# K012295: Human Igg Subclass Liquid Reagent Kits, Product Code NK001.T

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Aug 20, 2001 after 31 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-1071-2017: 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-1072-2017: 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 IgG subclasses 1, 2, 3 and 4 immnoglobulins in serum on the BNII. 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/K012295
Methodology: https://510kreport.com/methodology