Cleared Traditional

K852611 - TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (FDA 510(k) Clearance)

Class I Chemistry device.

K852611 · Miles Laboratories, Inc. · Chemistry device
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Sep 1985
Decision
76d
Days
Class 1
Risk

K852611 is an FDA 510(k) clearance for the TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1785 - the FDA in vitro diagnostics and chemistry 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K852611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date September 03, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
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.