# K124056: Frend Psa Plus (Reagent Cartridge)

- Pathway: 510(k) (Traditional)
- Applicant: Nanoentek, Inc.
- Decided: May 29, 2013 after 149 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P910065 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P910065: Aia-Pack Psa, Tosoh Bioscience, Inc. (1993) Summary page 2.

## Most influential descendants
- K162378: FREND PSA PLUS (reagent cartridge) (2017), 0 descendants of its own

## Indications for use
The FRENDTM PSA Plus as performed on the FRENDTM system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FRENDTM PSA Plus is designed for in vitro DIAGNOSTIC USE ONLY. for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FRENDTM System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer. The FRENDTM PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer. The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.

Source page: https://510kreport.com/device/K124056
Methodology: https://510kreport.com/methodology