Cleared Traditional

ALPHA-TOXIN DISCS (K821992) - FDA 510(k) Clearance

Class I Microbiology device.

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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K821992.
MS-2 BACTERIAL IDENTI. SYS
K830099 · Abbott Laboratories · Feb 1983
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
CEFINASE TM DISCS
K813442 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · Abbott Laboratories · Dec 1981