Cleared Traditional

CHEM KIT THEOPHYLLINE DIAG. KIT (K833683) - FDA 510(k) Clearance

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

K833683 · Abbott Laboratories · Toxicology device
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Dec 1983
Decision
57d
Days
Class 2
Risk

K833683 is an FDA 510(k) clearance for the CHEM KIT THEOPHYLLINE DIAG. KIT. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 27, 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 862.3880 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K833683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date December 27, 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 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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 40
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K833683.
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · Miles Laboratories, Inc. · Mar 1984
STRATUS THEOPHYLLINE ASSAY
K832965 · American Dade · Dec 1983
THEOPHYLLINE TEST PACK ACA
K831934 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
EMIT AAD THEOPHYLLINE ASSAY
K832034 · Syva Co. · Aug 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · Syva Co. · May 1983