Cleared Traditional

K992395 - URINE DRUG SCREENING CONTROL

K992395 is the FDA 510(k) clearance for URINE DRUG SCREENING CONTROL by Seracare Technology. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K992395 · Seracare Technology · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
38d
Days
Class 1
Risk

K992395 is an FDA 510(k) clearance for the URINE DRUG SCREENING CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Seracare Technology (Austin, US). The FDA issued a Cleared decision on August 26, 1999 after a review of 38 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 Seracare Technology devices

Submission Details

510(k) Number K992395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date August 26, 1999
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 87d · This submission: 38d
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 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K992395.
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
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
K990377 · Roche Diagnostics Corp. · Feb 1999
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
K983709 · Beckman Coulter, Inc. · Oct 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · Roche Diagnostic Systems, Inc. · Oct 1998