Cleared Traditional

K850052 - ANAEROBE KIT

K850052 is the FDA 510(k) clearance for ANAEROBE KIT by Austin Biological Laboratories. It is a Class 1 Microbiology device (product code JSP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K850052 · Austin Biological Laboratories · Microbiology device
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Mar 1985
Decision
56d
Days
Class 1
Risk

K850052 is an FDA 510(k) clearance for the ANAEROBE KIT. Classified as Kit, Anaerobic Identification (product code JSP), Class I - General Controls.

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 56 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 K850052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date March 05, 1985
Days to Decision 56 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
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSP Kit, Anaerobic Identification
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 - JSP Kit, Anaerobic Identification

All 9
Devices cleared under the same product code (JSP) and FDA review panel - the closest regulatory comparables to K850052.
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · Vitek Systems, Inc. · Apr 1991
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · Vitek Systems, Inc. · May 1990
DIAGNOSTIC REAGENT PET-RPLA
K855235 · Oxoid U.S.A., Inc. · Nov 1986
AMS ANA CARD
K843686 · Vitek Systems, Inc. · Dec 1984
API ANAIDENT
K831032 · Analytical Products, Inc. · May 1983
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
K830964 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1983