Cleared Traditional

K961191 - COLISCREEN

K961191 is an FDA 510(k) clearance for COLISCREEN, manufactured by Hardy Diagnostics. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K961191 · Hardy Diagnostics · Microbiology device
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Jun 1996
Decision
83d
Days
Class 1
Risk

K961191 is an FDA 510(k) clearance for the COLISCREEN. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on June 17, 1996 after a review of 83 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 Hardy Diagnostics devices

FDA 510(k) Submission Details - K961191

510(k) Number K961191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date June 17, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
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 K961191.
INDOLE SWAB
K970833 · Remel, Inc. · Apr 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · Microbiologics, Inc. · Feb 1997
IDS RAPID CB PLUS SYSTEM
K962966 · Innovative Diagnostic Systems, Inc. · Oct 1996
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics · Apr 1996
GIBSON ID-M. CAT.
K955826 · Gibson Laboratories, Inc. · Feb 1996
DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc. · Feb 1996