Cleared Traditional

K091024 - CHROMID MRSA AGAR

K091024 is the FDA 510(k) clearance for CHROMID MRSA AGAR by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K091024 · bioMerieux, Inc. · Microbiology device
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Jul 2009
Decision
98d
Days
Class 2
Risk

K091024 is an FDA 510(k) clearance for the CHROMID MRSA AGAR, MODEL: REF 43 841. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 17, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all bioMerieux, Inc. devices

Submission Details

510(k) Number K091024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2009
Decision Date July 17, 2009
Days to Decision 98 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
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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 - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 28
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K091024.
BBL CHROMAGAR MRSA II
K092767 · Becton, Dickinson & CO · Aug 2010
REMEL SPECTRA VRE
K092819 · Thermo Fisher Scientific · Jul 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · bioMerieux, Inc. · Mar 2010
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad · Jun 2008
SPECTRA MRSA
K073027 · Thermo Fisher Scientific · Feb 2008
MRSASELECT
K070361 · Bio-Rad · Sep 2007