Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1354](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1354) → SJD — Integrated Continuous Glucose Ketone Monitoring System, Factory Calibrated

# SJD · Integrated Continuous Glucose Ketone Monitoring System, Factory Calibrated

_Clinical Chemistry · 21 CFR 862.1354 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SJD

## Overview

- **Product Code:** SJD
- **Device Name:** Integrated Continuous Glucose Ketone Monitoring System, Factory Calibrated
- **Regulation:** [21 CFR 862.1354](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1354)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

The Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System is a prescription device indicated for the management of diabetes in persons age 2 years and older. It is intended to monitor glucose and ketone (beta-hydroxybutyrate) levels in real-time. The system provides alarms, detects trends, tracks glucose and ketone patterns, and aids in the detection of episodes of hyperglycemia, hypoglycemia, and hyperketonemia. It replaces blood glucose testing for diabetes treatment decisions and is intended to autonomously communicate with digitally connected devices for the purpose of managing diabetes.

## Classification Rationale

FDA has determined that the device can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250049](/device/DEN250049.md) | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care | Aug 25, 2026 | DENG |

## Top Applicants

- Abbott Diabetes Care — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/SJD](https://fda.innolitics.com/productcode/SJD)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com