Cleared Traditional

K963062 - IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BEC...

K963062 is an FDA 510(k) clearance for IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BEC..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K963062 · Beckman Instruments, Inc. · Toxicology device
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Dec 1996
Decision
128d
Days
Class 2
Risk

K963062 is an FDA 510(k) clearance for the IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 128 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K963062

510(k) Number K963062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date December 13, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 87d · This submission: 128d
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 K963062.
DIGOXIN DG-II FPIA REAGENT SET
K972794 · Sigma Diagnostics, Inc. · Jul 1997
CEDIA DIGOXIN II
K970883 · Boehringer Mannheim Corp. · May 1997
CEDIA DIGOXIN
K970881 · Boehringer Mannheim Corp. · May 1997
DIGOXIN ENZYME IMMUNOASSAY
K963835 · Diagnostic Reagents, Inc. · Dec 1996
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995
IMX DIGOXIN
K952079 · Abbott Laboratories · Jul 1995