Cleared Traditional

K073080 - QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (FDA 510(k) Clearance)

Class I Chemistry device.

K073080 · Bio-Rad Laboratories · Chemistry device
Jan 2008
Decision
85d
Days
Class 1
Risk

K073080 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on January 24, 2008 after a review of 85 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.

Submission Details

510(k) Number K073080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2007
Decision Date January 24, 2008
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
149d faster than avg
Panel avg: 234d · This submission: 85d
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.