FDA product code NAO: Test, Carbohydrate Deficient Transferrin
NAO is the FDA product code for test, carbohydrate deficient transferrin. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under NAO, from 3 different applicants. The average 510(k) review took 123 days (median 148). FDA has posted 2 recalls for NAO devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Carbohydrate Deficient Transferrin |
| Device class | Class I |
| Regulation | 21 CFR 862.1360 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NAO clearance
Top NAO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 1 | 2006-08-25 |
| Sangui Biotech, Inc. | 1 | 2000-08-23 |
| Axis | 1 | 1999-12-21 |
Most recent NAO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060677 | Dade Behring, Inc. | N LATEX CDT | 2006-08-25 | 164 |
| K001943 | Sangui Biotech, Inc. | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | 2000-08-23 | 58 |
| K992502 | Axis | AXIS %CDT TURBIDIMETRIC IMMUNOASSAY | 1999-12-21 | 148 |
Recalls for NAO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code NAO?
NAO is the FDA product code for test, carbohydrate deficient transferrin. It is a Class I device, regulated under 21 CFR 862.1360 and reviewed by the Clinical Chemistry panel.
What device class is NAO?
Class I, regulation 21 CFR 862.1360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NAO?
Across 3 cleared submissions the average was 123 days from receipt to decision (median 148).
Which companies have the most NAO clearances?
Dade Behring, Inc. (1); Sangui Biotech, Inc. (1); Axis (1).
Have NAO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-03-02.
Next steps
- Run an FDA pathway report with predicate devices for product code NAO
- Run a recall and safety report across every NAO manufacturer
- Watch product code NAO 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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