Cleared Traditional

K851494 - TWO-STEP ACID FAST BACTERIA STAIN

K851494 is an FDA 510(k) clearance for TWO-STEP ACID FAST BACTERIA STAIN, manufactured by Accra Laboratories, Inc.. The device is a Class 1 Pathology device with product code JTS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851494 · Accra Laboratories, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
14d
Days
Class 1
Risk

K851494 is an FDA 510(k) clearance for the TWO-STEP ACID FAST BACTERIA STAIN. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Accra Laboratories, Inc. (Bridgeport, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K851494

510(k) Number K851494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date April 29, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 77d · This submission: 14d
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 K851494.
TOMTEC GRAM STAINER CRYSTAL VIOLET
K871532 · Remel Co. · Apr 1987
GRAM STAIN KIT
K853896 · Sigma Diagnostics, Inc. · Oct 1985
KINYOUN ACID FAST STAIN KIT
K851493 · Accra Laboratories, Inc. · Apr 1985
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