Cleared Traditional

K042812 - BBLCHROMAGAR MRSA

K042812 is an FDA 510(k) clearance for BBLCHROMAGAR MRSA, manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K042812 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
41d
Days
Class 2
Risk

K042812 is an FDA 510(k) clearance for the BBLCHROMAGAR MRSA. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on November 22, 2004 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K042812

510(k) Number K042812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date November 22, 2004
Days to Decision 41 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
61d faster than avg
Panel avg: 102d · This submission: 41d
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 32
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K042812.
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad · Jun 2008
SPECTRA MRSA
K073027 · Thermo Fisher Scientific · Feb 2008
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics · Jan 1997
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · Becton Dickinson Microbiology Systems · Feb 1995