Cleared Traditional

K000116 - QUALITROL URINALYSIS WITH MICROSCOPICS ...

K000116 is the FDA 510(k) clearance for QUALITROL URINALYSIS WITH MICROSCOPICS ... by Consolidated Technologies, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K000116 · Consolidated Technologies, Inc. · Chemistry device
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Feb 2000
Decision
32d
Days
Class 1
Risk

K000116 is an FDA 510(k) clearance for the QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on February 15, 2000 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.

View all Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K000116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2000
Decision Date February 15, 2000
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
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 464
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