Cleared Traditional

K813031 - MS-2 BACTERIAL IDENTIFICATION SYS

K813031 is an FDA 510(k) clearance for MS-2 BACTERIAL IDENTIFICATION SYS, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K813031 · Abbott Laboratories · Microbiology device
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Dec 1981
Decision
50d
Days
Class 1
Risk

K813031 is an FDA 510(k) clearance for the MS-2 BACTERIAL IDENTIFICATION SYS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 17, 1981 after a review of 50 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K813031

510(k) Number K813031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date December 17, 1981
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 102d · This submission: 50d
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 166
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K813031.
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
PADAC
K812458 · Calbiochem-Behring Corp. · Sep 1981
KANAMYCIN DISK
K812082 · Remel Co. · Aug 1981
BILE DISK
K812083 · Remel Co. · Aug 1981