Cleared Traditional

K062467 - AXSYM HOLO TC REAGENT KIT

Also marketed or referenced as:
STANDARD CALIBRATOR KIT, MODEL 3L83-01 CONTROL KIT, MODEL 3L83-10

K062467 is the FDA 510(k) clearance for AXSYM HOLO TC REAGENT KIT by Axis-Shield Diagnostics, Ltd.. It is a Class 2 Chemistry device (product code CDD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K062467 · Axis-Shield Diagnostics, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
90d
Days
Class 2
Risk

K062467 is an FDA 510(k) clearance for the AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 22, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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 Axis-Shield Diagnostics, Ltd. devices

Submission Details

510(k) Number K062467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date November 22, 2006
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K062467.
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · Siemens Healthcare Diagnostics · Feb 2010
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
K090588 · Beckman Coulter, Inc. · May 2009
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc. · Nov 2007
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · Roche Diagnostics Corp. · Apr 2006
ABBOTT AXSYM B12
K051327 · Abbott Laboratories · Aug 2005
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · Bayer Healthcare, LLC · Jul 2004