Cleared Traditional

K102922 - HARDYCHROM MRSA

K102922 is an FDA 510(k) clearance for HARDYCHROM MRSA, manufactured by Hardy Diagnostics. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K102922 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
215d
Days
Class 2
Risk

K102922 is an FDA 510(k) clearance for the HARDYCHROM MRSA. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 4, 2011 after a review of 215 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 Hardy Diagnostics devices

FDA 510(k) Submission Details - K102922

510(k) Number K102922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date May 04, 2011
Days to Decision 215 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
113d slower than avg
Panel avg: 102d · This submission: 215d
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 K102922.
chromID MRSA
K151688 · bioMerieux, Inc. · Mar 2016
VRESELECT CULTURE MEDIUM
K122187 · Bio-Rad · Nov 2012
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad · Oct 2011
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · Bio-Rad · Oct 2010
REMEL SPECTRA MRSA
K092407 · Remel, Inc. · Oct 2010
BBL CHROMAGAR MRSA II
K092767 · Becton, Dickinson & CO · Aug 2010