Cleared Traditional

K033387 - QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL

K033387 is the FDA 510(k) clearance for QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K033387 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
40d
Days
Class 1
Risk

K033387 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 (Irvine, US). The FDA issued a Cleared decision on December 2, 2003 after a review of 40 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 Bio-Rad devices

Submission Details

510(k) Number K033387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date December 02, 2003
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K033387.
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · Bio-Rad Laboratories, Inc. · Mar 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091 · Cliniqa Corporation · Feb 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · Roche Diagnostics Corp. · Jan 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
K032074 · Cliniqa Corporation · Oct 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K033162 · Cliniqa Corporation · Oct 2003
AUDIT MICROCONTROLS MICROFD BNP CONTROL
K032122 · Aalto Scientific, Ltd. · Sep 2003