Cleared Traditional

K942991 - QMS THEOPHYLLINE CS

K942991 is an FDA 510(k) clearance for QMS THEOPHYLLINE CS, manufactured by Seradyn, Inc.. The device is a Class 2 Toxicology device with product code LGS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K942991 · Seradyn, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K942991

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
Combination Product No
PCCP Authorized No
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.

LGS Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (LGS) and FDA review panel - the closest regulatory comparables to K942991.
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
K955567 · Oxis Intl., Inc. · Jan 1996
AXSYM THEOPHYLLINE II
K953016 · Abbott Laboratories · Aug 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · Ciba Corning Diagnostics Corp. · Jun 1995
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · Abbott Laboratories · Aug 1993
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · Abbott Laboratories · Aug 1992
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · Innotron of Oregon, Inc. · Apr 1990