Cleared Traditional

K043211 - ONLINE DAT BARBITURATES PLUS

K043211 is an FDA 510(k) clearance for ONLINE DAT BARBITURATES PLUS, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K043211 · Roche Diagnostics Corp. · Toxicology device
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Dec 2004
Decision
40d
Days
Class 2
Risk

K043211 is an FDA 510(k) clearance for the ONLINE DAT BARBITURATES PLUS. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 29, 2004 after a review of 40 days - a notably fast clearance 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: 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K043211

510(k) Number K043211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2004
Decision Date December 29, 2004
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
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 82
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K043211.
VITROS CHEMISTRY PRODUCTS BARB REAGENT
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ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
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RANDOX BARBITURATE ASSAY
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'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