STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS

K972030 · Oxoid , Ltd. · JWX · Sep 8, 1997 · Microbiology

Device Facts

• Record ID: K972030
• Device Name: STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
• Applicant: Oxoid , Ltd.
• Product Code: JWX · Microbiology
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Indications for Use

Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.

Device Story

Staphytect Plus and Dryspot Staphytect Plus are in vitro diagnostic latex agglutination tests. Used in clinical laboratories to differentiate Staphylococci species. Principle of operation involves detecting clumping factor, Protein A, and specific capsular polysaccharides associated with MRSA. The presence of these markers causes visible agglutination of latex particles, providing a qualitative result to the clinician. This aids in the rapid identification of specific Staphylococci strains, facilitating appropriate clinical management and infection control decisions.

Technological Characteristics

Latex agglutination test; utilizes latex particles sensitized to detect clumping factor, Protein A, and specific capsular polysaccharides.

Indications for Use

Indicated for the differentiation of Staphylococci possessing clumping factor, Protein A, and specific capsular polysaccharides (including MRSA strains) from those lacking these markers.

Regulatory Classification

Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andy Hollingsworth QS Manaqer Oxoid Limited Wade Road Basingstoke Hants RG24 8PW ENGLAND

SEP - 8 1997

Re : K972030/S1 Staphytect Plus/Dryspot Staphytect Plus Trade Name: Requlatory Class: I Product Code: JWX Dated: Auqust 22, 1997 Received: August 22, 1997

Dear Mr. Hollingsworth:

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 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 requirement, 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 Failure to comply with the GMP regulation may result in assumptions. 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 [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

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## 510(k) Submission for Oxoid

## Staphytect Plus and Dryspot Staphytect Plus

510(K) Number : Unknown

Staphytect Plus Device Name : Dryspot Staphytect Plus

## Indications for Use :

Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.

Ade P

510(k) Num

✓ For Prescription Use