Chromogranin A
The Chromogranin A test (product code QXS) is a Class 2 Immunology in vitro diagnostic device (regulation 866.6010) intended to measure Chromogranin A (CgA) as an aid in monitoring the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXS
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222251 | 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 | Sep 18, 2023 | Substantially Equivalent | B.R.A.H.M.S GmbH, Part of Thermo Fisher |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.