Cleared Traditional

QMS THEOPHYLLINE CS (K942991) - FDA 510(k) Clearance

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

K942991 · Seradyn, Inc. · Toxicology device
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Sep 1994
Decision
81d
Days
Class 2
Risk

K942991 is an FDA 510(k) clearance for the QMS THEOPHYLLINE CS. Classified as Fluorescence Polarization Immunoassay, Theophylline (product code LGS), Class II - Special Controls.

Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 81 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 Seradyn, Inc. devices

Submission Details

510(k) Number K942991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date September 09, 1994
Days to Decision 81 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 87d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGS Fluorescence Polarization 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 - LGS Fluorescence Polarization Immunoassay, Theophylline

All 12
Devices cleared under the same product code (LGS) and FDA review panel - the closest regulatory comparables to K942991.
AXSYM THEOPHYLLINE II
K953016 · Abbott Laboratories · Aug 1995
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · Abbott Laboratories · Aug 1993
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · Abbott Laboratories · Aug 1992
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484 · Roche Diagnostic Systems, Inc. · May 1987
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
K843826 · Roche Diagnostic Systems, Inc. · Feb 1985