# K030655: Holotc Ria

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Biochemicals, Asa
- Decided: Jan 29, 2004 after 332 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: 1 generation back to K993571 (1999). 1 ancestor in all.
6 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)
- K993571: Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12, Bayer Corp. (1999) Summary page 1.

## Most influential descendants
- K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10 (2006), 5 descendants of its own
- 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

## Indications for use
The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative measurement of the fraction of cobalamin (vitamin B12) bound to the carrier protein transcobalamin in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency.

Source page: https://510kreport.com/device/K030655
Methodology: https://510kreport.com/methodology