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FREND Vitamin D Test System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K162754

by Nanoentek USA, Inc.

Identifiers

510(k) Number
K162754 FDA 510(k)
FDA Product Code
MRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1825 FDA 510(k)
Regulation Number
862.1825 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FREND Vitamin D Test System is a rapid, lateral flow immunoassay designed for the qualitative detection of 25-hydroxyvitamin D in human serum or plasma. It falls under the category of in vitro diagnostic devices for clinical chemistry applications, enabling point-of-care testing for vitamin D deficiency assessment.

This system is supplied as a single-use, non-sterile test kit intended for use in clinical laboratories and point-of-care settings. It requires no special storage conditions beyond refrigeration at 2–8°C and is not intended for MRI environments. The device holds FDA 510(k) clearance and IVD Directive compliance, with a classification under device class II. Each test includes all necessary reagents and components for a single use.

Frequently asked questions

What clinical setting is the FREND Vitamin D Test System designed for, and how does it differ from traditional lab testing?

The FREND Vitamin D Test System is designed for clinical laboratories and point-of-care settings, enabling rapid, on-site testing for vitamin D deficiency assessment. Unlike traditional lab-based methods, it uses a lateral flow immunoassay for qualitative detection of 25-hydroxyvitamin D in human serum or plasma, making it ideal for quick, decentralized testing where immediate results are needed. This aligns with point-of-care diagnostics, reducing turnaround time compared to centralized lab processing.

Is the FREND Vitamin D Test System single-use or reusable, and what does that mean for workflow efficiency?

The FREND Vitamin D Test System is single-use only, meaning each kit contains all necessary reagents and components for one test. This design ensures consistency in results and eliminates cross-contamination risks, but it may require clinicians to manage inventory more carefully. However, the simplicity of single-use kits can streamline workflows in busy settings by reducing preparation time per test.

What storage conditions are required for the FREND Vitamin D Test System, and can it be used in environments with MRI equipment?

The system requires refrigeration at 2–8°C—no additional storage conditions are specified. It is not intended for use in MRI environments, as lateral flow assays are generally incompatible with magnetic fields, which could interfere with test integrity or safety. Always store it in a cool, dry place away from direct light until use.

How do I know if this test is appropriate for my lab or point-of-care setting, given its regulatory classification?

The FREND Vitamin D Test System holds FDA 510(k) clearance and complies with the IVD Directive, classifying it as a Class II device under clinical chemistry. This means it has undergone regulatory review for safety and performance, making it suitable for clinical laboratories and certified point-of-care settings that meet regulatory standards. Check your facility’s accreditation to ensure compliance with handling in vitro diagnostics.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanoentek USA, Inc.

Sources (2)

  • FDA 510(k) K162754 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026