(210 days)
Unknown
The device uses "computer-vision algorithms for image processing" which can be a component of AI/ML, but the summary does not explicitly state the use of AI or ML, nor does it provide details about training or test sets typically associated with ML model development.
No.
The Sight OLO is an in vitro diagnostic device used for analyzing blood samples, not for providing therapy or treatment. Its function is to identify and quantify blood components, which aids in diagnosis rather than direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use." It then details its use in enumerating CBC parameters and identifying/classifying formed elements of blood, which are diagnostic activities.
No
The device description explicitly states that the Sight OLO consists of a "scanning and analyzing device" and a "CBC test kit, including disposable cartridges and sample preparation tools." This indicates the presence of physical hardware components beyond just software.
Yes, the Sight OLO device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states its intended use: "...intended for in vitro diagnostic use in screening capillary or venous whole blood samples..."
- Nature of Testing: It performs quantitative multi-parameter analysis of blood components (CBC parameters), which is a standard type of in vitro diagnostic testing.
- Sample Type: It analyzes whole blood samples, which are collected from the body but tested outside of it ("in vitro").
- Clinical Context: It is indicated for use in clinical laboratories to identify and classify blood elements, directly supporting clinical decision-making.
- Device Description: The description details how it analyzes blood samples using computer vision and staining, further confirming its role in laboratory diagnostics.
The information provided clearly aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
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.
Product codes
GKZ
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood (whole blood samples collected in K2EDTA blood collection tubes or fingertip samples).
Indicated Patient Age Range
Children 3 months and above, adolescents and adults.
Intended User / Care Setting
Clinical laboratories
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
Method comparison study:
- Sample size: 679 residual clinical K₂EDTA whole blood samples.
- Data source: Collected from both adults (≥22 years old) and pediatric patients (3 months to 21 years old) at three (3) US sites. The majority of samples were venous, with a few pediatric capillary samples. Samples included normal and pathological conditions.
- Annotation protocol: All samples were run in singlet on the predicate Sysmex XN and within 2 hours in singlet on the Sight OLO device.
Flagging study:
- Sample size: 208 samples.
- Data source: Collected at 3 clinical study sites.
- Annotation protocol: Three blood films were prepared for each sample. Two qualified morphology examiners evaluated one of the three blood films, performing a 200 cell count for a total of 400 cells. A third blood film was used if there was disagreement between the first two readers. Manual microscopy readings were compared to Sight OLO results.
Adult and pediatric reference intervals studies:
- Adult study:
- Sample size: 240 (120 male and 120 female) apparently healthy adults (≥22 years).
- Data source: Venous whole blood samples collected from a single US site.
- Annotation protocol: Each venous sample 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.
- Pediatric study:
- Sample size: 80 apparently healthy pediatric subjects (20 samples per subpopulation: baby (3 to 23 months), child (2 to
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
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
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.
4
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.
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 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 %/#,
ΜΟΝΟ %/#, 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. | The XN-Series modules (XN-10, XN-20) are
quantitative multi-parameter automated
hematology analyzers intended for in vitro
diagnostic use in screening patient
populations found in clinical laboratories.
The XN-Series modules classify and
enumerate the following parameters in whole
blood: 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 Body
Fluid mode for body fluids. The Body Fluid
mode enumerates the WBC-BF, RBC-BF,
MN%/#, PMN%/#, and TC-BF parameters in
cerebrospinal fluid (CSF), serous fluids
(peritoneal, pleural) and synovial fluids.
Whole blood should be collected in K2 or
K3EDTA anticoagulant and, Serous and
Synovial fluids in K2EDTA anticoagulant to
prevent clotting of fluid. The use of
anticoagulants with CSF specimens is
neither 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, 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) | aspirate, dilute, mix, and analyze blood and
body fluid samples (includes container and
cartridge reagents (diluent, lyse, stain)); (2)
Two Auto Sampler Units (SA-10, SA-20)
which supply samples to the Main Unit
automatically; (3) IPU (Information
Processing Unit) which processes data from
the Main Unit and provides the operator
interface with the system; (4) Pneumatic Unit
which supplies pressure and vacuum from
the 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 anticoagulated
whole blood samples collected into
K2EDTA microtubes / tubes, or capillary
samples collected directly from the fingertip
into the OLO test kit micro-capillary tubes | Capillary or venous whole blood samples
collected into K2 Or K3EDTA microtubes /
tubes | |
| 27 μL | 88 μL (aspiration volume) | |
| Factory calibrated
Optional control kit CBC-OPT (3 levels)
will be provided to user (used if needed) | Whole Blood:
XN-Check - 3 Levels
XN CAL (XN-10/X-20 Calibrator)
XN CAL PF (Platelet F Calibrator)
Body Fluid: Body Fluid: XN Check BF - 2
Levels | |
| Computer-vision algorithms visually scan
stained blood sample under device
fluorescence microscope and analyze the
captured images. Software identifies visual
differences between different blood
components while relying on characteristics
such as size, shape, intensity, and
morphology.
Optical density measurement (Hgb) | Performs hematology analyses according to
the Hydro Dynamic Focusing (DC Detection),
flow cytometry method (using a
semiconductor laser), and SLS hemoglobin
method.
Radiofrequency (RF) / Direct-current (DC)
Detection Method, Sheath Flow DC
Detection Method, and Flow Cytometry
Methods using a Semiconductor Laser and
Sodium Lauryl Sulfate (SLS)-hemoglobin.
Particle characterization and identification is
based on detection of forward scatter, | |
A table comparing the Sight OLO to the predicate device is included below.
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7
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 | | | | Median
Relative |
|----------------|-----|------------------|--------------------|-------------------------|----------------------------|----------------|--------------------|
| Measurand | N | Results
Range | Coefficient
(r) | Slope
(95% CI) | Intercept
(95% CI) | Median
Bias | Bias
(%) |
| WBC
x103/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% |
| RBC
x106/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% |
| PLT
x103/µL | 624 | 22 to 985 | 0.9849 | 1.006
(0.994, 1.021) | 8.937
(6.103, 11.801) | 10 | 5.2% |
| HGB
g/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
8
| MCV
fL | 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% |
| MCH
pg | 652 | 14.9 to 42.0 | 0.9781 | 1.000
(0.986, 1.007) | -0.400
(-0.583, 0.046) | -0.4 | -1.3% |
| MCHC
g/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 | Pooled | ||
| SD | Pooled | |||||
| CV% | 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
10
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
11
12
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.
13
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:
-
- There was no significant D-glucose interference at a concentration of 55 mmol/dL (1g/dL) for RBC, WBC, HGB, HCT and PLT parameters.
-
- 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.
-
- There was no significant bilirubin C interference at a concentration of 342 umol/L for RBC, WBC, HGB, HCT and PLT parameters.
-
- 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.
14
-
- There was no significant hemolytic hemoglobin interference at a concentration of 200 mg/dL for RBC, WBC, HGB, HCT and PLT parameters.
-
- 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.
-
- 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.
15
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
16
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