Cleared Traditional

K932685 - PARAMAX THEOPHYLLINE REAGENT AND CALIBR...

K932685 is the FDA 510(k) clearance for PARAMAX THEOPHYLLINE REAGENT AND CALIBR... by Baxter Diagnostics, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K932685 · Baxter Diagnostics, Inc. · Toxicology device
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Sep 1993
Decision
113d
Days
Class 2
Risk

K932685 is an FDA 510(k) clearance for the PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 113 days - within the typical 510(k) review window.

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

View all Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K932685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date September 24, 1993
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
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 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K932685.
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · Diagnostic Reagents, Inc. · Aug 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
VIDAS THEOPHYLLINE(THEO)
K933258 · Biomerieux Vitek, Inc. · Aug 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991