Cleared Traditional

LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924) - FDA 510(k) Clearance

Class I Chemistry device.

K033924 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
47d
Days
Class 1
Risk

K033924 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES). Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on February 3, 2004 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 K033924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date February 03, 2004
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 201
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K033924.
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990
EMIT (R) HVA NEGATIVE URINE
K883210 · Syva Co. · Sep 1988
DADE TDM CONTROL
K883190 · Baxter Healthcare Corp · Sep 1988
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · Baxter Healthcare Corp · Feb 1988