(23 days)
Not Found
No
The device description details a manual, reagent-based agglutination test. There is no mention of any computational analysis, algorithms, or learning processes.
No
This device is a diagnostic tool used to detect the presence of MRSA, not to treat a condition.
Yes
This device is a rapid slide latex test for the detection of penicillin binding protein 2' to confirm Methicillin-Resistant Staphylococcus aureus, which identifies a specific characteristic of an organism to aid in diagnosing a bacterial infection.
No
The device description clearly outlines a physical kit containing reagents (latex, extraction reagent) and a test card, which are hardware components used in a laboratory setting. It describes a manual process involving mixing liquids and observing agglutination, not a software-based analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus." This describes a test performed in vitro (outside the body) on a biological sample (bacterial culture) to provide diagnostic information about a patient's potential infection status.
- Device Description: The description details a laboratory test procedure involving reagents, a test card, and the analysis of a bacterial culture. This is characteristic of an in vitro diagnostic device.
- Care Setting: The intended user is "clinical microbiology laboratories," which are the typical settings where IVD tests are performed.
N/A
Intended Use / Indications for 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.
A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.
Product codes
MYI
Device 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).
The kit contains
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- Extraction Reagent 1 (Green Coloured Cap). Ready to use. 1 x 10ml of 0.1M sodium hydroxide.
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- Extraction Reagent 2 (Yellow Coloured Cap). 1 x 2.4ml of 0.5M potassium dihydrogen phosphate.
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- Test Latex (Red Coloured Cap). Ready to use. 1 x 1.2ml of latex particles sensitised with anti-PBP2' monoclonal antibodies.
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- Control Latex (White Coloured Cap). Ready to use. 1 x 1.2ml of unsensitised latex particles.
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- One tin containing 100 single use disposable wooden mixing sticks.
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- 1 pack of 24 four-well reaction cards.
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- Instruction leaflet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical microbiology laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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).
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
1
The kit contains
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- Extraction Reagent 1 (Green Coloured Cap). Ready to use. 1 x 10ml of 0.1M sodium hydroxide.
-
- Extraction Reagent 2 (Yellow Coloured Cap). 1 x 2.4ml of 0.5M potassium dihydrogen phosphate.
-
- Test Latex (Red Coloured Cap). Ready to use. 1 x 1.2ml of latex particles sensitised with anti-PBP2' monoclonal antibodies.
-
- Control Latex (White Coloured Cap). Ready to use. 1 x 1.2ml of unsensitised latex particles.
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- One tin containing 100 single use disposable wooden mixing sticks.
-
- 1 pack of 24 four-well reaction cards.
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- 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.
2
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).
3
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
4
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