Cleared Traditional

AFFINITY DIGOXIN IMMUNIT (K870552) - FDA 510(k) Clearance

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

K870552 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Apr 1987
Decision
62d
Days
Class 2
Risk

K870552 is an FDA 510(k) clearance for the AFFINITY DIGOXIN IMMUNIT. 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 April 13, 1987 after a review of 62 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K870552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date April 13, 1987
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 43
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K870552.
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories · Jul 1988
IQ DIGOXIN
K864223 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
DIGOXIN FPIA REAGENT SET
K870951 · Sigma Diagnostics, Inc. · Apr 1987
EMIT COLUMN DIGOXIN ASSAY
K861393 · Syva Co. · May 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · Syva Co. · May 1986