Cleared Traditional

K901270 - LYPHOCHEK URINE TOXICOLOGY CONTROL - SC...

K901270 is the FDA 510(k) clearance for LYPHOCHEK URINE TOXICOLOGY CONTROL - SC... by Bio-Rad. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K901270 · Bio-Rad · Toxicology device
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May 1990
Decision
44d
Days
Class 1
Risk

K901270 is an FDA 510(k) clearance for the LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 44 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 K901270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1990
Decision Date May 02, 1990
Days to Decision 44 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
43d faster than avg
Panel avg: 87d · This submission: 44d
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 K901270.
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333 · Medical Analysis Systems, Inc. · Apr 1991
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · Medical Analysis Systems, Inc. · Dec 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · Eastman Kodak Company · Aug 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · Bio-Rad · Apr 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · Baxter Healthcare Corp · Feb 1990
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · Bio-Rad · Dec 1989