FDA product code OND: Osmolality Of Tears
OND is the FDA product code for osmolality of tears. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under OND. The average 510(k) review took 198 days (median 198).
Definition
To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Classification
| Field | Value |
|---|---|
| Device name | Osmolality Of Tears |
| Device class | Class I |
| Regulation | 21 CFR 862.1540 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OND clearance
Top OND applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocusense, Inc. | 1 | 2009-05-14 |
Most recent OND clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083184 | Ocusense, Inc. | TEARLAB OSMOLARITY SYSTEM | 2009-05-14 | 198 |
Recalls for OND devices
openFDA lists no recalls for product code OND.
Frequently asked questions
What is FDA product code OND?
OND is the FDA product code for osmolality of tears. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel.
What device class is OND?
Class I, regulation 21 CFR 862.1540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OND?
Across 1 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most OND clearances?
Ocusense, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OND
- Run a recall and safety report across every OND manufacturer
- Watch product code OND 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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