K203136 is an FDA 510(k) clearance for the Diazyme PLAC® Test for Lp-PLA2 Activity. This device is classified as a Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 (Class II - Special Controls, product code NOE).
Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on August 6, 2021, 290 days after receiving the submission on October 20, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600. The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, Is Intended To Measure Lipoprotein-associated Phospholipase A2 In Human Plasma In Conjunction With Clinical Evaluation And Other Patient Risk Factors Including Biochemical Analyses As An Aid In Predicting Risk For Coronary Heat Disease. This Device Differs From The Classification Regulation In That It Is A Different Analyte, Thus A New Marker For Predicting Risk Of Coronary Heart Disease. This Device Is Measuring An Enzyme That Is Produced By Macrophages Where As The Regulation Is For The Measurement Of A Lipoprotein..
| 510(k) Number | K203136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2020 |
| Decision Date | August 06, 2021 |
| Days to Decision | 290 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NOE — Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |
| Definition | The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, Is Intended To Measure Lipoprotein-associated Phospholipase A2 In Human Plasma In Conjunction With Clinical Evaluation And Other Patient Risk Factors Including Biochemical Analyses As An Aid In Predicting Risk For Coronary Heat Disease. This Device Differs From The Classification Regulation In That It Is A Different Analyte, Thus A New Marker For Predicting Risk Of Coronary Heart Disease. This Device Is Measuring An Enzyme That Is Produced By Macrophages Where As The Regulation Is For The Measurement Of A Lipoprotein. |