Cleared Traditional

K041143 - RANDOX BARBITURATE ASSAY

K041143 is the FDA 510(k) clearance for RANDOX BARBITURATE ASSAY by Randox Laboratories, Ltd.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K041143 · Randox Laboratories, Ltd. · Toxicology device
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Nov 2004
Decision
189d
Days
Class 2
Risk

K041143 is an FDA 510(k) clearance for the RANDOX BARBITURATE ASSAY. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 5, 2004 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K041143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date November 05, 2004
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 67
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K041143.
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
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ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · ACON Laboratories, Inc. · May 2005
ONLINE DAT BARBITURATES PLUS
K043211 · Roche Diagnostics Corp. · Dec 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc. · May 2004
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · Lin-Zhi International, Inc. · Nov 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc. · Feb 2003