Cleared Traditional

K923892 - SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA

K923892 is an FDA 510(k) clearance for SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA, manufactured by Smith River Biologicals. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K923892 · Smith River Biologicals · Microbiology device
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Jun 1993
Decision
321d
Days
Class 2
Risk

K923892 is an FDA 510(k) clearance for the SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Smith River Biologicals (Ferrum, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Smith River Biologicals devices

FDA 510(k) Submission Details - K923892

510(k) Number K923892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date June 21, 1993
Days to Decision 321 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
219d slower than avg
Panel avg: 102d · This submission: 321d
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 38
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K923892.
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993
G C II AGAR WITH SENSIVITALEX
K932879 · Becton Dickinson Microbiology Systems · Sep 1993
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · Remel Co. · Jun 1989