Cleared Traditional

K832965 - STRATUS THEOPHYLLINE ASSAY

K832965 is an FDA 510(k) clearance for STRATUS THEOPHYLLINE ASSAY, manufactured by American Dade. The device is a Class 2 Chemistry device with product code KLS cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K832965 · American Dade · Chemistry device
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Dec 1983
Decision
120d
Days
Class 2
Risk

K832965 is an FDA 510(k) clearance for the STRATUS THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all American Dade devices

FDA 510(k) Submission Details - K832965

510(k) Number K832965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1983
Decision Date December 30, 1983
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLS Device Classification - Class 2, Special Controls

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 61
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K832965.
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · Miles Laboratories, Inc. · Mar 1984
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 AAD THEOPHYLLINE ASSAY
K832034 · Syva Co. · Aug 1983