# K101809: Fujirebio Diagnostics Tumor Marker Control Model 108-20

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Oct 5, 2010 after 98 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K940433 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082036: Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak, Bio-Rad Laboratories (2008) Summary page 1.
- K093957: Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01,, Fujirebio Diagnostics,Inc. (2010) Summary page 1.

## Indications for use
For In Vitro Diagnostic Use Only. Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.

Source page: https://510kreport.com/device/K101809
Methodology: https://510kreport.com/methodology