Cleared Traditional

'TDXFLX ANALYZER (K904226) - FDA 510(k) Clearance

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

K904226 · Abbott Laboratories · Chemistry device
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Oct 1990
Decision
46d
Days
Class 2
Risk

K904226 is an FDA 510(k) clearance for the 'TDXFLX ANALYZER. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 29, 1990 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3450 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

Submission Details

510(k) Number K904226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1990
Decision Date October 29, 1990
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCQ Fluorescent Immunoassay Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCQ Fluorescent Immunoassay Gentamicin

All 7
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K904226.
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad · Aug 1997
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · Sigma Diagnostics, Inc. · Nov 1994
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982
AMES TDA GENTAMICIN TEST
K810942 · Miles Laboratories, Inc. · Apr 1981