FDA product code QWH: Prognostic Test For Development Or Progression Of Preeclampsia
QWH is the FDA product code for prognostic test for development or progression of preeclampsia. It is a Class II device, regulated under 21 CFR 862.1602 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under QWH, 1 in the last five years. The average 510(k) review took 261 days (median 261); 261 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QWH devices, 1 initiated in the last five years.
Definition
A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.
Classification
| Field | Value |
|---|---|
| Device name | Prognostic Test For Development Or Progression Of Preeclampsia |
| Device class | Class II |
| Regulation | 21 CFR 862.1602 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QWH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 261 |
Compare with all 510(k) review times · Search every QWH clearance
Top QWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 1 | 2025-02-07 |
Most recent QWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241453 | Roche Diagnostics | Elecsys sFlt-1 and Elecsys PlGF | 2025-02-07 | 261 |
Recalls for QWH devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-12.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code QWH?
QWH is the FDA product code for prognostic test for development or progression of preeclampsia. It is a Class II device, regulated under 21 CFR 862.1602 and reviewed by the Clinical Toxicology panel.
What device class is QWH?
Class II, regulation 21 CFR 862.1602. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWH?
Across 1 cleared submissions the average was 261 days from receipt to decision (median 261).
Which companies have the most QWH clearances?
Roche Diagnostics (1).
Have QWH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-12.
Next steps
- Run an FDA pathway report with predicate devices for product code QWH
- Run a recall and safety report across every QWH manufacturer
- Watch product code QWH 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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