Cleared Traditional

MRSASelect II (K171061) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171061 · Bio-Rad · Microbiology device
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Dec 2017
Decision
262d
Days
Class 2
Risk

K171061 is an FDA 510(k) clearance for the MRSASelect II. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Bio-Rad (92430 Marnes-La-Coquette, FR). The FDA issued a Cleared decision on December 28, 2017 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 Bio-Rad devices

Submission Details

510(k) Number K171061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date December 28, 2017
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.

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 Consultant

MDC Associates, LLC
Fran White

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 39
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K171061.
HardyCHROM CRE
K190553 · Hardy Diagnostics · Apr 2019
CHROMID CARBA agar (CARB)
K181092 · Biomerieux S.A. · Jul 2018
chromID MRSA
K162076 · bioMerieux, Inc. · Oct 2016
chromID MRSA
K151688 · bioMerieux, Inc. · Mar 2016
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad · Nov 2012
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad · Oct 2011