# K021081: Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric Analyser

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jun 17, 2002 after 75 days
- Product code: DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- 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.

## Indications for use
This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070) 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/K021081
Methodology: https://510kreport.com/methodology