Cleared Traditional

TDX (R) DIGOXIN NXT (K882233) - FDA 510(k) Clearance

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

K882233 · Abbott Laboratories · Chemistry device
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Jul 1988
Decision
40d
Days
Class 2
Risk

K882233 is an FDA 510(k) clearance for the TDX (R) DIGOXIN NXT. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 6, 1988 after a review of 40 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

Submission Details

510(k) Number K882233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1988
Decision Date July 06, 1988
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
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 - KXT Enzyme Immunoassay, Digoxin

All 46
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K882233.
ENZYMUN TEST(R) DIGOXIN
K901216 · Boehringer Mannheim Corp. · May 1990
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · Syva Co. · Aug 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989
IQ DIGOXIN
K864223 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
DIGOXIN FPIA REAGENT SET
K870951 · Sigma Diagnostics, Inc. · Apr 1987