Cleared Traditional

K100589 - MRSA SELECT - SKIN AND SOFT TISSUE WOUN...

K100589 is the FDA 510(k) clearance for MRSA SELECT - SKIN AND SOFT TISSUE WOUN... by Bio-Rad. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K100589 · Bio-Rad · Microbiology device
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Oct 2010
Decision
241d
Days
Class 2
Risk

K100589 is an FDA 510(k) clearance for the MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS. 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 October 29, 2010 after a review of 241 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 K100589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date October 29, 2010
Days to Decision 241 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
139d slower than avg
Panel avg: 102d · This submission: 241d
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 K100589.
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad · Nov 2012
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad · Oct 2011
HARDYCHROM MRSA
K102922 · Hardy Diagnostics · May 2011
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