Cleared Traditional

K821992 - ALPHA-TOXIN DISCS

K821992 is an FDA 510(k) clearance for ALPHA-TOXIN DISCS, manufactured by Microchemical Specialities, Co.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K821992 · Microchemical Specialities, Co. · Microbiology device
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Oct 1982
Decision
103d
Days
Class 1
Risk

K821992 is an FDA 510(k) clearance for the ALPHA-TOXIN DISCS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Microchemical Specialities, Co. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microchemical Specialities, Co. devices

FDA 510(k) Submission Details - K821992

510(k) Number K821992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1982
Decision Date October 18, 1982
Days to Decision 103 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 102d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

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 197
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K821992.
SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP
K823718 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1983
BACTEC NAP TB DIFFERENTIATION TEST
K822946 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
CSM CHROMOGENIC B-LACTAMASE DISC
K822930 · Carr-Scarborough Microbiologicals, Inc. · Nov 1982
NEIDENT*
K821907 · Analytical Products, Inc. · Jul 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264 · Vitek Systems, Inc. · May 1982
RAPID SST
K821040 · Mds Laboratories, Inc. · May 1982