Cleared Traditional

K821038 - FAST VIOLET B

K821038 is an FDA 510(k) clearance for FAST VIOLET B, manufactured by Dms Laboratories. The device is a Class 1 Microbiology device with product code JTS cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K821038 · Dms Laboratories · Microbiology device
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May 1982
Decision
44d
Days
Class 1
Risk

K821038 is an FDA 510(k) clearance for the FAST VIOLET B. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Dms Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.1850 - 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 Dms Laboratories devices

FDA 510(k) Submission Details - K821038

510(k) Number K821038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date May 27, 1982
Days to Decision 44 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
58d faster than avg
Panel avg: 102d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

JTS Device Classification - Class 1, General Controls

Product Code JTS Stains, Microbiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - JTS Stains, Microbiologic

All 33
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K821038.
GRAM STAIN SET W/STABILIZED IODINE
K843429 · Accra Laboratories, Inc. · Sep 1984
GRAM STAIN
K843050 · Reagent Laboratory, Inc. · Sep 1984
TRICHROME STAIN
K831060 · American Micro Scan · Jun 1983
GRAM STAIN REAGENTS AND KIT
K813369 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
AFB STAIN SET
K812668 · Carr-Scarborough Microbiologicals, Inc. · Sep 1981
ACCRA-LAB GRAM STAIN SET 55760
K811780 · Accra Laboratories, Inc. · Jul 1981