510(k) · Cleared
ClearedAgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agamatrix, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 21, 2016 as substantially equivalent to K103544 (Agamatrix, Inc., 2011) after a 244-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Apr 21, 2016
- Review
- 244 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K952279 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 4 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 3 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- 2 generations backK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
- 1 generation backK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
- This deviceK152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161834 One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −4 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −3 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| −2 | K101597 | Wavesense Diabetes Manager Model Version 1.3.4 | Agamatrix | 2010 | — |
| −1 | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application… | Agamatrix, Inc. | 2011 | — |
| 0 (this device) | K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | 2016 | — |
| +1 | K161834 | One Drop Blood Glucose Monitoring System | Agamatrix, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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 |
|---|---|---|---|
| * | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DSummary page 6…le with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately: · AgaMatrix Glucose Control Solutions (cleared in K103544) - AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) J. Substantial Equivalence Information:… | 2011 |
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 |
|---|---|---|---|
| K161834 | One Drop Blood Glucose Monitoring System | 2016 | 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 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K161834 (Agamatrix, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K103544.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System: The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro…
Read the full statement (151 words)
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System:
The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for, diabetes and is not intended for use with neonates.
The AgaMatrix Jazz Blood Glucose Test Strips are for use with the AgaMatrix Jazz Wireless 2 Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152365
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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