Cleared Traditional

K844760 - UROL-QUAL

K844760 is the FDA 510(k) clearance for UROL-QUAL by Dimension Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K844760 · Dimension Diagnostics · Chemistry device
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Jan 1985
Decision
32d
Days
Class 1
Risk

K844760 is an FDA 510(k) clearance for the UROL-QUAL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Dimension Diagnostics (St. Charles, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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.

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Submission Details

510(k) Number K844760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1984
Decision Date January 08, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 475
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K844760.
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · Beckman Instruments, Inc. · Feb 1985
GELMAN TRIPHOR CONTROL
K850202 · Gelman Sciences, Inc. · Feb 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125 · Bio-Rad · Jan 1985
QUALIFY I & II AMER. MONITOR 2009 & 2010
K843611 · American Monitor Corp. · Sep 1984
KODAK EKTACHEM CONTROL
K841884 · Eastman Kodak Company · Jul 1984
NOVA STAT CONTROL LEVELS 1/2/3
K841452 · Nova Biomedical Corp. · Jun 1984