Search Results

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.

Ask a specific question about this device

The FREND™ Vitamin D test is a rapid indirect competitive fluorescent immunoassay designed for the quantitative measurement of 25-Hydroxy vitamin D and related hydroxylated metabolites in human serum and plasma (K;EDTA, lithium-heparin and citrate) specimens using the FREND™ System, and the FREND™ AP System. Measurements of total 25-hydroxy vitamin D and related hydroxylated metabolites are used to aid in the assessment of vitamin D sufficiency.

The FREND™ Vitamin D microfluidic flow cartridge is designed for use in the FREND™ System fluorescent immunoassay reader, and the FREND™ AP System. The FREND™ Vitamin D Test System is intended for use in clinical laboratories. For in vitro diagnostic use only. The test is not intended for use in point-of-care settings.

The FREND™ Vitamin D Test is a rapid fluorescence immunoassay designed to quantify the concentration of total 25-hydroxy (OH) vitamin D and related hydroxylated metabolites in human serum and plasma (K3 EDTA, lithium-heparin and citrate) samples using the FREND™ System.

The FREND™ Vitamin D Test System is a competitive immunoassay with gold microparticles labeled with Vitamin D-specific monoclonal anti-Vitamin D-antibody (mouse), Vitamin D-biotin labeled with fluorescence nanoparticles and fluorescence detection by the FREND™ System.

The FREND™ Vitamin D Cartridge is a single-use disposable rapid lateral flow fluorescence immunoassay designed to quantify the concentration of total 25-OH vitamin D and related hydroxylated metabolites in human serum and plasma (K3 EDTA, lithiumheparin and citrate) samples. Each test cartridge contains reagents to perform one test and bears a bar code with test type and lot information. Each FREND™ Vitamin D Cartridge contains a test zone and a reference zone (internal control). The fluorescence measured in the test and reference zones corresponds to the amount of fluorescent conjugates of Vitamin D-biotin that is bound to each zone. Cartridges are provided in individually sealed pouches and must be stored between 2 and 8 °C.

In addition to the QC Code Chip there is a Vitamin D Code Chip. Lot information and calibration data are loaded into the software via the Vitamin D Code Chip provided with each reagent kit. Up to three different Vitamin D Code Chip lots can be loaded and used at the same time. Each reagent cartridge bears a barcode that the FREND™ System uses to identify the test type and lot number and links it to the appropriate analytical program and calibration information. The FREND™ System will not output results if the Vitamin D Code Chip lot does not match the lot of the cartridge used.

The Vitamin D Pretreatment Tube is a small single-use disposable plastic tube that contains Vitamin D gold nano-particle coniugation antibody. The sample is diluted in the dilution tube containing perfluorohexanoic acid and transferred to the pretreatment tube prior to being inserted into the FREND™ AP System to be mixed and then added to the Vitamin D Test Cartridge. The test cartridge is then inserted into the FREND™ System to be analyzed.

The FREND™ AP System is an "Advanced Preparing" device that performs automated pre-analytical steps of mixing, timed heating, and pipetting of the sample from the Gold Antibody Pretreatment tube into the FREND Vitamin D test cartridge.

The FREND™ System utilizes microfluidic technology and detects immune-complexes bound to Vitamin D. The test cartridge is placed on the warming platform of the FREND™ AP System. A 35 µL patient sample is added to the dilution tube and 70 µL of diluted sample is pipetted into the pretreatment tube containing monoclonal anti-Vitamin D antibody conjugated with gold nanoparticles(Step 1). The tube is then loaded into the FREND™ AP System (Step 2). The tube is mixed and loaded into the test cartridge automatically. In the AP System (Step 3), mixing, reaction, sample addition, hydration of the Vitamin D-biotin fluorescent bead conjugate, and migration along the cartridge channel takes approximately 15 minutes, after which the cartridge is read on the FREND™ System. During migration, the bound Vitamin D in the sample and the fluorescent bead conjugates of Vitamin D-biotin compete to form antigen-antibody complex in the test zone. Unbound Vitamin D-biotin fluorescent conjugates flow through and bind to the anti-Vitamin D antibody that is fixed on the surface in the reference zone. The fluorescent signals in the test and reference zones are measured, typically within 4 minutes.

Vitamin D quantification is based upon the ratio of the intensity of the test and reference zones. A lower ratio of fluorescence is indicative of a higher Vitamin D concentration; in other words, the magnitude of the fluorescent ratio is inversely proportional to the amount of Vitamin D in the sample.

The measuring range of the FREND™ Vitamin D Test System is 13.0 to 96.0 ng/mL. Results are determined via a lot-specific calibration curve which is generated by the manufacturer using a four-point calibration determined from values averaged from 6 replicates at each level. The established curve is uploaded to the FREND™ System via the Vitamin D Code-chip and is valid until the lot expiration date.

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 test cartridge is a disposable plastic device that 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™ cartridge utilizes microfluidics 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.

The FREND™ System is a bench top fluorescence reader containing a touch screen user interface. The System has a slot that accepts the FREND™ Vitamin D 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.

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™ Vitamin D Test System includes the following in the reagent kit:

• . 20 FREND™ Vitamin D Test Cartridges
• 20 FREND™ Sample Dilution Tubes .
• 20 FREND™ Vitamin D Gold Antibody Pretreatment Tubes .
• 30 Disposable pipette tips
• 1 FREND™ Vitamin D Code Chip .
• . 1 FREND™ Vitamin D Package Insert

One cartridge contains:

• . Monoclonal mouse anti- Vitamin D 1.6 ± 0.16 na
• . 25-hydroxyvitamin D 136 ± 13.6 ng
• . Fluorescence particles 2.4 ± 0.24 µg

One sample dilution tube contains:

• . Perfluorohexanoic acid 9.5 ± 0.95 µg
  One Gold antibody pretreatment tube contains:

• . Gold nano-particle conjugation antibody 7.0 ± 0.7 µg
  The FREND™ System (previously cleared in K124056 (FREND™ PSA), K131928 (FREND™ TSH), K152422 (FREND™ Free T4), and K153577 (FREND™ Testosterone) is not provided with the kit but it is required for the FREND™ Vitamin D Test cartridge.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a codified format. However, based on the performance characteristics reported, we can infer the acceptance criteria implied by the study outcomes. For instance, the interference study specifies a recovery range of 90% to 110% for "no interference," which acts as an acceptance criterion. Similarly, the precision study reports specific CV% values, which are implicitly acceptable. For the method comparison, the slope, intercept, and correlation coefficient achieved are the performance metrics, implying that these values were considered acceptable for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision/Reproducibility: Not explicitly stated as "test set," but 3 serum pools were used. Each pool was assayed in duplicate twice per day for 20 days, totaling 80 measurements per level.
• Linearity: 9 levels of serum samples tested in quadruplicate.
• Limit of Quantitation (LoQ): Not specified (CLSI EP17-A2 protocol was used).
• Interference Studies: Triplicate determinations for two concentrations of Vitamin D for each interferent tested.
• Cross-Reactivity Studies: Triplicate measurements for each cross-reactant at two Vitamin D concentrations.
• Method Comparison: 133 de-identified leftover samples. The provenance is implied to be from a CLIA-certified hospital laboratory (presumably in the US, given FDA submission). The samples were retrospective ("de-identified leftover samples").
• Matrix Comparison: 36 paired samples.
• Expected Values/Reference Range: 300 serum specimens from apparently healthy individuals residing in north, central, and southern regions of the US. Collected during summer and winter months. This is a prospective or cross-sectional study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an in-vitro diagnostic (IVD) assay for measuring 25-hydroxy vitamin D. The "ground truth" for such devices is typically established by reference methods or gold-standard assays, not by expert human readers.

• For the method comparison study, the reference method was the Abbott ARCHITECT i 25-OH Vitamin D Assay (K110619) run on the Abbott ARCHITECT i System. This predicate device served as the "ground truth" for comparison.
• For traceability, calibrators were confirmed by measurement on the same predicate device (ARCHITECT i 25-OH Vitamin D assay).

Therefore, there were no human experts establishing ground truth in the way a medical imaging study might use radiologists. The ground truth was based on a previously cleared and accepted analytical method.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is an IVD assay where performance is compared against an established analytical method (predicate device), there is no human adjudication process involved in establishing ground truth for the test set as would be found in medical image analysis.

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. The FREND™ Vitamin D Test System is an automated in-vitro diagnostic device. It does not involve human readers interpreting results in a way that an MRMC study comparing human performance with and without AI assistance would be relevant. The device provides a quantitative measurement directly.

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

Yes, this entire submission focuses on the standalone performance of the FREND™ Vitamin D Test System. It is an automated system designed for use in clinical laboratories, which means it provides quantitative results directly from the sample without subjective human interpretation in the loop. The "FREND™ System" and "FREND™ AP System" are instrument-only components that analyze the cartridge.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance studies was predominantly based on comparison to a legally marketed predicate device, specifically the Abbott ARCHITECT i 25-OH Vitamin D Assay (K110619). For studies like linearity, precision, LoQ, interference, and cross-reactivity, the ground truth is defined by the known concentrations of analytes in the samples used (e.g., spiked samples, reference materials).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a fluorescent immunoassay, and its "training" or calibration is handled differently:

• The device uses a lot-specific calibration curve generated by the manufacturer.
• This curve is determined from values averaged from 6 replicates at each of four calibration levels.
• This calibration information is uploaded to the FREND™ System via a Vitamin D Code-chip for each reagent lot.

Therefore, the concept of a large "training set" of patient data as understood in AI/ML is not directly applicable here. The calibration is a much smaller, controlled process.

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

As noted above, "training set" in the AI/ML sense is not directly applicable. For the device's calibration (which serves a similar function to initial "training" for an assay):

• The calibrators are prepared gravimetrically. This means their concentrations are established by precisely weighing the components.
• These gravimetrically prepared calibrators are then confirmed by measurement on the ARCHITECT i 25-OH Vitamin D assay (K110619), the predicate device. This ensures they align with an established method.

Ask a specific question about this device