# K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Nov 22, 2006 after 90 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993571 (1999). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030655: Holotc Ria, Axis-Shield Biochemicals, Asa (2004) Summary page 1.

## Most influential descendants
- K112443: Architect Active B-12 (Holotranscobalamin) (2011), 4 descendants of its own
- K160757: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (2016), 1 descendant of its own
- K233541: ARCHITECT Active-B12 (Holotranscobalamin) (2024), 0 descendants of its own
- K172133: ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (2017), 0 descendants of its own
- K121946: Axis-Shield Acvtive-B12 (2013), 0 descendants of its own

## Indications for use
Reagents AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. Calibrators The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of holotranscobalmin (HoloTC) in human serum and plasma. Controls The AxSYM HoloTC Controls are for the use in quality control to monitor the accuracy and precision of the HoloTC assay when used for the quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma on the AxSYM System.

Source page: https://510kreport.com/device/K062467
Methodology: https://510kreport.com/methodology