Cleared Traditional

K082953 - ARCHITECT IDIGOXIN AND ARCHITECT IDIGOX...

K082953 is the FDA 510(k) clearance for ARCHITECT IDIGOXIN AND ARCHITECT IDIGOX... by Biokit, S.A.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K082953 · Biokit, S.A. · Toxicology device
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Dec 2008
Decision
80d
Days
Class 2
Risk

K082953 is an FDA 510(k) clearance for the ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP3.... Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on December 22, 2008 after a review of 80 days - a notably fast clearance cycle.

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: 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 Biokit, S.A. devices

Submission Details

510(k) Number K082953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date December 22, 2008
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 87d · This submission: 80d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 70
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K082953.
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
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RANDOX DIGOXIN ASSAY
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K093441 · Siemens Healthcare Diagnostics · Apr 2010
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp. · Sep 2001
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd. · Jul 2001