SQA-iOw Sperm Quality Analyzer
Device Facts
| Record ID | K243114 |
|---|---|
| Device Name | SQA-iOw Sperm Quality Analyzer |
| Applicant | Medical Electronic Systems , Ltd. |
| Product Code | POV · Hematology |
| Decision Date | May 2, 2025 |
| Decision | SESE |
| Submission Type | Dual Track |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
Indications for Use
The SQA-iOw is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen: Measured parameters: - Sperm Concentration/ Total Sperm Concentration, millions/mL - Motile Sperm Concentration (MSC), millions/mL - Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL) - Normal Forms (% Normal Morphology) Derived parameters: - Total Motility / Total Motile (PR + NP), % - Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) - Non-Progressive (NP), % - Immotile (IM), % The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.
Device Story
SQA-iOw is a PC-based, electro-optical analyzer for human semen. User aspirates 0.6 mL sample into disposable capillary; inserts into optical block. Device captures electrical signals as sperm move through light source; proprietary software converts light disturbances into semen parameters. Operates as cloud-based application on user PC; controlled via graphical user interface. Used in CLIA-waived settings by non-specialized personnel. Provides quantitative results for concentration, motility, and morphology; assists clinicians in assessing male fertility factors. Benefits include rapid, automated analysis (approx. 75 seconds) compared to manual methods.
Clinical Evidence
No clinical studies were performed. Analytical performance was established via bench testing. Precision (repeatability/reproducibility) was evaluated across multiple sites/operators using native semen and control beads, meeting all acceptance criteria. Method comparison study (N=380) against the SQA V predicate demonstrated strong agreement across all parameters using Passing-Bablok regression and PPA/NPA analysis.
Technological Characteristics
PC-based electro-optical analyzer. Sensing principle: light source and optical sensors convert sperm movement into electrical signals. Connectivity: PC-based cloud application for control/data. Dimensions: desktop unit. Sterilization: N/A (disposable capillaries). Software: proprietary algorithms for signal processing. Standards: IEC 61010-1, IEC 61010-1-2, ASTM D4169, ASTM D4332, CLSI EP05-A3.
Indications for Use
Indicated for use in CLIA Waived settings by operators with at least a high school diploma to analyze human semen parameters. Not for comprehensive male fertility evaluation.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
- SQA-V sperm analyzer (K021746)
Reference Devices
- QwikCheck Beads (K041600)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
I Background Information:
A 510(k) Number
K243114
B Applicant
Medical Electronic Systems Ltd.
C Proprietary and Established Names
SQA-iOw Sperm Quality Analyzer
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| POV | Class II | 21 CFR 864.5220 - Automated Differential Cell Counter | HE - Hematology |
II Submission/Device Overview:
A Purpose for Submission:
This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as K243114 and CW240024. CW240024 is for granting the CLIA Waiver by Application.
B Measurand:
Measured parameters:
- Sperm Concentration, M/mL
- Motile Sperm Concentration (MSC), M/mL
- Progressively Motile Sperm Concentration (PMSC), M/mL
- Normal Forms (Normal Morphology), %
Calculated parameters:
- Total Motility (PR + NP), %
- Progressive Motility (PR), %
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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- Non-Progressive Motility (NP), %
- Immotile (IM), %
C Type of Test:
Analysis of semen parameters
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The SQA-iOw is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:
Measured parameters:
- Sperm Concentration/ Total Sperm Concentration, millions/mL
- Motile Sperm Concentration (MSC), millions/mL
- Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
- Normal Forms (% Normal Morphology)
Derived parameters:
- Total Motility / Total Motile (PR + NP), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
- Non-Progressive (NP), %
- Immotile (IM), %
The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
The SQA-iOw Sperm Quality Analyzer is intended to be used by operators with a minimum of an earned high school diploma or equivalent.
IV Device/System Characteristics:
A Device Description:
The SQA-iOw Sperm Quality Analyzer is a PC-based automated device that tests human semen samples, using a cloud-based application for device control, data analysis, and data storage. The SQA-iOw utilizes software to both perform analysis of semen parameters and to present those results on the user interface. It provides directly measured and calculated measurements for total
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sperm concentration, percent motility, percent immotile, percent progressive motility, percent non-progressive motility, percent normal forms, motile sperm concentration, progressive motile sperm concentration, and functional sperm concentration.
The SQA-iOw package provides all the supplies necessary to perform semen analysis: SQA-iOw Sperm Quality Analyzer, USB cable, SQA disposable capillaries, and a cleaning kit.
The cleaning kit includes the following components:
- Long cleaning brush
- Fibrous material cleaning paddles (single use)
- Sponge-tipped drying paddles (single use)
- Cleaning fluid (50% Ethanol, 49.5% Distilled Water, 0.5% Tween 20) (single drop dispenser)
### B Principle of Operation:
After collection and preparation, 0.6 mL of semen sample is manually aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run. The SQA-iOw software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iOw optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.
### C Instrument Description Information:
1. Instrument Name:
SQA-iOw Sperm Quality Analyzer
2. Specimen Identification:
Specimen identification is manually entered in the 'Test Patient' field of the software, prior to sample analysis.
3. Specimen Sampling and Handling:
A minimum of 0.6 mL of semen is required. Sample should be self-collected without using lubricants or other creams. The sample should be maintained at room temperature (do not heat or refrigerate), tested fresh (within 1 hour of collection) and be fully liquified.
4. Calibration:
Internal electronic Self-Test/Auto-Calibration runs at start-up. Reference values verified prior to each test.
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# 5. Quality Control:
QwikCheck Beads (cleared under K041600) are used for performing quality control. The three levels should be analyzed every 24 hours or prior to sample analysis.
# **V Substantial Equivalence Information:**
# **A Predicate Device Name(s):**
SQA V, Sperm Quality Analyzer
# **B Predicate 510(k) Number(s):**
K021746
# **C Comparison with Predicate(s):**
| Device & Predicate Device(s): | K243114 | K021746 |
| --- | --- | --- |
| Device Trade Name | SQA-iOw Sperm Quality Analyzer | SQA V, Sperm Quality Analyzer |
| **General Device Characteristic Similarities** | | |
| Intended Use/Indications For Use | The SQA-iOw is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen: Measured parameters: - Sperm Concentration/ Total Sperm Concentration, millions/mL - Motile Sperm Concentration (MSC), millions/mL - Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly | The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for: - Total sperm concentration (TSC, millions/ml) - Percent motility (%MOT) and % progressive motility (%PMOT) - % Normal morphology (%MORPH) - Motile sperm concentration (MSC, millions/mL) and progressive |
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| | Progressive Motile Sperm Concentration, millions/mL) - Normal Forms (% Normal Morphology), % Derived parameters: - Total Motility / Total Motile (PR + NP), % - Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) - Non-Progressive (NP), % - Immotile (IM), % The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only. | MSC (PMSC) - Functional sperm concentration (FSC, millions/mL) |
| --- | --- | --- |
| Sample Type | Human Semen | Same |
| Testing Capillary | SQA-V testing capillary | Same |
| External Controls | QwikCheck Beads (cleared under K041600) | Same |
| Liquefaction | QwikCheck Liquefaction vials | Same |
| **General Device Characteristic Differences** | | |
| WHO Manual for the Laboratory Examination and Processing of Human Semen | 6^{th} edition | 4^{th} and 5^{th} edition |
| Technology | Desk-top unit consists of a light source and optical sensors, connected to a PC that | Desk-top unit consists of a light source, optical sensors, built-in video microscopy and an |
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| | runs the software containing algorithms for the assessment of semen parameters. This software is installed on the user's PC as a cloud-based application. | internal computer containing algorithms for the assessment of semen parameters. |
| --- | --- | --- |
| Sample Visualization | None | Contains built-in video microscopy system allowing for Sample visualization report. |
### VI Standards/Guidance Documents Referenced:
- IEC 61010-1-Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements, Edition 3.1 (Consolidated Version 2017)
- IEC 61010-1-2-Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Edition 4.1 (2020)
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition
### VII Performance Characteristics (if/when applicable):
#### A Analytical Performance:
##### 1. Precision:
a) Repeatability: The study was conducted at two sites with six operators using six instruments. Nine native semen samples were tested in duplicate. The samples were run post-liquefication at four timepoints (0, 10 minutes, 20 minutes, 30 minutes). Five lots of capillaries were used. Within-run and between-operator were evaluated, and the mean, standard deviation (SD), and coefficient of variation (%CV) are provided for each parameter. All samples were evaluated against all applicable acceptance criteria and met all acceptance criteria requirements.
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Sperm Concentration (M/mL)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 55.42 | 1.125 | 2.0% | 0.925 | 1.7% | 1.457 | 2.6% |
| 2 | 24 | 116.88 | 2.913 | 2.5% | 1.370 | 1.2% | 3.219 | 2.8% |
| 3 | 24 | 88.58 | 1.601 | 1.8% | 1.773 | 2.0% | 2.389 | 2.7% |
| 4 | 24 | 228.40 | 1.841 | 0.8% | 3.697 | 1.6% | 4.130 | 1.8% |
| 5 | 24 | 97.63 | 0.811 | 0.8% | 1.215 | 1.2% | 1.461 | 1.5% |
| 8 | 24 | 15.81 | 1.316 | 8.3% | 1.807 | 11.4% | 2.236 | 14.1% |
| 9 | 24 | 14.70 | 0.740 | 5.0% | 1.775 | 12.1% | 1.923 | 13.1% |
Motile Sperm Concentration (MSC, M/mL)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 27.06 | 0.976 | 3.6% | 0.230 | 0.9% | 1.003 | 3.7% |
| 2 | 24 | 57.63 | 2.137 | 3.7% | 1.000 | 1.7% | 2.359 | 4.1% |
| 3 | 24 | 41.78 | 1.367 | 3.3% | 0.428 | 1.0% | 1.433 | 3.4% |
| 4 | 24 | 120.41 | 3.410 | 2.8% | 2.324 | 1.9% | 4.127 | 3.4% |
| 5 | 24 | 32.43 | 3.169 | 9.8% | 1.906 | 5.9% | 3.698 | 11.4% |
| 6 | 24 | 1.60 | 0.000 | N/A | 0.000 | N/A | 0.000 | N/A |
| 7 | 24 | 1.60 | 0.000 | N/A | 0.000 | N/A | 0.000 | N/A |
| 8 | 24 | 9.42 | 0.632 | N/A | 1.219 | N/A | 1.373 | N/A |
| 9 | 24 | 4.32 | 0.627 | N/A | 1.684 | N/A | 1.797 | N/A |
Progressively Motile Sperm Concentration (PMSC, M/mL)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 22.50 | 0.921 | 4.1% | 0.432 | 1.9% | 1.017 | 4.5% |
| 2 | 24 | 49.03 | 2.551 | 5.2% | 1.129 | 2.3% | 2.790 | 5.7% |
| 3 | 24 | 33.52 | 1.535 | 4.6% | 0.447 | 1.3% | 1.599 | 4.8% |
| 4 | 24 | 108.70 | 3.610 | 3.3% | 2.497 | 2.3% | 4.389 | 4.0% |
| 5 | 24 | 24.69 | 3.103 | 12.6% | 1.915 | 7.8% | 3.646 | 14.8% |
| 6 | 24 | 0.03 | 0.041 | N/A | 0.014 | N/A | 0.043 | N/A |
| 7 | 24 | 0.09 | 0.245 | N/A | 0.088 | N/A | 0.260 | N/A |
| 8 | 24 | 6.80 | 0.535 | N/A | 0.652 | N/A | 0.844 | N/A |
| 9 | 24 | 2.97 | 0.538 | N/A | 1.083 | N/A | 1.209 | N/A |
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# Normal Forms (Morphology, %)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 7.67 | 0.707 | 9.2% | 0.354 | 4.6% | 0.791 | 10.3% |
| 2 | 24 | 7.96 | 0.736 | 9.2% | 0.382 | 4.8% | 0.829 | 10.4% |
| 3 | 24 | 7.08 | 0.500 | 7.1% | 0.204 | 2.9% | 0.540 | 7.6% |
| 4 | 24 | 9.67 | 0.408 | 4.2% | 0.479 | 5.0% | 0.629 | 6.5% |
| 5 | 24 | 4.04 | 0.612 | 15.2% | 0.354 | 8.7% | 0.707 | 17.5% |
| 6 | 24 | 0.13 | 0.204 | N/A | 0.204 | N/A | 0.289 | N/A |
| 7 | 24 | 0.33 | 0.764 | N/A | 0.289 | N/A | 0.816 | N/A |
| 8 | 24 | 8.38 | 0.736 | 8.8% | 0.500 | 6.0% | 0.890 | 10.6% |
| 9 | 24 | 3.50 | 0.913 | N/A | 0.722 | N/A | 1.164 | N/A |
# Total Motility (%)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 48.83 | 2.290 | 4.7% | 1.145 | 2.3% | 2.561 | 5.2% |
| 2 | 24 | 49.37 | 2.757 | 5.6% | 1.378 | 2.8% | 3.082 | 6.2% |
| 3 | 24 | 47.24 | 3.031 | 6.4% | 1.516 | 3.2% | 3.389 | 7.2% |
| 4 | 24 | 52.73 | 4.404 | 8.4% | 2.202 | 4.2% | 4.924 | 9.3% |
| 5 | 24 | 33.24 | 2.641 | 7.9% | 1.320 | 4.0% | 2.952 | 8.9% |
| 6 | 24 | 29.66 | 1.109 | 3.7% | 0.555 | 1.9% | 1.240 | 4.2% |
| 7 | 24 | 31.08 | 0.955 | 3.1% | 0.478 | 1.5% | 1.068 | 3.4% |
| 8 | 24 | 59.59 | 3.039 | 5.1% | 1.519 | 2.5% | 3.397 | 5.7% |
| 9 | 24 | 30.91 | 3.028 | 9.8% | 1.514 | 4.9% | 3.385 | 11.0% |
# Progressive Motility (%)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 40.59 | 2.219 | 5.5% | 1.110 | 2.7% | 2.481 | 6.1% |
| 2 | 24 | 42.03 | 2.880 | 6.9% | 1.440 | 3.4% | 3.220 | 7.7% |
| 3 | 24 | 37.93 | 3.073 | 8.1% | 1.536 | 4.1% | 37.93 | 3.436 |
| 4 | 24 | 47.60 | 4.496 | 9.4% | 2.248 | 4.7% | 5.027 | 10.6% |
| 5 | 24 | 25.31 | 2.594 | 10.2% | 1.297 | 5.1% | 2.900 | 11.5% |
| 6 | 24 | 0.47 | 1.111 | N/A | 0.556 | N/A | 1.243 | N/A |
| 7 | 24 | 1.75 | 1.029 | N/A | 0.514 | N/A | 1.150 | N/A |
| 8 | 24 | 42.97 | 2.882 | 6.7% | 1.441 | 3.4% | 3.222 | 7.5% |
| 9 | 24 | 21.24 | 2.852 | 13.4% | 1.426 | 6.7% | 3.189 | 15.0% |
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# Non-Progressive (%)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 8.24 | 2.504 | N/A | 1.252 | N/A | 2.800 | N/A |
| 2 | 24 | 7.34 | 2.822 | N/A | 1.411 | N/A | 3.155 | N/A |
| 3 | 24 | 9.30 | 2.930 | N/A | 1.465 | N/A | 3.276 | N/A |
| 4 | 24 | 5.13 | 3.520 | N/A | 1.760 | N/A | 3.935 | N/A |
| 5 | 24 | 7.93 | 2.713 | N/A | 1.357 | N/A | 3.034 | N/A |
| 6 | 24 | 29.19 | 1.758 | 6.0% | 0.879 | 3.0% | 1.966 | 6.7% |
| 7 | 24 | 29.33 | 1.672 | 5.7% | 0.836 | 2.8% | 1.869 | 6.4% |
| 8 | 24 | 16.62 | 2.875 | 17.3% | 1.438 | 8.6% | 3.215 | 19.3% |
| 9 | 24 | 9.67 | 2.850 | N/A | 1.425 | N/A | 3.187 | N/A |
# Immotile (%)
| Sample # | N | Mean | Repeatability | | Between-operator | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 24 | 51.17 | 2.290 | 4.5% | 1.145 | 2.2% | 2.561 | 5.0% |
| 2 | 24 | 50.63 | 2.757 | 5.4% | 1.378 | 2.7% | 3.082 | 6.1% |
| 3 | 24 | 52.76 | 3.031 | 5.7% | 1.516 | 2.9% | 3.389 | 6.4% |
| 4 | 24 | 47.27 | 4.404 | 9.3% | 2.202 | 4.7% | 4.924 | 10.4% |
| 5 | 24 | 66.76 | 2.641 | 4.0% | 1.320 | 2.0% | 2.952 | 4.4% |
| 6 | 24 | 70.34 | 1.109 | 1.6% | 0.555 | 0.8% | 1.240 | 1.8% |
| 7 | 24 | 68.92 | 0.955 | 1.4% | 0.478 | 0.7% | 1.068 | 1.5% |
| 8 | 24 | 40.41 | 3.039 | 7.5% | 1.519 | 3.8% | 3.397 | 8.4% |
| 9 | 24 | 69.09 | 3.028 | 4.4% | 1.514 | 2.2% | 3.385 | 4.9% |
b) **Reproducibility:** The study was conducted at three sites with three operators per site using three instruments for three days. Three levels of QwikCheck control beads (Level 1, Level 2, Negative) were tested in duplicate per day with three lots of capillaries. Within-run, between-operator, between-day, and between-site were evaluated. The mean, standard deviation (SD), and coefficient of variation (%CV) are provided for all sites combined for each concentration level. All samples were evaluated against all applicable acceptance criteria and met all acceptance criteria requirements.
| Sample | N | Mean | Repeatability (Within-run) | | Between-day | | Between-run/ operator | | Between site/ instrument | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Level 1 | 90 | 47.8 | 0.12 | 0.24% | 0.40 | 0.83% | 0.35 | 0.74% | 0.69 | 1.45% | 0.88 | 1.84% |
| Level 2 | 90 | 24.9 | 0.06 | 0.23% | 0.57 | 2.28% | 0.45 | 1.83% | 0.68 | 2.73% | 1.00 | 4.01% |
| Negative | 90 | 0.0 | 0.00 | 0.00% | 0.00 | 0.00% | 0.00 | 0.00% | 0.00 | 0.00% | 0.00 | 0.00% |
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# 2. Linearity:
Please refer to K220828.
# 3. Analytical Specificity/Interference:
Please refer to K220828.
# 4. Assay Reportable Range:
The measuring range for Sperm concentration was determined from the Linearity and the Limit of Quantitation study results.
| Parameter | Range |
| --- | --- |
| Sperm Concentration (M/mL) | <6–400 |
| Total Motility (%) | 0–100 |
| Progressive Motility (%) | 0–100 |
| Non-Progressive (%) | 0–100 |
| Immotile (%) | 0–100 |
| Normal Forms (%) | 0–30 |
| Motile Sperm Concentration (M/ml) | 0.2–250 |
| Progressively Motile Sperm Concentration (M/mL) | 0–200 |
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Please refer to K220828.
# 6. Detection Limit:
Please refer to K220828.
# 7. Assay Cut-Off:
Not applicable
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# 8. Accuracy (Instrument):
See Method Comparison study section.
# 9. Carry-Over:
Not Applicable
# **B Comparison Studies:**
1. Method Comparison: The study was conducted across three U.S. sites with nine untrained operators to evaluate the performance of the SQA-iOw system compared to the comparative method, SQA V system. A total of 380 native semen samples were included in the study. At each site, one SQA-iOw device and one SQA V device were used. The data were analyzed with the Passing-Bablok regression and the results for combined sites are shown in the table below. The results met the acceptance criteria.
| Parameter | N | Range | Intercept (95% CI) | Slope (95% CI) |
| --- | --- | --- | --- | --- |
| Sperm Concentration, M/mL | 380 | 6–272.5 | 0.05 (-0.18, 0.27) | 0.98 (0.97, 0.98) |
| Motility, % | 380 | 0–100 | 1.94 (1.13, 2.77) | 0.94 (0.92, 0.96) |
| Progressive Motility, % | 380 | 0–88 | -0.26 (-0.79, 0.00) | 0.94 (0.93, 0.96) |
| Non-Progressive, % | 380 | 1–30 | -0.33 (-0.63, 0.00) | 1.33 (1.25, 1.38) |
| Immotile, % | 380 | 0–99 | 3.37 (2.47, 4.35) | 0.95 (0.93, 0.97) |
| Morphology, % | 380 | 0–22 | -1.00 (-1.00, 0.00) | 1.00 (0.90, 1.00) |
| MSC, M/mL | 380 | 0.2–151.7 | 0.27 (0.05, 0.46) | 0.95 (0.93, 0.95) |
| PMSC, M/mL | 380 | 0–139.5 | -0.17 (-0.31, 0.00) | 0.92 (0.91, 0.93) |
Agreement analysis (positive percent agreement (PPA), negative percent agreement (NPA))
| Parameter | N | PPA (95%CI) | NPA (95%CI) |
| --- | --- | --- | --- |
| Sperm Concentration, M/mL | 398 | 98.5% (96.6%, 99.4%) | 96.8% (89.1%, 99.1%) |
| Morphology, % | 373 | 95.1% (92%, 97.1%) | 96.6% (90.3%, 98.8%) |
| MSC, M/mL | 398 | 98.1% (95.9%, 99.1%) | 90% (81.5%, 94.8%) |
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| Parameter | N | PPA (95%CI) | NPA (95%CI) |
| --- | --- | --- | --- |
| PMSC, M/mL | 381 | 96.9% (94.4%, 98.3%) | 96.7% (88.6%, 99.1%) |
| Motility, % | 398 | 97.4% (94.6%, 98.7%), | 95.5% (90.5%, 97.9%) |
| Progressive Motility, % | 379 | 94.9% (91.7%, 97.0%) | 98.0% (93.1%, 99.5%) |
| Non-Progressive, % | 379 | 99.5% (98.1%, 99.9%) | 0.0% (0.0%, 65.8%) |
| Immotile, % | 379 | 99.7% (98.5%, 100%) | 46.6% (24.8%, 69.9%) |
# 2. Matrix Comparison:
Not applicable
# **C Clinical Studies:**
# 1. Clinical Sensitivity:
Not applicable
# 2. Clinical Specificity:
Not applicable
# 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable
# **D Clinical Cut-Off:**
Not applicable
# **E Expected Values/Reference Range:**
Please refer to K220828.
# **F Other Supportive Instrument Performance Characteristics Data:**
Not applicable
K243114 - Page 12 of 13
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# **VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
# **IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K243114 - Page 13 of 13
