510(k) · Cleared
ClearedTricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin); Noradrenalin Ria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibl GmbH · CHQ Chromatographic/Fluorometric Method, Catecholamines
Cleared on Oct 3, 2005 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 3, 2005
- Review
- 75 days
- Class
- Class I
- Product code
- CHQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHQ? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CHQ devicesCHQ Chromatographic/Fluorometric Method, Catecholamines: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHQ
FDA has decided no CHQ device since 2007.
Median 510(k) review, days · CHQ
Too few CHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CHQ
No recall names CHQ since 2007.
Adverse event reports per year · CHQ
No MAUDE report names CHQ 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination and/or of the catecholamines adrenaline (epinephrine), noradrenaline (norepinephrine) dopamine (either separate or combined) in human plasma and urine.
The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of the tumor diseases of the nervous system, especially of the pheochromocytoma, but also neuroblastoma and the ganglioneuroma.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051969: Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin); Noradrenalin Ria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051969
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026