Cleared Traditional

K844380 - BILE DIFFERENTIAL DISK

K844380 is the FDA 510(k) clearance for BILE DIFFERENTIAL DISK by Anaerobe Systems. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K844380 · Anaerobe Systems · Microbiology device
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Jan 1985
Decision
52d
Days
Class 1
Risk

K844380 is an FDA 510(k) clearance for the BILE DIFFERENTIAL DISK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Anaerobe Systems (Santa Clara, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 52 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 Anaerobe Systems devices

Submission Details

510(k) Number K844380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 04, 1985
Days to Decision 52 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
50d faster than avg
Panel avg: 102d · This submission: 52d
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 K844380.
GENERAL DIAGNOSTICS RAPID E. COLI TEST
K852889 · Warner-Lambert Co. · Jul 1985
SPOTTEST INDIA INK
K851184 · Difco Laboratories, Inc. · Apr 1985
IDENTIFICATION STICKS OXIDASE
K844887 · Oxoid U.S.A., Inc. · Feb 1985
COLISTIN 10 MCG. DIFFERENTIAL DISK
K844381 · Anaerobe Systems · Jan 1985
VANCOMYCIN 5MCG DIFFERENTIAL DISK
K844382 · Anaerobe Systems · Jan 1985
KANAMYCIN 1000 MCG DIFFERENTIAL DISK
K844383 · Anaerobe Systems · Jan 1985