Cleared Traditional

K900626 - ALPHA URINE SAMPLE

K900626 is an FDA 510(k) clearance for ALPHA URINE SAMPLE, manufactured by Toxi-Lab, Inc.. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K900626 · Toxi-Lab, Inc. · Chemistry device
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Mar 1990
Decision
26d
Days
Class 1
Risk

K900626 is an FDA 510(k) clearance for the ALPHA URINE SAMPLE. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Toxi-Lab, Inc. (Irvine, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 26 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 Toxi-Lab, Inc. devices

FDA 510(k) Submission Details - K900626

510(k) Number K900626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date March 06, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 177
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K900626.
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · Eastman Kodak Company · Aug 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · Bio-Rad · May 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
KIT- CIBA CORNING L-TDM I, II, III
K893682 · Ciba Corning Diagnostics Corp. · Sep 1989