Cleared Traditional

K091025 - CHROMID VRE AGAR, MODEL: REF 43 851

K091025 is an FDA 510(k) clearance for CHROMID VRE AGAR, manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K091025 · bioMerieux, Inc. · Microbiology device
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Mar 2010
Decision
326d
Days
Class 2
Risk

K091025 is an FDA 510(k) clearance for the CHROMID VRE AGAR, MODEL: REF 43 851. 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 March 2, 2010 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K091025

510(k) Number K091025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2009
Decision Date March 02, 2010
Days to Decision 326 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
224d slower than avg
Panel avg: 102d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K091025.
REMEL SPECTRA MRSA
K092407 · Remel, Inc. · Oct 2010
BBL CHROMAGAR MRSA II
K092767 · Becton, Dickinson & CO · Aug 2010
REMEL SPECTRA VRE
K092819 · Thermo Fisher Scientific · Jul 2010
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc. · Jul 2009
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad · Jun 2008
SPECTRA MRSA
K073027 · Thermo Fisher Scientific · Feb 2008