(290 days)
The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
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The provided text is a 510(k) clearance letter for a medical device, the Diazyme PLAC® Test for Lp-PLA2 Activity. It largely focuses on regulatory aspects and the indication for use, not detailed study data or acceptance criteria. Therefore, I cannot extract the information required to populate all sections of your request from the provided text.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance (country, retrospective/prospective).
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Information on MRMC studies or effect sizes.
- Standalone performance information.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training was established.
The only relevant information I can derive is the device name and its intended use:
Device Name: Diazyme PLAC® Test for Lp-PLA2 Activity
Indication for Use: "The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events."
To fulfill your request for detailed acceptance criteria and study information, you would need access to the full 510(k) summary or the premarket submission itself, as this letter is merely the FDA's clearance notification.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).