510(k) · Cleared
ClearedDiazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Apr 24, 2026 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 24, 2026
- Review
- 270 days
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What is it indicated for?
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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K252336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252336: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252336
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026