510(k) · Cleared
ClearedHuman CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls FO
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 Jul 11, 2012 after a 240-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 11, 2012
- Review
- 240 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. 2012, 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?
Human CH5O reagent pack for use on the SPA PLUS: These reagents are intended for the quantification of total classical complement activity (CH5O) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests.…
Read the full statement (144 words)
Human CH5O reagent pack for use on the SPA PLUS:
These reagents are intended for the quantification of total classical complement activity (CH5O) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests.
Human CH5O calibrator set for use on the SPA PLUS:
The Human CH5O calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH5O reagent pack (product code: NK095.S) for the determination of total complement activity.
Human CH5O controls for use on the SPA PLUS:
The Human CH5O controls are intended for use in conjunction with the Binding Site Human CH5O reagent pack for use on the SPAPLUS (product code: NK095.S).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113349: Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the Spaplus, Human CH50 Controls FO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113349
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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