(253 days)
For Over-the-Counter Setting:
The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.
For Point-of-Care Professional Setting:
The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.
Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including sperm pH, semen concentration, motility, and morphology. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.
The provided FDA 510(k) clearance letter and summary for the LensHooke X3 PRO Semen Quality Analyzer offer a high-level overview of the device and the studies conducted. However, it does not provide explicit details on the acceptance criteria for each performance metric (e.g., specific thresholds for accuracy, sensitivity, specificity, or precision for motility, concentration, and morphology), nor does it present the reported device performance against these criteria in a quantitative manner. The summary largely discusses the types of studies performed (repeatability, reproducibility, linearity, etc.) rather than the results of those studies.
Based on the provided text, here's an attempt to structure the information, highlighting where details are not explicitly stated in the document:
Acceptance Criteria and Device Performance Study for LensHooke X3 PRO Semen Quality Analyzer
The LensHooke X3 PRO Semen Quality Analyzer was evaluated through non-clinical and user performance studies to demonstrate substantial equivalence to its predicate device, the LensHooke X1 PRO Semen Quality Analyzer. While the document mentions various types of evaluations, explicit quantitative acceptance criteria and detailed performance results are not provided for each parameter.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability" and lists types of evaluations (repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions, and stability). It also mentions a "User Performance Study." However, specific numerical acceptance criteria (e.g., minimum accuracy percentages, CVs for precision) and the achieved performance metrics are not detailed in this summary. The table below reflects the parameters measured but cannot fill in the acceptance criteria or reported performance based solely on this document.
| Parameter Measured | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|---|
| Sperm Concentration (M/mL) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| Total Motility (PR+NP, %) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| - Progressive Motility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| - Non-Progressive Motility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| - Immotility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| Sperm Morphology (Normal forms, %) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| pH Value | e.g., Accuracy within X units of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the "System Accuracy Study" or the "User Performance study." It mentions "various test results" and "seminal samples," implying multiple samples were used.
- Data Provenance: The document does not explicitly state the country of origin for the data. The studies appear to be prospective in nature, given the description of a "user performance study... performed to demonstrate that English speaking and reading adult lay users... can easily understand and follow the labeling/user instructions to obtain accurate results."
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: For the "User Performance study," it states that "Point-of-Care professionals or licensed registered nurses" obtained POC test findings, and the LensHooke X1 PRO Semen Quality Analyzer performed by POC personnel was used as the reference method. This implies that the ground truth for this specific study was established by the predicate device and trained personnel, rather than independent human experts performing manual semen analysis (e.g., according to WHO guidelines).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth within the studies mentioned. The predicate device's output, performed by trained personnel, served as the reference for the user performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No explicit MRMC comparative effectiveness study is described where human readers improve with AI vs. without AI assistance. The study focuses on the device's performance and a "user performance study" with lay users, comparing the device's output to a reference method (the predicate device). The device itself appears to be largely automated, and the user study assessed the ability of lay users to operate the device and interpret its output, not the improvement of human readers' diagnostic accuracy with AI assistance.
6. Standalone Performance (Algorithm Only)
The document implies a standalone performance component ("Verification and validation of test results were evaluated to establish the performance, functionality and reliability... The evaluation included repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions and stability."). These non-clinical tests would assess the device's inherent capability to measure semen parameters, which is essentially its standalone algorithm performance, as it integrates "optical design and image analysis and combined with artificial intelligence image processing method." However, the specific metrics of this standalone performance (e.g., accuracy against a gold standard manual count) are not provided.
7. Type of Ground Truth Used
- For the "System Accuracy Study" and other non-clinical tests (e.g., linearity, LoB/LoD/LoQ), the implied ground truth would be reference methods or controlled samples with known values (e.g., samples with analytically confirmed sperm concentrations or motility percentages).
- For the "User Performance study," the ground truth was derived from the predicate device (LensHooke X1 PRO Semen Quality Analyzer) results, obtained by Point-of-Care professionals or licensed registered nurses. This indicates a comparative study against an established, cleared device, rather than a direct comparison to a true biological ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not specify the sample size used for training the artificial intelligence image processing methods.
9. How Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established for the AI models used in the device. It only mentions the use of "artificial intelligence image processing method" without detailing its development or training process.
FDA 510(k) Clearance Letter - LensHooke X3 PRO Semen Quality Analyzer
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
Bonraybio Co., LTD.
Clare Huang
Manager
4F., No. 118, Gongye 9th Rd., Dali Dist.
Taichung, 41280
Taiwan
Re: K242830
Trade/Device Name: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Regulation Number: 21 CFR 864.5220
Regulation Name: Automated Differential Cell Counter
Regulatory Class: Class II
Product Code: POV
Dated: September 18, 2024
Received: September 19, 2024
Dear Clare Huang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K242830 - Clare Huang Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K242830 - Clare Huang Page 3
Sincerely,
MIN WU -S
Min Wu, Ph.D.
Branch Chief
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
510(k) Number (if known): K242830
Device Name:
LensHooke X3 PRO SE Semen Quality Analyzer
LensHooke X3 PRO Semen Quality Analyzer
Indications for Use (Describe)
For Over-the-Counter Setting:
The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.
For Point-of-Care Professional Setting:
The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
FORM FDA 3881 (8/23) Page 2 of 2
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 6
Sec 07a-1 (Rev. 2025/05/26) Confidential
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K242830
1 Submitter's Identification:
1.1 Bonraybio Co., Ltd.
4F., No.118, Gongye 9th Rd., Dali Dist., Taichung City 41280, Taiwan
Contact Person: Clare Huang
TEL: +886-4-24912385
FAX: +886-4-24912885
1.2 Date Summary Prepared: May 26th, 2025
2 Name of the device:
LensHooke X3 PRO Semen Quality Analyzer
LensHooke X3 PRO SE Semen Quality Analyzer
3 Common or Usual Name: Semen Analysis Device
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| POV; Semen Analysis Device | Class II | 21 CFR 864.5220 | Hematology |
4 Device Description
Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including sperm pH, semen concentration, motility, and morphology. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.
Product Information
4.1 For Over-the-Counter Setting:
LensHooke X3 PRO SE Semen System, consist of the following devices:
- LensHooke X3 PRO SE Semen Quality Analyzer
- LensHooke CS1 Semen Test Cassette
- LensHooke X QC Beads (For Semen)
- LensHooke X QC Reticle (For Semen)
- LensHooke X QC Video (For Semen)
- C-KUP Liquefaction Test Cup
Page 7
Sec 07a-2 (Rev. 2025/05/26) Confidential
- LensHooke Cleaning Wipe CW0
- LensHooke Cleaning Wipe CW1
- LensHooke Cleaning Wipe Holder CWA
The LensHooke X3 PRO SE Semen Quality Analyzer and accessories are manufactured by Bonraybio.
4.2 For Point-of-Care Professional Setting:
LensHooke X3 PRO Semen System, consist of the following devices:
- LensHooke X3 PRO Semen Quality Analyzer
- LensHooke CS1 Semen Test Cassette
- LensHooke X QC Beads (For Semen)
- LensHooke X QC Reticle (For Semen)
- LensHooke X QC Video (For Semen)
- C-KUP Liquefaction Test Cup
- LensHooke Cleaning Wipe CW0
- LensHooke Cleaning Wipe CW1
- LensHooke Cleaning Wipe Holder CWA
The LensHooke X3 PRO Semen Quality Analyzer and accessories are manufactured by Bonraybio.
4.3 Accessories Description
LensHooke CS1 Semen Test Cassette
LensHooke CS1 Semen Test Cassette is a well-designed microscopic slide for the optical analyzer, LensHooke Semen Quality Analyzer. Top and bottom plastic case and pH paper are the components of LensHooke Semen Test Cassette. There are two polished windows which analyzed concentration, motility and morphology of the semen and the pH of semen respectively.
LensHooke X QC Beads (For Semen)
LensHooke X QC Beads is the quality control material for semen analysis. The LensHooke X QC Beads (For Semen) are supplied as three different levels of control and it has been developed as a tool to assess the accuracy and precision of sperm counting by providing a known target value and +/- range.
LensHooke X QC Reticle (For Semen)
LensHooke X QC Reticle is the quality control material for semen analysis. The LensHooke X QC Reticle (For Semen) are supplied as three different levels of control and it has been developed as a tool to assess the accuracy and precision of sperm counting method by providing a known target value and +/- range.
LensHooke X QC Video (For Semen)
LensHooke X QC Video is the quality control material for semen analysis. The LensHooke X QC Video (For Semen) are supplied as three different levels of control and it has been developed as a tool to assess the accuracy and precision of sperm scoring method for motility and morphology by providing a known target value and +/- range.
Page 8
Sec 07a-3 (Rev. 2025/05/26) Confidential
C-KUP Liquefaction Test Cup
C-KUP Liquefaction Test Cup is used to collecting semen samples to liquefaction and volume testing. Collected semen samples are applicable for semen quality analysis. Cup, cup cover and drip cover are the components of C-KUP Liquefaction Test Cup. The V-Stick on cup cover is used to check the liquefaction's status. The Scale on cup is used to check the volume of the semen sample.
LensHooke CW0 Cleaning Wipe
LensHooke Cleaning Wipe is a plastic stick with lens cotton. Using LensHooke Cleaning Wipe to clean the Test Cassette Insert Slot of LensHooke Semen Quality Analyzer. This is the cleaning and maintenance procedures usually used for microscopic analyzers.
LensHooke CW1 Cleaning Wipe and LensHooke CWA Cleaning Wipe Holder
LensHooke CW1 Cleaning Wipe is a lens cotton used with a LensHooke CWA Cleaning Wipe Holder. Using LensHooke Cleaning Wipe to clean the Test Cassette Insert Slot of LensHooke Semen Quality Analyzer. This is the cleaning and maintenance procedures usually used for microscopic analyzers.
5 Indications for Use
5.1 For Over-the-Counter Setting:
The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.
5.2 For Point-of-Care Professional Setting:
The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
Page 9
Sec 07a-4 (Rev. 2025/05/26) Confidential
- pH value
The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in clinical laboratories and point-of-care setting to evaluate male fertility.
6 Predicate Device Information
LensHooke X3 PRO and X3 PRO SE Semen Quality Analyzer are substantially equivalent to：
LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzer
Device Company: Bonraybio Co., LTD.
510(k) Number: K202089
7 Comparison to Predicate Device:
7.1 LensHooke X3 PRO Semen Quality Analyzer:
| Product Name | LensHooke X3 PRO Semen Quality Analyzer (Subject Device) | LensHooke X1 PRO Semen Quality Analyzer (Predicate Device) |
|---|---|---|
| Intended Use | The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated measurements for:(1) Sperm concentration (M/mL)(2) Total motility (PR+NP, %)- Progressive motility (%)- Non-Progressive motility (%)- Immotility (%)(3) Sperm morphology (normal forms, %)(4) pH valueThe LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in clinical laboratories and point-of-care setting to evaluate male fertility. | The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:(1) Sperm concentration (10^6 per ml)(2) Total motility (PR+NP, %) • Progressive motility (%) • Non-Progressive motility (%)(3) Sperm morphology (normal forms, %)(4) pH valueThe LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility. |
| Male Fertility Factor | Yes | Same |
| Technology | Desk-top unit consists of light sources, built-in video microscopy and an internal computer containing algorithms for the assessment of semen parameters. | Same |
| Transmission interface | HDMI/USB/Ethernet | HDMI/USB |
| Intended | Point-of-Care professional | Same |
Page 10
Sec 07a-5 (Rev. 2025/05/26) Confidential
| User | ||
|---|---|---|
| Compatible Consumable | Semen Test Cassette (CS1) | Semen Test Cassette (CS0, CS1) |
| Control Material | X QC Beads, X QC Reticle, X QC Video | X QC Beads, X QC Reticle |
7.2 LensHooke X3 PRO SE Semen Quality Analyzer:
| Product Name | LensHooke X3 PRO SE Semen Quality Analyzer (Subject Device) | LensHooke X1 PRO SE Semen Quality Analyzer (Predicate Device) |
|---|---|---|
| Intended Use | The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated measurements for:(1) Sperm concentration (M/mL)(2) Total motility (PR+NP, %)- Progressive motility (%)- Non-Progressive motility (%)- Immotility (%)(3) Sperm morphology (normal forms, %)(4) pH valueThe LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. | The LensHooke X1 PRO SE Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:(1) Sperm concentration (10^6 per ml)(2) Total motility (PR+NP, %)(3) Sperm morphology (normal forms, %)(4) pH valueThe LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared. |
| Male Fertility Factor | Yes | Same |
| Technology | Desk-top unit consists of light sources, built-in video microscopy and an internal computer containing algorithms for the assessment of semen parameters. | Same |
| Transmission interface | HDMI/USB/Ethernet | HDMI/USB |
| Intended User | Over-the-Counter | Same |
| Compatible Consumable | Semen Test Cassette (CS1) | Semen Test Cassette (CS0, CS1) |
| Control Material | X QC Beads, X QC Reticle, X QC Video | X QC Beads, X QC Reticle |
Page 11
Sec 07a-6 (Rev. 2025/05/26) Confidential
8 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows：
Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X3 PRO Semen Quality Analyzer and LensHooke X3 PRO SE Semen Quality Analyzer. The evaluation included repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions and stability.
9 Discussion of Clinical Tests Performed
System Accuracy Study and User Performance study
The user performance study was performed to demonstrate that English speaking and reading adult lay users including male and female across different education backgrounds can easily understand and follow the labeling/user instructions to obtain accurate results while using Subject Device. The study was performed using Point-of-Care professionals or licensed registered nurses to obtain POC test findings. LensHooke X1 PRO Semen Quality Analyzer performed by POC personnel was used as reference method. The study results demonstrate that the layperson user accuracy and ease of use (via participant questionnaire scoring) of subject device.
10 Conclusions
Any noted differences do not raise new issues of safety and effectiveness that the benefit outweighs the total and residual risks. Results of performance evaluation of LensHooke X3 PRO Semen Quality Analyzer and LensHooke X3 PRO SE Semen Quality Analyzer demonstrate that the subject devises are substantial equivalence to the predicate device, LensHooke X1 PRO Semen Quality Analyzer and LensHooke X1 PRO SE Semen Quality Analyzer.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”