510(k) · Cleared
ClearedOptilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DAE Complement C9, Antigen, Antiserum, Control
Cleared on Aug 28, 2015 after a 191-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 28, 2015
- Review
- 191 days
- Class
- Class II
- Product code
- DAE
- 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 DAE? 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 DAE devicesDAE Complement C9, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DAE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DAE
Too few DAE 510(k)s in any year since 2007 to give a median.
Recalls per year · DAE
No recall names DAE since 2007.
Adverse event reports per year · DAE
No MAUDE report names DAE 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 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 CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro…
Read the full statement (176 words)
The Optilite CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CHS50 Reagent (product code NK095.0PT) for the determination of total complement activity.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.0PT) for the determination of total complement activity.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150412: Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150412
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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