Diazyme PLAC® Test for Lp-PLA2 Activity

K203136 · Diazyme Laboratories, Inc. · NOE · Aug 6, 2021 · Immunology

Device Facts

• Record ID: K203136
• Device Name: Diazyme PLAC® Test for Lp-PLA2 Activity
• Applicant: Diazyme Laboratories, Inc.
• Product Code: NOE · Immunology
• Decision Date: Aug 6, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Indications for Use

The Diazyme PLAC® Test for Lp-PLA2 Activity is an in vitro diagnostic test for the quantitative determination of lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in human serum and plasma on automated clinical chemistry analyzers. The measurement of Lp-PLA2 activity is intended for use in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of future coronary heart disease (CHD) events in patients with no history of cardiovascular disease.

Device Story

Diazyme PLAC® Test is an in vitro enzyme assay measuring Lp-PLA2 activity in EDTA plasma or serum samples. Designed for use on automated clinical chemistry analyzers in clinical laboratory settings; operated by trained laboratory personnel. The assay quantifies Lp-PLA2 activity, which serves as a biomarker for cardiovascular risk. Results are provided to clinicians to supplement standard clinical evaluation and patient risk assessment for coronary heart disease (CHD). By identifying elevated Lp-PLA2 activity in patients without prior cardiovascular events, the test assists in early risk stratification, potentially enabling earlier clinical intervention and improved patient management.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by analytical verification and validation activities, including limit of blank, limit of detection, limit of quantitation, linearity, and method comparison studies performed under design controls to confirm performance following calibration material modification.

Technological Characteristics

In vitro diagnostic enzymatic assay for automated clinical chemistry analyzers. Modification: lyophilized calibration material requiring reconstitution. Fundamental technology remains consistent with predicate (immunological/enzymatic activity measurement).

Indications for Use

Indicated for quantitative determination of Lp-PLA2 activity in human serum and plasma to aid in predicting risk of future coronary heart disease (CHD) events in patients with no history of cardiovascular disease.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Predicate Devices

• PLAC® Test for Lp-PLA2 Activity (K052101)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K203136

B Applicant

Diazyme Laboratories Inc.

C Proprietary and Established Names

Diazyme PLAC® Test for Lp-PLA2 Activity

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NOE | Class II | 21 CFR 866.5600 - Low-Density Lipoprotein Immunological Test System | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) The PLAC Test for Lp-PLA2 Activity, K141575.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- The device calibration was changed so that the modified device is calibrated using calibration material that is supplied lyophilized and requires reconstitution prior to use.
- Change in the name of the device from PLAC Test For Lp-pla2 Activity to Diazyme PLAC Test For Lp-pla2 Activity.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used (analytical sensitivity [limit of blank, limit of detection, limit of quantitation], linearity, and method comparison studies) and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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