Cleared Traditional

K891581 - COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS

K891581 is an FDA 510(k) clearance for COBAS-FP REAGENT FOR VALPROIC ACID & CA..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LEG cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K891581 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1989
Decision
148d
Days
Class 2
Risk

K891581 is an FDA 510(k) clearance for the COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K891581

510(k) Number K891581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date August 15, 1989
Days to Decision 148 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
61d slower than avg
Panel avg: 87d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEG Device Classification - Class 2, Special Controls

Product Code LEG Enzyme Immunoassay, Valproic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 - LEG Enzyme Immunoassay, Valproic Acid

All 30
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K891581.
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · Roche Diagnostic Systems, Inc. · Dec 1992
BECKMAN VALPROIC ACID REAGENT
K922844 · Beckman Instruments, Inc. · Oct 1992
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · Pb Diagnostic Systems, Inc. · Jun 1990
EMIT VALPROIC ACID ASSAY
K862652 · Syva Co. · Jul 1986
EMIT AED VALPROIC ACID ASSAY
K832719 · Syva Co. · Oct 1983
AMES TDA VALPROIC ACID TEST
K830789 · Miles Laboratories, Inc. · Apr 1983