Cleared Traditional

K832033 - EMIT AED PHENYTOIN ASSAY

K832033 is the FDA 510(k) clearance for EMIT AED PHENYTOIN ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code DIP) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K832033 · Syva Co. · Chemistry device
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Aug 1983
Decision
39d
Days
Class 2
Risk

K832033 is an FDA 510(k) clearance for the EMIT AED PHENYTOIN ASSAY. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 1, 1983 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - the FDA in vitro diagnostics and chemistry 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 K832033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date August 01, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 Chemistry devices follow this clearance model.

Regulatory Peers - DIP Enzyme Immunoassay, Diphenylhydantoin

All 36
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K832033.
EMIT QST PHENYTOIN ASSAY
K834406 · Syva Co. · Feb 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806 · Abbott Laboratories · Jan 1984
A-GENT PHERYTOIN
K832419 · Abbott Laboratories · Sep 1983
VIRGO IPA FOR DETECTION OF PHENYTOIN
K811745 · Electro-Nucleonics Laboratories, Inc. · Jul 1981
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
K780218 · Syva Co. · Mar 1978
EMIT ANTIEPILEPTIC DRUG ASSAYS
K772179 · Syva Co. · Dec 1977