Cleared Traditional

K911846 - URI-THREE(TM)

K911846 is the FDA 510(k) clearance for URI-THREE(TM) by Culture Kits, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K911846 · Culture Kits, Inc. · Microbiology device
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Oct 1991
Decision
169d
Days
Class 1
Risk

K911846 is an FDA 510(k) clearance for the URI-THREE(TM), MODIFICATION. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 169 days - an extended review 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: 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 Culture Kits, Inc. devices

Submission Details

510(k) Number K911846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1991
Decision Date October 04, 1991
Days to Decision 169 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
67d slower than avg
Panel avg: 102d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
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 - JXA Kit, Screening, Urine

All 11
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K911846.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984