Cleared Traditional

K821040 - RAPID SST

K821040 is an FDA 510(k) clearance for RAPID SST, manufactured by Mds Laboratories, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K821040

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.

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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K821040.
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 ZYME
K813612 · Dms Laboratories · Feb 1982
RAPID CH
K813613 · Dms Laboratories · Feb 1982
ZYME B
K820209 · Dms Laboratories · Feb 1982