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The FREND™ PSA Plus as performed on the FREND™ system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FREND™ PSA Plus is designed for in vitro DIAGNOSTIC USE ONL Y for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FREND™ 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 FREND™ 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.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and EDTA plasma using the FREND™ system. The FREND™ PSA Plus is intended for use as an aid for prostate cancer management. The FREND™ PSA Plus Test is a single use fluorescence immunoassay designed to quantify the concentration of total PSA in serum and lithium heparin and EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (30 µL) to be delivered into the FREND™ PSA Plus Test Cartridge. The Cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The reaction and analysis time is approximately 6 minutes. The PSA quantification is based on the amount of fluorescence detected by the FREND™ System at the FREND™ PSA Plus Test Cartridge window. A higher level of fluorescence is indicative of a higher PSA concentration. In other words, the magnitude of the fluorescent signal is directly proportional to the amount of total PSA in the sample.

The FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the FREND™ PSA Plus Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer through the RS232C interface.

Here's a summary of the acceptance criteria and study findings for the FREND™ PSA Plus on the FREND™ system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

| Performance Metric | Acceptance Criteria (Stated or Implied) | Total (Total CV%) | |
| Site-to-Site Value) | 3.50% | 1.57% | 1.67% | 3.47% | 1.61% | 2.06% | |
| Inter-cartridge | 18.45% | 6.81% | 7.94% | 20.03% | 6.17% | 7.49% | |
| Total (Total CV%) | 20.87% | 7.74% | 10.79% | 21.22% | 7.69% | 9.81% | |

Note: The document explicitly states "acceptance criteria" for some tests (e.g., dilution linearity, spiked recovery, interference) but for others (e.g., imprecision, method comparison), it describes the results and concludes they are "acceptable" or "compared well," implying that the performance met internal thresholds comparable to predicate devices.

2. Sample Sizes and Data Provenance

• Clinical Samples: 1219 evaluable clinical serum samples.
  • Provenance: Prospectively collected stored samples were utilized for the clinical study. No specific country of origin is explicitly stated, but NanoEnTek is a Korean company with a CRO (DOCRO, Inc.) in the US, and testing was done at both NanoEnTek facilities and CLIA licensed facilities in the US.
• Precision (Analytical):
  • Intra-assay/inter-assay/complex imprecision: Three clinical samples (0.186, 2.757, 16.625 ng/mL) assayed in duplicates twice a day for 20 days using a single lot cartridge (total 80 measurements per sample).
  • Multi-Site, Multi-Lot Imprecision: Four replicates each of Material A, B, C and two replicates of QC 1, 2, 3 were evaluated in two runs performed for five days at each of three geographically diverse sites. This yielded a total of 40 results on each material per site, and 120 total replicates for each material across all sites.
• Dilution Linearity & Recovery: A serum pool with elevated PSA (34 ng/mL) was diluted to seven levels, plus neat and zero samples. Each level was tested in 6 replicates.
• Spiked Recovery: A serum pool from females (tPSA

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