Cleared Traditional

K953247 - GIBSON ID A.E. TEST

K953247 is an FDA 510(k) clearance for GIBSON ID A.E. TEST, manufactured by Gibson Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K953247 · Gibson Laboratories, Inc. · Microbiology device
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Nov 1995
Decision
132d
Days
Class 1
Risk

K953247 is an FDA 510(k) clearance for the GIBSON ID A.E. TEST. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Gibson Laboratories, Inc. (Lexington, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gibson Laboratories, Inc. devices

FDA 510(k) Submission Details - K953247

510(k) Number K953247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date November 20, 1995
Days to Decision 132 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
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 K953247.
GIBSON ID-M. CAT.
K955826 · Gibson Laboratories, Inc. · Feb 1996
DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc. · Feb 1996
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · Microbiologics, Inc. · Dec 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · Microbiologics, Inc. · Aug 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · Microbiologics, Inc. · Apr 1995
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · Microbiologics, Inc. · Apr 1995