Cleared Traditional

K961436 - ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

K961436 is an FDA 510(k) clearance for ABUSCREEN ONLINE LSD REAGENT (90 ML TES..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DLB cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K961436 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1996
Decision
67d
Days
Class 2
Risk

K961436 is an FDA 510(k) clearance for the ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT). Classified as Radioimmunoassay, Lsd (125-i) (product code DLB), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3580 - 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

FDA 510(k) Submission Details - K961436

510(k) Number K961436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date June 21, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLB Device Classification - Class 2, Special Controls

Product Code DLB Radioimmunoassay, Lsd (125-i)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3580
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 - DLB Radioimmunoassay, Lsd (125-i)

Devices cleared under the same product code (DLB) and FDA review panel - the closest regulatory comparables to K961436.
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
K955448 · Behring Diagnostics, Inc. · Feb 1996
CEDIA DAU LSD ASSAY
K955814 · Microgenics Corp. · Feb 1996
STC DIAGNOSTICS LSD MICRO-PLATE EIA
K954073 · Solarcare Technologies Corp,Inc. · Nov 1995
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · Diagnostic Products Corp. · May 1989
REVISED LABELING FOR LSD TEST KIT
K874270 · Roche Diagnostic Systems, Inc. · Nov 1987
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
K860525 · Roche Diagnostic Systems, Inc. · Apr 1986