Cleared Traditional

K902640 - DMAC INDOLE REAGENT

K902640 is an FDA 510(k) clearance for DMAC INDOLE REAGENT, manufactured by Api Analytab Products. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K902640 · Api Analytab Products · Microbiology device
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Jul 1990
Decision
32d
Days
Class 1
Risk

K902640 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 Api Analytab Products (Plainveiw, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 32 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 Api Analytab Products devices

FDA 510(k) Submission Details - K902640

510(k) Number K902640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date July 16, 1990
Days to Decision 32 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 102d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 197
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K902640.
NITRATE DISK
K905163 · Remel Co. · Feb 1991
VANCOMYCIN DISK-5 MCG
K905151 · Remel Co. · Jan 1991
CATARRHALIS TEST STRIP
K902595 · Remel Co. · Oct 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · Difco Laboratories, Inc. · Jun 1990
PATHODX PYR KIT
K902037 · Diagnostic Products Corp. · Jun 1990
DMAC INDOLE REAGENT
K901390 · Analytical Products, Inc. · Apr 1990