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510(k) Data Aggregation
K Number
K062864Device Name
MASTALEX -MRSA, MODEL RST501
Manufacturer
MAST GROUP LTD.
Date Cleared
2006-10-18
(23 days)
Product Code
MYI
Regulation Number
866.1640Why did this record match?
Applicant Name (Manufacturer) :
MAST GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.
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).
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