Cleared Special

K172133 - ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172133 · Axis-Shield Diagnostics, Ltd. · Chemistry device
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Oct 2017
Decision
105d
Days
Class 2
Risk

K172133 is an FDA 510(k) clearance for the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay. 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 October 27, 2017 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Axis-Shield Diagnostics, Ltd. devices

Submission Details

510(k) Number K172133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date October 27, 2017
Days to Decision 105 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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.