Cleared Traditional

K840584 - SPOTTEST ACRIDINE ORANGE STAIN

K840584 is the FDA 510(k) clearance for SPOTTEST ACRIDINE ORANGE STAIN by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K840584 · Difco Laboratories, Inc. · Microbiology device
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Mar 1984
Decision
23d
Days
Class 1
Risk

K840584 is an FDA 510(k) clearance for the SPOTTEST ACRIDINE ORANGE STAIN. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 23 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K840584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date March 02, 1984
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K840584.
REAGENTS
K840030 · Anaerobe Systems · Mar 1984
MICROBIAL DIFFERENTIATION
K840031 · Anaerobe Systems · Mar 1984
NOVOBIOCIN DISC
K840483 · Remel Co. · Mar 1984
RIM GRAM REACTION SWAB
K840252 · Austin Biological Laboratories · Feb 1984
SPOTTEST OXIDASE REAGENT
K840575 · Difco Laboratories, Inc. · Feb 1984
SPOTTEST DMACA INDOLE REAGENT
K840576 · Difco Laboratories, Inc. · Feb 1984