510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NOEClass II

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

21 CFR 866.5600 / Immunology
FDA source (opens on fda.gov)

NOE is the FDA product code for Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2, a class II device type, regulated under 21 CFR 866.5600. FDA's definition for this code reads: "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...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
NOE
Device name
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
FDA 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.
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
12

Clearances, product code NOE

By decision year
8 clearances under product code NOE with a decision year between 2003 and 2021, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NOE by decision year
YearClearances
20031
20041
20051
20061
20071
20111
20141
20211

Applicants with the most clearances

Product code NOE
Applicants holding the most 510(k) clearances under product code NOE
ApplicantClearances
Diadexus, Inc.7
Diazyme Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code