Cleared Traditional

K252336 - Diazyme Immunoglobulin A Assay (FDA 510(k) Clearance)

Also includes:
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

Submission Details

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
166d slower than avg
Panel avg: 104d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -