FDA product code QXS: Chromogranin A
QXS is the FDA product code for chromogranin a. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under QXS, 1 in the last five years. The average 510(k) review took 418 days (median 418).
Definition
In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors.
Classification
| Field | Value |
|---|---|
| Device name | Chromogranin A |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for QXS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 418 |
Compare with all 510(k) review times · Search every QXS clearance
Top QXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B.R.A.H.M.S GmbH, Part of Thermo Fisher | 1 | 2023-09-18 |
Most recent QXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222251 | B.R.A.H.M.S GmbH, Part of Thermo Fisher | B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | 2023-09-18 | 418 |
Recalls for QXS devices
openFDA lists no recalls for product code QXS.
Frequently asked questions
What is FDA product code QXS?
QXS is the FDA product code for chromogranin a. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is QXS?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXS?
Across 1 cleared submissions the average was 418 days from receipt to decision (median 418).
Which companies have the most QXS clearances?
B.R.A.H.M.S GmbH, Part of Thermo Fisher (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXS
- Run a recall and safety report across every QXS manufacturer
- Watch product code QXS 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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