510(k) · Cleared
ClearedON Call Vivid Blood Glucose Monitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 9, 2012 as substantially equivalent to K002134 (Selfcare, Inc., 2000) after a 210-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- Apr 9, 2012
- Review
- 210 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002134 (2000). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- This deviceK112653 ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK130284 ON Call Sharp Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK181527 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync…ACON Laboratories, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK132086 ON Call Express Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK193340 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose…Microtech Medical, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK200277 Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130284ON Call Sharp Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013 · cites it directly3descendants
- K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring…ACON Laboratories, Inc. · 2018 · 2 generations on1descendant
- K132086ON Call Express Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013 · cites it directly1descendant
- K193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring SystemMicrotech Medical, Inc. · 2020 · 2 generations on0descendants
- K200277Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| 0 (this device) | K112653 | ON Call Vivid Blood Glucose Monitoring Systems | ACON Laboratories, Inc. | 2012 | — |
| +1 | K130284 | ON Call Sharp Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2013 | — |
| +2 | K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose… | ACON Laboratories, Inc. | 2018 | — |
| +1 | K132086 | ON Call Express Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2013 | — |
| +2 | K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose… | Microtech Medical, Inc. | 2020 | — |
| +3 | K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 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 |
|---|---|---|---|
| * | K002134 | One Touch Ultra Blood Glucose Monitoring SystemSummary page 1…tem Predicate Device: One Touch Ultra Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. 510(k) Number: K002 134 2 Device Name: On Call Vivid Blood Glucose Monitoring Syste… | 2000 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2012, 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?
The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). The On Call®)…
Read the full statement (207 words)
The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). The On Call®) Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. It is for in vitro diagnostic use only.
The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use.
The On Call® Vivid Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in fresh capillary blood from the fingertip, forearm, and palm.
The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid Blood Glucose Meter and Test 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 as stated in the FDA summary.
https://510kreport.com/device/K112653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112653: ON Call Vivid Blood Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112653
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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