Cleared Traditional

K062864 - MASTALEX -MRSA, MODEL RST501

K062864 is an FDA 510(k) clearance for MASTALEX -MRSA, manufactured by Mast Group , Ltd.. The device is a Class 2 Microbiology device with product code MYI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K062864 · Mast Group , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
23d
Days
Class 2
Risk

K062864 is an FDA 510(k) clearance for the MASTALEX -MRSA, MODEL RST501. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Mast Group , Ltd. (Bootle, Merseyside, GB). The FDA issued a Cleared decision on October 18, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mast Group , Ltd. devices

FDA 510(k) Submission Details - K062864

510(k) Number K062864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date October 18, 2006
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYI Device Classification - Class 2, Special Controls

Product Code MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

All 7
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