Cleared Traditional

K932127 - TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCL...

K932127 is an FDA 510(k) clearance for TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCL..., manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code LGS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K932127 · Abbott Laboratories · Hematology device
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Aug 1993
Decision
98d
Days
Class 2
Risk

K932127 is an FDA 510(k) clearance for the TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II. Classified as Fluorescence Polarization Immunoassay, Theophylline (product code LGS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.3880 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K932127

510(k) Number K932127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date August 09, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
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 Hematology devices follow this clearance model.

Regulatory Peers - LGS Fluorescence Polarization Immunoassay, Theophylline

All 9
Devices cleared under the same product code (LGS) and FDA review panel - the closest regulatory comparables to K932127.
AXSYM THEOPHYLLINE II
K953016 · Abbott Laboratories · Aug 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169 · Ciba Corning Diagnostics Corp. · Jun 1995
QMS THEOPHYLLINE CS
K942991 · Seradyn, Inc. · Sep 1994
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · Abbott Laboratories · Aug 1992
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · Innotron of Oregon, Inc. · Apr 1990
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484 · Roche Diagnostic Systems, Inc. · May 1987