510(k) · Cleared
ClearedExtendsure Lyophilized HBA1C Linearity Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canterbury Scientific, Ltd. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 22, 2007 as substantially equivalent to K003030 (Bio-Rad, 2000) after a 65-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 22, 2007
- Review
- 65 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003030 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003030 Lyphochek Hemoglobin Alc Linearity SetBio-Rad · 2000
- This deviceK071648 Extendsure Lyophilized HBA1C Linearity ControlsCanterbury Scientific, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003030 | Lyphochek Hemoglobin Alc Linearity Set | Bio-Rad | 2000 | — |
| 0 (this device) | K071648 | Extendsure Lyophilized HBA1C Linearity Controls | Canterbury Scientific, Ltd. | 2007 | — |
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 JJX? 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? (1)
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 |
|---|---|---|---|
| * | K003030 | Lyphochek Hemoglobin Alc Linearity SetSummary page 1…Lyphochek® Hemoglobin Al c Linearity Set Levels 1, 2, 3 and 4 510(k) Number K003030 Product Code GGM Description of Device The extendSURETM Lyophilized Hemoglobin… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. The extendSURETM lyophilized hemoglobin Alc linearity controls are intended to verify the linearity of HbAlc assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071648: Extendsure Lyophilized HBA1C Linearity Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071648
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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