OXOID PBP2 1 LATEX AGGLUTINATION TEST

K011710 · Oxoid , Ltd. · MYI · Apr 2, 2002 · Microbiology

Device Facts

• Record ID: K011710
• Device Name: OXOID PBP2 1 LATEX AGGLUTINATION TEST
• Applicant: Oxoid , Ltd.
• Product Code: MYI · Microbiology
• Decision Date: Apr 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

Device Story

The PBP21 Latex Agglutination Test is an in vitro diagnostic kit used in clinical laboratory settings. It detects the presence of penicillin binding protein 2' (PBP2') in Staphylococcus isolates. The test utilizes latex agglutination technology; specific antibodies bound to latex particles react with PBP2' present in the sample, resulting in visible agglutination. This provides a rapid method to assist healthcare professionals in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci. The output is a qualitative visual result (agglutination vs. no agglutination) interpreted by laboratory personnel. This information aids clinicians in confirming methicillin resistance, which informs antibiotic treatment decisions and infection control measures for patients.

Clinical Evidence

No clinical data provided; the submission relies on bench testing for performance validation of the latex agglutination assay.

Technological Characteristics

Latex agglutination assay; utilizes antibody-coated latex particles to detect penicillin binding protein 2' (PBP2'). Manual diagnostic test kit format. No electronic components, software, or connectivity.

Indications for Use

Indicated for the detection of penicillin binding protein 2' in Staphylococcus isolates to aid in the identification of Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke, Hants RG24 8PW England

APR 0 2 2002

Re: k011710

> Trade/Device Name: PBP21 Latex Agglutination Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: MYI Dated: January 29, 2002 Received: January 30, 2002

Dear Mr. Hollingsworth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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 PBP21 Latex Agglutination Test

## Oxoid Ltd

이 위 해 이어 에 대해 대해 이 대 (이 역) 이 역 에 대해 대 대

Unknown (510K) Number :

PBP21 Latex Agglutination Test Device Name :

Indications for Use :

This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

## (PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED).

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|-----------------------------------------|
| Prescription Use | OR | Over the Counter |
| <div style="text-align: left;">✓</div> | | |
| (Division Sign Off) | | |
| Division of Clinical Devices | | (Division Sign-Off) |
| 510(K) Number | | Division of Clinical Laboratory Devices |
| | | 510(k) Number K011710 |

Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England Telephone [phone] Facsimile [phone] Telex 858793 Oxoid G ... .. ... ...