Cleared Traditional

K812668 - AFB STAIN SET

K812668 is the FDA 510(k) clearance for AFB STAIN SET by Carr-Scarborough Microbiologicals, Inc.. It is a Class 1 Microbiology device (product code JTS) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K812668 · Carr-Scarborough Microbiologicals, Inc. · Microbiology device
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Sep 1981
Decision
8d
Days
Class 1
Risk

K812668 is an FDA 510(k) clearance for the AFB STAIN SET. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Carr-Scarborough Microbiologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 8 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 Carr-Scarborough Microbiologicals, Inc. devices

Submission Details

510(k) Number K812668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1981
Decision Date September 29, 1981
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 102d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K812668.
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532 · Remel Co. · Apr 1987
GRAM STAIN KIT
K853896 · Sigma Diagnostics, Inc. · Oct 1985
GRAM STAIN REAGENTS AND KIT
K813369 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
DROPPERS, SOLUTION, IODINE
K781061 · Marion Laboratories, Inc. · Aug 1978
MIF PROCEDURE KIT
K780346 · Marion Laboratories, Inc. · Mar 1978