FDA product code PQW: Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
PQW is the FDA product code for alpha-d-galactosidase a (gla) newborn screening test system. It is a Class II device, regulated under 21 CFR 862.1488 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under PQW, from 2 different applicants. The average 510(k) review took 148 days (median 148). 1 De Novo request was granted under it.
Definition
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1488 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PQW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 212 |
| 2019 | 1 | 84 |
Compare with all 510(k) review times · Search every PQW clearance
Top PQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perkinelmer, Inc. | 1 | 2019-05-03 |
| Wallac Oy, A Subsidiary of Perkinelmer | 1 | 2018-07-18 |
Most recent PQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190266 | Perkinelmer, Inc. | NeoLSD MSMS Kit | 2019-05-03 | 84 |
| K173829 | Wallac Oy, A Subsidiary of Perkinelmer | NeoLSD MSMS kit | 2018-07-18 | 212 |
Recalls for PQW devices
openFDA lists no recalls for product code PQW.
Frequently asked questions
What is FDA product code PQW?
PQW is the FDA product code for alpha-d-galactosidase a (gla) newborn screening test system. It is a Class II device, regulated under 21 CFR 862.1488 and reviewed by the Clinical Chemistry panel.
What device class is PQW?
Class II, regulation 21 CFR 862.1488. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQW?
Across 2 cleared submissions the average was 148 days from receipt to decision (median 148).
Which companies have the most PQW clearances?
Perkinelmer, Inc. (1); Wallac Oy, A Subsidiary of Perkinelmer (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PQW
- Run a recall and safety report across every PQW manufacturer
- Watch product code PQW 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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