Cleared Traditional

K884528 - SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES

K884528 is an FDA 510(k) clearance for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/..., manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code KXT cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K884528 · Heraeus Kulzer, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
131d
Days
Class 2
Risk

K884528 is an FDA 510(k) clearance for the SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K884528

510(k) Number K884528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date March 08, 1989
Days to Decision 131 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
43d slower than avg
Panel avg: 88d · This submission: 131d
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 Chemistry 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 K884528.
ENZYMUN TEST(R) DIGOXIN
K901216 · Boehringer Mannheim Corp. · May 1990
EZ-BEAD DIGOXIN EIA KIT
K893843 · Immunotech Corp. · Sep 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · Syva Co. · Aug 1989
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