Cleared Traditional

K012999 - TRIAGE TOX DRUG SCREEN CONTROLS

K012999 is the FDA 510(k) clearance for TRIAGE TOX DRUG SCREEN CONTROLS by Biosite Incorporated. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K012999 · Biosite Incorporated · Toxicology device
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Oct 2001
Decision
27d
Days
Class 1
Risk

K012999 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 27 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 Biosite Incorporated devices

Submission Details

510(k) Number K012999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date October 03, 2001
Days to Decision 27 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
60d faster than avg
Panel avg: 87d · This submission: 27d
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 K012999.
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · Bio-Rad · May 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
K021414 · Bio-Rad · May 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
K021415 · Bio-Rad · May 2002
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · Biosite Incorporated · Oct 2001
LIQUICHEK TDM CONTROL
K012741 · Bio-Rad · Sep 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · Randox Laboratories, Ltd. · Aug 2001