# K191635: Optilite IgM Kit

- Pathway: 510(k) (Special)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jul 15, 2019 after 26 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 K082129 (2009). 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)
- K082129: Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer, The Binding Site, Ltd. (2009) Summary page 5.

## Most influential descendants
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own

## Recalls of this device
- Jul 29, 2019 · Class II · Z-1327-2020: There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in po

## Indications for use
The Optilite IgM Kit is intended for the quantitative in vitro measurement of IgM in human serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K191635
Methodology: https://510kreport.com/methodology