Cleared Traditional

K932685 - PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS

K932685 is an FDA 510(k) clearance for PARAMAX THEOPHYLLINE REAGENT AND CALIBR..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Toxicology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K932685

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.

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 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