Cleared Traditional

3M MICROBIAL PROFILE SYSTEM GRAM (K791789) - FDA 510(k) Clearance

Class I Microbiology device.

K791789 · 3M Company · Microbiology device
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Nov 1979
Decision
63d
Days
Class 1
Risk

K791789 is an FDA 510(k) clearance for the 3M MICROBIAL PROFILE SYSTEM GRAM. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 63 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 3M Company devices

Submission Details

510(k) Number K791789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date November 16, 1979
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
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 48
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K791789.
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc. · Sep 1992
GI MOTILITY TEST MEDIUM W/TTC
K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · Abbott Laboratories · Apr 1983
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981