Cleared Traditional

K842086 - SPOTTEST LACTOPHENOL COTTON BLUE STAIN

K842086 is the FDA 510(k) clearance for SPOTTEST LACTOPHENOL COTTON BLUE STAIN by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K842086 · Difco Laboratories, Inc. · Microbiology device
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Jul 1984
Decision
40d
Days
Class 1
Risk

K842086 is an FDA 510(k) clearance for the SPOTTEST LACTOPHENOL COTTON BLUE 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 July 3, 1984 after a review of 40 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 K842086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1984
Decision Date July 03, 1984
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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 K842086.
PYR BROTH
K843987 · Remel Co. · Oct 1984
DIFFERENTIATION DISKS NITRATE
K843521 · Difco Laboratories, Inc. · Oct 1984
GNC PLUS
K842587 · Vitek Systems, Inc. · Jul 1984
RIM ONPG KIT
K841329 · Austin Biological Laboratories · May 1984
DIFFERENTIATION DISKS SPECTINOMYCIN
K841453 · Difco Laboratories, Inc. · May 1984
RIM GARDNERELLA VAGINALIS KIT
K841460 · Austin Biological Laboratories · May 1984