Cleared Traditional

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20 (K062467) - FDA 510(k) Clearance

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

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 77
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K062467.
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · Axis-Shield Diagnostics, Ltd. · Jul 2024
Access Vitamin B12
K223289 · Beckman Coulter, Inc. · Dec 2022
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
K190298 · Beckman Coulter Biomedical GmbH · Oct 2019
LIAISON Vitamin B12
K192064 · DiaSorin, Inc. · Oct 2019
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
K140496 · Beckman Coulter, Inc. · Sep 2014
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012