MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA by DADE BEHRING, INC.

The Syva MicroTrak II Chlamydia EIA is a n enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens. The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist

Device Description

The Syva MicroTrak II Chlamydia EIA has been modified in that the preservative system in the Enzyme/Antibody reagent has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci. The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system.

AI/ML Overview

The provided text describes a 510(k) submission for a device modification, specifically a change in the preservative system of the Syva MicroTrak II Chlamydia EIA. The core statement in the summary is: "The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system."

This indicates that the acceptance criteria for this modification are that the new device's performance is non-inferior or substantially equivalent to the previous version of the device. The study would have demonstrated that the change in preservative did not adversely affect the analytical performance (sensitivity, specificity, accuracy) of the EIA.

However, the provided text does not contain the detailed study information required to fill out the requested table and answer all questions comprehensively. It only states that the performance characteristics were not affected.

Based on the available information, here's what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Modified Device vs. Unmodified Device)
Primary Goal: Maintain equivalent performance characteristics (sensitivity, specificity, accuracy) to the unmodified device.	"meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system."
Secondary Goal: Meet USP Challenge test requirements for the preservative system.	The modified preservative system "has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci."

Study Details (Based on Inference and Missing Information)

Since this is a 510(k) for a device modification, the study would primarily be a comparative study demonstrating that the modified device performs equivalently to the predicate (unmodified) device.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. A typical comparative study for an EIA would involve a sufficient number of positive and negative clinical samples to demonstrate equivalent analytical performance.
- Data Provenance: Not specified in the provided text (e.g., country of origin of the data, retrospective or prospective). Historically, such studies often involve multi-center prospective or retrospective clinical sample testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not specified. For Chlamydia EIA, ground truth is typically established by:
  - Confirmatory laboratory methods (e.g., PCR, culture, or another validated reference method) on the same samples.
  - Clinical diagnosis, sometimes supplemented by expert adjudication if discordant results occur.
- The term "experts" in the context of establishing ground truth for an in vitro diagnostic (IVD) device like an EIA usually refers to the reference method itself and the laboratory personnel performing and interpreting the reference tests, rather than clinical experts adjudicating images.
Adjudication Method for the Test Set:
- Not specified. If there were discrepancies between the EIA results and the ground truth method(s), an adjudication process would typically involve retesting or further confirmatory testing to resolve conflicts. The specific method (e.g., 2+1) is not mentioned.
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. This device is an Enzyme Immunoassay (EIA) for the qualitative detection of Chlamydia. It is an in vitro diagnostic (IVD) device, not an imaging device or an AI-based diagnostic tool that would involve human readers interpreting AI outputs. Therefore, an MRMC study is not applicable.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. An EIA device, by its nature, is a standalone analytical test. Its performance (sensitivity, specificity, accuracy) is determined by the reaction occurring in the MTP-wells, the spectrophotometric reading, and the interpretation criteria. There is no "human-in-the-loop" once the assay is run and read, other than the initial sample preparation and final interpretation of the numerical results against established cutoffs. The "algorithm" here is the assay's chemistry and readout interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but for Chlamydia EIA, the ground truth would most likely be established by confirmatory laboratory methods such as:
  - Nucleic Acid Amplification Tests (NAATs) like PCR.
  - Cell culture (historically a gold standard for Chlamydia).
  - Potentially, a combination of clinical diagnosis and a reference laboratory method for discordant results.
The Sample Size for the Training Set:
- Not applicable as this is an EIA, not a machine learning or AI-based device that requires a training set in the typical sense. The "training" for an EIA occurs during its initial design, optimization, and validation by the manufacturer using internal characterization studies, not through external data sets in an AI context.
How the Ground Truth for the Training Set was Established:
- Not applicable for the reasons mentioned above.

Summary

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0 10388 JUL Summary: "Special (510): Device Modification" Syva MicroTrak II Chlamydia EIA K982210 July 02, 1998 Addendum

The Syva MicroTrak II Chlamydia EIA has been modified in that the preservative system in the Enzyme/Antibody reagent has been changed to meet USP Challenge test requirements and to be effective against pseudomonads and staphylococci. The modified preservative system meets those design requirements without affecting the performance characteristics, claims, and labeling of the assay as compared to the product with the unmodified preservative system.

Paul Rogers, Sr. Mgr. Regulatory Affairs,

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Image /page/1/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 caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded design. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

9 1998 JUL

Paul Rogers Senior Manager, Regulatory Affairs Dade Behring, Inc. P.O. Box 49013 San Jose, CA 95161-9013

Re: K982210

Trade Name: Syva Micro Trak II Chlamydia EIA Regulatory Class: I Product Code: LJC Dated: June 22, 1998 Received: June 23, 1998

Dear Mr. Rogers:

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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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 Autman

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 (if known):

Syva MicroTrak II Chlamydia EIA Device Name:

Indications For Use: The Syva MicroTrak II Chlamydia EIA is a n enzyme immunoassay intended for use in the qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens.

The assay may be used to detect the presence of chlamydia where infection is suspected or likely to exist

(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 Dulaes

Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number .

Regulation Number and Section

§ 866.3120 Chlamydia serological reagents.

(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).