Cleared Traditional

K042446 - QUANTIFY CONTROL AND QUANTIFY PLUS CONT...

K042446 is the FDA 510(k) clearance for QUANTIFY CONTROL AND QUANTIFY PLUS CONT... by Bio-Rad Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K042446 · Bio-Rad Laboratories, Inc. · Chemistry device
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Nov 2004
Decision
54d
Days
Class 1
Risk

K042446 is an FDA 510(k) clearance for the QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on November 2, 2004 after a review of 54 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 Laboratories, Inc. devices

Submission Details

510(k) Number K042446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date November 02, 2004
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJW Urinalysis Controls (assayed And Unassayed)
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 - JJW Urinalysis Controls (assayed And Unassayed)

All 30
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K042446.
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K031231 · Bio-Rad · Jun 2003
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K023928 · Medical Analysis Systems, Inc. · Dec 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · Medical Analysis Systems, Inc. · Apr 2002