Cleared Traditional

K821040 - RAPID SST

K821040 is the FDA 510(k) clearance for RAPID SST by Mds Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K821040 · Mds Laboratories, Inc. · Microbiology device
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May 1982
Decision
20d
Days
Class 1
Risk

K821040 is an FDA 510(k) clearance for the RAPID SST. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 20 days - a notably fast clearance cycle.

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: 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 Mds Laboratories, Inc. devices

Submission Details

510(k) Number K821040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date May 03, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
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 148
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K821040.
BACTEC NAP TB DIFFERENTIATION TEST
K822946 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
NEIDENT*
K821907 · Analytical Products, Inc. · Jul 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264 · Vitek Systems, Inc. · May 1982
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · Oxoid U.S.A., Inc. · Dec 1981
CEFINASE TM DISCS
K813442 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · Abbott Laboratories · Dec 1981