Cleared Traditional

BBLCHROMAGAR MRSA (K042812) - FDA 510(k) Clearance

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

K042812 · Becton, Dickinson & CO · Microbiology device
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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

Submission Details

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.

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 21
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K042812.
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc. · Jul 2009
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad · Jun 2008
MRSASELECT
K070361 · Bio-Rad · Sep 2007
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990