Cleared Traditional

K831654 - RIM BETA LACTAMASE TEST

K831654 is the FDA 510(k) clearance for RIM BETA LACTAMASE TEST by Austin Biological Laboratories. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K831654 · Austin Biological Laboratories · Microbiology device
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Jun 1983
Decision
30d
Days
Class 1
Risk

K831654 is an FDA 510(k) clearance for the RIM BETA LACTAMASE TEST. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Austin Biological Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Austin Biological Laboratories devices

Submission Details

510(k) Number K831654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date June 22, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 147
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K831654.
BILE AESCULIN DISCS
K832306 · Oxoid U.S.A., Inc. · Aug 1983
OXY-SWAB
K831673 · Austin Biological Laboratories · Jun 1983
RIM-CAMP TEST
K831674 · Austin Biological Laboratories · Jun 1983
RAPID IDENTIFI-METHOD NEISSERIA KIT
K830968 · Austin Biological Laboratories · Jun 1983
THYMINE/THYMIDINE DISCS DDG
K830939 · Oxoid U.S.A., Inc. · Apr 1983
LYSOSTAPHIN REAGENT SET
K830323 · Remel Co. · Feb 1983