Cleared Traditional

VRESELECT CULTURE MEDIUM (K122187) - FDA 510(k) Clearance

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

K122187 · Bio-Rad · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
105d
Days
Class 2
Risk

K122187 is an FDA 510(k) clearance for the VRESELECT CULTURE MEDIUM. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Bio-Rad (Beverly, US). The FDA issued a Cleared decision on November 6, 2012 after a review of 105 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 Bio-Rad devices

Submission Details

510(k) Number K122187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2012
Decision Date November 06, 2012
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
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 39
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K122187.
HardyCHROM CRE
K190553 · Hardy Diagnostics · Apr 2019
CHROMID CARBA agar (CARB)
K181092 · Biomerieux S.A. · Jul 2018
MRSASelect II
K171061 · Bio-Rad · Dec 2017
chromID MRSA
K162076 · bioMerieux, Inc. · Oct 2016
chromID MRSA
K151688 · bioMerieux, Inc. · Mar 2016
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad · Oct 2011