MTM301 Blood Glucose and Ketone Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202534 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MTM301 Blood Glucose and Ketone Monitoring System is an in vitro diagnostic device classified as a blood glucose test system (product code NBW). It is designed to quantitatively measure blood glucose and ketone levels in fresh capillary whole blood obtained from fingertip samples, aiding in the self-monitoring of diabetes management at home.
This system is intended for single-use, over-the-counter use by individuals with diabetes mellitus. It operates outside the body and requires no regulatory sterilisation or reprocessing. The device holds FDA 510(k) clearance (K202534) under the Clinical Chemistry advisory committee and is intended for home-based self-testing without medical supervision.
Frequently asked questions
What types of blood samples can the MTM301 system measure, and is it designed for home use by individuals without medical training?
The MTM301 is designed to measure blood glucose and ketone levels in fresh capillary whole blood obtained from fingertip samples. It is explicitly intended for single-use, over-the-counter home testing by individuals with diabetes mellitus, requiring no medical supervision. The system is not meant for clinical or professional laboratory use.
How is the MTM301 system supplied, and is it reusable or intended for single-use?
The MTM301 is a single-use device, meaning each test strip and meter combination is intended for one measurement only. Since it operates outside the body and does not require regulatory sterilization or reprocessing, users should follow the manufacturer’s instructions for proper disposal after each use.
Does the MTM301 system require any special storage conditions, and what should users be aware of when handling it?
The device specifications do not explicitly detail storage conditions, but as a single-use in vitro diagnostic device, it should be stored according to the manufacturer’s guidelines (likely provided in the user manual) to maintain accuracy. Users should ensure the system is protected from extreme temperatures, moisture, and contamination until use.
What regulatory pathway was followed for the MTM301, and which advisory committee was involved in its clearance?
The MTM301 received FDA 510(k) clearance (K202534) under the Clinical Chemistry advisory committee (CH). It was determined to be substantially equivalent to a predicate device and followed a traditional review process. The clearance confirms its compliance for home-based self-monitoring of blood glucose and ketone levels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MTM301 Blood Glucose and Ketone Monitoring System (K202534) — FDA 510 ..., K202534 - MTM301 Blood Glucose and Ketone Monitoring System, MTM301 Blood Glucose And Ketone Monitoring System… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202534 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (1)
- FDA 510(k) K202534 24 fields · synced Oct 6, 2026