SQA-iO Sperm Quality Analyzer

K220828 · Medical Electronic Systems , Ltd. · POV · Aug 7, 2023 · Hematology

Device Facts

• Record ID: K220828
• Device Name: SQA-iO Sperm Quality Analyzer
• Applicant: Medical Electronic Systems , Ltd.
• Product Code: POV · Hematology
• Decision Date: Aug 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensve evaluation of a male's fertility status. The SQA-iO provides direct and calculated quantitative measurements for the following parameters: Directly measured parameters: - Sperm Concentration, M/mL - Motile Sperm Concentration (MSC), M/mL - Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL) - Normal Forms (Normal Morphology), % Calculated parameters: - Total Motility (PR + NP), % - Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %) - Non-Progressive Motility (NP), % - Immotile (IM), % - Functional Sperm Concentration (FSC), millions/mL

Device Story

PC-based point-of-care automated analyzer for human semen; utilizes disposable capillaries for sample delivery. Input: 0.6 mL fresh semen sample. Operation: sample inserted into optical block; sperm movement through light source generates electrical signals; proprietary software algorithms process signals to calculate sperm concentration, motility, and morphology parameters. Output: quantitative semen analysis results displayed on user interface. Used in clinical settings by trained lab technicians. Benefits: rapid, automated quantitative assessment of semen quality; aids clinical decision-making regarding male fertility status. System includes cleaning kit and cloud-based application for device control and data storage.

Clinical Evidence

Method comparison study of 165 matched native semen samples (155 for morphology/FSC) comparing SQA-iO to SQA-V predicate. Passing-Bablok regression analysis showed high correlation (r ≥ 0.8) across all parameters. Slopes ranged 0.9–1.2 with intercepts near zero. Bench testing included precision (repeatability/reproducibility), analytical sensitivity (LoB 0, LoD 1.73, LoQ 5.96 M/mL), linearity (R > 0.9), interference, and sample stability.

Technological Characteristics

Electro-optical sensing; light source and optical sensors. PC-based architecture with cloud-based software. Disposable SQA capillaries. Cleaning kit includes ethanol/distilled water/Tween 20 solution. Connectivity: USB to PC, cloud-based application. Calibration: internal electronic self-test/auto-calibration at start-up. Software: proprietary algorithms for signal processing of electrical signals derived from light disturbances.

Indications for Use

Indicated for semen analysis in adult males performed by trained healthcare professionals in point-of-care settings. Not for comprehensive 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 INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K220828

B Applicant

Medical Electronic Systems LTD

C Proprietary and Established Names

SQA-iO 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:

Clearance of a new device

B Type of Test:

Quantitative analysis of semen parameters (Sperm Concentration/ Total Sperm Concentration, Percent Motility/Total Motile (PR + NP) %, Progressive Motility (PR) % (combines Rapidly and Slowly Progressive, %), Normal Forms (% Normal Morphology) %, Motile Sperm Concentration (MSC), Progressively Motile Sperm Concentration (PMSC) (combines Rapidly and Slowly Motile Sperm Concentration), Functional Sperm Concentration (FSC))

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

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## B Indication(s) for Use:

The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male’s fertility status.

The SQA-iO provides direct and calculated quantitative measurements for the following parameters:

Directly measured parameters:
- Sperm Concentration, M/mL
- Motile Sperm Concentration (MSC), M/mL
- Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL)
- Normal Forms (Normal Morphology), %

Calculated parameters:
- Total Motility (PR + NP), %
- Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %)
- Non-Progressive Motility (NP), %
- Immotile (IM), %
- Functional Sperm Concentration (FSC), millions/mL

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:

The SQA-iO is a PC-based POC automated device that tests human semen samples, using a cloud-based application for device control, data analysis, and data storage. The SQA-iO utilizes proprietary software code to both perform analysis of semen parameters and to present those results on the user interface. It provides direct and calculated measurements for total sperm concentration, percent motility, percent immotile, percent progressive (rapid and slow) motility, percent non-progressive motility, percent normal forms, motile sperm concentration, progressive motile sperm concentration (rapid and slow), and functional sperm concentration.

The SQA-iO package provides all the supplies necessary to perform semen analysis: SQA-iO device, 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)

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- 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-iO 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-iO 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-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iO software. The SQA-iO 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-iO 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 cremes. 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.

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

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B Predicate 510(k) Number(s):

K021746

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K220828 | K021746 |
| --- | --- | --- |
| Device Trade Name | SQA-iO Sperm Quality Analyzer | SQA-V |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male's fertility status.

The SQA-iO provides direct and calculated quantitative measurements for the following parameters:

Directly measured parameters:
• Sperm Concentration, M/mL
• Motile Sperm Concentration (MSC), M/mL
• Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL)
• Normal Forms (Normal Morphology), %

Calculated parameters:
• Total Motility (PR + NP), %
• Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %)
• Non-Progressive Motility (NP), %
• Immotile (IM), %
• Functional Sperm Concentration (FSC), millions/mL | 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 MSC (PMSC)
• Functional sperm concentration (FSC, millions/mL) |

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| Sample Type | Human Semen | Human Semen |
| --- | --- | --- |
| Testing Capillary | SQA-V testing capillary | SQA-V testing capillary |
| External Controls | Use of QwikCheck Beads (cleared under K041600) for performing quality control | Same |
| General Device Characteristic Differences | | |
| Technology | Desk-top unit consists of a light source and optical sensors, connected to a PC that 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. | Desk-top unit consists of a light source, optical sensors, built-in video microscopy and an 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:

WHO Laboratory Manual for the Examination and Processing of Human Semen 6th Edition (2021)
IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
CLSI EP17-A2 (2012), Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – 2nd edition
CLSI EP07 (2018), Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
CLSI EP05-A3 (2014): Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition
CLSI EP06-A2 (2020): Evaluation of the Linearity of Quantitative Measurement Procedures; Approved Guideline – Second Edition

VII Performance Characteristics (if/when applicable):

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# A Analytical Performance:

# 1. Precision/Reproducibility:

# Repeatability

Eight native donor samples, spanning low, middle and high levels of five parameters (concentration, motility, MSC, PMSC, and morphology), were assayed in duplicate on five devices over four time-points. Due to the limited stability of semen samples, each "day" in the statistical analysis represented different times of day with testing at the 0, 20, 40, and 60-minute time points resulting in 40 replicate results per sample, for each of the five parameters. Standard deviations (SDs) and percent coefficients of variation (%CVs) were calculated for each sample. The results were found to be acceptable.

SQA-iO Sperm Concentration Precision

| Sample | N | Mean M/mL | Within-Run | | Between-Run | | Between-Operator/Lot/Instrument | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 40 | 8.5 | 0.63 | 7.4% | 0.61 | 7.2% | 0.60 | 7.1% |
| 2 | 40 | 34.5 | 1.66 | 4.8% | 1.70 | 4.9% | 1.31 | 3.8% |
| 3 | 40 | 45.4 | 3.25 | 7.2% | 3.30 | 7.3% | 3.09 | 6.8% |
| 4 | 40 | 58.5 | 3.12 | 5.3% | 3.07 | 5.2% | 2.11 | 3.6% |
| 5 | 40 | 62.2 | 2.42 | 3.9% | 2.38 | 3.8% | 2.30 | 3.7% |
| 6 | 40 | 181.6 | 5.25 | 2.9% | 5.35 | 2.9% | 3.83 | 2.1% |
| 7 | 40 | 227.6 | 5.87 | 2.6% | 6.25 | 2.7% | 3.48 | 1.5% |
| 8 | 40 | 212.9 | 3.74 | 1.8% | 4.42 | 2.1% | 2.67 | 1.3% |

SQA-iO Motile Sperm Concentration (MSC) Precision

| Sample | N | Mean M/mL | Within-Run | | Between-Run | | Between-Operator/Lot/Instrument | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 40 | 2.0 | 0.00 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% |
| 2 | 40 | 26.5 | 1.31 | 5.0% | 1.36 | 5.1% | 0.68 | 2.6% |
| 3 | 40 | 27.9 | 1.40 | 5.0% | 1.55 | 5.5% | 1.08 | 3.9% |
| 4 | 40 | 47.0 | 2.99 | 6.4% | 2.99 | 6.4% | 2.27 | 4.8% |
| 5 | 40 | 35.5 | 1.42 | 4.0% | 1.56 | 4.4% | 1.27 | 3.6% |
| 6 | 40 | 79.4 | 2.87 | 3.6% | 3.54 | 4.5% | 1.09 | 1.4% |
| 7 | 40 | 69.3 | 4.26 | 6.2% | 5.05 | 7.3% | 1.37 | 2.0% |
| 8 | 40 | 106.2 | 3.43 | 3.2% | 4.48 | 4.2% | 2.18 | 2.1% |

SQA-iO Progressively Motile Sperm Concentration (PMSC) Precision

| Sample | N | Mean M/mL | Within-Run | | Between-Run | | Between-Operator/Lot/Instrument | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 40 | 0.0 | 0.00 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% |
| 2 | 40 | 23.2 | 1.11 | 4.8% | 1.14 | 4.9% | 0.74 | 3.2% |
| 3 | 40 | 24.2 | 1.27 | 5.2% | 1.35 | 5.6% | 0.90 | 3.7% |
| 4 | 40 | 42.2 | 2.80 | 6.6% | 2.81 | 6.7% | 2.11 | 5.0% |
| 5 | 40 | 31.5 | 1.78 | 5.6% | 1.86 | 5.9% | 1.11 | 3.5% |
| 6 | 40 | 70.3 | 2.64 | 3.8% | 3.34 | 4.8% | 0.92 | 1.3% |
| 7 | 40 | 51.0 | 4.60 | 9.1% | 5.34 | 10.6% | 2.51 | 4.9% |
| 8 | 40 | 93.4 | 3.58 | 3.8% | 4.39 | 4.7% | 2.21 | 2.4% |

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SQA-iO Percent Normal Morphology Precision

| Sample | N | Mean % | Within-Run | | Between-Run | | Between-Operator/Lot/Instrument | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV |
| 1 | 40 | 0.0 | 0.00 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% |
| 2 | 40 | 15.4 | 0.87 | 5.7% | 0.87 | 5.7% | 0.78 | 5.1% |
| 3 | 40 | 11.2 | 1.00 | 9.0% | 1.00 | 8.9% | 0.89 | 8.0% |
| 4 | 40 | 16.5 | 0.78 | 4.7% | 0.83 | 5.0% | 0.59 | 3.6% |
| 5 | 40 | 10.2 | 0.58 | 5.7% | 0.61 | 6.0% | 0.45 | 4.4% |
| 6 | 40 | 7.2 | 0.35 | 4.8% | 0.39 | 5.4% | 0.26 | 3.6% |
| 7 | 40 | 3.6 | 0.42 | 11.9% | 0.46 | 13.0% | 0.22 | 6.2% |
| 8 | 40 | 8.5 | 0.48 | 5.6% | 0.53 | 6.3% | 0.35 | 4.2% |

## Reproducibility

This study was designed to establish the reproducibility of the SQA-iO utilizing three levels of QwikCheck beads (controls) assayed by three different operators in three locations over a 5-day period. Six replicates of each level of QwikCheck Beads, representing varying concentration levels (High, Normal and Negative) were included. For each level of control sample, the mean, SD and %CV were calculated, along with the %CV for repeatability and reproducibility (total precision). The results were found to be acceptable.

## 2. Linearity:

Linearity of SQA-iO device was evaluated for sperm concentration only using three analyzers with one replicate per analyzer. Semen samples were prepared by pooling ten native donors and concentrating sperm via centrifugation and removal of supernatant. The cell pellet was resuspended in Earle's buffer to create high concentration stock, which was serial diluted to prepare nine linearity samples total. At each level, the mean of the three replicates was calculated, and regression analysis was used to verify the linear range. Sperm concentration was demonstrated to be linear from $2 - 400\mathrm{M / mL}$.

## 3. Analytical Specificity/Interference:

The potential interference of various substances on SQA-iO results were evaluated by using two sperm concentration levels (15–60 M/mL and 100–200 M/mL). The parameters of sperm concentration, MSC, PMSC, and %normal morphology were evaluated. The following 11 interfering substances were tested in the study at the recommended level: vitamin B, testosterone, yeast, E. Coli, red blood cells (RBCs), white blood cells (WBCs), urine, saliva, agglutination of semen sample, D-norgestrel, and $\beta$-estradiol. Samples were compared to matched native control samples (no interferent added, only seminal plasma to compensate for volume). Results showed that all tested interfering substances met the acceptance criteria, so no significant interference was caused by the tested substances at the evaluated level.

## 4. Accuracy (Instrument):

### Method comparison

Method comparison data were based on comparative testing of 165 matched native semen samples that were assayed on the SQA-iO and the predicate SQA-V device across three sites. At each site, one SQA-iO device and one SQA-V device were used. Each sample was

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assayed in duplicate on the SQA-V, and the means of the SQA-V results were used for comparison. The data were analyzed by the Passing-Bablok regression and the results are shown in the table below. The results met the acceptance criteria.

| Parameter | N | Range | Slope (95% CI) | Intercept (95% CI) | Correlation (95% CI) |
| --- | --- | --- | --- | --- | --- |
| Concentration, M/mL | 165 | 5.0 to 418.2 | 1.0
(1.0, 1.0) | -1.5
(-2.0, -0.7) | 1.0
(0.98, 0.99) |
| Motility, % | 165 | 1.5 to 78.2 | 1.0
(1.0, 1.0) | -3.0
(-3.1, -1.7) | 1.0
(0.95, 0.97) |
| Progressive motility, % | 165 | 0.0 to 70.0 | 0.9
(0.9, 1.0) | -0.8
(-1.0, 0.0) | 1.0
(0.97, 0.98) |
| Rapidly Progressive, % | 165 | 0.0 to 53.7 | 1.0
(0.9, 1.0) | 0.1
(0.0, 0.3) | 0.9
(0.90, 0.94) |
| Slowly Progressive, % | 165 | 0.0 to 42.2 | 1.0
(0.9, 1.0) | -0.8
(-1.0, 0.0) | 0.9
(0.86, 0.93) |
| Non-Progressive, % | 165 | 0.0 to 44.0 | 1.2
(1.0, 1.3) | -1.9
(-3.0, -1.0) | 0.8
(0.71, 0.83) |
| Immotile, % | 165 | 22.0 to 98.0 | 1.0
(1.0, 1.0) | 3.0
(1.0, 5.0) | 1.0
(0.95, 0.97) |
| MSC, M/mL | 165 | 0.22 to 238.6 | 1.0
(1.0, 1.0) | -0.9
(-1.7, -0.6) | 1.0
(0.98, 0.99) |
| PMSC, M/mL | 165 | 0.0 to 218.6 | 1.0
(0.9, 1.0) | -0.4
(-0.7, -0.3) | 1.0
(0.99, 1.00) |
| Rapid PMSC, M/mL | 165 | 0.0 to 185.8 | 1.0
(1.0, 1.0) | 0.0
(-0.1, 0.0) | 1.0
(0.96, 0.98) |
| Slow PMSC, M/mL | 165 | 0.0 to 97.5 | 1.0
(0.9, 1.0) | -0.1
(-0.4, -0.1) | 1.0
(0.98, 0.99) |
| Morphology, % | 155 | 0.0 to 16.0 | 1.0
(0.9, 1.0) | 0.0
(0.0, 0.1) | 1.0
(0.96, 0.98) |
| FSC, M/mL | 155 | 0.0 to 60.2 | 0.9
(0.9, 1.0) | -0.1
(-0.1, 0.0) | 1.0
(0.97, 0.99) |

5. Carry-Over:

Not applicable.

B Expected Values/Reference Range:

The lower limit of the reference range for parameters Sperm Concentration, Total Motility (%), Progressive Motility (%) (including rapidly and slowly progressive motility), Normal Forms (%), Immotile (%), and Non-progressive motility (%) were directly reported as the 5th percentile in the WHO Laboratory Manual for the Examination and Processing of Human Semen, 6th Edition (Table 8.3). The lower limit of the reference range for parameters Motile Sperm Concentration, Progressive Motile Sperm Concentration (including Rapid and Slow PMSC), and Functional Sperm Concentration were calculated as the 5th percentile based on the raw data from the study conducted by Campbell et al¹.

Reference Values for Semen Parameters

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| SEMEN PARAMETER | REFERENCE RANGE | SOURCE |
| --- | --- | --- |
| SPERM CONCENTRATION, M/mL | ≥ 16 | WHO
6^{th} Edition |
| TOTAL MOTILITY (PR+NP), % | ≥ 42 | |
| PROGRESSIVE MOTILITY (PR), %
(RAPIDLY PROGRESSIVE + SLOWLY PROGRESSIVE MOTILITY) | ≥ 30 | |
| NON-PROGRESSIVE (NP), % | ≤1 | |
| IMMOTILE (IM), % | ≤ 20 | |
| MOTILE SPERM CONCENTRATION (MSC), M/mL | ≥ 7.0 | |
| PROGRESSIVELY MOTILE SPERM CONCENTRATION (PMSC), M/mL | ≥ 5.0 | |
| RAPID PMSC, M/mL | ≥ 1.8 | |
| SLOW PMSC, M/mL | ≥ 3.2 | |
| NORMAL FORMS (normal morphology), % | ≥ 4 | |
| FUNCTIONAL SPERM CONCENTRATION FSC), M/mL | ≥ 0.2 | |

C Other Supportive Instrument Performance Characteristics Data:

1. Sample Stability:

This study was performed to demonstrate the stability of semen parameters. In this study, samples were held at room temperature and the parameters of sperm concentration, %morphology, % motility, MSC and PMSC were assessed at various time intervals, and results were compared to their initial (T0) results. The study results support the recommendations to perform semen analysis within 1 hour of collection with samples held at room temperature prior to analysis.

2. Detection Limit:

A study was conducted to determine the detection limits of Sperm Concentration analyzed on the SQA-iO Sperm Quality Analyzer. Blank seminal plasma was used to represent a surrogate for the blank sample. Low level semen samples were prepared by pooling ten native donors and concentrating sperm via centrifugation and removal of supernatant. The cell pellet was resuspended in seminal plasma and diluted to create low concentration samples. Results were calculated and the detection limits were determined to be:

Limit of Blank (LoB) = 0 M/mL

Limit of Detection (LoD) = 1.73 M/mL

Limit of Quantitation (LoQ) = 5.96 M/mL

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.

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