Cleared Traditional

K151688 - chromID MRSA

K151688 is an FDA 510(k) clearance for chromID MRSA, 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 262-day FDA review.

K151688 · bioMerieux, Inc. · Microbiology device
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Mar 2016
Decision
262d
Days
Class 2
Risk

K151688 is an FDA 510(k) clearance for the chromID MRSA. 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 11, 2016 after a review of 262 days - an extended review cycle.

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

FDA 510(k) Submission Details - K151688

510(k) Number K151688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2015
Decision Date March 11, 2016
Days to Decision 262 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
160d slower than avg
Panel avg: 102d · This submission: 262d
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 34
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K151688.
Remel Spectra ESBL
K162620 · Remel, Inc. · May 2017
HardyCHROM ESBL
K160512 · Hardy Diagnostics · Nov 2016
chromID MRSA
K162076 · bioMerieux, Inc. · Oct 2016
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad · Nov 2012
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad · Oct 2011
HARDYCHROM MRSA
K102922 · Hardy Diagnostics · May 2011