MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA

K982210 · Dade Behring, Inc. · LJC · Jul 9, 1998 · Microbiology

Device Facts

• Record ID: K982210
• Device Name: MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
• Applicant: Dade Behring, Inc.
• Product Code: LJC · Microbiology
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended 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

Device Story

Syva MicroTrak II Chlamydia EIA is an enzyme immunoassay (EIA) for qualitative detection of Chlamydia. Device processes clinical specimens (female endocervical, male urethral, male urine, ocular) to identify presence of Chlamydia. Modification involves updated preservative system in Enzyme/Antibody reagent to meet USP Challenge test requirements for efficacy against pseudomonads and staphylococci. Used in clinical laboratory settings by trained personnel. Output provides qualitative result indicating presence or absence of Chlamydia, aiding clinicians in diagnosing suspected infections.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing confirming that the modified preservative system meets design requirements and does not affect assay performance characteristics.

Technological Characteristics

Enzyme immunoassay (EIA). Modified preservative system in Enzyme/Antibody reagent to meet USP Challenge test requirements for efficacy against pseudomonads and staphylococci.

Indications for Use

Indicated for qualitative detection of Chlamydia in female endocervical, male urethral, male urine, and ocular specimens where infection is suspected or likely.

Regulatory Classification

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 genus Chlamydia 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).

Submission Summary (Full Text)

{0}------------------------------------------------

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,

{1}------------------------------------------------

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.

{2}------------------------------------------------

## 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

{3}------------------------------------------------

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)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)

Woody Dulaes

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