Cleared Traditional

K981590 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON

K981590 is an FDA 510(k) clearance for LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, manufactured by Bio-Rad. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K981590 · Bio-Rad · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
37d
Days
Class 1
Risk

K981590 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTR.... Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on June 10, 1998 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device 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

FDA 510(k) Submission Details - K981590

510(k) Number K981590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date June 10, 1998
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K981590.
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649 · Ortho-Clinical Diagnostics, Inc. · Aug 1998
AC/AD LINEARITY VERIFIERS
K982217 · Sc Calibrators & Controls, LLC · Jul 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · Medical Analysis Systems, Inc. · Jun 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · Bio-Rad · Apr 1998
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
K980331 · More Diagnostics · Mar 1998
VIGIL TDM CONTROLS
K972819 · Beckman Instruments, Inc. · Aug 1997