Cleared Traditional

K233541 - ARCHITECT Active-B12 (Holotranscobalamin)

K233541 is an FDA 510(k) clearance for ARCHITECT Active-B12 (Holotranscobalamin), manufactured by Axis-Shield Diagnostics, Ltd.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K233541 · Axis-Shield Diagnostics, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
271d
Days
Class 2
Risk

K233541 is an FDA 510(k) clearance for the ARCHITECT Active-B12 (Holotranscobalamin). 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 July 31, 2024 after a review of 271 days - an extended review cycle.

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

FDA 510(k) Submission Details - K233541

510(k) Number K233541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date July 31, 2024
Days to Decision 271 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 88d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K233541.
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
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133 · Axis-Shield Diagnostics, Ltd. · Oct 2017
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
K161721 · Diazyme Laboratories · Sep 2016
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
K160757 · Axis-Shield Diagnostics Limited · Jul 2016