# K982100: Igg and Igg Subclass Nephelometric Diagnostic Test Kits

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Dec 20, 1999 after 553 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
- Sep 11, 2014 · Class II · Z-1073-2017: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

## Indications for use
This assay is designed for the in vitro measurement of human IgG3 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal IgG3 metabolism.

Source page: https://510kreport.com/device/K982100
Methodology: https://510kreport.com/methodology