510(k) · Cleared
ClearedOptilite C1 Inactivator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Cleared on Jul 18, 2014 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 18, 2014
- Review
- 80 days
- Class
- Class II
- Product code
- DBA
- 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 DBA? 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 DBA devicesDBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DBA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DBA
Too few DBA 510(k)s in any year since 2007 to give a median.
Recalls per year · DBA
No recall names DBA since 2007.
Adverse event reports per year · DBA
No MAUDE report names DBA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 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 Optilite C1 Inactivator Kit is intended for the quantitative in vitro measurement of human ClI Inactivator in human serum using the Binding Site Optilite analyser. Measurement of ClI inactivator levels in serum is an aid in the diagnosis of hereditary angioedemna (RAE) in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K141100 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141100: Optilite C1 Inactivator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141100
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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