510(k) · Cleared
ClearedAuto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Sens, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Sep 5, 2012 as substantially equivalent to K103396 (I-Sens, Inc., 2011) after a 92-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Sep 5, 2012
- Review
- 92 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 3 generations backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- 2 generations backK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- 1 generation backK103396 Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool…I-Sens, Inc. · 2011
- This deviceK121654 Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip.…I-Sens, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −3 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| −2 | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| −1 | K103396 | Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution | I-Sens, Inc. | 2011 | — |
| 0 (this device) | K121654 | Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check… | I-Sens, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K103396 | Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control SolutionSummary page 2…Logbook. Substantial 1) Predicate Device Name: COOL Blood Glucose Monitoring System Equivalence Information: 2) Predicate 510(k) Number: k103396 2) Comparison with Predicate Device: The modified AUTO-CHEK BGMS has the fo… | 2011 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 AUTO-CHEK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The AUTO-CHEK Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home…
Read the full statement (180 words)
The AUTO-CHEK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The AUTO-CHEK Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121654: Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121654
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