X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

K220013 · Scopio Labs , Ltd. · JOY · May 3, 2022 · Hematology

Device Facts

• Record ID: K220013
• Device Name: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
• Applicant: Scopio Labs , Ltd.
• Product Code: JOY · Hematology
• Decision Date: May 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
White Blood Cell Differential	Pre-defined acceptance criteria including regression analysis for WBC cell types.	Passing-Bablok regression correlation coefficients: Neutrophil (0.990), Lymphocyte (0.984), Monocyte (0.984), Eosinophil (0.935).	Not specified in document.	Automatic Workflow study: 30 clinical peripheral blood smear (PBS) Romanowsky-stained test slides prepared and collected from three different clinical sites, compared against seven reference devices.
Platelet Estimation	Pre-defined acceptance criteria including regression analysis for platelets.	Passing-Bablok regression correlation coefficient: 0.990; Intercept: 0.72 (-7.18, 4.94); Slope: 1.02 (0.99, 1.08).	Not specified in document.	Automatic Workflow study: 30 clinical peripheral blood smear (PBS) Romanowsky-stained test slides prepared and collected from three different clinical sites, compared against seven reference devices.

Indications for Use

The X100HT 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.

Device Story

X100HT is an automated hematology slide processing and imaging system. It accepts up to 30 peripheral blood smear slides in cassettes; automatically applies mounting media and coverslips; and loads slides into an integrated scanner. The scanner captures high-resolution images of blood cells; uses deterministic artificial neural networks to pre-classify white blood cells and locate platelets; and presents images to a technologist for review, manual classification, or estimation. Used in clinical laboratories; operated by trained personnel. The system automates the previously manual steps of coverslipping and slide loading, improving workflow efficiency while maintaining the diagnostic performance of the predicate X100 system.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including software verification and validation, EMC testing (IEC 60601-1-2), and safety testing (IEC 61010-2-101, IEC 61010-1, IEC 62471).

Technological Characteristics

Automated slide loader with 30-slide capacity; automated mounting media and coverslip application. Imaging system captures multiple illumination conditions for 100X magnification reconstruction without immersion oil. Software uses deterministic artificial neural networks (ANNs) for cell classification. Complies with IEC 61010-2-101, IEC 61010-1, IEC 62471, and IEC 60601-1-2. Power: 120/100-240V, 50-60 Hz.

Indications for Use

Indicated for professional use by qualified technologists to assist in WBC differential, RBC morphology evaluation, and platelet estimation from fixed and stained peripheral blood smears.

Regulatory Classification

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.)

Predicate Devices

• X100 with Full Field Peripheral Blood Smear (PBS) Application (K201301)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K220013

B Applicant

Scopio Labs Ltd.

C Proprietary and Established Names

X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JOY | Class II | 21 CFR 864.5260 - Automated Cell-Locating Device | HE - Hematology |

## II Submission/Device Overview:

A Purpose for Submission:

The purpose of the submission is to add a Slide Loader to the cleared X100 with Full Field PBS (K201301) that allows up to 30 slides to be analyzed.

B Type of Test:

White blood cell (WBC) differential, red blood cell (RBC) morphology evaluation and platelet estimation

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

The X100HT 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.

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

Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:

The X100HT with Slide Loader and Full Field Peripheral Blood Smear automatically locates and presents images of blood cells on peripheral blood film smears. The user browses through the imaged smear to gain high-level general impression. The user reviews the suggested classification of each white cell according to type and may manually change the suggested classification of any cell. The user can evaluate red cell morphology on observed images. The user reviews each detected platelet and the suggested platelet estimation and may manually change the detections or the estimation. The X100HT with Full Field PBS is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

The X100HT with Full Field PBS shares the same intended use as the previously 510(k)-cleared X100 Full Field PBS (K201301). Specifically, it is comprised of the identical X100 scanner and Full Field PBS application, but it is assembled with an external Slide Loader, and additional slide locks were added to the X100 tray. A minor software change to the 'Scanning' interface was also introduced to allow interaction with the Slide Loader. The Slide Loader was designed as an optional manufacturer assembly part to the cleared X100 scanner, to replace this preliminary need of a manual mounting media application and a coverslip placement. As with the predicate, the preparation of the stained blood smear and barcoding of the slide are identical for the X100HT and are still externally prepared by the user, either manually or by third party devices. The Slide Loader comes with three cassettes, each cassette may hold up to 10 slides. The user manually inserts non-cover slipped PBS-stained blood smear slides into the cassettes. In turn, the Slide Loader, upon the user's request, adds mounting media, cover slips each slide and loads them sequentially into the X100 for processing.

### B Instrument Description Information:

1. Instrument Name:
X100HT with Slide Loader with Full Field Peripheral Blood Smear Application

2. Specimen Identification:
The slide's barcode is captured automatically and assigned to each case. The device also supports typing the barcode manually.

3. Specimen Sampling and Handling:
A peripheral blood sample collected in K2EDTA or K3EDTA tubes is mixed manually or automatically. A thin blood film is wedged on a clean dry glass slide (a blood smear) and stained with Romanowsky stain. The user manually places up to 30 slides into 3 extractable

K220013 - Page 2 of 10

{2}

cassettes and inserts them into the Slide Loader. The Slide Loader sequentially inserts the slides into the scanner. The instrument automatically coverslips and adds immersion oil to slide for scanning.

4. Calibration:
The Full Field PBS system requires initial calibration for its mechanical and optical performances. An initial calibration process is performed on a standard blood smear slide as part of the manufacturing process of the device. The calibration is verified after installation by a technician or a qualified operator. Calibration can also be performed if a problem arises in the daily QC testing.

5. Quality Control:
Quality Control (QC) testing is performed on a daily basis ("daily QC"). The daily QC involves testing a standard blood smear slide prepared on the same day. During the daily QC the user reviews the images received from the Full Field PBS and verifies that at least 95% of the WBCs in the scanned image were identified and located correctly by the system. The Full Field PBS application maintains a digital QC log, enabling the user to review and to track the history of QC testing performed by the Full Field PBS.

V Substantial Equivalence Information:

A Predicate Device Name(s):
X100 with Full Field Peripheral Blood Smear (PBS) Application

B Predicate 510(k) Number(s):
K201301

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K220013 | K201301 |
| --- | --- | --- |
| Device Trade Name | X100HT with Full Field PBS | X100 with Full Field PBS |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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 | Same |

K220013 - Page 3 of 10

{3}

K220013 - Page 4 of 10
| | in vitro diagnostic use only. For professional use only. | |
| --- | --- | --- |
| Sample Type | Peripheral whole blood | Same |
| Sample Smear | Sample is smeared on a glass microscope slide (Either manually or by third party device). | Same |
| Sample Staining | Sample’s smear is fixed and stained with Romanowsky stain. (Either manually or by third party device) | Same |
| Sample Identification | Sample’s microscope slide is identified by a unique barcode label. (Barcode label is applied either manually or by third party device). | Same |
| High-Resolution Image Acquisition | 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. | Same |
| Analysis Technique: White Blood Cells | WBCs are located/counted by moving according to the battlement pattern (ensuring that each cell is counted only once). Cell images are analyzed 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 | Same |

{4}

K220013 - Page 5 of 10
| | suggested classification, and accepts or reclassifies the images. | |
| --- | --- | --- |
| 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 |
| Daily QC | The QC procedure controls for slide preparation (both smearing and staining) and device performance. If the QC procedure does not pass, the operator must resolve the problem and rerun the QC before processing samples. | Same |
| Analysis Technique: Platelets | 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. | Same |
| Pre-classified WBC | Cell images are grouped into eighteen (18) categories:
• Band Neutrophils
• Segmented Neutrophils
• Lymphocytes
• Atypical Lymphocytes
• Large Granular Lymphocytes
• Aberrant Lymphocytes
• Monocytes
• Eosinophils
• Basophils | Same |

{5}

| | • Promyelocyte
• Metamyelocytes
• Myelocytes
• Blasts
• Plasma Cells
• Nucleated Red Blood Cells
• Unclassified
• Smudge cells
• Dirt | |
| --- | --- | --- |
| Power Source | 120/100 – 240V, 1.5A, 50 – 60 Hz | Same |
| General Device Characteristic Differences | | |
| Sample Cover Slipping | The X100HT automatically applies mounting media and a glass cover slip onto the sample’s microscope slide. | User manually applies mounting media and a glass cover slip onto the sample’s microscope slide. |
| Sample Loading | The user manually places up to 30 slides into 3 extractable cassettes, and inserts them into the Slide Loader. The Slide Loader sequentially inserts the slides into the X100 scanner. | User manually inserts up to 3 slides into an extractable tray, and manually inserts the tray in to the X100 scanner. |
| Dimensions | Width: 39cm
Length: 42cm
Height: 55cm | Width: 32cm
Length: 32cm
Height: 35cm |
| Weight | 33kg | 14kg |

VI Standards/Guidance Documents Referenced:

- IEC 62471 First edition 2006-07: Photobiological safety of lamps and lamp systems, FDA recognition number 12-249. Test Report is documented in the company’s QMS, and may be submitted for agency review by request.
- IEC 60601-1-2:2014, 4th edition: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, FDA recognition number 19-8. Test Report is documented in the company’s QMS, and may be submitted for agency review by request.

K220013 - Page 6 of 10

{6}

- ISO 14971:2019, Medical Devices - Application of risk management to medical devices, FDA recognition number 5-125.
- IEC 62304:2006+AMD1:2015 CSV, Medical Device Software – Software Life-Cycle Processes, FDA recognition number 13-79.
- ISO 13485:2016(en) Medical devices — Quality management systems — Requirements for regulatory purposes
- IEC 61010-2-101:2015 / EN 61010-2-101: 2017 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical 038
- equipment. Test Report is documented in the company’s QMS, and may be submitted for agency review by request.
- IEC / EN 61010-1: 2010 (3rd Edition) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. Test Report is documented in the company’s QMS, and may be submitted for agency review by request.
- FCC CFR 47 Part 15 Subpart B, ANSI C63.4:2014. Test Report is documented in the company’s QMS, and may be submitted for agency review by request.

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

1. **Precision/Reproducibility:**
Refer to K201301

2. **Linearity:**
Refer to K201301

3. **Analytical Specificity/Interference:**
Refer to K201301

4. **Accuracy (Instrument):**
Refer to K201301

5. **Carry-Over:**
Not applicable

### B Other Supportive Instrument Performance Characteristics Data:

#### Verification and Validation

1. **Oil application:**
The Oil application study was performed to evaluate automatic application of mounting media (oil) onto the slide. The study was conducted using three (3) X100HT devices, each

K220013 - Page 7 of 10

{7}

device tested with 1,000 consecutive oil application procedures totaling 3,000 slides. The study results passed pre-defined acceptance criteria.

| | X100HT-Test Device #1 | X100HT-Test Device #2 | X100HT-Test Device #3 |
| --- | --- | --- | --- |
| Average oil coverage of the scan area | 99.88% | 99.71% | 99.66% |
| Average bubble count | 0.06% | 0.19% | 0.22% |
| Average bubble coverage | 0.09% | 0.28% | 0.36% |

# 2. Cover Slip application:

The Cover Slip application study was performed to evaluate automatic placement of glass coverslips onto the slide. The study was conducted using three (3) X100HT devices, each device tested with 1,000 consecutive coverslip application procedures totaling 3,000 slides. The study results passed pre-defined acceptance criteria.

| | X100HT-Test Device #1 | X100HT-Test Device #2 | X100HT-Test Device #3 |
| --- | --- | --- | --- |
| Successful cover slip placement, from 1000 slides per device | 99.7%
997/1000 | 99.8%
998/1000 | 99.7%
997/1000 |

# 3. Loading of Slides:

The study was performed to evaluate automatic loading of the slides. The study was conducted using three (3) X100HT devices, each device tested with 100 loading cycles and Full Field scanning. In total 300 were loaded and scanned. The study results passed predefined acceptance criteria.

| | X100HT-Test Device #1 | X100HT-Test Device #2 | X100HT-Test Device #3 |
| --- | --- | --- | --- |
| Number of scans with % FOVs in focus. | 100/100 (100%) | 100/100 (100%) | 100/100 (100%) |

# 4. Complete process from Oil application to Loading slides:

The study was performed to evaluate a complete cycle of oil application, glass cover slipping, and automatic loading of the slides. The study was conducted using three (3) X100HT devices, each device tested with 1000 cycles totaling 3000 complete cycles. The study results passed pre-defined acceptance criteria.

K220013 - Page 8 of 10

{8}

K220013 - Page 9 of 10

| | X100HT-Test Device #1 | X100HT-Test Device #2 | X100HT-Test Device #3 |
| --- | --- | --- | --- |
| Number of successful operational cycles | 995/1000 (99.5%) | 992/1000 (99.2%) | 993/1000 (99.3%) |
| Number of aborted cycles due to system alerts, which required user intervention | 5/1000 (0.5%) | 8/1000 (0.9%) | 7/1000 (0.8%) |

## 5. Electrical Safety

To evaluate electrical safety, testing was performed for electromagnetic (EMC) and Electrical Safety according to consensus standards. The study met pre-defined acceptance criteria.

## 6. Scanning Module

The Scanning page module was changed to support the 'start scan' option for a cassette rather than a slide. The change was tested throughout the different verification and validation tests for any user interface errors. The study results passed pre-defined acceptance criteria.

## 7. Automatic Workflow

The Automatic workflow study was performed with 30 clinical peripheral blood smear (PBS) Romanowsky-stained test slides prepared and collected from three (3) different clinical sites, seven (7) X100 with Full Field PBS devices (reference device), and three (3) candidate devices (X100HT). The sample slides represented a variety of clinical conditions that were included in the original 510(k) study. The study met predefined acceptance criteria including regression analysis for the four WBC cell types and platelets.

| Cell Type | Total Observations | Total Observations in Reference Range | % Of Total Observations in Reference Range |
| --- | --- | --- | --- |
| Neutrophil | 450 | 448 | 99.56% |
| Lymphocyte | 450 | 449 | 99.78% |
| Variant Lymphocyte | 450 | 444 | 98.67% |
| Monocyte | 450 | 445 | 98.89% |
| Eosinophil | 450 | 448 | 99.56% |
| Eosinophil | 450 | 449 | 99.78% |
| Basophil | 450 | 450 | 100.00% |
| Plasma Cell | 450 | 447 | 99.33% |
| Immature Cell | 450 | 447 | 99.33% |
| Blast | 450 | 447 | 99.33% |
| NRBC | 450 | 450 | 100.00% |
| Platelets | 450 | 448 | 99.56% |

{9}

Passing-Bablok Regression Results for WBC Differential

| Cell Type | Intercept with 95% CI | Slope with 95% CI | Correlation coefficient |
| --- | --- | --- | --- |
| Neutrophil (%) | 0.06
(-1.05, 1.36) | 1.01
(0.97, 1.04) | 0.990 |
| Lymphocyte (%) | -0.16
(-0.59, 0.65) | 1.02
(0.99, 1.03) | 0.984 |
| Monocyte (%) | 0.16
(-0.33, 0.48) | 1.03
(0.99, 1.10) | 0.984 |
| Eosinophil (%) | 0.00
(-0.01, 0.03) | 1.04
(0.97, 1.09) | 0.935 |

Passing-Bablok Regression Results for PLT estimation

| Cell Type | Intercept with 95% CI | Slope with 95% CI | Correlation coefficient |
| --- | --- | --- | --- |
| Platelets Estimation (10^3/μL) | 0.72
(-7.18, 4.94) | 1.02
(0.99, 1.08) | 0.990 |

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.

K220013 - Page 10 of 10