# K073487: Olympus Igm 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950900 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950900: Olympus Igm Immunoturbidimetric Reagent, Olympus America, Inc. (1995) Summary page 1.

## Most influential descendants
- K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (2020), 0 descendants of its own

## Recalls of this device
- May 27, 2024 · Class II · Z-2428-2024: LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

## Indications for use
System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers. The spectrum of abnormalities in serum immunoglobulin concentrations is broad. Abnormal concentrations range from a virtual absence of one or more of the three major classes of immunoglobulin (IgA, IgG, and IgM) to polyclonal increases in one or more immunoglobulins. Measurement of these immunoglobulins 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/K073487
Methodology: https://510kreport.com/methodology