Cleared Traditional

K860905 - URICHECK

K860905 is an FDA 510(k) clearance for URICHECK, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with 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.

FDA 510(k) Submission Details - K860905

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.

JXA Device Classification - Class 1, General Controls

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 40
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K860905.
RAPID BACTERIURIA SCREEN (RBS)
K862195 · New Horizons Diagnostics Co. · Jun 1986
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
FILTRA-CHECK-UTI
K860483 · Applied Polytechnology, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
BACTERIURIA DETECT DEVICE, MULTI SAMPLER
K843833 · Applied Polytechnology, Inc. · Nov 1984
BACTERIURIA DETECT. DEVICE APTEK II
K843834 · Applied Polytechnology, Inc. · Nov 1984
K860905 · URICHECK
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