Cleared Traditional

K834216 - EMIT QST PHENOBARBITAL ASSAY

K834216 is the FDA 510(k) clearance for EMIT QST PHENOBARBITAL ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K834216 · Syva Co. · Toxicology device
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Jan 1984
Decision
50d
Days
Class 2
Risk

K834216 is an FDA 510(k) clearance for the EMIT QST PHENOBARBITAL ASSAY. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 50 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 K834216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date January 24, 1984
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K834216.
ENDAB PHENOBARBITAL
K852995 · Immunotech Corp. · Aug 1985
VENTREZYME PHENOBARBITAL KIT IMMUNO
K842264 · Ventrex Laboratories, Inc. · Aug 1984
CHEM KIT PHENOBARBITAL
K833796 · Abbott Laboratories · Jan 1984
A-GENT PHENOBARBITAL
K832457 · Abbott Laboratories · Sep 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · Syva Co. · Aug 1983
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · Syva Co. · Jun 1981