Cleared Traditional

MODIFICA-OF EMIT AED PRIMIDONE ASSAY (K832798) - FDA 510(k) Clearance

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

K832798 · Syva Co. · Toxicology device
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Oct 1983
Decision
57d
Days
Class 2
Risk

K832798 is an FDA 510(k) clearance for the MODIFICA-OF EMIT AED PRIMIDONE ASSAY. Classified as Enzyme Immunoassay, Primidone (product code DJD), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3680 - 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 K832798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date October 14, 1983
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJD Enzyme Immunoassay, Primidone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3680
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 - DJD Enzyme Immunoassay, Primidone

All 7
Devices cleared under the same product code (DJD) and FDA review panel - the closest regulatory comparables to K832798.
EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE
K910527 · Syva Co. · Mar 1991
EMIT QST PRIMIDONE ASSAY
K840939 · Syva Co. · Apr 1984
PRIMIDONE REAGENT TEST KIT
K820138 · Beckman Instruments, Inc. · Jan 1982
TDX PRIMIDONE
K813597 · Abbott Laboratories · Jan 1982
ANALYTICAL TEST PACK, PRIMIDONE
K781957 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1979