Cleared Traditional

K791932 - AMS ENTEROBACTERIACEASE CARE

K791932 is the FDA 510(k) clearance for AMS ENTEROBACTERIACEASE CARE by Vitek Systems, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K791932 · Vitek Systems, Inc. · Microbiology device
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Nov 1979
Decision
47d
Days
Class 1
Risk

K791932 is an FDA 510(k) clearance for the AMS ENTEROBACTERIACEASE CARE. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 47 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 Vitek Systems, Inc. devices

Submission Details

510(k) Number K791932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1979
Decision Date November 13, 1979
Days to Decision 47 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
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
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 - JSS Kit, Identification, Enterobacteriaceae

All 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K791932.
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ENTERIC-TEK
K792058 · Flow Laboratories, Inc. · Jan 1980
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · 3M Company · Nov 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056 · Vitek Systems, Inc. · Jan 1979
MS-2 BACTERIAL ID. SYSTEM
K781427 · Abbott Laboratories · Sep 1978
ENTEROTUBE II
K781236 · Hoffmann-La Roche, Inc. · Aug 1978