(16 days)
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No
The summary describes a change to a preservative system in an enzyme immunoassay and does not mention any AI or ML components.
No
The device is an enzyme immunoassay for the qualitative detection of Chlamydia, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "enzyme immunoassay intended for use in the qualitative detection of Chlamydia," which is a method for identifying the presence of a disease-causing agent, indicating its use in diagnosing Chlamydia infection.
No
The device description clearly indicates it is an enzyme immunoassay (EIA), which is a laboratory test involving physical reagents and procedures, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of Chlamydia in female endocervical, male urethral, male urine and ocular specimens." This describes a test performed on samples taken from the human body to provide information about a disease state (Chlamydia infection).
- Device Description: The description details an "enzyme immunoassay," which is a common type of in vitro diagnostic test.
- Anatomical Site: The specified anatomical sites (endocervical, urethral, urine, ocular) are all sources of biological specimens.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
LJC
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
female endocervical, male urethral, male urine, ocular
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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,
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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)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Woody Dulaes
Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number .