Cleared Traditional

K041143 - RANDOX BARBITURATE ASSAY

K041143 is an FDA 510(k) clearance for RANDOX BARBITURATE ASSAY, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K041143

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.

DIS Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K041143.
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · ACON Laboratories, Inc. · May 2005
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
K042975 · Ameditech, Inc. · Dec 2004
ONLINE DAT BARBITURATES PLUS
K043211 · Roche Diagnostics Corp. · Dec 2004
'RAPIDTEC 4' TEST
K041712 · American Bio Medica Corp. · Nov 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc. · May 2004
PROFILE -ER
K033334 · Medtox Diagnostics, Inc. · Nov 2003