Cleared Traditional

K901390 - DMAC INDOLE REAGENT

K901390 is the FDA 510(k) clearance for DMAC INDOLE REAGENT by Analytical Products, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K901390 · Analytical Products, Inc. · Microbiology device
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Apr 1990
Decision
21d
Days
Class 1
Risk

K901390 is an FDA 510(k) clearance for the DMAC INDOLE REAGENT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 21 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 Analytical Products, Inc. devices

Submission Details

510(k) Number K901390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date April 16, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
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 112
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K901390.
CATARRHALIS TEST STRIP
K902595 · Remel Co. · Oct 1990
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K901784 · Difco Laboratories, Inc. · Jun 1990
PATHODX PYR KIT
K902037 · Diagnostic Products Corp. · Jun 1990
DIFCO OXIDASE DRYSLIDE
K896398 · Difco Laboratories, Inc. · Dec 1989
PYR/ESCULIN DISK
K880950 · Remel Co. · Apr 1988
LD PRESUMPTO QUAD
K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987