K Number
K201301
Device Name
X100 with Full Field Peripheral Blood Smear (PBS) Application
Manufacturer
Date Cleared
2020-10-02

(140 days)

Product Code
Regulation Number
864.5260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X100 with Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.
Device Description
X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the suggested classification of each automatically detected WBC, and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelet estimation, and may manually change the detections or the estimation. The X100 with Full Field Peripheral Blood Smear Application is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.
More Information

K092116, 21CFR 864.3600

Not Found

Yes
The summary explicitly states that "Cell images are analysed using standard mathematical methods, including deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells." Artificial Neural Networks are a type of machine learning algorithm.

No
This device is for in vitro diagnostic use, assisting a technologist in analyzing blood smears rather than directly treating a patient.

Yes

The "Intended Use / Indications for Use" states that the device is for "in vitro diagnostic use only" and "assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate". These activities are diagnostic in nature, aimed at evaluating aspects of a patient's health based on laboratory analysis.

No

The device description explicitly states that the X100 with Full Field Peripheral Blood Smear Application "automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears." This implies the existence of hardware components responsible for image acquisition and presentation, which are not solely software functions. The predicate device also includes a "Cell Locator," further suggesting a hardware component.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
  • Purpose of the Device: The device is intended to analyze biological specimens (peripheral blood smears) in vitro (outside of the body) to provide information that assists in making a diagnosis or evaluating a medical condition (WBC differential, RBC morphology evaluation, and platelet estimate). This aligns directly with the definition of an IVD.
  • Professional Use: The device is intended for use by "qualified technologist" and "For professional use only," which is typical for IVD devices used in a clinical laboratory setting.

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Intended Use / Indications for Use

The X100 with Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Product codes (comma separated list FDA assigned to the subject device)

JOY

Device Description

X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears.

The user browses through the imaged smear to gain high-level general impressions of the sample.

In conducting white blood cells (WBC) differential, the user reviews the suggested classification of each automatically detected WBC, and may manually change the suggested classification of any cell.

In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images.

In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelet estimation, and may manually change the detections or the estimation.

The X100 with Full Field Peripheral Blood Smear Application is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes (The predicate device K092116 used deterministic artificial neural networks (ANN's) trained to distinguish between classes of white blood cells. The subject device has the same Analysis Technique for White Blood Cells.)

Input Imaging Modality

Not Found

Anatomical Site

Peripheral blood smears

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified technologist, skilled users, trained in the use of the device and in the identification of blood cells. For in vitro diagnostic use only. For professional use only.

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

A total of 645 specimens were collected and analyzed at three sites. 335 specimens were from normal (healthy) subjects and 310 were from subjects with specific disease conditions. Slides were prepared from each specimen. The slides were randomly selected, blinded and read by two examiners at each site.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Method Comparison:

  • A Method Comparison was conducted to compare the results achieved by trained examiners using the X100 with Full Field Peripheral Blood Smear Application (the Test Method) to the results achieved by using a manual light microscope.
  • Sample Size: 645 specimens (335 normal, 310 disease conditions) across 3 sites.
  • Key Results:
    • WBC Correlation (Deming Regression): Neutrophil (r=98%, Slope=1.00, Intercept=0.39), Lymphocyte (r=96%, Slope=0.99, Intercept=-0.51), Monocyte (r=94%, Slope=0.94, Intercept=-0.15), Eosinophil (r=98%, Slope=0.89, Intercept=0.00).
    • WBC Differential Efficiency: Morphological Abnormality 96.82%, Distributional Abnormality 95.75%, Overall 96.29%.
    • WBC Differential Sensitivity: Morphological Abnormality 85.46%, Distributional Abnormality 88.83%, Overall 87.86%.
    • WBC Differential Specificity: Morphological Abnormality 97.79%, Distributional Abnormality 97.43%, Overall 97.62%.
    • RBC Morphology Evaluation Overall Agreement: 99.77%.
    • Platelet Estimation Correlation (Deming Regression): Platelets Estimation (103/μL) (r=94%, Slope=1.03, Intercept=-10.31).
    • Platelet Estimation Efficiency: 94.89%.
    • Platelet Estimation Sensitivity: 90.00%.
    • Platelet Estimation Specificity: 96.28%.
  • All method comparison testing met acceptance criteria.

Precision Studies (Repeatability & Reproducibility):

  • Repeatability: A 20x2x2 repeatability study (20 testing days, 2 daily runs, 2 replicas) using 15 selected test samples. 1,200 scans analyzed. Results met predefined acceptance criteria.
  • Reproducibility: A 3x5x5 reproducibility study (3 sites, 10 samples, 5 testing days, 5 replicas) across 3 different sites. 750 scans analyzed. Results met predefined acceptance criteria.

Software Verification and Validation Testing:

  • Conducted and documentation provided as recommended by FDA's guidance.
  • Software application considered "moderate" level of concern.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Efficiency:
    • WBC Morphological Abnormality: 96.82% (96.12% to 97.43%)
    • WBC Distributional Abnormality: 95.75% (94.95% to 96.46%)
    • WBC Overall: 96.29% (95.77% to 96.76%)
    • Platelet estimation Overall: 94.89% (92.78% to 96.53%)
  • Sensitivity:
    • WBC Morphological Abnormality: 85.46% (80.19% to 89.78%)
    • WBC Distributional Abnormality: 88.83% (85.94% to 91.31%)
    • WBC Overall: 87.86% (85.38% to 90.06%)
    • Platelet estimation Overall: 90.00% (83.51% to 94.57%)
  • Specificity:
    • WBC Morphological Abnormality: 97.79% (97.16% to 98.31%)
    • WBC Distributional Abnormality: 97.43% (96.70% to 98.03%)
    • WBC Overall: 97.62% (97.16% to 98.02%)
    • Platelet estimation Overall: 96.28% (94.11% to 97.82%)
  • Overall Agreement:
    • RBC Morphology Overall: 99.77% (99.71% to 99.83%)
    • RBC Morphology Color: 99.49% (99.14% to 99.73%)
    • RBC Morphology Shape: 99.77% (99.68% to 99.84%)
    • RBC Morphology Size: 99.61% (99.36% to 99.78%)
    • RBC Morphology Inclusions: 100.00% (99.93% to 100.00%)
    • RBC Morphology Arrangement: 96.65% (95.52% to 97.57%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K092116, 21CFR 864.3600

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 864.5260 Automated cell-locating device.

(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 2, 2020

Scopio Labs LTD. % Yarmela Pavlovic Regulatory Counsel Manatt Health 1 Embarcadero Center, 30th Floor San Francisco, California 94111

Re: K201301

Trade/Device Name: X100 with Full Field Peripheral Blood Smear (PBS) Application Regulation Number: 21 CFR 864.5260 Regulation Name: Automated Cell-Locating Device Regulatory Class: Class II Product Code: JOY Dated: May 15, 2020 Received: May 15, 2020

Dear Yarmela Pavlovic:

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. 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 located 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.

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

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

Sincerely,

Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201301

Device Name

X100 with Full Field Peripheral Blood Smear (PBS) Application

Indications for Use (Describe)

The X100 with Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

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

This 510(k) Premarket Notification Summary is prepared in accordance with 21 CFR 807.92.

I. Submitter Information

Sponsor Name:Scopio Labs Ltd.
Sponsor Address:Scopio Labs Ltd.
11 Tiomkin Street
Tel Aviv 6578313
Israel
Sponsor Email:info@scopiolabs.com
Contact Person:
Contact Email:Shahar Karny
Director of Clinical AI
Scopio Labs
shahar@scopiolabs.com
Contact Telephone:+972-54-6542164
Date Summary Prepared:May 5, 2020

II. Device

Trade (Proprietary) Name: X100 with Full Field Peripheral Blood Smear Application Common (Usual) Name: Full Field PBS, Scopio Regulation Number: 21CFR864.5260 Regulation Name: Automated cell-locating device Regulatory Class: II JOY Product Code: Hematology Product Panel:

III. Predicate Device

Predicate A
Device Name:EasyCell Cell Locator
Device 510(k):K092116
ManufacturerMedica Corporation
Predicate B
Device Name:Romanowsky stain manual light microscope
process for cell classification
Device 510(k):21CFR 864.3600 Class I exempted from pre-
market notification procedure

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IV. Device Description

X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears.

The user browses through the imaged smear to gain high-level general impressions of the sample.

In conducting white blood cells (WBC) differential, the user reviews the suggested classification of each automatically detected WBC, and may manually change the suggested classification of any cell.

In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images.

In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelet estimation, and may manually change the detections or the estimation.

The X100 with Full Field Peripheral Blood Smear Application is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

V. Intended Use

The X100 with Full Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Comparison of Technological Characteristics with the Predicate Devices VI.

The X100 with Full Field Peripheral Blood Smear Application is substantially equivalent to its predicate devices, the EasyCell (K092116), and the manual light microscope. The subject device has the same intended use as the predicates in that all devices are intended to assist a qualified user in conducting evaluations of white blood cells, red blood cells and platelets within a fixed and stained peripheral blood smear. Additionally, the devices are also substantially equivalent with respect to technological characteristics. While the specific information provided by the subject device varies somewhat compared to the predicates, in the case of all devices the information provided must be interpreted and confirmed or adjusted by the trained user. Thus, these differences do not raise different questions of safety or effectiveness.

The similarities and differences between the subject device and the predicate devices are summarized in Table 1 below.

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Image /page/5/Picture/1 description: The image shows the logo for a company called "Scopio". The logo consists of a square made of two smaller squares, one pink and one dark blue, stacked on top of each other. To the right of the square is the company name, "Scopio", in a dark blue sans-serif font.

Table 1 Comparison of Characteristics with the Predicate Devices

| Item | Manual light
microscopic process | EasyCell
K092116 | Full Field PBS |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Similarities | |
| Intended use | Intended to locate and
display images of white
cells, red cells, and
platelets acquired from
fixed and stained
peripheral blood smears.
For in vitro diagnostic
use only. For
professional use only | Intended to locate and display
images of white cells, red cells,
and platelets acquired from fixed
and stained peripheral blood
smears and assists a qualified
technologist in conducting a
WBC differential, RBC
morphology evaluation, and
platelet estimate using those
images. For in vitro diagnostic
use only. For professional use
only. | Same as for EasyCell |
| Sample Type | Stained blood film glass
slides of peripheral
whole blood | Same | Same |
| Sample Preparation | Romanowsky stain | Same | Same |
| Analysis Technique:
White Blood Cells | WBC are manually
located, classified and
counted by moving
according to the
battlement pattern
(ensuring that each cell
is counted only once). | WBC are located/counted by
moving according to the
battlement pattern (ensuring that
each cell is counted only once).
Cell images are analysed using
standard mathematical methods,
including deterministic artificial
neural networks (ANN's) trained
to distinguish between classes of
white blood cells. The cell
images are pre-classified, and the
user reviews the suggested
classification, and accepts or
reclassifies the images. | Same as for EasyCell |
| Analysis Technique:
Red Blood Cells | Red blood cells: The
device presents an
overview image. The
examiners characterize
red blood cell
morphology from the
image. | Same | Same |
| Daily QC | N/A | The QC procedure controls for
slide preparation (both smearing
and staining) and EasyCell
performance. If the QC
procedure does not pass, the
operator must resolve the
problem and rerun the QC before
processing samples. | Same as for EasyCell |
| Item | Manual light
microscopic process | EasyCell
K092116 | Full Field PBS |
| Differences | | | |
| Analysis Technique:
Platelets | Platelets are manually
located and estimated by
moving according to the
battlement pattern
(ensuring that each cell
is counted only once). | The device presents a series of
images. The reviewers manually
count and estimate the platelet
concentration from the images
according to a procedure in the
User's Manual. | Platelets are automatically
located/counted by moving
according to the battlement
pattern (ensuring that each cell
is counted only once).
The user reviews the suggested
estimate of the platelet
concentration, and accepts or
modifies the result. |
| Pre-classified WBC | N/A | Cell images are grouped into
eight (8) categories:
Neutrophils (Band or Segmented Lymphocytes Monocytes Eosinophils Basophils Nucleated Red Blood Cells Smudge cells Other (which is intended to hold morphologically abnormal cells.) | Cell images are grouped into
eighteen (18) categories:
Band Neutrophils Segmented Neutrophils Lymphocytes Atypical Lymphocytes Large Granular Lymphocytes Aberrant Lymphocytes Monocytes Eosinophils Basophils Promyelocyte Metamyelocytes Myelocytes Blasts Plasma Cells Nucleated Red Blood Cells Unclassified Smudge cells Dirt |
| High-Resolution
Image Acquisition | Manual image viewing
through a 100X
magnification lens and
immersion oil. | Fully automated scan and image
acquisition.
Captures images at 10X
resolution to locate certain cells
and then capture images of those
cells using a 100X magnification
lens and immersion oil. | Fully automated scan and image
acquisition.
Captures multiple images under
plurality of illumination
conditions and reconstructs a
100X magnification image of
the viewed area, without the
need for immersion oil. |

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Transforming Diagnostics

Driving Hematology Forward

� Scopio

7

Performance Data VII.

Method Comparison

A Method Comparison was conducted to compare the results achieved by trained examiners using the X100 with Full Field Peripheral Blood Smear Application (the Test Method) to the results achieved by using a manual light microscope.

A total of 645 specimens were collected and analyzed at three sites. 335 specimens were from normal (healthy) subjects and 310 were from subjects with specific disease conditions. Slides were prepared from each specimen. The slides were randomly selected, blinded and read by two examiners at each site.

White Blood Cells

Table 2 WBC Correlation between Reference Method and Test Method

Results from Deming regression analyses on readings between subject device and manual microscope are as follows:

| Cell Type | Correlation
Coefficient (r) | Slope | Intercept |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------|
| Neutrophil (% ) | 98% | 1.00 | 0.39 |
| Lymphocyte (%) | 96% | 0.99 | -0.51 |
| Monocyte (%) | તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તે | 0.94 | -0.15 |
| Eosinophil (%) | 98% | 0.89 | 0.00 |

Table 3 WBC differential efficiency, sensitivity and specificity.

Measurements of distributional WBC (Band and Segmented Neutrophil, Monocyte, Lymphocyte and Eosinophil) and morphological WBC (Immature Granulocyte, Variant Forms Lymphocyte, Blast, NRBC and Plasma cell) between subject and manual microscope. In parenthesis are the calculated 95% confidence intervals.

| | Morphological
Abnormality | Distributional
Abnormality | Overall |
|-------------|------------------------------|-------------------------------|--------------------|
| Efficiency | 96.82% | 95.75% | 96.29% |
| | (96.12% to 97.43%) | (94.95% to 96.46%) | (95.77% to 96.76%) |
| Sensitivity | 85.46% | 88.83% | 87.86% |
| | (80.19% to 89.78%) | (85.94% to 91.31%) | (85.38% to 90.06%) |
| Specificity | 97.79% | 97.43% | 97.62% |
| | (97.16% to 98.31%) | (96.70% to 98.03%) | (97.16% to 98.02%) |

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Image /page/8/Picture/1 description: The image shows the logo for Scorpio. The logo consists of a square with a smaller pink square overlapping the bottom left corner. To the right of the square is the word "Scorpio" in a dark blue sans-serif font. The logo is simple and modern.

Red Blood Cells

Table 4 Red Blood Cells Morphology Evaluation

Results of overall agreement for RBC morphology evaluation are as follows:

RBC MorphologyOverall Agreement with 95% CI
Overall99.77%
(99.71% to 99.83%)
RBC Morphology GroupOverall Agreement with 95% CI
Color99.49%
(99.14% to 99.73%)
Shape99.77%
(99.68% to 99.84%)
Size99.61%
(99.36% to 99.78%)
Inclusions100.00%
(99.93% to 100.00%)
Arrangement96.65%
(95.52% to 97.57%)

Platelets

Table 5 Platelet estimation correlation between reference method and test method

Results from Deming regression analyses on readings with subject and manual microscope are as follows:

| Cell Type | Correlation
Coefficient (r) | Slope | Intercept |
|-------------------------------------|--------------------------------|-------|-----------|
| Platelets
Estimation
(103/μL) | 94% | 1.03 | -10.31 |

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Table 6 Platelet estimation efficiency, sensitivity and specificity

Overall
Efficiency94.89%
(92.78% to 96.53%)
Sensitivity90.00%
(83.51% to 94.57%)
Specificity96.28%
(94.11% to 97.82%)

All method comparison testing met acceptance criteria.

Precision (Repeatability & Reproducibility)

Repeatability

The repeatability study was performed according to the CLSI's EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition.

A 20x2x2 repeatability study for the analyses of white blood cells differential and platelets estimation was conducted using a single instrument at a single site with 15 selected test samples. Over the course of 20 testing days, 2 daily runs were performed using 2 replicas. The selected samples represented different clinical conditions, to include all automatically located and pre-classified cell types. In total, 1,200 scans were analyzed.

For each tested sample, SD and %CV were estimated for the four variance components: repeatability, between-run (within-day), between-day and within-laboratory. The results met the predefined acceptance criteria.

Reproducibility

The reproducibility study was performed according to the CLSI's EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition.

A 3x5x5 reproducibility study for the analyses of white blood cells differential and platelets estimation was performed across 3 different sites. The study was conducted at each site, with 10 test samples, for 5 testing days, using 5 replicas scanned with the local device. The selected samples represented different clinical conditions, to include all automatically located and pre-classified cell types. In total, 750 scans were analyzed.

For each tested sample. SD and %CV were estimated for the five variance components: repeatability, between day (within-site), within-laboratory, between site, and reproducibility. The results met the predefined acceptance criteria.

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Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's guidance. The software application was considered as a "moderate" level of concern, since a malfunction failure or latent design flaw in the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that could lead to a minor injury.

VIII. Conclusion

Study results demonstrated that X100 with Full Field Peripheral Blood Smear Application is substantially equivalent to the predicate device.