The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in KyEDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit micro-capillary tubes.

When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, RDW, PLT, NEUT%#, LYMPH %#, MONO %#, EOS%#, and BASO%/#.

The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.

Device Description

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface.

The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%#, LYMPH %#, MONO %/#, EOS%# and BASO%#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Category	Measurand	Acceptance Criteria	Reported Device Performance
Method Comparison	WBC, RBC, PLT, HGB, HCT, MCV, RDW, MCH, MCHC, NEUT%, NEUT#, LYMPH%, LYMPH#, MONO%, MONO#, EOS%, EOS#, BASO%, BASO#	Correlation, bias, slope, and intercept (and their 95% two-sided confidence intervals) met pre-specified criteria.	All measurands met the pre-specified acceptance criteria for correlation, bias, slope, intercept (and the 95% two-sided confidence interval (CI) around the slope and intercept). (See Table 1 for specific values for each measurand).
Repeatability	All measurands	All measurands in all tested ranges met predefined acceptance criteria for mean, standard deviation (SD), and coefficient of variation (CV).	All measurands in all tested ranges met the predefined acceptance criteria. (See Table 2 for specific values for each measurand across target ranges).
Reproducibility	All measurands	All components of variation (within-run, between-run, between-day, between-instrument, between-site, total precision) met predefined acceptance criteria for SD and %CV.	All components of variation that were calculated met the pre-defined acceptance criteria. (See Table 3 for specific values for each measurand across low, normal, and high levels).
Detection Limits (LoB, LoD, LoQ)	WBC, PLT, HGB	LoB defined as 95th percentile of study variable. LoD determined mathematically. LoQ defined as lowest concentration (≥LoD) where total error (TE) accuracy goals were satisfied. Test results met these definitions.	WBC: LoB = 0.04 x 10³/μL, LoD = 0.17 x 10³/μL, LoQ = 0.18 x 10³/μLPLT: LoB = 8.00 x 10³/μL, LoD = 11.00 x 10³/μL, LoQ = 13.40 x 10³/μLHGB: LoB = 0 g/dL, LoD = 3.9 g/dL, LoQ = 3.9 g/dL. (All met acceptance criteria).
Linearity	HGB, PLT, WBC	The final linearity range was determined as the intersection of the results from three instruments, and no lower than the LoD.	HGB: (3.9-21.75) g/dLPLT: (18-1028.5) x 10³/μLWBC: (0.18-100.13) x 10³/μL. (All met acceptance criteria).
Analytical Specificity/Interference	RBC, WBC, HGB, HCT, PLT	No significant interference for D-Glucose, Bilirubin F, Bilirubin C, Chyle, Hemolytic Hemoglobin, Intralipids at specified concentrations. No interference from RBC fragments, high leukocytosis, and high thrombocytosis.	Results demonstrated no significant interference from D-Glucose, Bilirubin F (except for WBC above 8.86 mg/dL), Bilirubin C, Chyle (except for PLT above 530 FTU), Hemolytic Hemoglobin, and Intralipids within tested concentrations. No interference from abnormal specimen conditions.
Sample Stability	All measurands	Supports a sample stability claim of 8 hours from blood collection at room temperature, with RDW specifically 4 hours.	Data support a sample stability claim of 8 hours from blood collection at room temperature for all Sight OLO measurands, with RDW having a stability of 4 hours.
Test Kit Shelf-Life	Functional and analytical tests	Met predefined acceptance criteria at defined time points. Initial shelf life of 6 months.	Functional and analytical tests were conducted and results met the predefined acceptance criteria. Initial shelf life set at 6 months. Ongoing study with 3 lots (4, 8, 12, 18, 24, 26, 30, 36, 38 months).
Transportation Stability	Device and Test Kit	Device maintains calibration and functional specifications. Test kit met all acceptance criteria for functionality and expected analytical results.	The Sight OLO device maintains its calibration and functional specifications. The Sight OLO test kit met all acceptance criteria for functionality and expected analytical results.
Flagging Study	Sensitivity and Specificity	Met predefined acceptance criteria.	Sensitivity (PPA): 93.0%Specificity (NPA): 80.6%Overall Agreement: 86.5% (Met predefined acceptance criteria).
Adult and Pediatric Reference Intervals	All measurands	Adults: Reference intervals calculated for each measurand. Pediatrics: Supports validity of pre-established pediatric reference intervals.	Adult reference intervals were calculated. Results supported the validity of pre-established pediatric reference intervals.
Matrix Comparison (Capillary vs. Venous)	All applicable measurands	Comparable performance characteristics for capillary and venous whole blood specimens.	The results show comparable performance characteristics for capillary and venous whole blood specimens.
Matrix Comparison (Capillary Microtube vs. Sight OLO Test Kit Micro-capillaries)	All applicable measurands	Comparable performance between K2EDTA anticoagulated microtube capillary samples and 2-drop fingertip samples.	The results of the regression and bias analysis showed comparable performance between the K2EDTA anticoagulated microtube capillary samples and the 2-drop fingertip samples.

2. Sample Size Used for the Test Set and Data Provenance:

Method Comparison Study: 679 residual clinical K₂EDTA whole blood samples.
- Provenance: Collected from both adults (≥22 years old) and pediatric patients (3 months to 21 years old) at three (3) US sites. The majority were venous samples; a few pediatric samples were capillary whole blood. The study included normal and pathological samples, covering an age range of 3 months to 94 years old. 32% were pediatric samples. Consisted of 355 males (52%) and 324 females (48%). This was a retrospective study using residual clinical samples.
Repeatability Study: Minimum of 11 samples per site, covering the laboratory reference range and medical decision levels for HGB, PLT, WBC, and upper range for RBC, HGB, WBC, and PLT.
- Provenance: Residual K₂EDTA whole blood samples. Performed at 3 US sites.
Reproducibility Study: 3 lots of commercial control material (low, normal, high concentrations). For a total of 240 measurements per level of control material (presumably 4 replicates x 2 runs/day x 5 days x 2 instruments/site x 3 sites, though the exact breakdown to reach 240/level is not fully detailed).
- Provenance: Commercial control material. Conducted at 3 sites, including 2 US sites.
Detection Limits (LoB, LoD, LoQ):
- LoB: Preserved RBC samples (WBC and PLT), diluent (HGB). Two Sight OLO instruments, two reagent lots, 60 measurements per instrument.
- LoD and LoQ: Six low concentration samples (manipulated concentrated and diluted venous blood samples), each measured 10 times, for a total of 60 repeated measurements per test. This was repeated for a different test reagent lot (another 60 measurements).
- Provenance: Manipulated venous blood samples for LoD/LoQ.
Linearity Studies: Ten (10) venous whole blood samples manipulated to create linearity panels. Seven concentrations for WBC and PLT, ten for RBC and HGB. Each concentration scanned in duplicate. Repeated on three OLO devices.
Analytical Specificity/Interference Study: Not explicitly stated as a sample size of patient samples, but implied various samples manipulated with interferents.
Sample Stability Study: 10 freshly collected venous whole blood samples (7 normal, 3 around medical decision levels).
Test Kit Shelf-Life: Three lots of test kits.
Transportation Studies: Not specified in terms of sample size, but indicates testing of the physical device and test kits.
Flagging Study: 208 samples.
- Provenance: Collected at 3 clinical study sites.
Adult Reference Intervals Study: 240 (120 male and 120 female) apparently healthy adults.
- Provenance: K₂EDTA venous whole blood samples collected from apparently healthy adults (≥22 years) at a single US site. This was a prospective study.
Pediatric Reference Intervals Study: 80 apparently healthy pediatric subjects (20 per subpopulation: baby (3-23 months), child (2-<12 years), adolescent (12-<18 years), transitional adolescent (18-<22 years)).
- Provenance: Residual blood samples collected from apparently healthy pediatric subjects. This was a retrospective study.
Capillary vs. Venous Matrix Comparison: 67 normal and pathological paired capillary and venous whole blood specimens.
- Provenance: Paired specimens collected from the same individuals.
Capillary Microtube vs. Sight OLO Test Kit Micro-capillaries Matrix Comparison: 40 paired K₂EDTA anticoagulated capillary microtube samples and 2-drop finger prick samples.
- Provenance: Collected from healthy volunteer subjects at the company's internal laboratory.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Flagging Study:
- Number of Experts: Two qualified morphology examiners (initially). A third qualified morphology examiner was used for adjudication.
- Qualifications: "Qualified morphology examiners" (specific experience level not provided in the summary).

4. Adjudication Method for the Test Set:

Flagging Study: A 2+1 adjudication method was used. Two qualified morphology examiners evaluated one of the three blood films for each sample. In case of disagreement between the first two readers (who performed a 200-cell count each, totaling 400 cells), a third qualified morphology examiner reviewed the third blood film.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The studies compared the Sight OLO device's performance against a predicate device (Sysmex XN-Series) or manual microscopy (for flagging), but not a direct comparison of human readers with and without AI assistance. The study focuses on the performance of the device itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the performance studies described (Method Comparison, Repeatability, Reproducibility, Detection Limits, Linearity, Analytical Specificity, Stability) are all standalone performance evaluations of the Sight OLO device. It tests the accuracy and precision of the automated hematology analyzer without human intervention in the CBC parameter enumeration process.
The Flagging Study involves a comparison to manual light microscopy, which is a human-read method, to establish agreement in flagging abnormal samples. While this involves human input for comparison, the Sight OLO's flagging itself is an automated algorithm-only output being evaluated.

7. Type of Ground Truth Used:

Method Comparison: Predicate device (Sysmex XN-Series) results.
Repeatability/Reproducibility/Detection Limits/Linearity/Analytical Specificity/Stability: Internal reference methods, commercial control materials, or manipulated samples (e.g., concentrated/diluted blood samples), and comparison to expected analytical results.
Flagging Study: Manual light microscopy by qualified morphology examiners.
Adult and Pediatric Reference Intervals: Literature reference limits (for verification in pediatric study), and statistical calculation from healthy population samples.
Matrix Comparison: Paired samples compared to each other on the OLO device.

8. Sample Size for the Training Set:

This information is not provided in the given 510(k) summary. The document focuses on performance testing (validation) datasets.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided in the given 510(k) summary, as it does not detail the development or training of the device's algorithms.

Summary

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November 1, 2019

Sight Diagnostics Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103

Re: K190898

Trade/Device Name: Sight OLO Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: April 5, 2019 Received: April 5, 2019

Dear Janice Hogan:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 Acting Deputy Director 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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510(k) Number (if known)

Device Name

Sight OLO

Indications for Use (Describe)

When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, RDW, PLT, NEUT%#, LYMPH %#, MONO %#, EOS%#, and BASO%/#.

The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Sight Diagnostics Ltd.'s Sight OLO

Submitter's Name, Address, Telephone Number, Contact Person

Sarah Levy СТО Sight Diagnostics Ltd. Derech Menachem Begin 23 Tel Aviv, Israel Tel: +972 3 5418580 Fax: E-mail: sarah@sightdx.com

Date Prepared: October 21, 2019

Name of Device:

Sight OLO

Common or Usual Name:

Automated Hematology Analyzer

Classification:

21 CFR 864.5220, Class II, Product Code: GKZ

Predicate Devices

Sysmex® XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605)

Reference device

PixCell Medical Technologies, Ltd.'s HemoScreen Hematology Analyzer (K180020)

Device Description

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Intended Use / Indications for Use

The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in K2EDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit micro-capillary tubes.

When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EOS%/#, and BASO%/#.

The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.

Summary of Substantial Equivalence

The Sight OLO has the same intended use, similar indications for use and technological characteristics compared to the Sysmex XN predicate device. Both devices are quantitative, multi-parameter, automated in vitro diagnostic hematology analyzers. Both devices screen whole blood samples collected from venous and/or capillary blood. The Sight OLO diagnostic parameters are encompassed by those of the Sysmex XN predicate device.

The general components and functions of the Sight OLO are similar to those of the predicate device. The Sight OLO includes a scanning and analyzing device (including microscope) and a test kit (including a disposable cartridge, a Microsafe micro-capillary tube, a dropper cap containing dried reagents and attached to another micro-capillary tube and a mixing bottle containing liquid diluent). Similarly, the Sysmex XN predicate device includes a main unit that aspirates, dilutes, mixes, and analyzes the samples (including container and cartridge reagents). The Sysmex XN device includes a unit that automatically supplies the samples to the main unit, and a unit that processes data from the main unit and provides the operator interface with the system. The Sight OLO design incorporates and automates the different units (e.g., user interface/display, samples processing) within the device, and carries out all processes automatically after the samples have been manually loaded into the disposable cartridge chambers. Therefore, both devices incorporate similar general steps necessary for blood analysis within the device design (i.e., proceeding from sample provided to processing of sample and analysis of the sample).

For the Sysmex XN predicate, calibration is performed as needed. The Sight OLO is factory calibrated prior to shipping to end user, and does not require further calibration. Whole blood quality control material (three levels; high, medium, low) is available for both devices to monitor the performance of the analyzers.

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In terms of the technology underlying the analyses, both the Sight OLO and the predicate device utilize similar methods of analyzing cell morphology and fluorescence. Although the Sysmex XN uses different technological methods from the Sight OLO, i.e., DC detection, flow cytometry, and Sodium Lauryl Sulfate (SLS)-hemoglobin, these differences do not raise different types of safety or effectiveness question. For both devices, the same question remains as to whether the device will be able to accurately and reproducibly provide complete blood count information. In addition, the HemoScreen reference device also uses computer vision algorithms to scan and analyze the stained blood samples similar to the Sight OLO, and was found to be substantially equivalent to the Sysmex XN predicate device.

Therefore, the minor differences in features between the Sight OLO and its predicate device do not present new types of safety or effectiveness questions. Furthermore, performance testing demonstrated comparable performance characteristics between the Sight OLO and its predicate.

	Sight Diagnostics Sight OLO	Sysmex® XN-Series (XN-10, XN-20)Automated Hematology Analyzers(K112605)
Regulation	21 CFR 864.5220	21 CFR 864.5220
Product code	GKZ	GKZ
Indications	The Sight OLO is a quantitative multi-parameter automated hematology analyzerintended for in vitro diagnostic use inscreening capillary or venous whole bloodsamples collected in K2EDTA bloodcollection tubes, or fingertip samplescollected using the Sight OLO test kitmicro-capillary tubes.When used with the Sight OLO cartridge,the Sight OLO enumerates the followingCBC parameters in whole blood: WBC,RBC, HGB, HCT, MCV, MCH, MCHC,RDW, PLT, NEUT%/#, LYMPH %/#,ΜΟΝΟ %/#, EOS%/#, and BASO%/#.The Sight OLO is indicated for use inclinical laboratories to identify and classifyone or more of the formed elements ofblood in children 3 months and above,adolescents and adults.	The XN-Series modules (XN-10, XN-20) arequantitative multi-parameter automatedhematology analyzers intended for in vitrodiagnostic use in screening patientpopulations found in clinical laboratories.The XN-Series modules classify andenumerate the following parameters in wholeblood: WBC, RBC, HGB, HCT, MCV, MCH,MCHC, PLT, NEUT%/#, LYMPH%/#,ΜΟΝΟ%/#, EO%/#, BASO%/#, IG%/#,RDW-CV, RDW-SD, MPV, NRBC#/%,RET%/#, IPF, IRF, RET-He and has a BodyFluid mode for body fluids. The Body Fluidmode enumerates the WBC-BF, RBC-BF,MN%/#, PMN%/#, and TC-BF parameters incerebrospinal fluid (CSF), serous fluids(peritoneal, pleural) and synovial fluids.Whole blood should be collected in K2 orK3EDTA anticoagulant and, Serous andSynovial fluids in K2EDTA anticoagulant toprevent clotting of fluid. The use ofanticoagulants with CSF specimens isneither required nor recommended.
Components	Scanning and analyzing device (including	(1) Two Main Units (XN-10, XN-20) which
microscope)Test kit (including a disposable cartridge, aMicrosafe micro-capillary tube, a droppercap containing dried reagents and attachedto another micro-capillary tube and amixing bottle containing liquid diluent)	aspirate, dilute, mix, and analyze blood andbody fluid samples (includes container andcartridge reagents (diluent, lyse, stain)); (2)Two Auto Sampler Units (SA-10, SA-20)which supply samples to the Main Unitautomatically; (3) IPU (InformationProcessing Unit) which processes data fromthe Main Unit and provides the operatorinterface with the system; (4) Pneumatic Unitwhich supplies pressure and vacuum fromthe Main Unit.
WBC, RBC, HGB, HCT, MCV, MCH,MCHC, RDW, PLT, NEUT%/#, LYMPH%/#, MONO %/#, EOS%/#, and BASO%/#	WBC, RBC, HGB, HCT, MCV, MCH, MCHC,PLT, NEUT%/#, LYMPH%/#, MONO%/#,EO%/#, BASO%/#, NRBC%/#, RDW-CV,RDW-SD, MPV, RET%/#, IRF, IG%/#, RET-He#, IPF, WBC-BF, RBC-BF, MN%/#,PMN%/#, and TC-BF
Whole blood (capillary and venous)	Whole blood (capillary and venous)Body fluid
Either capillary and venous anticoagulatedwhole blood samples collected intoK2EDTA microtubes / tubes, or capillarysamples collected directly from the fingertipinto the OLO test kit micro-capillary tubes	Capillary or venous whole blood samplescollected into K2 Or K3EDTA microtubes /tubes
27 μL	88 μL (aspiration volume)
Factory calibratedOptional control kit CBC-OPT (3 levels)will be provided to user (used if needed)	Whole Blood:XN-Check - 3 LevelsXN CAL (XN-10/X-20 Calibrator)XN CAL PF (Platelet F Calibrator)Body Fluid: Body Fluid: XN Check BF - 2Levels
Computer-vision algorithms visually scanstained blood sample under devicefluorescence microscope and analyze thecaptured images. Software identifies visualdifferences between different bloodcomponents while relying on characteristicssuch as size, shape, intensity, andmorphology.Optical density measurement (Hgb)	Performs hematology analyses according tothe Hydro Dynamic Focusing (DC Detection),flow cytometry method (using asemiconductor laser), and SLS hemoglobinmethod.Radiofrequency (RF) / Direct-current (DC)Detection Method, Sheath Flow DCDetection Method, and Flow CytometryMethods using a Semiconductor Laser andSodium Lauryl Sulfate (SLS)-hemoglobin.Particle characterization and identification isbased on detection of forward scatter,

A table comparing the Sight OLO to the predicate device is included below.

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Performance Data

The following nonclinical and clinical performance testing has been conducted in accordance with relevant standards to support the substantial equivalence of the Sight OLO to its predicate device.

Method comparison study with predicate device (CLSI H20-A2, H26-A2 and EP09-A3)

Method comparison studies were conducted to assess the performance of the Sight OLO device, compared to the predicate device. The testing was conducted at three (3) US sites using a total of 679 residual clinical K₂EDTA whole blood samples that were collected from both adults (≥22 years old) and pediatric patients (3 months to 21 years old). The majority of samples were venous samples while a few pediatric samples were capillary whole blood samples collected into tubes or micro tubes. All samples were run in singlet on the predicate Sysmex XN and within 2 hours in singlet on the Sight OLO device.

The studies included normal and pathological samples to assess the OLO performance across the analytical measuring range (AMR) as well as around medical decision points. The pathological samples included the following conditions: acute inflammation, bacterial and viral infections, aplastic anemia, acute and chronic leukemias (lymphocytic or myelocytic), multiple myeloma (plasma cell leukemia), microcytic anemia, normocytic anemia, macrocytic anemia, hemoglobinopathies, thalassemia, iron and folate deficiencies and giant platelets. The samples collected covered an age range of 3 months to 94 years old, 32% of samples were pediatric samples (3 months to 21 years of age), and the study population included 355 males (52%) and 324 females (48%).

The results demonstrated that all measurands met the pre-specified acceptance criteria for correlation, bias, slope, intercept (and the 95% two-sided confidence interval (CI) around the slope and intercept). A summary of the results is presented in the table below:

			Correlation				MedianRelative
Measurand	N	ResultsRange	Coefficient(r)	Slope(95% CI)	Intercept(95% CI)	MedianBias	Bias(%)
WBCx103/μL	608	0.30 to 97.16	0.9973	1.011(1.003, 1.020)	0.033(-0.016, 0.082)	0.1	1.6%
RBCx106/µL	657	1.86 to 7.69	0.9906	1.019(1.008, 1.030)	0.089(0.043, 0.129)	0.16	4.1%
PLTx103/µL	624	22 to 985	0.9849	1.006(0.994, 1.021)	8.937(6.103, 11.801)	10	5.2%
HGBg/dL	673	4.9 to 21.2	0.9904	1.031(1.020, 1.042)	-0.028(-0.150, 0.104)	0.3	2.9%
HCT	657	15.2 to 63.7	0.9824	1.030(1.014, 1.045)	-0.639(-1.214, -0.044)	0.4	1.3%

Table 1: Method Comparison Acceptance Criteria

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MCVfL	657	57.3 to 121.2	0.9414	0.889(0.862, 0.916)	7.489(5.119, 9.821)	-2.3	-2.6%
RDW	647	10.6 to 29.4	0.9393	1.000(0.980, 1.036)	-0.100(-0.607, 0.171)	-0.1	-0.7%
MCHpg	652	14.9 to 42.0	0.9781	1.000(0.986, 1.007)	-0.400(-0.583, 0.046)	-0.4	-1.3%
MCHCg/dL	652	26.0 to 36.6	0.6931	0.667(0.625, 0.731)	11.567(9.431, 12.944)	0.5	1.5%
NEUT%	419	0.4 to 96.4	0.9894	0.994(0.980, 1.008)	0.980(0.051, 1.861)	0.5	0.9%
NEUT#x10³/μL	412	0.01 to 52.59	0.9953	1.023(1.011, 1.033)	0.020(-0.014, 0.070)	0.12	2.9%
LYMPH%	423	0.9 to 99.6	0.992	1.000(0.989, 1.013)	0.800(0.452, 1.033)	0.8	3.3%
LYMPH#x10³/μL	415	0.02 to 8.44	0.9867	1.025(1.007, 1.044)	0.050(0.022, 0.083)	0.09	5.7%
MONO%	423	0.0 to 23.4	0.8861	0.962(0.910, 1.000)	-0.646(-0.900, -0.264)	-0.9	-12.5%
MONO#x10³/μL	415	0.00 to 3.74	0.9635	0.982(0.941, 1.000)	-0.049(-0.060, -0.027)	-0.06	-10.9%
EOS%	436	0.0 to 33.3	0.9792	1.023(1.000, 1.071)	0.170(0.100, 0.200)	0.2	11.1%
EOS#x10³/μL	427	0.00 to 4.24	0.9856	1.042(1.000, 1.094)	0.014(0.009, 0.020)	0.02	15.0%
BASO%	438	0.0 to 3.1	0.6701	1.500(1.333, 1.667)	-0.250(-0.300, -0.167)	0	0.0%
BASO#x10³/μL	429	0.00 to 0.34	0.6412	1.333(1.200, 1.500)	-0.010(-0.015, -0.006)	0	0.0%

Repeatability study (CLSI EP05-A3)

Repeatability studies were performed at 3 US sites according to CLSI EP05-A3 to evaluate the precision of the Sight OLO. Within-run repeatability studies were performed using residual K₂EDTA whole blood samples around medical decision levels and within the laboratory reference range. Each of the 3 sites collected a minimum of 11 samples to cover the laboratory reference range, medical decision levels for HGB, PLT and WBC and the upper range for RBC, HGB, WBC and PLT. Each sample was measured 20 consecutive times by 2 operators at each site using the Sight OLO device. For each measurand, the mean, standard deviation (SD) and coefficient of variation (CV) were computed.

All measurands in all tested ranges met the predefined acceptance criteria, as summarized in Table 2 below.

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Pooled Results of Repeatability Study
Measurand	Units	Target Range	Mean	PooledSD	PooledCV%	Status
WBC	10³/µL	0.5-4.0	2.04	0.12	7.0%	Pass
WBC	10³/µL	4.0-80.0	9.26	0.40	4.1%	Pass
RBC	10⁶/µL	1.0-3.5	3.02	0.06	2.20%	Pass
RBC	10⁶/µL	3.5-8.0	5.04	0.11	2.10%	Pass
PLT	10³/µL	20-150	78.52	4.76	6.90%	Pass
PLT	10³/µL	150-800	309.01	16.69	4.80%	Pass
HGB	g/dL	5-11	8.95	0.2	2.20%	Pass
HGB	g/dL	11-25	14.81	0.28	1.90%	Pass
HCT	%	10-70	40.45	0.91	2.20%	Pass
MCV	fL	50-150	85.28	0.58	0.70%	Pass
RDW	%	10-40	15	0.34	2.20%	Pass
MCH	pg	10-45	28.5	0.2	0.70%	Pass
MCHC	g/dL	26-38	33.26	0.28	0.80%	Pass
NEUT%	%	WBC≤4.0x10³/µL	56.97	1.78	3.1%	Pass
NEUT%	%	WBC>4.0x10³/µL	66.82	1.41	2.3%	Pass
NEUT#	10³/µL	WBC≤4.0x10³/µL	0.97	0.09	11.4%	Pass
NEUT#	10³/µL	WBC>4.0x10³/µL	6.45	0.31	4.8%	Pass
LYMPH%	%	WBC≤4.0x10³/µL	31.80	2.00	6.3%	Pass
LYMPH%	%	WBC>4.0x10³/µL	22.62	1.26	6.3%	Pass
LYMPH#	10³/µL	WBC≤4.0x10³/µL	0.84	0.07	9.5%	Pass
LYMPH#	10³/µL	WBC>4.0x10³/µL	1.89	0.13	7.3%	Pass
ΜΟΝΟ%	%	WBC≤4.0x10³/µL	8.30	1.20	14.5%	Pass
ΜΟΝΟ%	%	WBC>4.0x10³/µL	7.74	0.86	12.2%	Pass
ΜΟΝΟ#	10³/µL	WBC≤4.0x10³/µL	0.16	0.03	26.9%	Pass
ΜΟΝΟ#	10³/µL	WBC>4.0x10³/µL	0.69	0.09	12.8%	Pass
EOS%	%	WBC≤4.0x10³/µL	2.00	0.63	31.4%	Pass
EOS%	%	WBC>4.0x10³/µL	2.29	0.49	30.6%	Pass
EOS#	10³/µL	WBC≤4.0x10³/µL	0.04	0.02	65.1%	Pass
EOS#	$10^3/µL$	WBC>4.0x $10^3/µL$	0.19	0.04	30.5%	Pass
BASO%	%	WBC≤4.0x $10^3/µL$	0.94	0.40	42.6%	Pass
BASO%	%	WBC>4.0x $10^3/µL$	0.54	0.25	51.4%	Pass
BASO#	$10^3/µL$	WBC≤4.0x $10^3/µL$	0.02	0.01	90.1%	Pass
BASO#	$10^3/µL$	WBC>4.0x $10^3/µL$	0.04	0.02	50.8%	Pass

Table 2: Repeatability Results

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Reproducibility study (CLSI EP05-A3)

A reproducibility study of the Sight OLO was conducted at 3 sites, including 2 US sites, over 5 days with 4 replicates per 2 runs per day by 2 operators and 2 instruments per site. Study used 3 lots of commercial control material (low, normal and high concentrations of all reported parameters) for a total of 240 measurements per each level of control material. The data generated from this assessment was used to calculate within run, between run, between day, between instrument, between site and total precision. For each reported parameter and for each level of control tested, the mean, SD and %CV of the various components of precision.

All components of variation that were calculated met the pre-defined acceptance criteria. The results are summarized below.

Measurand	Level	N	Mean	Within run		Between Run		Between Day		Between instrument		Between Site		Total
				SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%
WBC	Low	240	3.33	0.17	5.2	0.06	1.7	0.00	0.0	0.11	3.3	0.00	0.0	0.21	6.4
	Normal	240	8.19	0.26	3.2	0.09	1.1	0.00	0.0	0.17	2.1	0.00	0.0	0.32	4.0
	High	240	23.02	0.62	2.7	0.25	1.1	0.10	0.4	0.39	1.7	0.00	0.0	0.78	3.4
RBC	Low	240	2.61	0.04	1.5	0.04	1.7	0.00	0.0	0.07	2.8	0.00	0.0	0.09	3.6
	Normal	240	5.14	0.05	0.9	0.04	0.8	0.00	0.0	0.10	1.9	0.00	0.0	0.12	2.2
	High	240	5.91	0.06	1.0	0.03	0.6	0.02	0.4	0.10	1.7	0.00	0.0	0.12	2.1
PLT	Low	240	70.7	5.1	7.2	1.0	1.4	0.0	0.0	1.5	2.1	3.1	4.4	6.2	8.8
	Normal	240	218.2	9.4	4.3	2.5	1.2	2.1	0.9	3.1	1.4	2.7	1.2	10.8	4.9
	High	240	432.6	19.7	4.5	7.0	1.6	6.9	1.6	10.9	2.5	0.0	0.0	24.5	5.7
HGB	Low	240	7.05	0.10	1.4	0.09	1.2	0.00	0.0	0.10	1.4	0.00	0.0	0.16	2.3
	Normal	240	14.41	0.10	0.7	0.05	0.4	0.02	0.1	0.11	0.7	0.11	0.8	0.19	1.3
	High	240	17.32	0.13	0.7	0.06	0.3	0.05	0.3	0.11	0.6	0.20	1.2	0.27	1.6
HCT	Low	240	21.15	0.39	1.9	0.25	1.2	0.10	0.5	0.51	2.4	0.00	0.0	0.70	3.3
	Normal	240	43.99	0.60	1.4	0.35	0.8	0.00	0.0	0.81	1.8	0.00	0.0	1.06	2.4
	High	240	56.55	0.84	1.5	0.44	0.8	0.17	0.3	0.82	1.5	0.00	0.0	1.26	2.2
	Low	240	80.91	0.84	1.0	0.74	0.9	0.00	0.0	0.79	1.0	0.00	0.0	1.37	1.7
MCV	Normal	240	85.62	0.81	1.0	0.72	0.8	0.00	0.0	0.98	1.1	0.00	0.0	1.46	1.7
	High	240	95.66	0.86	0.9	0.52	0.5	0.00	0.0	1.51	1.6	0.00	0.0	1.82	1.9
	Low	240	14.20	0.26	1.8	0.07	0.5	0.01	0.1	0.03	0.2	0.16	1.2	0.32	2.2
RDW	Normal	240	13.17	0.19	1.5	0.00	0.0	0.01	0.1	0.06	0.5	0.07	0.6	0.22	1.6
	High	240	12.57	0.19	1.5	0.00	0.0	0.00	0.0	0.07	0.6	0.07	0:5	0.21	1.7
	Low	240	26.99	0.19	0.7	0.17	0.6	0.05	0.2	0.49	1.8	0.00	0.0	0.55	2.1
MCH	Normal	240	28.04	0.18	0.6	0.15	0:5	0.00	0.0	0.44	1.6	0.00	0.0	0.50	1.8
	High	240	29.30	0.22	0.7	0.04	0.1	0.05	0.2	0.46	1.6	0.00	0.0	0.52	1.8
	Low	240	33.37	0.38	1.1	0.26	0.8	0.00	0.0	0.60	1.8	0.00	0.0	0.76	2.3
MCHC	Normal	240	32.76	0.39	1.2	0.23	0.7	0.02	0.1	0.46	1.4	0.00	0.0	0.65	2.0
	High	240	30.63	0.40	1.3	0.15	0.5	0.00	0.0	0.32	1.0	0.31	1.0	0.62	2.0
	Low	240	50.32	2.44	4.9	0.00	0.0	0.46	0.9	0.43	0.9	0.97	1.9	2.70	5.4
NEUT%	Normal	240	41.73	1.62	3.9	0.00	0.0	0.00	0.0	0.21	0:5	0.00	0.0	1.64	3.9
	High	240	54.35	1.05	1.9	0.16	0.3	0.19	0.4	0.48	0.9	0.63	1.2	1.34	2.5
NEUT#	Low	240	1.68	0.12	7.0	0.02	1.4	0.03	1.7	0.05	3.2	0.00	0.0	0.13	8.0
	Normal	240	3.42	0.16	4.7	0.05	1.3	0.00	0.0	0.06	1.9	0.00	0.0	0.18	5.2
	High	240	12.51	0.39	3.1	0.14	1.2	0.10	0.8	0.26	2.1	0.16	1.3	0.53	4.2
	Low	240	17.62	1.69	9.6	0.29	1.6	0.00	0.0	0.00	0.0	0.00	0.0	1.71	9.7
LYMPH%	Normal	240	36.41	1.42	3.9	0.00	0.0	0.30	0.8	0.00	0.0	0.29	0.8	1.48	4.1
	High	240	25.30	0.91	3.6	0.00	0.0	0.17	0.7	0.07	0.3	0.00	0.0	0.93	3.7
	Low	240	0.59	0.06	10.4	0.02	3.7	0.00	0.0	0.01	2.5	0.00	0.0	0.07	11.4
LYMPH#	Normal	240	2.98	0.15	5.2	0.01	0.5	0.02	0.7	0.08	2.5	0.00	0.0	0.17	5.8
	High		240 5.82	0.28	4.7	0.00	0.0	0.03	0.6	0.09	1.5	0.00	0.0	0.29	5.0
	Low	240	12.21	1.53	12.5	0.00	0.0	0.22	1.8	0.73	6.0	0.59	4.9	1.81	14.8
MONO%	Normal	240	8.44	0.89	10.6	0.14	1.6	0.07	0.9	0.30	3.6	0.43	5.1	1.05	12.4
	High	240	11.88	0.76	6.4	0.00	0.0	0.00	0.0	0.42	3.6	0.72	6.0	1.12	റി.5
MONO#	Low	240	0.41	0.05	13.4	0.00	0.0	0.00	0.0	0.04	9.3	0.01	1.5	0.07	16.4
	Normal	240	0.69	0.08	11.2	0.02	2.3	0.00	0.0	0.04	5.2	0.03	3.7	0.09	13.1
	High	240	2.73	0.19	7.0	0.03	0.9	0.00	0.0	0.12	4.4	0.14	5.0	0.26	9.7
	Low	240	11.75	1.69	14.4	0.30	2.6	0.00	0.0	0.00	0.0	0.41	3.5	1.76	15.0
EOS%	Normal	240	7.09	0.85	11.9	0.19	2.7	0.00	0.0	0.08	1.1	0.14	2.0	0.88	12.5
	High	240	3.94	0.47	11.9	0.00	0.0	0.00	0.0	0.00	0.0	0.00	0.0	0.47	11.9
EOS#	Low	240	0.39	0.06	16.2	0.01	2.2	0.00	0.0	0.02	5.3	0.01	1.3	0.07	17.2
	Normal	240	0.58	0.07	12.4	0.02	3.9	0.00	0.0	0.02	2.8	0.00	0.0	0.08	13.3
	High	240	0.91	0.11	12.6	0.00	0.0	0.01	1.4	0.01	0.6	0.00	0.0	0.12	12.7
BASO%	Low	240	8.12	1.23	15.1	0.00	0.0	0.20	2.5	0.03	0.3	0.21	2.6	1.26	15.5
	Normal	240	6.33	0.75	11.9	0.00	0.0	0.00	0.0	0.00	0.0	0.16	2.5	0.77	12.1
	High	240	4.54	0.48	10.5	0.13	2.8	0.00	0.0	0.00	0.0	0.12	2.5	0.51	11.2
BASO#	Low	240	0.27	0.04	15.4	0.01	2.3	0.01	1.9	0.00	1.8	0.00	1.0	0.04	15.8
	Normal	240	0.52	0.07	12.6	0.00	0.0	0.00	0.0	0.01	1.7	0.01	2.6	0.07	12.9
	High	240	1.04	0.11	10.7	0.04	3.5	0.00	0.0	0.03	3.1	0.02	2.4	0.12	11.9

Table 3: Reproducibility Results

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Detection limits studies, including LoB, LoD, and LoQ (CLSI EP17-A2)

The study for LoB was conducted using two Sight OLO instruments. To determine LoB, testing was performed with two reagent lots. Each reagent lot was scanned on four test days conducting 60 measurements on each instrument with 15 measurements performed on each testing day. For the WBC and PLT LoB determination, preserved RBC samples, which contained no white blood cells or platelets, were used. For the HGB LoB determination, a diluent without any blood cells was used. The study results are provided in the following table. The limit of blank was determined as the 95th percentile of the study variable, and the data are summarized below for all three measurands of interest.

For the LoD and LoQ study, six low concentration samples using concentrated and diluted venous blood samples were each measured 10 times for a total of 60 repeated measurements using three instruments over the course of six days. Each sample was also measured on a reference device in triplicate. This was then repeated with a different test reagent lot for another 60 measurements. Based on the LoB results and the study measurements the LoD was determined mathematically. The LoQ was defined as the lowest concentration (≥LoD) in which predetermined total error (TE) accuracy goals were satisfied.

The LoB, LoD, and LoQ for the three measurands are shown in the table below.

Measurand	LoB	LoD	LoQ
WBC	0.04 x 103/μL	0.17 x 103/μL	0.18 x 103/μL
PLT	8.00 x 103/μL	11.00 x 103/μL	13.40 x 103/μL
HGB	0 g/dL	3.9 g/dL	3.9 g/dL

Table 4: LoB, LoD, and LoQ of Sight OLO

Linearity studies (CLSI H26-A2 and EP06-A)

Ten (10) venous whole blood samples were manipulated to create the linearity panels for WBC, RBC, HGB, and PLT. Seven concentrations were used for WBC and PLT. Ten concentrations were used for RBC and HGB. Each concentration was scanned in duplicate. For each measurand, the linearity study was repeated on three OLO devices.

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Determination of linearity was performed using 1st (linear), 2nd and 3rd order polynomials regressions. The data analysis was performed on each instrument separately and the final linearity range of the OLO device was determined as the intersection of the results from the three instruments, and no lower than the LoD.

The linear ranges of these measurands were determined as follows:

Measurand	Range
HGB (g/dL)	(3.9-21.75)
PLT (103/μL)	(18-1028.5)
WBC (103/μL)	(0.18-100.13)

Table 5: Linearity Ranges for Sight OLO

Analytical specificity/interference study (CLSI EP07-A2 and EP09-2)

Interference studies for D-Glucose, Billirubin F, Hemolytic Hemoglobin, Chyle and Intralipids (Lipemia) were performed on the Sight OLO. For the first five substances, a by-bias study was initially conducted to evaluate whether any of the main measurands (RBC, WBC. HGB. HCT and PLT) is susceptible to the presence of clinically high levels of each interferant. For the measurands that were susceptible a by-addition dose response was subsequently conducted to determine the critical concentration of the interferant, as well as the critical concentration of intralipids for all main measurands. In addition, to determine interference by abnormal specimen studies were performed to characterize the susceptibility of the Sight OLO device to three potential interfering conditions due to abnormal specimen: RBC fragments, high leukocytosis (WBC > 50x10*/μL), and high thrombocytosis (PLT > 500x10 /μL).

The results of the interference studies demonstrated that:

1. There was no significant D-glucose interference at a concentration of 55 mmol/dL (1g/dL) for RBC, WBC, HGB, HCT and PLT parameters.
1. There was no significant bilirubin F interference at a concentration of 20 mg/dL for RBC, HGB, HCT and PLT parameters. There was no significant bilirubin F interference up to a concentration 8.86 mg/dL for the WBC parameter.
1. There was no significant bilirubin C interference at a concentration of 342 umol/L for RBC, WBC, HGB, HCT and PLT parameters.
1. There was no significant chyle interference at a concentration of 2800 FTU for RBC, WBC, HGB, and HCT parameters. There was no significant chyle interference up to a concentration 530 FTU for the PLT parameter.

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1. There was no significant hemolytic hemoglobin interference at a concentration of 200 mg/dL for RBC, WBC, HGB, HCT and PLT parameters.
1. There was no significant intralipid interference up to a concentration of 4.20 mg/mL for PLT, up to a concentration of 3.10 mg/mL for WBC, up to a concentration of 2.77 mg/mL for RBC, up to a concentration 2.42 mg/mL for HGB, and of up to a concentration of 1.94 mg/mL for HCT.
1. No interference was noted from RBC fragments, high leukocytosis (WBC > 50x103/μL), and high thrombocytosis (PLT > 500x103/μL).

Stability studies, including sample stability, test kit stability, and device calibration stability (CLSI EP25-A)

Sample Stability

Sample stability was determined for 10 freshly collected venous whole blood samples including 7 normal whole blood samples and 3 whole blood samples around medical decision levels. The venous blood samples were collected into KsEDTA tubes. The samples were stored at room temperature (18-26°C) and were analyzed again, in quadruplicate at the following time points: 4 hours, 6 hours and 10 hours. For each time point, results were compared to the respective baseline results. The data support a sample stability claim of 8 hours from blood collection at room temperature for all Sight OLO measurands with the exception of RDW, which has a stability of 4 hours after blood collection when stored at room temperature.

Test Kit Shelf-Life

Real-time stability study is being conducted to establish the shelf-life stability of the Sight OLO TK1 Test Kit when it is stored at the recommended storage conditions. Three lots of test kits are tested. Each test lot is stored at room temperature (18-26°C) and tested at defined time points (4, 8, 12, 18, 24, 26, 30, 36, 38 months), for a total of 11 time points per lot, including baseline.

At each predefined time point, the test kits are subjected to functional tests and analytical tests. The test kit lot is considered no longer stable only when the same acceptance criterion is not met for two consecutive time points for a specific measurand with the same test kit lot. The last time point before this happens is the time for which the test kit is considered stable. The overall shelf-life is the minimum of the shelf-life for three lots.

The initial shelf life for the test kit was set at 6 months at the recommended temperature, based on an internal study that included stability verification at 7 months after release. Functional and analytical tests were conducted and results met the predefined acceptance criteria.

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Transportation studies

The stability of the Sight OLO during transportation has been tested for the device and for the test kit separately, in accordance with ASTM D7386-16. The results of this testing indicated that the Sight OLO device maintains its calibration and functional specifications during shipping per the acceptance criteria. The Sight OLO test kit met all acceptance criteria for functionality and expected analytical results when exposed to expected environmental conditions during shipment of the kits.

Flaqqing study (CLSI H20-A2)

Flagging studies were conducted, where Sight OLO was compared to manual light microscopy for normal (no flags) and abnormal (flags present) for 208 samples collected at 3 clinical study sites. Three blood films were prepared for each sample. Two qualified morphology examiners evaluated one of the three blood films. In each blood film a 200 cells count was performed for a total of 400 cells count for the two examiners together. The third blood film was saved for reading by a third qualified morphology examiner in the event that there was disagreement between the first two readers. Two types of abnormalities were evaluated: (1) distributional abnormal samples, which are samples where the quantity of at least one of the WBC diff % parameters resides outside of the normal concentrations, and (2) morphological abnormal samples, which are samples that contain atypical forms of the normal cell types contained in ordinary blood samples. The manual microscopy readings were compared to the results obtained with the Sight OLO for the same patient blood sample.

The overall flagging capabilities of the Sight OLO device met the predefined acceptance criteria for both sensitivity and specificity, as seen in the table below:

Sensitivity (PPA)	93.0%
Specificity (NPA)	80.6%
Overall Agreement	86.5%

Adult and pediatric reference intervals studies (CLSI EP28-A3c)

The adult reference intervals study was conducted at a single US site to establish adult reference intervals for the Sight OLO device. The study followed CLSI EP28-A3c and was performed using KzEDTA venous whole blood samples collected from 240 (120 male and 120 female) apparently healthy adults (≥22 years). Each of the venous samples was analyzed in singlet on one Sight OLO device for all 19 measurands. Outliers were identified by the Reed-Dixon method and replaced with new samples. The reference intervals were calculated for each measurand. The lower and upper limits of the 95% reference intervals

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were determined based on the 2.5th and 97.5th percentiles of all valid measurements for each sex group, respectively.

Pediatric reference intervals based on literature reference limits were verified on the Sight OLO instrument. The study followed CLSI EP28-A3c and was performed using residual blood samples collected from 80 apparently healthy pediatric subjects, including 20 samples per each of the pediatric subpopulations: baby (3 to 23 months); child (2 to <12 years old); adolescent (12 to < 18 years old); and transitional adolescent (18 to < 22 years old). Each of the samples was analyzed in singlet on one Sight OLO device. The results were compared to the literature reference intervals. The result supports the validity of the pre-established pediatrics reference intervals for the Sight OLO.

Matrix comparison studies between different sample collection methods (CLSI EP09-A3)

Capillary vs. Venous Matrix Comparison

The study was performed to demonstrate equivalency between K-EDTA capillary whole blood samples and K2EDTA venous whole blood samples on the Sight OLO Device. A total of 67 normal and pathological paired capillary and venous whole blood specimens were collected. Paired specimens collected from the same individuals were assayed in duplicate on the OLO device to compare performance between capillary whole blood samples and venous whole blood samples, and the results were analyzed for all applicable measurands.

The results show comparable performance characteristics for capillary and venous whole blood specimens. Therefore, the study results support the claim of using the two specimen types for measurement on the OLO device.

Capillary Microtube vs. Sight OLO Test Kit Micro-capillaries Matrix Comparison

This study was conducted to demonstrate the equivalency between (a) approximately 350µL of capillary whole blood samples collected from fingertip into a K2EDTA microtube and (b) 2drops of capillary whole blood from fingertip collected using the Sight OLO test kit directly.

A total of 40 paired K₂EDTA anticoagulated capillary microtube samples and the 2-drop finger prick samples were collected from healthy volunteer subjects at the company's internal laboratory. The specimens were compared to assess matrix effects on all applicable measurands. The K₂EDTA anticoagulated capillary microtube samples were run in duplicate on the Sight OLO device and two of the 2-drop blood samples were collected from two different fingers and run on the same device.

The results of the regression and bias analysis showed comparable performance between the K2EDTA anticoagulated microtube capillary samples and the 2-drop fingertip samples. Therefore, the study results support the claim of using the two specimen types for measurement on the OLO device.

In addition, usability, electromagnetic compatibility and electrical safety testing, as well as software testing, were conducted for the Sight OLO device.

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In all instances, the Sight OLO functioned as intended. Therefore, these studies demonstrate that the performance, functionality, and reliability of the Sight OLO analyzer are substantially equivalent to the predicate device.

Conclusions

The Sight OLO and its predicate device have the same intended use as well as similar indications for use, technological characteristics, and principles of operation. The differences between the devices do not present new issues of safety or effectiveness. Furthermore, performance testing demonstrated comparable performance characteristics between the Sight OLO and its predicate. Substantial equivalence is further supported by the comparison with the reference device. Thus, the Sight OLO is substantially equivalent to its predicate device.

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”