Cleared Traditional

K880444 - LYPHOCHEK URINE TOXICOLOGY CONTROL - NE...

K880444 is the FDA 510(k) clearance for LYPHOCHEK URINE TOXICOLOGY CONTROL - NE... by Bio-Rad. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K880444 · Bio-Rad · Toxicology device
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Feb 1988
Decision
23d
Days
Class 1
Risk

K880444 is an FDA 510(k) clearance for the LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE. 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 February 25, 1988 after a review of 23 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 K880444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date February 25, 1988
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
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 K880444.
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
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · Baxter Healthcare Corp · Feb 1988
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · Abbott Laboratories · Nov 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987