# K073490: Olympus Igg Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 11, 2008 after 61 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- 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: 2 generations back to K943997 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951013: Olympus Igg Immunoturbidimetric Reagent, Olympus America, Inc. (1995) Summary page 1.
- K050113: Tina-Quant Igg Gen.2, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (2017), 1 descendant of its own
- K221114: Immunoglobulin G (IgG) (2023), 0 descendants of its own
- K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (2020), 0 descendants of its own

## Indications for use
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K073490
Methodology: https://510kreport.com/methodology