# K092450: Human Igd Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Dec 28, 2009 after 140 days
- Product code: CZJ (Igd, 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 measuring human immunoglobulin D (IgD) in serum as an aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test result is to be used in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K092450
Methodology: https://510kreport.com/methodology