510(k) · Cleared
Recalled · Class II · 2017Human Alpha-1 Antitrypsin Kit Spaplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Cleared on Jul 3, 2013 after a 258-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jul 3, 2013
- Review
- 258 days
- Class
- Class II
- Product code
- DEM
- Recalls
- 1
- 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 DEM? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2017 | Class II | Z-0002-2018 | Under Investigation by firm | The high control for the kit is recovering low and may be out of range for assigned values. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DEM devicesDEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DEM
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DEM
Too few DEM 510(k)s in any year since 2007 to give a median.
Recalls per year · DEM
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEM
1in 2024
MAUDE reports naming product code DEM, not matched to any one device; reports are not rates.
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 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Human al-antitrypsin Kit for use on SPAPLUS is designed for the quantitative in vitro determination of al-antitrypsin in human serum using the SPApius turbidimetric analyzer. The measurement of al-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, al-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123256: Human Alpha-1 Antitrypsin Kit Spaplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123256
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026