Cleared Traditional

BRAIN HEART INFUSION AGAR (K944554) - FDA 510(k) Clearance

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

K944554 · Carr-Scarborough Microbiologicals, Inc. · Microbiology device
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Oct 1994
Decision
18d
Days
Class 2
Risk

K944554 is an FDA 510(k) clearance for the BRAIN HEART INFUSION AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 18 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 Carr-Scarborough Microbiologicals, Inc. devices

Submission Details

510(k) Number K944554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1994
Decision Date October 04, 1994
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
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 K944554.
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
K122187 · Bio-Rad · Nov 2012