FREND PSA Plus Reagent Cartridge
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K124056 FDA 510(k)
- FDA Product Code
- LTJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6010 FDA 510(k)
- Regulation Number
- 866.6010 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FREND PSA Plus Reagent Cartridge is an in vitro diagnostic device classified as a Prostate-Specific Antigen (PSA) test for the quantitative measurement of total PSA in human serum and plasma. It is designed to support the management of prostate cancer by providing serial monitoring of PSA levels, aiding clinical decision-making in immunology-based diagnostics.
This single-use cartridge is intended for use exclusively with the FREND System and requires no sterilization beyond manufacturer-provided packaging. It is regulated under FDA 510(k) clearance and the In Vitro Diagnostic Device Directive (IVDD), adhering to regulatory standards for Class II devices (regulation number 866.6010). Compatible with serum, Li-heparinized plasma, and K3-EDTA plasma, it is supplied sterile and pre-packaged for immediate diagnostic use.
Frequently asked questions
What types of samples can the FREND PSA Plus Reagent Cartridge analyze, and why is this important for clinical use?
The FREND PSA Plus Reagent Cartridge is designed to measure total Prostate-Specific Antigen (PSA) levels in human serum, as well as Li-heparinized plasma and K3-EDTA plasma. This versatility is important because it allows clinicians to use the cartridge with different sample types depending on patient preparation or lab workflow, ensuring flexibility in monitoring PSA trends for prostate cancer management without requiring sample-specific adjustments.
Is the FREND PSA Plus Reagent Cartridge reusable, and if not, how should it be handled after use?
The cartridge is explicitly labeled as a single-use device, meaning it is intended for one diagnostic test only. After use, it should be disposed of according to standard biohazard waste protocols to prevent contamination or reuse. The manufacturer’s packaging ensures sterility, so no additional sterilization is required before use.
What regulatory pathways does the FREND PSA Plus Reagent Cartridge follow, and how does this affect its use in clinical settings?
The cartridge is cleared under FDA 510(k) (K124056) and complies with the In Vitro Diagnostic Device Directive (IVDD), classifying it as a Class II device (regulation number 866.6010). This means it has undergone rigorous review by the FDA’s Immunology (IM) Advisory Committee to ensure safety, performance, and equivalence to predicate devices. Clinicians can rely on its regulatory status as evidence of its validated use for quantitative PSA measurement in serum/plasma for prostate cancer monitoring.
How should the FREND PSA Plus Reagent Cartridge be stored, and why is this important?
The cartridge is supplied sterile and pre-packaged for immediate diagnostic use, meaning it should remain in its original, unopened packaging until ready for use. Proper storage ensures sterility and prevents exposure to contaminants or environmental damage. Since it is single-use, storage conditions also protect its integrity until the next test, maintaining accuracy and reliability for serial PSA monitoring.
What is the primary clinical purpose of the FREND PSA Plus Reagent Cartridge, and how does it support prostate cancer management?
The cartridge quantifies total PSA levels in human serum/plasma, enabling clinicians to track changes over time. This serial monitoring aids in prostate cancer management by helping assess disease progression, treatment response, or recurrence risk. By providing precise PSA measurements, it supports evidence-based decision-making in immunology-based diagnostics, such as determining whether further diagnostic evaluation (e.g., biopsy) or intervention is warranted.
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™ PSA Plus - Prostate-Specific Antigen Test Cartridge, FREND PSA PLUS (REAGENT CARTRIDGE) by NANOEN TEK, INC. | FDA 510 (k ..., FREND PSA PLUS (reagent cartridge) (K162378) - Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K124056 | Class II | Active |
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Manufacturer
- Manufacturer
- NanoEnTek, Inc.
Sources (2)
- FDA 510(k) K124056 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026