FREND Testosterone Test System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K153577 FDA 510(k)
- FDA Product Code
- CDZ FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1680 FDA 510(k)
- Regulation Number
- 862.1680 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FREND Testosterone Test System is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of total testosterone in human serum and plasma (EDTA and Lithium-heparin). It is designed for use in the FREND System fluorescent immunoassay reader and is for professional use only.
The system uses disposable microfluidic cartridges and provides quantitative results in under 3 minutes from a single drop of blood. It is FDA 510(k) cleared, IVDD, and IVDR authorized. The device is intended for point-of-care testing and is not MRI safe.
Frequently asked questions
What types of blood samples can the FREND Testosterone Test System measure, and how quickly does it provide results?
The FREND Testosterone Test System is designed to measure total testosterone levels in human serum and plasma collected with EDTA or Lithium-heparin. It delivers quantitative results in under 3 minutes from a single drop of blood, making it ideal for rapid point-of-care testing.
Is the FREND Testosterone Test System reusable, or does it require disposable components?
The system uses disposable microfluidic cartridges, which are intended for single-use. This ensures accuracy and hygiene for each test, as the cartridges are not designed for reuse.
What kind of reader is required to operate the FREND Testosterone Test System, and is it suitable for all clinical settings?
The FREND Testosterone Test System is designed exclusively for use with the FREND System fluorescent immunoassay reader, which must be available in the testing environment. It is intended for professional use only and is specifically engineered for point-of-care settings, not general clinical labs or MRI environments (as it is not MRI safe).
How was the FREND Testosterone Test System evaluated for regulatory approval, and what does that mean for its clinical use?
The device was cleared through an FDA 510(k) submission (K153577) under the Traditional 510(k) Review pathway, with a substantially equivalent determination by the Clinical Chemistry (CH) Advisory Committee. This means it was compared to legally marketed predicate devices (like radioimmunoassays) and deemed safe and effective for its intended use—quantitative measurement of total testosterone in serum/plasma—without implying any specific clinical indication beyond what’s stated in the labeling.
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: FREND Testosterone - NanoEntek, FREND™ Testosterone - Quantitative Testosterone Test, FREND™ System Fluorescence Immunoassay Analyzer | NanoEntek
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Active |
| EUDAMED | European Union | IVDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K153577 | Class I | Active |
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Manufacturer
- Manufacturer
- Nanoentek USA, Inc.
Sources (2)
- FDA 510(k) K153577 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026