510(k) · Cleared
ClearedExtendsure Hbfasc Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cantebury Scientific, Ltd. · JCM Control, Hemoglobin, Abnormal
Cleared on Dec 7, 2005 as substantially equivalent to K933086 (Helena Laboratories, 1994) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 7, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- JCM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933086 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933086 Afsc Hemo Control #5331, AA2 Hemo Control #5328Helena Laboratories · 1994
- This deviceK053031 Extendsure Hbfasc ControlCantebury Scientific, Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933086 | Afsc Hemo Control #5331, AA2 Hemo Control #5328 | Helena Laboratories | 1994 | — |
| 0 (this device) | K053031 | Extendsure Hbfasc Control | Cantebury Scientific, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JCM? 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933086 | Afsc Hemo Control #5331, AA2 Hemo Control #5328Summary page 1…unassayed) Class If Product Code JCM Equivalent Device Helena Laboratories, AFSC Hemo Control. (51 0(k) 1*K933086) Canterbury Health Laboratories, Hemoglobin F & A2 Control (51 0(… | 1994 |
| * | K011389 | Hemoglobin F & A2 Control (Beta-Thalassaemia Control)Summary page 1…SC Hemo Control. (51 0(k) 1*K933086) Canterbury Health Laboratories, Hemoglobin F & A2 Control (51 0(k) # K0 11389) Description of Device The Hemoglobin FASO Variant Control kit contains HbA, HbF, HbS… | 2001 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All JCM devicesJCM Control, Hemoglobin, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCM
FDA has decided no JCM device since 2007.
Median 510(k) review, days · JCM
Too few JCM 510(k)s in any year since 2007 to give a median.
Recalls per year · JCM
No recall names JCM since 2007.
Adverse event reports per year · JCM
No MAUDE report names JCM 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?
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053031: Extendsure Hbfasc Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053031
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026