Cleared Traditional

K802039 - PHENOBARBITAL REAGENT TEST KIT

K802039 is an FDA 510(k) clearance for PHENOBARBITAL REAGENT TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code DLZ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K802039 · Beckman Instruments, Inc. · Toxicology device
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Oct 1980
Decision
59d
Days
Class 2
Risk

K802039 is an FDA 510(k) clearance for the PHENOBARBITAL REAGENT TEST KIT. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 59 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K802039

510(k) Number K802039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1980
Decision Date October 23, 1980
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLZ Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K802039.
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · Syva Co. · Aug 1983
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · Syva Co. · Jun 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · Kallestad Laboratories, Inc. · May 1981
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1977