# K150526: Optilite IgG4 Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: May 30, 2015 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 23, 2016 · Class III · Z-1089-2017: A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided

## Indications for use
The Optilite IgG4 Kit is intended for the quantitative in vitro measurement of IgG4 in serum using the Binding Site Optilite analyser. Measurement of this immunoglobulin is an aid in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. The test result should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K150526
Methodology: https://510kreport.com/methodology