Cleared Traditional

K832034 - EMIT AAD THEOPHYLLINE ASSAY

K832034 is the FDA 510(k) clearance for EMIT AAD THEOPHYLLINE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code KLS) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K832034 · Syva Co. · Chemistry device
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Aug 1983
Decision
39d
Days
Class 2
Risk

K832034 is an FDA 510(k) clearance for the EMIT AAD THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), 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 862.3880 - 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 K832034 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 KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 - KLS Enzyme Immunoassay, Theophylline

All 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K832034.
STRATUS THEOPHYLLINE ASSAY
K832965 · American Dade · Dec 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · Abbott Laboratories · Dec 1983
THEOPHYLLINE TEST PACK ACA
K831934 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · Syva Co. · May 1983
DETECTION OF THEOPHYLLINE
K821544 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
A-GENT THEOPHYLLINE
K812003 · Abbott Laboratories · Jul 1981