510(k) · Cleared
Recalled · Class II · 2016IN Touch Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eoshealth, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Sep 8, 2014 as substantially equivalent to K112653 (ACON Laboratories, Inc., 2012) and 1 other predicate after a 291-day review. Its family tree reaches back 2 generations to 2009. It has been recalled once.
- Decided
- Sep 8, 2014
- Review
- 291 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K091820 (2009). 4 ancestors in all, the oldest K002134 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux… | Bayer Healthcare | 2009 | — |
| −1 | K101371 | ON Call Plus Diabetes Monitoring Software | ACON Laboratories, Inc. | 2011 | — |
| 0 (this device) | K133584 | IN Touch Blood Glucose Monitoring System | Eoshealth, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K112653 | ON Call Vivid Blood Glucose Monitoring SystemsSummary page 7…erver to the In Touch® meter. 8. Legally Marketed Predicate Device(s) ACON Laboratories, Inc. On Call® Vivid Blood Glucose Monitoring System, 510(k) Number k112653 ACON Laboratories, Inc. On Call® Diabetes Management Software, 510(k) Number k101371 9. In Touch® Substantial Equivalence Di… | 2012 |
| * | K101371 | ON Call Plus Diabetes Monitoring SoftwareSummary page 7…ratories, Inc. On Call® Vivid Blood Glucose Monitoring System, 510(k) Number k112653 ACON Laboratories, Inc. On Call® Diabetes Management Software, 510(k) Number k101371 9. In Touch® Substantial Equivalence Discussion The comparison chart below provides information to demonstrate the substant… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2016 | Class II | Z-1587-2016 | Error in labeling | The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K112653.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for…
Read the full statement (182 words)
The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared.
The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.
The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133584: IN Touch 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/K133584
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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