Cleared Traditional

K031231 - LIQUICHECK URINALYSIS CONTROL BILEVEL

K031231 is the FDA 510(k) clearance for LIQUICHECK URINALYSIS CONTROL BILEVEL by Bio-Rad. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K031231 · Bio-Rad · Chemistry device
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Jun 2003
Decision
61d
Days
Class 1
Risk

K031231 is an FDA 510(k) clearance for the LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTRO.... Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on June 18, 2003 after a review of 61 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 K031231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2003
Decision Date June 18, 2003
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 35
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K031231.
RANDOX URINE CONTROLS
K043266 · Randox Laboratories, Ltd. · Feb 2005
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · Bio-Rad Laboratories, Inc. · Nov 2004
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · Medical Analysis Systems, Inc. · Jul 2003
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
K023928 · Medical Analysis Systems, Inc. · Dec 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · Medical Analysis Systems, Inc. · Apr 2002
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · Bio-Rad · Apr 2000