One Drop Blood Glucose Monitoring System is an AI-enabled medical device from AgaMatrix, Inc. that the U.S. FDA cleared through 510(k) K161834 on November 30, 2016. Its lead review panel is Clinical Chemistry and its primary product code is NBW (System, Test, Blood Glucose, Over The Counter).
See also all FDA AI clearances in 2016.
Key facts
| Submission number | K161834 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | AgaMatrix, Inc. |
| Lead review panel | Clinical Chemistry |
| Primary product code | NBW — System, Test, Blood Glucose, Over The Counter |
| Applicant (openFDA) | Agamatrix, Inc. |
| Applicant location | Salem, NH, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.1345 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. One Drop Blood Glucose Monitoring System went through this pathway (K161834).
openFDA lists it as a Class 2 device under 21 CFR 862.1345. Class II devices are moderate risk and are subject to general and special controls.
Product code NBW covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. AgaMatrix, Inc. has 1 AI-enabled device on the list, and the Clinical Chemistry panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.