Cleared Traditional

Lipoprotein (a) Molarity Assay (K253069) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253069 · Diazyme Laboratories, Inc. · Chemistry device
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Jun 2026
Decision
266d
Days
Class 2
Risk

K253069 is an FDA 510(k) clearance for the Lipoprotein (a) Molarity Assay. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on June 16, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - the FDA in vitro diagnostics and chemistry framework. 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diazyme Laboratories, Inc. devices

Submission Details

510(k) Number K253069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date June 16, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 12
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K253069.
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · Roche Diagnostics Operations · Jan 2025
Lp(a) Ultra
K211058 · SENTINEL CH. SpA · Dec 2022
Diazyme Lipoprotein (a) Assay
K180074 · Diazyme Laboratories, Inc. · Mar 2018
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · Siemens Healthcare Diagnostics, Inc. · Dec 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722 · Roche Diagnostics · Nov 2012
N LATEX LP(A)
K013128 · Dade Behring, Inc. · Jan 2002