Cleared Traditional

A-GENT PHENOBARBITAL (K832457) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832457 · Abbott Laboratories · Toxicology device
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Sep 1983
Decision
48d
Days
Class 2
Risk

K832457 is an FDA 510(k) clearance for the A-GENT PHENOBARBITAL. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 48 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 Abbott Laboratories devices

Submission Details

510(k) Number K832457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date September 12, 1983
Days to Decision 48 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
39d faster than avg
Panel avg: 87d · This submission: 48d
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 22
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K832457.
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · Miles Laboratories, Inc. · Sep 1985
CHEM KIT PHENOBARBITAL
K833796 · Abbott Laboratories · Jan 1984
EMIT QST PHENOBARBITAL ASSAY
K834216 · Syva Co. · Jan 1984
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · Syva Co. · Aug 1983
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · Syva Co. · Jun 1981
PHENOBARBITAL REAGENT TEST KIT
K802039 · Beckman Instruments, Inc. · Oct 1980