# K252336: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Apr 24, 2026 after 270 days
- 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
Diazyme Immunoglobulin A Assay is intended as an immunoturbidimetric assay for the quantitative determination of Immunoglobulin A (IgA) in human serum. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body’s inability to resist infectious agents. For in vitro diagnostics use only. Diazyme Immunoglobulin G Assay is intended as an immunoturbidimetric assay for the quantitative determination of Immunoglobulin G (IgG) in human serum. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body’s inability to resist infectious agents. For in vitro diagnostics use only. Diazyme Immunoglobulin M Assay is intended as an immunoturbidimetric assay for the quantitative determination of Immunoglobulin M (IgM) in human serum. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body’s inability to resist infectious agents. For in vitro diagnostics use only.

Source page: https://510kreport.com/device/K252336
Methodology: https://510kreport.com/methodology