# K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Jun 26, 2020 after 190 days
- Product code: CZP (Iga, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943997 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073489: Olympus Iga Reagent, Olympus America, Inc. (2008) Summary page 7.
- K073490: Olympus Igg Reagent, Olympus America, Inc. (2008) Summary page 7.
- K073487: Olympus Igm Reagent, Olympus America, Inc. (2008) Summary page 7.

## Indications for use
Yumizen C 1200 Immunoglobulin A reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin A (IgA) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.This test should be used in conjunction with other laboratory and clinical findings. Yumizen C1200 Immunoglobulin G reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin G (IgG) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers.Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.This test should be used in conjunction with other laboratory and clinical findings. Yumizen Cl200Immunoglobulin M reagent is intended for the quantitative in vitro diagnostic determination of Immunoglobulin M (IgM) in serum and lithium heparin plasma by immunoturbidimetry on Yumizen analyzers. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K193525
Methodology: https://510kreport.com/methodology