Cleared Traditional

K961462 - CEDIA THEOPHYLLINE ASSAY

K961462 is an FDA 510(k) clearance for CEDIA THEOPHYLLINE ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K961462 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K961462

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.

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 56
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K961462.
RANDOX THEOPHYLLINE
K011771 · Randox Laboratories, Ltd. · Jan 2002
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · Bayer Corp. · Oct 2001
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · Diagnostic Reagents, Inc. · Aug 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995