Cleared Traditional

K952596 - THEOPHYLLINE ENZYME IMMUNOASSAY

K952596 is an FDA 510(k) clearance for THEOPHYLLINE ENZYME IMMUNOASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K952596 · Diagnostic Reagents, Inc. · Toxicology device
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Aug 1995
Decision
66d
Days
Class 2
Risk

K952596 is an FDA 510(k) clearance for the THEOPHYLLINE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 66 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 Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K952596

510(k) Number K952596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date August 11, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 87d · This submission: 66d
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 Toxicology 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 K952596.
ACCUMETER THEOPHYLLINE TEST
K972495 · Chemtrak, Inc. · Oct 1997
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · Baxter Diagnostics, Inc. · Sep 1993