Agamatrix: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Agamatrix” (first 2006, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 60 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 196 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Agamatrix took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 14 | 14 |
Review panels
- Clinical Chemistry (14)
Most recent Agamatrix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | NBW | 2024-06-06 | 28 |
| K161834 | One Drop Blood Glucose Monitoring System | NBW | 2016-11-30 | 148 |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | NBW | 2016-04-21 | 244 |
| K132821 | AGAMATRIX HEALTH MANAGER | NBW | 2013-11-20 | 72 |
| K130535 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION | NBW | 2013-04-17 | 47 |
| K103544 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D | NBW | 2011-12-07 | 370 |
| K101597 | WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 | NBW | 2010-10-18 | 132 |
| K083265 | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 | NBW | 2009-02-03 | 90 |
| K073573 | WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-01-30 | 41 |
| K072413 | MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2007-09-27 | 30 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Agamatrix.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Agamatrix is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01889355: User Study for Enhanced Meter Feature (Completed, started 2014-01)
- NCT01885546: Accuracy Study for Enhanced Meter Feature (Completed, started 2013-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Agamatrix?
FDA lists 14 510(k) clearances under the applicant name “Agamatrix” (first 2006, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Agamatrix?
The median time from FDA receipt to decision across 510(k)s cleared under the name Agamatrix is 78 days.
Which FDA product codes appear under Agamatrix?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 14).
Next steps
- See all 14 Agamatrix clearances with predicates and recalls
- Run predicate analysis for product code NBW, Agamatrix's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.