# K042152: Binding Site Igg Sublcass Olympus Kits

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Nov 22, 2004 after 105 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 2 (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
- Sep 11, 2014 · Class II · Z-1067-2017: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
- Sep 11, 2014 · Class II · Z-1068-2017: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

## Indications for use
This kit is intended for quantifying human IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the Olympus AU series analysers. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K042152
Methodology: https://510kreport.com/methodology