
< 1 Month from onset	86.1% agreement
Prospective Study (EIA Pos. or Equiv.)	2.89% (5/173)
Prospective Study (EIA Pos. or Equiv. and Western Blot Pos.)	0.58% (1/173)
Prospective Study (% Western Blot Pos. among EIA Pos. or Equiv.)	20% (1/5)
Intra-assay Precision (CV)	Range: 9.89% - 17.23% (across sites, positive and negative sera)
Inter-assay Precision (CV)	Range: 11.23% - 30.41% (across sites, positive and negative sera)
Cross-Reactivity	Mostly 0 positive/equivocal results in various cross-reactive panels (1 equivocal in RPR+, 1 equivocal/1 positive in EBV+)
Manual vs. MAGO Plus Correlation	Pearson Correlation Coefficient: 0.973
MAGO Plus Intra-assay Precision (CV)	Range: 6.70% - 35.14% (across runs, positive and negative sera)
MAGO Plus Inter-assay Precision (CV)	Range: 10.72% - 23.79% (across runs, positive and negative sera)

Study Information

Sample size used for the test set and the data provenance:
- Clinical Sensitivity and Specificity (CDC Panel):
  - Test set size: 47 sera (42 Lyme disease, 5 normal).
  - Data provenance: Characterized sera obtained from the CDC (Centers for Disease Control and Prevention). This suggests the data may be retrospective, well-characterized samples collected for reference.
- Clinical Sensitivity (Wisconsin Panel):
  - Test set size: 72 sera with a clinical diagnosis of Lyme disease.
  - Data provenance: Characterized sera obtained from a clinical lab in Wisconsin. Likely retrospective.
- Prospective Sample Study:
  - Test set size: 173 prospective sera.
  - Data provenance: Sera from patients of various ages and gender from an endemic area, submitted to a clinical laboratory for B. burgdorferi antibody testing. This indicates prospective collection.
- Precision Studies (Manual and MAGO Plus):
  - 6 sera (4 positive, 2 negative) tested 10 times each in 3 different runs at 3 different sites (for manual precision).
  - 6 sera tested 10 times each in 3 different runs (for MAGO Plus precision).
  - Data provenance: Not explicitly stated, but likely laboratory-prepared or reference sera.
- Specificity with Potentially Cross-Reactive Sera:
  - N varies for each condition, totaling around 71 sera.
  - Data provenance: Sera with specific laboratory results that may cross-react or interfere.
- Correlation of Manual and MAGO Plus Results:
  - Test set size: 294 sera.
  - Data provenance: Not explicitly detailed, but likely a mix of clinical samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing the ground truth.
- For the CDC panel, it states "characterized sera obtained from the CDC," implying a robust characterization process, but details on experts are absent.
- For the Wisconsin panel, it mentions "characterized sera obtained from a clinical lab" with a "clinical diagnosis of Lyme disease," again, without specific expert details.
- For the prospective study, "Western blot method" was used as a supplemental second-step, which is a standardized diagnostic procedure, but expert interpretation of these results beyond the standard protocol is not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for establishing the primary ground truth of the test sets. Ground truth appears to be based on pre-characterized panels (CDC, Wisconsin) or a combination of clinical context and Western Blot results (prospective study).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done, as this is a serological assay (ELISA) and not an AI-assisted diagnostic device requiring human reader interpretation in the context described by MRMC.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics (clinical sensitivity/specificity, precision, cross-reactivity) are all standalone performance metrics of the ELISA kit itself. The "MAGO PLUS Automated EIA Processor" represents an automated method, and its correlation and precision studies are also standalone evaluations of the device's performance when automated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- CDC Panel: "Clinical diagnosis of Lyme disease" for positives, and "normal sera" for negatives. This suggests a combination of clinical findings, potentially confirmed by other reference tests at the CDC, forming a characterized reference standard.
- Wisconsin Panel: "Clinical diagnosis of Lyme disease." This is primarily a clinical diagnosis standard.
- Prospective Study: A two-step diagnostic algorithm where equivocal or positive ELISA results were supplemented by a standardized Western blot method. "Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease." This forms a hybrid ground truth involving the primary test, a confirmatory test, and clinical context.
The sample size for the training set:
- The document does not describe a separate "training set" in the context of machine learning or AI. This is a traditional diagnostic kit, and the performance studies evaluate the kit directly using characterized and prospective samples. There is no mention of an algorithm being "trained."
How the ground truth for the training set was established:
- As there is no mention of a training set for an algorithm, this question is not applicable.

Summary

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DEC 1 6 1998

KC983606

510k Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements 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, #559Columbia, MD 21045

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

Device Information:

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

Equivalent Device: Zeus Lyme Elisa

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

Intended Use: For the qualitative presumptive detection of 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 Equivocal or positive results must be supplemented by testing with a standardized Western blot disease. 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 IgM ELISA Kit is an enzymelinked immunosorbent assay to detect IgM to Borrelia burgdorferi in human serum. Partially purified Borrelia burgdorferi antigen is attached to a solid phase (microtiter well). Prediluted test sera an added to each well. If antibodies which recognize the, Borrelia

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

Performance Characteristics

1.Clinical Sensitivity and Specificity :

The following information is from a panel of characterized sera obtained from the CDC (Centers for Disease Control and Prevention) and assayed by Diamedix Corp. using the Is-anti B.burgdorferi IgM Test Kit. The panel consists of 5 normal sera and 42 sera with a clinical diagnosis of Lyme disease and obtained at different times from onset of disease. The results as a 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 1 illustrates the performance of the assay with this serum panel.

Elapsed TimeFrom Onset	Positive	Equiv.	Negative	Total	% Agreement
> 1 Yr	1	0	7	8	12.5%
3 - 12 Months	8	1	11	20	45.0%
1 - 2 Months	3	0	6	9	33.3%
<1 Month	1	0	4	5	20.0%
Negatives	0	0	5	5	100.0%
Total	13	1	33	47	40.4%

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 equivocals samples would be tested by immunoblotting in a 2-step system.

The following information is from a panel of characterized sera obtained from a clinical lab in Wisconsin and assayed by Diamedix Corp. using the Is-anti B.burgdorferi IgM Test Kit. The panel consists 72 sera with a clinical diagnosis of Lyme disease and obtained 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	0	2	1	3	66.7%
3 - 12 Months	9	2	2	13	84.6%
1 - 2 Months	9	0	4	13	69.2%
<1 Month	34	3	6	43	86.1%
Total	52	7	13	72	81.9%

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

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2. Prospective Sample Study

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

		Western Blot
		Pos	Neg
Is-IgM	Pos	0	2
EIA	Equ.	1	2
Other IgG/IgM	Pos	11	12
EIA	Equ.	3	10

Table 3 : Prospective Study Results

The results from Table 3 are summarized as follows :

Result	Is-IgM EIA	(95% CI)	Other IgG/IgM EIA	(95% CI)
EIA Pos. or Equiv.	$5/173 = 2.89%$	(0.34-5.44%)	$36/173 = 20.8%$	(14.6-27.0%)
EIA Pos. or Equiv.and Western Blot Pos.	$1/173 = 0.58%$	(0-1.73%)	$14/173 = 8.09%$	(3.95-12.24%)
% Western Blot Pos.among EIA Pos. or Equiv.	$1/5 = 20%$	(0-55.8%)	$14/36 = 38.9%$	(22.64-55.14%)

3. Precision

To determine the precision of the Is-anti-B burgdorferi IgM Test Kit, four positive and two negative sera were assayed ten times cach in three different runs at three different sites. The intra- and interassay precision obtained at each site is shown in Tables 4, 5 and 6

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RUN 1			RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	2.07	10.51%	2.27	9.89%	2.25	10.92%	2.10	11.23%
2 (POS)	1.38	13.42%	1.19	11.49%	1.26	11.81%	1.23	16.22%
3 (POS)	1.49	14.41%	1.41	9.13%	1.56	9.17%	1.47	13.05%
4 (POS)	1.87	13.85%	1.73	12.56%	1.95	12.16%	1.86	12.70%
5 (NEG)	0.16	14.66%	0.14	14.80%	0.13	17.05%	0.14	23.82%
6 (NEG)	0.10	16.52%	0.13	14.09%	0.13	17.23%	0.12	21.31%
						CAL	0.97	10.89%
						PC	1.42	9.99%
						NC	0.20	10.58%

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

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

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

RUN 1			RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	2.53	8.22%	3.10	8.13%	3.68	9.95%	3.10	17.68%
2 (POS)	1.45	11.69%	1.84	13.86%	2.11	13.86%	1.80	20.12%
3 (POS)	1.77	13.78%	2.09	10.59%	2.77	21.57%	2.21	25.72%
4 (POS)	2.20	8.99%	2.61	12.01%	3.18	8.75%	2.66	18.20%
5 (NEG)	0.16	12.14%	0.15	20.81%	0.19	18.92%	0.17	19.79%
6 (NEG)	0.14	12.90%	0.12	18.75%	0.13	16.37%	0.13	15.94%
						CAL	1.00	6.10%	PC	1.49	4.10%	NC	0.19	20.13%
						CAL	1.00	6.10%
						PC	1.49	4.10%
						NC	0.19	20.13%

n = 30 PC and NC n = 12 n = 18 CAL

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	RUN 1		RUN 2		RUN 3		INTER ASSAY
SERUM	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV	MeanIndex	CV
1 (POS)	1.85	7.11%	2.14	12.14%	2.29	9.74%	2.09	13.14%
2 (POS)	1.07	10.74%	1.23	13.61%	1.22	12.45%	1.17	13.71%
3 (POS)	1.26	10.40%	1.45	15.68%	1.59	4.81%	1.43	14.40%
4 (POS)	1.54	11.02%	1.86	13.04%	1.97	10.62%	1.79	15.26%
5 (NEG)	0.08	17.35%	0.11	29.22%	0.14	15.02%	0.11	30.41%
6 (NEG)	0.11	18.65%	0.10	24.37%	0.10	9.85%	0.10	18.09%
						CAL	1.00	11.82%
						PC	1.46	7.96%
						NC	0.21	11.17%

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

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

4. Specificity with Potentially Cross-Reactive Sera

To cvaluate the performance of the Is-anti-B.burgdorferi IgM 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.

Table 7 : Results with Potentially Cross-Reactive Sera.

Laboratory Test	Lab Results	N	# equivocal	# positive
RPR +	1:2 - 1:32	20	1	0
ds-DNA +	52 - 1072 IU	15	0	0
RF +	245 - 338 IU	5	0	0
Lipemic +	+++	5	0	0
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	0	0
Rocky MT Spotted Fever	1:64 G	4	0	0

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5. Correlation of Manual and MAGO Plus Results

The Is-anti-B.burgdorferi IgM Test Kit has been developed for automated as well as manual use. To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 294 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 Cofficient of 0.973.

Image /page/5/Figure/2 description: This image is a scatter plot that compares MAGO Plus Index Values to Manual Index Values. The x-axis represents the Manual Index Values, ranging from 0.00 to 12.00, while the y-axis represents the MAGO Plus Index Values, ranging from 0.00 to 10.00. The scatter plot shows a positive correlation between the two variables, with most of the data points clustered in the lower-left corner of the plot. The correlation coefficient, r, is 0.973, indicating a strong positive correlation.

Image /page/5/Figure/3 description: The image is a title that reads "Figure 3: Correlation of MAGO Plus and Manual Results". The title is written in a bold, sans-serif font. The text is centered horizontally and vertically within the image. The purpose of the title is to introduce a figure that shows the correlation between MAGO Plus and manual results.

6. MAGO Plus Precision

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)	2.17	13.04%	1.79	8.51%	2.23	6.70%	2.06	13.56%
2 (POS)	1.24	9.47%	1.00	14.14%	1.20	17.57%	1.15	16.47%
3 (POS)	1.59	8.62%	1.32	8.60%	1.61	9.47%	1.51	12.44%
4 (POS)	1.88	6.04%	1.61	7.44%	1.91	9.38%	1.80	10.72%
5 (NEG)	0.12	35.14%	0.10	0.00%	0.10	0.00%	0.11	23.79%
6 (NEG)	0.11	28.75%	0.10	0.00%	0.10	0.00%	0.10	17.67%
						CAL	0.97	9.76%
						PC	1.36	9.33%
						NC	0.19	7.90%

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

PC and NC n = 3 CAL n = 9

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 16 1998

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

Re: K983606

Trade Name: Is-Borrelia burgdorferi 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 OS 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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510(k) Number: K983606

Device Name: Borrelia burgdorferi IgM ELISA Test

Indications For Use: For the qualitative presumptive detection of 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (Per 21 CFR 801. 109)

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

Woody Dubois

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).