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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.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and K3-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 K3-EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (35 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 4 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 total PSA detection range of the FREND™ PSA Plus Test System is 0.08 to 25 ng/mL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a six-point calibration determined from values averaged from five replicates at each level. The established curve is uploaded to the FREND™ via the PSA Plus Code-chip and is valid until the lot expiration date. The established curve is saved in the code-chip and valid until the expiration date of the test cartridge lot.

The FREND™ PSA Plus Test cartridge is a disposable plastic device that houses the reagents and contains a port or opening (inlet) where the sample is applied. Once the sample is applied, it will mix with the reagents and travel towards the detection area via capillary action.

The FREND™ System is a portable, automated FREND™ cartridge reader. The FREND™ System is based on quantitative immunoassay technology capable of quantifying single or multiple analytes by measuring laser-induced fluorescence in a single-use disposable reagent cartridge. The FREND™ cartridge utilizes micro-fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. The concentration of the analyte of interest in an unknown sample is calculated using the ratio of the fluorescent intensity of the test zone and the reference zone.

FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the sample loaded FREND™ PSA Plus Test Cartridge, 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.

The FREND™ System software controls the graphical user interface, communication with hardware, database management and data analysis. The software also controls the functions of the mechanical components including the motor, laser, printer control and acquisition of data from the sensor. The user can set the time and date and enter patient ID through the graphic user interface. The user cannot make any changes to the software.

The FREND™ PSA Plus includes the following in the kit:

• 25 FREND™ PSA Plus cartridges
• · 30 Disposable pipette tips
• 1 FREND™ PSA Plus Code Chip
• 1 FREND™ PSA Plus Package Insert

The FREND™ System (previously cleared in K124056, K131928, K152422, K153577, and K162754) is not provided with the kit but is required for the use of the FREND™ PSA Plus test cartridge.

Here's a breakdown of the requested information regarding the acceptance criteria and study for the NanoEnTek FREND™ PSA Plus device:

The provided text describes a 510(k) submission for a modified version of the FREND™ PSA Plus, comparing it to its predicate device (the previously cleared FREND™ PSA Plus assay, K124056). Therefore, the "acceptance criteria" are implicitly the performance of the predicate device, and the "study" aims to demonstrate that the modified device's performance is substantially equivalent to this predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are based on the performance of the predicate device (FREND™ PSA Plus, K124056), and the "reported device performance" refers to the modified FREND™ PSA Plus.

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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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The TPSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma:

• as an aid in the detection of prostate cancer when used in conjunction with digital rectal 1. exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer
• as an aid in management (monitoring) of prostate cancer patients. 2.

The TPSA Flex® reagent cartridge with the labeling revision referenced in this submission is substantially equivalent in intended use, principle and performance to the current Dade Behring Total Prostate Specific Antigen assay (P000021/S2). Both assays are in vitro immunoassays with intended uses for the measurement of Prostate Specific Antigen in serum and plasma. There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes.

This 510(k) submission (K031343) is for a labeling change to the TPSA Flex® Reagent Cartridge, not a new device or a design change. Therefore, it primarily focuses on demonstrating that the revised labeling does not alter the substantial equivalence of the device to its predicate. As a result, the document does not contain the typical detailed performance study information that would be present for a novel device or a device with significant design modifications.

Here's a breakdown based on the provided text, highlighting what is not applicable or not provided for this specific type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this submission. The submission states: "There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes." The core of the acceptance criteria here is "substantial equivalence" based on the absence of change impacting performance, rather than new performance data against specific metrics.

2. Sample size used for the test set and the data provenance

Not provided. Since there are no new performance studies involving a test set, this information is not relevant to this submission. The device itself (TPSA Flex® Reagent Cartridge) was previously approved (P000021/S2); performance data for that original approval would have been submitted at that time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth was evaluated in this submission.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was evaluated in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic reagent cartridge for measuring PSA, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an in vitro diagnostic reagent cartridge, not an algorithm.

7. The type of ground truth used

Not applicable. No new performance studies requiring a ground truth were conducted for this submission.

8. The sample size for the training set

Not applicable. This submission is for a labeling change to an existing device, not for the development or training of an algorithm.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study and Acceptance Criteria for K031343:

Acceptance Criteria for K031343 (Labeling Change):

The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Dade Behring TPSA Flex® reagent cartridge, P000021/S2) despite a revision to the labeling. This means proving that the change in labeling would not alter the fundamental safety or effectiveness of the device.

Reported Device Performance (as per this submission):

The substance of this submission is that there is no change in device performance because there is no underlying change to the device itself.

• Intended Use: Identical to the predicate.
• Principle: Identical to the predicate.
• Performance: Identical to the predicate, as "there are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes."

Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the comparison document itself, which asserts and provides justification for the substantial equivalence.

• Evidence Presented: The submitter highlighted that the proposed change was solely a labeling revision related to the availability of a specific calibrator (removing reference to TPSA Calibrator, RC459, which would no longer be available for sale, and now having approval for the Free PSA product).
• Key Argument: The core of the argument is that the two previously referenced calibrators (RC 459 and RC 452) had the "same formulation but different packaging and labeling." The decision to keep them separate was based on a prior FDA request related to the Free PSA Flex® product, which has now received approval. Therefore, consolidating the calibrator instruction in the Total PSA Flex® insert by removing RC459 is deemed a change without impact on performance.
• Conclusion: The submitter concludes, and the FDA concurs, that "The revised PSA Flex® reagent cartridge is substantially equivalent in principle and performance to the current PSA Flex® reagent cartridge."

In essence, for this specific 510(k) for a labeling change, the "study" is the explicit declaration and justification provided by the manufacturer that the device itself remains unchanged and thus its performance remains identical to the already-approved predicate device. Performance data from the original approval (P000021/S2) would implicitly support the underlying performance characteristics of the unchanged device.

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The Bayer ADVIA® IMS PSA assay is an in vitro diagnostic device intended to quantitatively measure prostate specific antigen (PSA) in human serum. This assay is indicated for the measurement of serum PSA as an aid in management (monitoring) of prostate cancer patients. PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Not Found

The provided text describes the acceptance criteria and the study for the Bayer ADVIA® IMS PSA assay.

Here's the information extracted and organized as requested:

Acceptance Criteria and Device Performance for Bayer ADVIA® IMS PSA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather reports performance characteristics. Based on the data presented and common analytical testing standards, the implicit acceptance criteria are inferred to be comparable or superior to the predicate device (Immuno 1 PSA Assay).

2. Sample sizes used for the test set and the data provenance

• Correlation Studies (Test Set):

  • N=54 serum samples (0.37-79.70 ng/mL)
  • N=44 serum samples (0.07-62.93 ng/mL)

• Imprecision Study: Six calibrator levels and commercial controls were tested. The exact number of individual samples (replicates for each level) is not specified but implied to be sufficient for robust CV calculation.

• Interfering Substances Study: Serum pool with PSA concentration of 4.0 ng/mL was spiked. Specific number of samples beyond "serum pool" is not detailed.

• Recovery Study: Four samples were used, each with several dilutions (5 dilution points per sample).

• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The study type is retrospective as it involves analyzing existing serum samples and comparing the new assay results to those obtained from a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of in vitro diagnostic device (immunoassay) does not typically involve human expert interpretation for establishing ground truth in the same way as imaging or pathology studies. The "ground truth" for the test set is established by the measurements from the predicate device (Immuno 1 PSA Assay), which is itself a legally marketed and presumably validated diagnostic tool. Therefore:

• Number of experts: Not applicable in the context of interpretation.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable. The ground truth for comparative studies of quantitative assays is typically the result from the established predicate method, not a consensus of human interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an imaging or AI-assisted diagnostic tool that involves human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Recovery, Analytical Range, Minimum Detectable Concentration) are all standalone performance evaluations of the ADVIA IMS PSA assay system. There is no human intervention in the measurement process once the sample is loaded and the assay runs. The results are quantitative values generated directly by the device.

7. The type of ground truth used

The primary ground truth used for performance validation is:

• Predicate Device Measurements: For correlation studies, the results obtained from the Immuno 1 PSA Assay on the same samples serve as the comparison (reference) "ground truth" for the new ADVIA IMS assay.
• Known Concentrations/Spikes: For imprecision, recovery, and interfering substance studies, known concentrations of PSA or spiked substances are used as the "ground truth" against which the device's measurements are evaluated.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI models. For an immunoassay, the concept of a training set is not directly applicable. The assay is developed and optimized during its R&D phase, and the studies presented here are for validation.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI model in this document. The "ground truth" for developing an immunoassay would be established through a combination of chemical principles, antibody specificity, detection methods, and extensive optimization using known calibrators and reference materials.

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The Bayer ADVIA® IMS cPSA assay is an in vitro diagnostic device intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum. This assay is indicated for the measurement of serum complexed PSA as an aid in management (monitoring) of prostate cancer patients. Complexed PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Prostate Specific Antigen (PSA) is a secretory product of the epithelial cells of human prostatic tissue, whether normal, benign, or malignant. The tissue specificity of PSA makes it a sensitive and specific tumor marker as an aid in management (monitoring) prostate cancer patients and disease progression following surgery or other therapies. PSA in serum exists in several forms including free, uncomplexed PSA and PSA complexed to several protease inhibitors including a-2-macroglobulin, a-1antichymotrypsin (ACT), and a-1-antitrypsin. It should be noted that there are no existing commercial methods that can recognize PSA bound to α-2-macroglobulin. However, it has been demonstrated that the proportion of PSA complexed with ACT increases as a function of the total PSA concentration, and that the majority of immunoreactive PSA in cancer patients is in complex with ACT. The Bayer cPSA Assay uses a monoclonal antibody for capture which recognizes both free and complexed PSA, but which, when bound to free PSA, precludes the binding of other antibodies specific for the free form of PSA. The inclusion of a second, unlabelled monoclonal antibody which is specific for free PSA prevents the binding of free PSA in the cPSA assay and allows measurement of only PSA which is complexed with ACT. cPSA can be used as a single test alternative to free and total PSA in management of patients with CaP.

Here's a summary of the acceptance criteria and study details for the Bayer ADVIA® IMS cPSA assay, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

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