Cleared Traditional

CEDIA THEOPHYLLINE ASSAY (K961462) - FDA 510(k) Clearance

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

K961462 · Boehringer Mannheim Corp. · Toxicology device
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Jun 1996
Decision
71d
Days
Class 2
Risk

K961462 is an FDA 510(k) clearance for the CEDIA THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 71 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K961462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1996
Decision Date June 27, 1996
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 87d · This submission: 71d
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 39
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K961462.
EMIT CAFFEINE ASSAY
K042407 · Dade Behring, Inc. · Oct 2004
ROCHE ONLINE THEOPHYLLINE
K020740 · Roche Diagnostics Corp. · Apr 2002
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994