Cleared Traditional

K880694 - B. CAT CONFIRM

K880694 is an FDA 510(k) clearance for B. CAT CONFIRM, manufactured by Scott Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K880694 · Scott Laboratories, Inc. · Microbiology device
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Jun 1988
Decision
115d
Days
Class 1
Risk

K880694 is an FDA 510(k) clearance for the B. CAT CONFIRM. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Scott Laboratories, Inc. (Sulphur, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 115 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 Scott Laboratories, Inc. devices

FDA 510(k) Submission Details - K880694

510(k) Number K880694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1988
Decision Date June 16, 1988
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
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 197
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K880694.
ROSCO PYRR
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K882636 · Carr-Scarborough Microbiologicals, Inc. · Feb 1989
PYR/ESCULIN DISK
K880950 · Remel Co. · Apr 1988
LD PRESUMPTO QUAD
K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422 · Gen-Probe, Inc. · Apr 1987