Cleared Traditional

K940569 - DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET

K940569 is an FDA 510(k) clearance for DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code KXT cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K940569 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
155d
Days
Class 2
Risk

K940569 is an FDA 510(k) clearance for the DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 155 days - an extended review 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: 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K940569

510(k) Number K940569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date July 13, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
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 K940569.
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
AXSYM DIGOXIN
K944506 · Abbott Laboratories · Dec 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · Microgenics Corp. · Jun 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · Schiapparelli Biosystems, Inc. · May 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994