(162 days)
The OSOM® Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A streptococcal antigen directly from throat swab specimens.
The OSOM® Strep A Test is a color immunochromatographic assay.
This document is a 510(k) clearance letter from the FDA for the OSOM® Ultra Strep A Test. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study proving the device meets acceptance criteria, or any of the specific information requested in your prompt.
The letter is primarily focused on confirming the regulatory clearance for the device and outlining the manufacturer's ongoing responsibilities. It mentions the "indications for use" as an enclosure, but this enclosure (Attachment #1) only describes what the device is for (qualitative detection of Group A streptococcal antigen from throat swab specimens) and not the performance criteria or study results.
Therefore, based solely on the provided document, I cannot answer your questions regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the 510(k) submission itself or in a summary document within that submission, not in the clearance letter.
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JAN 1 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Shu-Ching Cheng VP Operations Wyntek Diagnostics, Inc. 6146 Nancy Ridge Drive San Diego, California 92121
K992658 Re: Trade Name: OSOM® Ultra Strep A Test Regulatory Class: I Product Code: GTY Dated: November 22, 1999 Received: November 23, 1999
Dear Ms. Cheng:
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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Attachment #1
Device Indications For Use
510 (k) Number: K992658
Device Name: OSOM®Ultra Strep A Test
Indication For Use:
The OSOM® Strep A Test is a color immunochromatographic assay intended for the The OSOM® Strep A Test is a color inimunouncentually from throat swab
qualitative detection of Group A streptococcal antigen directly from throat swab specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992658
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.