510(k) · Cleared
ClearedThermo Electron Angiotensin Converting Enzyme Infinity (Ace) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron Corporation · KQN Radioassay, Angiotensin Converting Enzyme
Cleared on Aug 30, 2004 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 30, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- KQN
- 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 KQN? 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 KQN devicesKQN Radioassay, Angiotensin Converting Enzyme: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQN
FDA has decided no KQN device since 2007.
Median 510(k) review, days · KQN
Too few KQN 510(k)s in any year since 2007 to give a median.
Recalls per year · KQN
No recall names KQN since 2007.
Adverse event reports per year · KQN
No MAUDE report names KQN 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?
1. The Thermo Electron InfinityTM ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen. 2. The Thermo…
Read the full statement (124 words)
1. The Thermo Electron InfinityTM ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only.
Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.
2. The Thermo Electron Infinity TM ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041657: Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041657
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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