FDA product code NOE: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
NOE is the FDA product code for test, system, immunoassay, lipoprotein-associated phospholipase a2. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Immunology panel. FDA has cleared 8 510(k) submissions under NOE, from 2 different applicants. The average 510(k) review took 134 days (median 130). FDA has posted 12 recalls for NOE devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 |
| Device class | Class II |
| Regulation | 21 CFR 866.5600 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NOE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 290 |
Compare with all 510(k) review times · Search every NOE clearance
Top NOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diadexus, Inc. | 7 | 2014-12-15 |
| Diazyme Laboratories, Inc. | 1 | 2021-08-06 |
Most recent NOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203136 | Diazyme Laboratories, Inc. | Diazyme PLAC® Test for Lp-PLA2 Activity | 2021-08-06 | 290 |
| K141575 | Diadexus, Inc. | PLAC TEST FOR LP-PLA2 ACTIVITY | 2014-12-15 | 186 |
| K101853 | Diadexus, Inc. | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | 2011-01-03 | 186 |
| K072599 | Diadexus, Inc. | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | 2007-12-20 | 97 |
| K062234 | Diadexus, Inc. | MODIFICATION TO DIADEXUS PLAC TEST | 2006-09-11 | 40 |
Recalls for NOE devices
12 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-08-20.
Frequently asked questions
What is FDA product code NOE?
NOE is the FDA product code for test, system, immunoassay, lipoprotein-associated phospholipase a2. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Immunology panel.
What device class is NOE?
Class II, regulation 21 CFR 866.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOE?
Across 8 cleared submissions the average was 134 days from receipt to decision (median 130).
Which companies have the most NOE clearances?
Diadexus, Inc. (7); Diazyme Laboratories, Inc. (1).
Have NOE devices been recalled?
Yes: 12 product recalls across 6 recall events; the most recent began 2010-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code NOE
- Run a recall and safety report across every NOE manufacturer
- Watch product code NOE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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