Cleared Traditional

K872175 - TDXR FLECAINIDE

K872175 is an FDA 510(k) clearance for TDXR FLECAINIDE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LBZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K872175 · Abbott Laboratories · Chemistry device
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Aug 1987
Decision
66d
Days
Class 2
Risk

K872175 is an FDA 510(k) clearance for the TDXR FLECAINIDE. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 13, 1987 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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

FDA 510(k) Submission Details - K872175

510(k) Number K872175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date August 13, 1987
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBZ Device Classification - Class 2, Special Controls

Product Code LBZ Enzyme Immunoassay, Quinidine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LBZ Enzyme Immunoassay, Quinidine

All 24
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K872175.
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · Syva Co. · Feb 1991
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · Innotron of Oregon, Inc. · Apr 1990
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · Innotron of Oregon, Inc. · Jun 1989
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607 · Em Diagnostic Systems, Inc. · Jan 1987
EMIT QUINIDINE ASSAY
K862214 · Syva Co. · Jun 1986
DETERMINATION OF QUINIDINE
K860049 · Clinical Data, Inc. · Jan 1986