Cleared Traditional

K811621 - EMIT-ST SERUM PHENOBARBITAL ASSAY

K811621 is the FDA 510(k) clearance for EMIT-ST SERUM PHENOBARBITAL ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811621 · Syva Co. · Toxicology device
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Jun 1981
Decision
17d
Days
Class 2
Risk

K811621 is an FDA 510(k) clearance for the EMIT-ST SERUM PHENOBARBITAL ASSAY. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981 after a review of 17 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 Syva Co. devices

Submission Details

510(k) Number K811621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date June 25, 1981
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
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 K811621.
EMIT QST PHENOBARBITAL ASSAY
K834216 · Syva Co. · Jan 1984
A-GENT PHENOBARBITAL
K832457 · Abbott Laboratories · Sep 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · Syva Co. · Aug 1983
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · Kallestad Laboratories, Inc. · May 1981
PHENOBARBITAL REAGENT TEST KIT
K802039 · Beckman Instruments, Inc. · Oct 1980
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1977