MASTALEX -MRSA, MODEL RST501

K062864 · Mast Group , Ltd. · MYI · Oct 18, 2006 · Microbiology

Device Facts

• Record ID: K062864
• Device Name: MASTALEX -MRSA, MODEL RST501
• Applicant: Mast Group , Ltd.
• Product Code: MYI · Microbiology
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The kit is used in clinical microbiology laboratories on pre-isolated organisms which have already been identified as Staphylococcus aureus, for confirmation of MRSA for epidemiological and research purposes.

Device Story

MASTALEX MRSA is an in-vitro diagnostic rapid slide latex agglutination kit. It detects PBP2' (penicillin binding protein 2'), a product of the mecA gene, to confirm MRSA. Input: pre-isolated Staphylococcus aureus colonies from culture media. Process: organisms are emulsified in extraction reagent, boiled under alkaline conditions, neutralized, and centrifuged; supernatant is mixed with test latex (sensitized with anti-PBP2' monoclonal antibodies) and control latex on a test card. Output: visual agglutination on the test card. Used in clinical microbiology laboratories by trained laboratory personnel. Positive reaction with test latex only indicates presence of PBP2' and presumptive MRSA. Benefits include rapid confirmation of MRSA for epidemiological and research purposes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device being identical to the predicate device (reagents sourced from the same manufacturer).

Technological Characteristics

In-vitro diagnostic latex agglutination kit. Components: 0.1M sodium hydroxide extraction reagent, 0.5M potassium dihydrogen phosphate, latex particles sensitized with anti-PBP2' monoclonal antibodies, and unsensitized control latex. Manual slide-based test format. No electronic or software components.

Indications for Use

Indicated for the confirmation of Methicillin-resistant Staphylococcus aureus (MRSA) in pre-isolated Staphylococcus aureus organisms in clinical microbiology laboratories.

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.

Predicate Devices

• MRSA-SCREEN (K011400)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for MAST GROUP LTD. The logo includes the company name in bold, black letters, along with the company's address: Mast House, Derby Road, Bootle, Merseyside L20 1EA, United Kingdom. The phone number is 0151-933 7277, and the fax number is 0151-944 1332. There is also a handwritten number: K062864.

# 510(k) Summary

0C1 1 8 2006

510(k) Owner: Mast Group Ltd. Mast House Derby Road Bootle Merseyside L20 1EA UK Phone: ( +44 ) 151 944 1332 Fax : Contact: Barbara A Lee, Regulatory Affairs Manager e-mail [e-mail]

## Date prepared: 22nd September 2006

## Name of Device:

- Trade name MASTALEX MRSA .
- Common name In-vitro-diagnostic kit, rapid slide latex kit for . confirmation of Methicillin-resistant Staphylococcus aureus (MRSA).
- . Classification name - System, test, Genotypic Detection, Resistant markers, Staphylococcus colonies. (21 CFR 866.1640, product code MYI)

## Equivalence:

The device is identical to MRSA-SCREEN manufactured by Denka Seiken of Japan, 510(k) number K011400. Mast Group Ltd purchases the unlabelled bottled reagents from Denka Seiken and labels and packs them in the Mast livery. A copy of a letter from Denka Seiken is enclosed at Section 12. confirming the relationship.

Description: Rapid slide latex kit for confirmation of Methicillin-resistant Staphylococcus aureus (MRSA).

The kit tests for the mecA gene coding for methicillin resistance, by detecting its product, PBP2' (penicillin binding protein 2'). Organisms grown on suitable culture medium and believed to be Staphylococcus aureus, are emulsified in an extraction reagent, boiled for a set period of time under alkaline conditions, neutralised and centrifuged. A specified volume of supernatant liquid is mixed with a drop of test latex sensitised with a monoclonal antibody directed against PBP2' and control (unsensitised) latex on a test card. The cards are rotated for a defined length of time and examined for agglutination. A positive reaction observed with the test latex only indicates that the organism contains PBP2' and should be reported as a presumptive methicillin-resistant Staphylococcus aureus (MRSA).

Image /page/0/Picture/13 description: The image contains two logos. The logo on the left is for Lloyd's Register Quality Company and includes the letters 'RQ' inside a circle. The logo on the right features a crown above a checkmark, with the text 'NATIONAL ACCREDITATION OF CERTIFICATION BODIES' below. The certificate number '932114' is printed at the bottom of the image.

Section 5 510(k) Summary Page 1 of 2

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The kit contains

- 1. Extraction Reagent 1 (Green Coloured Cap). Ready to use. 1 x 10ml of 0.1M sodium hydroxide.
- 2. Extraction Reagent 2 (Yellow Coloured Cap). 1 x 2.4ml of 0.5M potassium dihydrogen phosphate.
- 3. Test Latex (Red Coloured Cap). Ready to use. 1 x 1.2ml of latex particles sensitised with anti-PBP2' monoclonal antibodies.
- 4. Control Latex (White Coloured Cap). Ready to use. 1 x 1.2ml of unsensitised latex particles.
- 5. One tin containing 100 single use disposable wooden mixing sticks.
- 6. 1 pack of 24 four-well reaction cards.
- 7. Instruction leaflet.

#### Intended use:

The kit is used in clinical microbiology laboratories on pre-isolated organisms which have already been identified as Staphylococcus aureus, for confirmation of MRSA for epidemiological and research purposes. The intended use is identical to the intended use of the predicate device, MRSA-SCREEN manufactured by Denka Seiken of Japan, 510(k) number K011400.

#### Technological characteristics:

The technological characteristics of the device are identical to those of the predicate device.

#### Performance data

The determination of substantial equivalence is not based on performance data. No comparisons are necessary because the device reagents are identical to the predicate device. The only difference is that the device is marketed in Mast's packaging.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Barbara A. Lee Regulatory Affairs Manager Mast Group Limited Mast House, Derby Road Bootle Merseyside L20 1EA UK

OCT 1 8 2006

Re: k062864 Trade/Device Name: MASTALEX® - MRSA Regulation Number: 21 CFR & 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: MYI Dated: September 22, 2006 Received: September 25, 2006

Dear Ms. Lee:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 tolli alle
4000 600 0041 - 12011 110 1557 110 1557 1557 110 11 15 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, attorn

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

KO62864 510(k) number: not known

Device name : MASTALEX™-MRSA

#### Indications for use :

A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.

Prescription use?: Yes

Over-the-counter use ? No

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie Lee Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

100(k) K062864