Cleared Traditional

K010858 - VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

K010858 is an FDA 510(k) clearance for VELOGENE GENOMIC IDENTIFICATION ASSAY F..., manufactured by Id Biomedical Corp.. The device is a Class 2 Microbiology device with product code MYI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K010858 · Id Biomedical Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
63d
Days
Class 2
Risk

K010858 is an FDA 510(k) clearance for the VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Id Biomedical Corp. (Bothell, US). The FDA issued a Cleared decision on May 24, 2001 after a review of 63 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.

FDA 510(k) Submission Details - K010858

510(k) Number K010858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2001
Decision Date May 24, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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 9
Devices cleared under the same product code (MYI) and FDA review panel - the closest regulatory comparables to K010858.
MASTALEX -MRSA, MODEL RST501
K062864 · Mast Group , Ltd. · Oct 2006
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · Oxoid , Ltd. · Apr 2002
MRSA-SCREEN
K011400 · Denka Seiken'S · Mar 2002
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640 · Id Biomedical Corp. · Jul 1999
K010858 · VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
Download PDF FDA Summary Id Biomedical Corp.