9 devices · 7 companies · 2015 to 2023
AI-enabled clinical chemistry devices on FDA's list
9 devices in the Clinical Chemistry panel, 2015 to 2023, from 7 companies across 6 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Clinical Chemistry panel
- JIR · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)2
- QCC · Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals2
- NBW · System, Test, Blood Glucose, Over The Counter2
- QWZ · Prognostic Test For Assessment Of Chronic Kidney Disease Progression1
- JFY · Enzymatic Method, Creatinine1
- JIL · Method, Enzymatic, Glucose (Urinary, Non-Quantitative)1
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Minuteful-kidney testK222921 · 510(k) | Healthy.io Ltd. | JIR | database entry | |
| KidneyIntelX.dkdDEN200052 · De Novo | Renalytix AI, Inc. | QWZ | database entry | |
| Minuteful - kidney testK210069 · 510(k) | Healthy.io Ltd. | JIR | database entry | |
| ACR LAB Urine Analysis Test SystemK182384 · 510(k) | Healthy.io Ltd | JFY | database entry | |
| DreaMed Advisor ProK191370 · 510(k) | DreaMed Diabetes Ltd | QCC | database entry | |
| DIP/U.S. Urine Analysis Test SystemK173327 · 510(k) | Healthy.io Ltd | JIL | database entry | |
| DreaMed Advisor ProDEN170043 · De Novo | DreaMed Diabetes, Ltd. | QCC | database entry | |
| One Drop Blood Glucose Monitoring SystemK161834 · 510(k) | AgaMatrix, Inc. | NBW | database entry | |
| Dario Blood Glucose Monitoring SystemK150817 · 510(k) | LabStyle Innovations Ltd. | NBW | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.