Cleared Traditional

K945911 - CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS

K945911 is an FDA 510(k) clearance for CULTURE MEDIA, manufactured by Bioclinical Systems, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K945911 · Bioclinical Systems, Inc. · Microbiology device
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Apr 1995
Decision
123d
Days
Class 2
Risk

K945911 is an FDA 510(k) clearance for the CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Bioclinical Systems, Inc. (Annapolis Junction, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 123 days - within the typical 510(k) review window.

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 Bioclinical Systems, Inc. devices

FDA 510(k) Submission Details - K945911

510(k) Number K945911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date April 04, 1995
Days to Decision 123 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
21d slower than avg
Panel avg: 102d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
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 - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 45
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K945911.
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · Becton Dickinson Microbiology Systems · Oct 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · Becton Dickinson Microbiology Systems · Apr 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · Remel, L.P. · Mar 1996
MUELLER HINTON AGAR W/OXACILLIN
K941985 · Carr-Scarborough Microbiologicals, Inc. · Aug 1994
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · Lakewood Biochemical Co., Inc. · Jun 1988
MULLER HINTON BROTH
K880105 · Hardy Media · Mar 1988