510(k) · Cleared
ClearedDS-a Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance International Co., Ltd. · CGA Glucose Oxidase, Glucose
Cleared on Dec 7, 2009 as substantially equivalent to K043474 (Roche Diagnostics Corp., 2005) after a 430-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Dec 7, 2009
- Review
- 430 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010362 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 1 generation backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- This deviceK082965 DS-a Blood Glucose Monitoring SystemAlliance International Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK132663 I-Qare DS-W Blood Glucose Monitoring SystemAlliance International Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K132663I-Qare DS-W Blood Glucose Monitoring SystemAlliance International Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −1 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| 0 (this device) | K082965 | DS-a Blood Glucose Monitoring System | Alliance International Co., Ltd. | 2009 | — |
| +1 | K132663 | I-Qare DS-W Blood Glucose Monitoring System | Alliance International Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K043474 | Accu-Chek Aviva SystemSummary page 1….2. Safety and Effectiveness Information * Predicate Device: Claim of Substantial Equivalence (SE) is made to ACCU-CHEK Aviva System. (k043474). * Device Description: Based on an electrochemical biosensor technology - and the pr… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132663 | I-Qare DS-W Blood Glucose Monitoring System | 2015 | 0 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K132663 (Alliance International Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K043474.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness, of diabetes control. These are not…
Read the full statement (232 words)
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness, of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082965: DS-a Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082965
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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