Cleared Traditional

K870378 - ABUSCREEN EIA BARBITURATE

K870378 is the FDA 510(k) clearance for ABUSCREEN EIA BARBITURATE by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K870378 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1987
Decision
46d
Days
Class 2
Risk

K870378 is an FDA 510(k) clearance for the ABUSCREEN (R) EIA BARBITURATE. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 46 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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K870378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date March 16, 1987
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
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 64
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K870378.
ACA URINE BARBITURATES SCREEN METHOD
K873623 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
LABELING CHANGE BARBITURATES IN URINE
K873754 · Diagnostic Products Corp. · Oct 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936 · Diagnostic Products Corp. · Mar 1987
EMIT D.A.U. BARBITURATE ASSAY
K842675 · Syva Co. · Sep 1984
EMIT 700 BARBITURATE ASSAY
K843418 · Syva Co. · Sep 1984
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984