Cleared Traditional

K860905 - URICHECK

K860905 is the FDA 510(k) clearance for URICHECK by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K860905 · Difco Laboratories, Inc. · Microbiology device
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Apr 1986
Decision
25d
Days
Class 1
Risk

K860905 is an FDA 510(k) clearance for the URICHECK. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 25 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K860905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date April 04, 1986
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
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 9
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K860905.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · Marion Laboratories, Inc. · Mar 1983