510(k) · Cleared
ClearedB·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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.R.A.H.M.S GmbH, Part of Thermo Fisher · QXS Chromogranin A
Cleared on Sep 18, 2023 as substantially equivalent to K990774 (Abbott Laboratories, 1999) after a 418-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Sep 18, 2023
- Review
- 418 days
- Class
- Class II
- Product code
- QXS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990774 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990774 Abbott Architect CeaAbbott Laboratories · 1999
- This deviceK222251 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 GmbH, Part of Thermo Fisher · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990774 | Abbott Architect Cea | Abbott Laboratories | 1999 | — |
| 0 (this device) | 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… | B.R.A.H.M.S GmbH, Part of Thermo Fisher | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QXS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990774 | Abbott Architect CeaSummary page 6…retrieved after a 29 min incubation time. 7. Substantial Equivalence Information a. Predicate Device Name(s)/510(k) number(s)/product code(s): ARCHITECT CEA / K990774 / DHX b. Reference Device Name(s) 510(k) number(s)/product code(s): B·R·A·H·M·S™ PCT sensitive KRYPTOR™ / B·R·A·H·M·S™… | 1999 |
| † | K171338 | B R A H M S PCT sensitive KRYPTOR | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K990774.
How does its category compare?
All QXS devicesQXS Chromogranin A: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QXS
Too few QXS 510(k)s in any year since 2007 to give a median.
Recalls per year · QXS
No recall names QXS since 2007.
Adverse event reports per year · QXS
No MAUDE report names QXS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
B·R·A·H·M·S™ CgA II KRYPTOR™ is an automated immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE™) technology for quantitative determination of Chromogranin A concentration in human serum.
B·R·A·H·M·S™ CgA II KRYPTOR™ is to be used in conjunction with other clinical methods as an aid in monitoring of disease progression during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors (GEP-NETs, grade 1 and grade 2).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222251 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222251
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026