Cleared Traditional

K880823 - AMERLITE DIGOXIN ASSAY

K880823 is an FDA 510(k) clearance for AMERLITE DIGOXIN ASSAY, manufactured by Amersham Corp.. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K880823 · Amersham Corp. · Toxicology device
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May 1988
Decision
91d
Days
Class 2
Risk

K880823 is an FDA 510(k) clearance for the AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Amersham Corp. devices

FDA 510(k) Submission Details - K880823

510(k) Number K880823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 31, 1988
Days to Decision 91 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
4d slower than avg
Panel avg: 87d · This submission: 91d
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 71
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K880823.
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054 · Microgenics Corp. · Dec 1988
TDX (R) DIGOXIN NXT
K882233 · Abbott Laboratories · Jul 1988
IQ DIGOXIN
K864223 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
CEDIA DIGOXIN CR ASSAY
K872583 · Microgenics Corp. · Aug 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987