Precichek NS-101 POCT Professional Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113314 FDA 510(k)
- FDA Product Code
- LFR 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 Precichek NS-101 is a point-of-care (POCT) professional blood glucose monitoring system designed for the quantitative measurement of glucose in whole blood samples. It employs glucose dehydrogenase technology to provide accurate glucose readings from capillary, venous, or arterial blood sources, supporting clinical chemistry applications. This device is intended for use by healthcare professionals in settings requiring precise glucose monitoring, such as hospitals, clinics, or emergency care environments.
The system is supplied as a reusable medical device and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. It is intended for single-patient use per test strip and does not require sterilization between uses. The device operates in non-MRI environments and is packaged for storage in controlled conditions to maintain performance. Authorized distribution is governed by FDA registration number 3011121740 and regulatory classification under 862.1345.
Frequently asked questions
What is the Precichek NS-101 POCT Professional Blood Glucose Monitoring System used for?
The Precichek NS-101 is designed for quantitative measurement of glucose levels in whole blood samples. It supports clinical chemistry applications and is intended for use by healthcare professionals in environments requiring precise glucose monitoring, such as hospitals, clinics, or emergency care settings. The system accepts capillary, venous, or arterial blood samples for reliable results.
Is the Precichek NS-101 a single-use or reusable device?
The Precichek NS-101 is a reusable medical device. However, it is intended for single-patient use per test strip, meaning each strip should be used only once for a single test. The reusable meter itself does not require sterilization between uses, but proper cleaning and maintenance are necessary to ensure accuracy and performance.
How should the Precichek NS-101 be stored to maintain its performance?
The Precichek NS-101 is packaged for storage under controlled conditions to preserve its functionality. It is designed for use in non-MRI environments, and storage should follow manufacturer guidelines to avoid exposure to extreme temperatures, humidity, or direct sunlight. Always refer to the included instructions for specific storage recommendations.
What type of blood samples can the Precichek NS-101 measure?
The Precichek NS-101 is capable of measuring glucose levels in capillary, venous, or arterial whole blood samples. This versatility makes it suitable for a variety of clinical settings where different blood sources may be available, ensuring flexibility for healthcare professionals.
What regulatory approval does the Precichek NS-101 hold?
The Precichek NS-101 has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device. It is authorized for distribution under FDA registration number 3011121740 and falls under the regulatory category 862.1345. This approval ensures it meets the necessary safety and performance standards for use in clinical settings.
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: Precichek Ns-101 Poct Professional Blood Glucose Monitoring System, Precichek Ns-101 Poct Professional Blood Glucose Monitoring System, PDF 510(k) Summary - Food and Drug Administration, GlucoLeader | | Enhance | NS101 - HMD Biomedical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113314 | Class II | Active |
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Manufacturer
- Manufacturer
- Hmd Biomedical Inc.
- FDA Applicant
- Hmd Biomedical, Inc.
Sources (1)
- FDA 510(k) K113314 24 fields · synced Oct 6, 2026