# K162378: FREND PSA PLUS (reagent cartridge)

- Pathway: 510(k) (Traditional)
- Applicant: Nanoentek USA, Inc.
- Decided: May 17, 2017 after 266 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: 2 generations back to P910065 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124056: Frend Psa Plus (Reagent Cartridge), Nanoentek, Inc. (2013) Summary page 6.

## Indications for use
The NanoEnTek FREND™PSA Plus is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, Li-heparinized plasma, and K3-EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA to be used as an aid in the management of patients with prostate cancer.

Source page: https://510kreport.com/device/K162378
Methodology: https://510kreport.com/methodology