FDA product code NDW: Assay, Porphyrin, Spectrophotometry, Lithium
NDW is the FDA product code for assay, porphyrin, spectrophotometry, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under NDW, 1 in the last five years, from 7 different applicants. The average 510(k) review took 204 days (median 121); 266 days on average over the last three years. FDA has posted 7 recalls for NDW devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Porphyrin, Spectrophotometry, Lithium |
| Device class | Class II |
| Regulation | 21 CFR 862.3560 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NDW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 266 |
Compare with all 510(k) review times · Search every NDW clearance
Top NDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories, Inc. | 1 | 2025-08-01 |
| Siemens Healthcare Diagnostics | 1 | 2011-11-04 |
| Roche Diagnostics Corp. | 1 | 2008-03-21 |
| Thermo Electron OY | 1 | 2007-10-09 |
| SENTINEL CH. SpA | 1 | 2007-08-02 |
2 more applicants have NDW clearances. See the full list in Caduvo.
Most recent NDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243462 | Diazyme Laboratories, Inc. | Diazyme Colorimetric Lithium Assay | 2025-08-01 | 266 |
| K112142 | Siemens Healthcare Diagnostics | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | 2011-11-04 | 101 |
| K063684 | Roche Diagnostics Corp. | COBAS LITHIUM | 2008-03-21 | 465 |
| K063705 | Thermo Electron OY | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | 2007-10-09 | 300 |
| K070987 | SENTINEL CH. SpA | SENTINEL LITHIUM ASSAY | 2007-08-02 | 118 |
Recalls for NDW devices
7 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-09-19.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 3 |
Frequently asked questions
What is FDA product code NDW?
NDW is the FDA product code for assay, porphyrin, spectrophotometry, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel.
What device class is NDW?
Class II, regulation 21 CFR 862.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDW?
Across 7 cleared submissions the average was 204 days from receipt to decision (median 121).
Which companies have the most NDW clearances?
Diazyme Laboratories, Inc. (1); Siemens Healthcare Diagnostics (1); Roche Diagnostics Corp. (1); Thermo Electron OY (1); SENTINEL CH. SpA (1).
Have NDW devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code NDW
- Run a recall and safety report across every NDW manufacturer
- Watch product code NDW 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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