Cleared Traditional

K252336 - Diazyme Immunoglobulin A Assay

Also marketed or referenced as:
Diazyme Immunoglobulin G Assay Diazyme Immunoglobulin M Assay
K252336 · Diazyme Laboratories, Inc. · Immunology device
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Apr 2026
Decision
270d
Days
-
Risk

K252336 is an FDA 510(k) clearance for the Diazyme Immunoglobulin A Assay.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on April 24, 2026 after a review of 270 days - an extended review cycle.

This device falls under the Immunology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diazyme Laboratories, Inc. devices

FDA 510(k) Submission Details - K252336

510(k) Number K252336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2025
Decision Date April 24, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 105d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -