(266 days)
No
The summary describes a fluorescence immunoassay system that quantifies PSA based on fluorescence intensity and a pre-generated calibration curve. There is no mention of AI, ML, or any learning algorithms used for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) device designed to measure total PSA levels, which aids in the management of prostate cancer patients. It does not directly treat or prevent a disease, but rather provides information used in diagnosis or monitoring.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for in vitro DIAGNOSTIC USE ONLY" and is "to be used as an aid in the management of patients with prostate cancer."
No
The device description clearly states that the FREND™ PSA Plus is a rapid fluorescence immunoassay that uses a disposable test cartridge and requires the FREND™ System, which is a portable, automated cartridge reader with hardware components like a laser, motor, and sensor. While the FREND™ System has software, the overall device system includes significant hardware components for sample analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 statement clearly identifies the device as being used outside of the body (in vitro) for the purpose of diagnosis (diagnostic use). The description of measuring an analyte (PSA) in biological samples (serum, plasma) further confirms its nature as an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LTJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical performance
a. Precision/Reproducibility
Study Type: Precision and Reproducibility study based on CLSI protocol EP5-A3.
Sample Size: Not explicitly stated for initial precision, but involved four clinical samples assayed in replicates of two at two separated times per day for twenty days using three lots of cartridge.
Key Results: Allowable total imprecision was 0.05 ng/mL up to 0.5 ng/mL then 10% at concentrations >0.5 ng/mL but
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
NanoEnTek, Inc Dr. Sunmi Han 12F, 5, Digital-ro, 26-gil Guro-gu, Seoul 08389 KOREA
Re: K162378
Trade/Device Name: FREND™ PSA Plus Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: II Product Code: LTJ Dated: April 18, 2017 Received: April 19, 2017
Dear Dr. Han:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner -S
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162378
Device Name FREND™ PSA Plus
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92, a 510(k) summary is provided
A. Applicant
| Company Name: | NanoEnTek, Inc. |
|---|---|
| Address: | 12F, 5, Digital-ro, 26-gil, Guro-gu |
| Seoul 08389, KOREA | |
| Contact Person: | Sunmi Han |
| Phone Number: | +82-2-6220-7887 |
| Facsimile Number: | +82-2-6220-7999 |
B. 510(k) Preparer Information (Contact Person)
| Company Name: | NanoEnTek, Inc. |
|---|---|
| Contact Person: | Sunmi Han |
| Phone Number: | +82-2-6220-7887 |
| Facsimile Number: | +82-2-6220-7999 |
| Email: | shan@nanoentek.com |
C. Purpose for Submission
Measuring range and sample volume change on FREND™ PSA Plus
- D. Measurand: Total Prostate Specific Antigen
- E. Type of Test: Quantitative, Fluorescence Immunoassay
- F. Proprietary and Established Device Name: FREND™ PSA Plus
- G. Regulatory Information:
| Proprietary Name | FREND™ PSA Plus |
|---|---|
| Regulation Number | 21 CFR §866.6010 |
| Product Code | LTJ Tumor Associated Antigen Immunologic Test System |
| Classification | Class II with special controls |
| Classification Name | Prostate-Specific Antigen (Psa) For Management of Prostate Cancers |
| Panel | Immunology |
H. Intended Use:
-
- Intended Use(s):
See indications for use below:
- Intended Use(s):
-
- Indication(s) for use:
4
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 Ks-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.
3. Special conditions for use statement(s): For prescription use only
-
- Special instrument requirements: NanoEnTek FREND™ System
I. Device Description
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
5
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.
6
J. Substantial Equivalence Information:
A general comparison of the similarities and differences of the assays is presented in the table below:
| Item | FREND™ PSA Plus (modified) | FREND™ PSA Plus
(K124056) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended 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. | Same |
| Sample Type | Human serum, Li-heparinized and K3-EDTA plasma | Same |
| Analyte | Total PSA | Same |
| Type of Test | Fluorescent Immunoassay | Same |
| Interpretation of Results | Interpolation from a lot-specific calibration curve | Same |
| Item | FREND™ PSA Plus (modified) | FREND™ PSA Plus
(K124056) |
| Dynamic Range | 0.08 ~ 25 ng/mL | 0.1 ~ 25 ng/mL |
| Test Cartridge | Disposable single-use cartridge | Same |
| Sample size | 35 µL | 30 µL |
| Random Access/Degree of Automation | No random access, manual manipulation | Same |
K. Performance Characteristics
1. Analytical performance
a. Precision/Reproducibility
Three different lots of FREND™ PSA Plus were evaluated in the NanoEnTek, Inc. facility. Precision data was determined as described in the CLSI protocol EP5-A3. Four clinical samples were assayed in replicates of two at two separated times per day for twenty days using three lots of cartridge. Results are shown below in table format. Allowable total imprecision was 0.05 ng/mL up to 0.5 ng/mL then 10% at concentrations >0.5 ng/mL but