FDA product code SJD: Integrated Continuous Glucose Ketone Monitoring System
SJD is the FDA product code for integrated continuous glucose ketone monitoring system. It is a Class II device, regulated under 21 CFR 862.1354 and reviewed by the Clinical Chemistry panel. Devices under SJD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An integrated continuous glucose ketone monitoring system (iCGK) is intended to automatically measure glucose and ketones in bodily fluids continuously or frequently for a specified period of time. iCGK systems are designed to reliably and securely transmit glucose and ketone measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control or ketone fluctuation. When making therapeutic adjustments, ketone output should be used in conjunction with glucose levels, symptoms, and factors that may affect ketone levels such as eating patterns and exercise.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Ketone Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 862.1354 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for SJD devices
openFDA lists no recalls for product code SJD.
Frequently asked questions
What is FDA product code SJD?
SJD is the FDA product code for integrated continuous glucose ketone monitoring system. It is a Class II device, regulated under 21 CFR 862.1354 and reviewed by the Clinical Chemistry panel.
What device class is SJD?
Class II, regulation 21 CFR 862.1354. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SJD
- Run a recall and safety report across every SJD manufacturer
- Watch product code SJD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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