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).

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets them. Instead, it describes a 510(k) summary for the MASTALEX MRSA rapid slide latex kit, stating its equivalence to a predicate device and noting that no new performance data was submitted because the device's reagents are identical to the predicate.

Therefore, most of the requested information cannot be extracted from this document. However, based on the principle of substantial equivalence described, we can infer some details.

Here's a summary of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document explicitly states: "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." This means no new performance data for MASTALEX MRSA is reported, nor are specific acceptance criteria for a new study. The device is deemed substantially equivalent based on its identical nature to an already approved predicate device (MRSA-SCREEN, K011400).

2. Sample size used for the test set and the data provenance

Cannot be provided. No new test set data was generated or submitted for this 510(k) application. The substantial equivalence relies on the predicate device's performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. No new test set data was generated or submitted.

4. Adjudication method for the test set

Cannot be provided. No new test set data was generated or submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This device is a rapid slide latex test for pathogen identification, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. This device is a manual rapid slide latex test, not an algorithm.

7. The type of ground truth used

Cannot be provided for MASTALEX MRSA directly. However, for the predicate device (MRSA-SCREEN), the ground truth for confirming MRSA would typically be established through molecular methods (e.g., PCR for mecA gene) or possibly conventional culture and methicillin susceptibility testing if the mecA gene detection was not the primary confirmation method for that predicate.

8. The sample size for the training set

Cannot be provided. No new training set data was generated or submitted as it's not an AI/machine learning device.

9. How the ground truth for the training set was established

Cannot be provided. Not applicable as it's not an AI/machine learning device.

In summary, the provided document focuses on substantiating equivalence to a predicate device (MRSA-SCREEN), rather than presenting new performance data for the MASTALEX MRSA kit itself. This approach means that details about specific acceptance criteria and detailed study parameters for the MASTALEX MRSA are not included in this 510(k) summary. The performance of the predicate device is implicitly accepted as meeting the required criteria.

Summary

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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 balee@mastgrp.com

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).

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.
1. Extraction Reagent 2 (Yellow Coloured Cap). 1 x 2.4ml of 0.5M potassium dihydrogen phosphate.
1. Test Latex (Red Coloured Cap). Ready to use. 1 x 1.2ml of latex particles sensitised with anti-PBP2' monoclonal antibodies.
1. Control Latex (White Coloured Cap). Ready to use. 1 x 1.2ml of unsensitised latex particles.
1. One tin containing 100 single use disposable wooden mixing sticks.
1. 1 pack of 24 four-well reaction cards.
1. 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 (240)276-0450. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).