Cleared Traditional

ORNITHINE INDOLE MOTILITY (K842851) - FDA 510(k) Clearance

Class I Microbiology device.

K842851 · Anarobe Systems · Microbiology device
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Aug 1984
Decision
18d
Days
Class 1
Risk

K842851 is an FDA 510(k) clearance for the ORNITHINE INDOLE MOTILITY. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Anarobe Systems (Mchenry, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Anarobe Systems devices

Submission Details

510(k) Number K842851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date August 07, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 43
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K842851.
SF BROTH
K844522 · bioMerieux, Inc. · Jan 1985
TRIPLE SUGAR IRON
K844531 · bioMerieux, Inc. · Jan 1985
SIMMONS CITRATE AGAR
K844532 · bioMerieux, Inc. · Jan 1985
ACETAMIDE AGAR SLANTS
K834509 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
MIDDLEBROOK & COHN 7H11 AGAR BASE
K834204 · Acumedia Manufacturers, Inc. · Jan 1984
MIDDLEBROOK & COHN 7H10 AGAR BASE
K834205 · Acumedia Manufacturers, Inc. · Jan 1984