Cleared Traditional

K896861 - OPUS PHENOBARBITAL TEST SYSTEM

K896861 is the FDA 510(k) clearance for OPUS PHENOBARBITAL TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K896861 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jan 1990
Decision
37d
Days
Class 2
Risk

K896861 is an FDA 510(k) clearance for the OPUS PHENOBARBITAL TEST SYSTEM. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K896861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date January 11, 1990
Days to Decision 37 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
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLZ Enzyme Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - DLZ Enzyme Immunoassay, Phenobarbital

All 31
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K896861.
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · Baxter Diagnostics, Inc. · Mar 1994
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · Syva Co. · Aug 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · Instrumentation Laboratory CO · Apr 1991
TECHNICON RA-PHENOBARBITAL
K884419 · Technicon Instruments Corp. · Nov 1988
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625 · Syva Co. · Dec 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · Em Diagnostic Systems, Inc. · Jan 1987