Cleared Traditional

K781643 - ACID FAST KIT

K781643 is an FDA 510(k) clearance for ACID FAST KIT, manufactured by Bioscientific. The device is a Class 1 Pathology device with product code JTS cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K781643 · Bioscientific · Pathology device
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Oct 1978
Decision
8d
Days
Class 1
Risk

K781643 is an FDA 510(k) clearance for the ACID FAST KIT. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 8 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 Bioscientific devices

FDA 510(k) Submission Details - K781643

510(k) Number K781643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1978
Decision Date October 03, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 77d · This submission: 8d
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 34
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K781643.
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
DROPPERS, SOLUTION, IODINE
K781061 · Marion Laboratories, Inc. · Aug 1978
MIF PROCEDURE KIT
K780346 · Marion Laboratories, Inc. · Mar 1978