Cleared Traditional

K932127 - TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (FDA 510(k) Clearance)

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

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.

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Submission Details

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
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.

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 Hematology devices follow this clearance model.