Cleared Traditional

K881990 - LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW

K881990 is the FDA 510(k) clearance for LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW by Bio-Rad. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K881990 · Bio-Rad · Toxicology device
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Jun 1988
Decision
39d
Days
Class 1
Risk

K881990 is an FDA 510(k) clearance for the LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 20, 1988 after a review of 39 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

Submission Details

510(k) Number K881990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date June 20, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
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: 87d · This submission: 39d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K881990.
EMIT HVA CONTROL KIT
K881944 · Syva Co. · Jul 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · Bio-Rad · Jun 1988
PAR(TM) BRAND DRUG OF ABUSE CONTROLS
K880152 · Medical Analysis Systems, Inc. · May 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · Bio-Rad · Apr 1988