# K082036: Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Sep 8, 2008 after 53 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: 4 generations back to K940433 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011579: Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580, Bio-Rad (2001) Summary page 1.

## Most influential descendants
- K101809: Fujirebio Diagnostics Tumor Marker Control Model 108-20 (2010), 0 descendants of its own

## Indications for use
Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Domestic Analytes Listed * Adrenocorticotropic Hormone (ACTH) * Alpha Fetoprotein (AFP) * Aldosterone Beta-2-Microglobulin (B2M) * CA 15-3 * CA 19-9 * CA 27.29 * CA 125 * Calcitonin * Carcinoembryonic Antigen (CEA) * Ferritin * hCG Beta Subunit (P-hCG)/ hCG · Prostatic Acid Phosphatase (PAP) * Prolactin · Prostate Specific Antigen, Total ( PSA) * Prostate Specific Antigen, Free (Free PSA) · Thyroglobulin (Tg)

Source page: https://510kreport.com/device/K082036
Methodology: https://510kreport.com/methodology