Cleared Traditional

K864223 - IQ DIGOXIN

K864223 is an FDA 510(k) clearance for IQ DIGOXIN, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K864223 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Toxicology device
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Aug 1987
Decision
304d
Days
Class 2
Risk

K864223 is an FDA 510(k) clearance for the IQ DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 28, 1987 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K864223

510(k) Number K864223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date August 28, 1987
Days to Decision 304 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 87d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 78
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K864223.
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054 · Microgenics Corp. · Dec 1988
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories · Jul 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823 · Amersham Corp. · May 1988
CEDIA DIGOXIN CR ASSAY
K872583 · Microgenics Corp. · Aug 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
DIGOXIN FPIA REAGENT SET
K870951 · Sigma Diagnostics, Inc. · Apr 1987