The OScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDT A whole blood:

White blood cell count (WBC)
· Neutrophils (NEUT#)
· Lymphocytes (LYMPH#)
· Monocytes (MONO#)
· Eosinophils (EOS#)
· Basophils (BASO#)
· Immature Granulocytes (IG#)
· Percent Neutrophils (NEUT%)
Percent Lymphocytes (LYMPH%)
· Percent Monocytes (MONO%)
· Percent Eosinophils (EOS%)
· Percent Basophils (BASO%)
· Percent Immature Granulocytes (IG%)
· Neutrophil to Lymphocyte Ratio (NLR)

Device Description

The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. It includes the QScout Lab analyzer, the QScout RLD (Rapid Leukocyte Differential) test, software, and handheld barcode scanner. The QScout system reports white blood cell count and neutrophil to lymphocyte ratio and enumerates and classifies six white blood cell types including immature granulocytes.
The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the QScout Lab and QScout RLD.

Note: The provided document primarily focuses on demonstrating substantial equivalence to a predicate device through various performance studies (method comparison, repeatability, reproducibility, detection limits, linearity, interference, stability, and flagging studies for clinical sensitivity). It does not explicitly define a single, overarching "acceptance criteria" table with pre-defined thresholds for all parameters, but rather implicitly defines acceptance through CLSI guidelines and successful outcomes of the tests. The "reported device performance" is the results shown in the tables.

1. Table of Acceptance Criteria and the Reported Device Performance

As noted above, a single clear table of acceptance criteria with numerical thresholds is not presented. Instead, acceptance is demonstrated by meeting the "pre-defined acceptance criteria" for various studies, often referencing CLSI standards. The reported device performance is provided in the tables and textual summaries of each study.

Here's a synthesized table based on common analytical performance metrics found in the document:

Metric Type / Parameter	Implicit Acceptance Criteria (based on study outcome & CLSI)	Reported Device Performance (as per document)
Method Comparison (vs. Predicate)	Correlation, slope, and bias met pre-defined acceptance criteria (implicit adherence to CLSI EP09c, H20-A2, H26-A2)	All parameters met pre-defined acceptance criteria (e.g., WBC Slope: 1.008 (0.998, 1.020), Pearson's r: 0.996; NEUT# Slope: 0.976 (0.963, 0.987), Pearson's r: 0.985; MONO# Slope: 1.100 (1.050, 1.146), Pearson's r: 0.907; etc. - see Table 1)
Repeatability (Precision)	Acceptable Coefficient of Variation (CV%) and Standard Deviation (SD) around medical decision levels and within reference range (implicit adherence to CLSI H26-A2)	See Table 2 for detailed pooled CV% results (e.g., WBC <4 x10³/μL: CV 6.07%; WBC ≥4 x10³/μL: CV 3.64%; NEUT# <4 x10³/μL: CV 15.05%; etc.)
Reproducibility (Precision)	Acceptable CV% and SD for within-run, between-run, between-day, between-lot, between-site, and total precision (implicit adherence to CLSI EP05-A3 and H26-A2)	See Table 3 for detailed pooled CV% results across different control levels (e.g., WBC Low Total Reproducibility CV: 5.54%; NEUT# Normal Total Reproducibility CV: 5.23%; LYMPH% High Total Reproducibility CV: 5.65%; etc.)
Detection Limits (LoB, LoD, LoQ)	Specific numerical limits for LoB, LoD, and LoQ (implicit adherence to CLSI EP17-A2 and H26-A2)	WBC LoB: 0.02 x 10³ /μL; WBC LoD: 0.08 x 10³ /μL; WBC LoQ: 0.38 x 10³ /μL
Linearity	Demonstrated linearity across the analytical measuring range (implicit adherence to CLSI EP06-Ed2 and H26-A2)	WBC: 0.5 – 60.0 x 10³ /μL
Analytical Specificity/Interference	No significant interference from specified substances at clinically high levels (implicit adherence to CLSI EP07 and EP37)	No significant interference found for glucose (1000 mg/dL), hemolysate (1000 mg/dL), lipemia (1500 mg/dL), conjugated bilirubin (40 mg/dL), unconjugated bilirubin (up to 20 mg/dL), total protein (up to 12.3 g/dL), and thrombocytosis (750 x 10³ platelets/μL). nRBCs flagged at ≥ 0.56 per 100 WBC.
Sample Stability	Acceptable stability over time at room temperature (implicit adherence to CLSI EP25-A and H26-A2)	3 hours stability for venous whole blood
Clinical Sensitivity/Flagging	Overall flagging capability met predefined acceptance criteria (implicit adherence to CLSI H20-A2)	Overall Agreement: 87.00% (81.53, 91.33); Sensitivity: 88.00% (79.98, 93.64); Specificity: 86.00% (77.63, 92.13) (See Table 8)
Reference Interval Study	Establishment of 95% reference intervals for specified parameters (implicit adherence to CLSI EP28-A3c)	Established reference intervals for all parameters for females and males (e.g., WBC Female: 4.00-11.30 x10³/μL; WBC Male: 3.78-12.12 x10³/μL; etc. - see Table 9)
Matrix Comparison (K2EDTA vs K3EDTA)	Comparable performance characteristics between K2EDTA and K3EDTA samples (implicit adherence to CLSI EP09c and H26-A2)	Results show comparable performance characteristics.

2. Sample Sizes Used for the Test Set and the Data Provenance

Method Comparison Study:
- Sample Size: 396 K₂EDTA/K₃EDTA whole blood samples.
- Data Provenance: Conducted at a clinical laboratory and seven point-of-care sites. Included normal and pathological samples (allergic reaction, anemia, infections, etc.). Implying a mix of retrospective and prospective, likely prospectively collected for the study purposes but from existing patient populations. No specific country of origin is mentioned, but implicitly US given the FDA submission.
Repeatability Study:
- Sample Size: 12 samples for WBC <4 x10³/μL range, 19 samples for WBC ≥4 x10³/μL range. Each sample measured at least 20 times (20-31 replicates).
- Data Provenance: K₂EDTA/K₃EDTA whole blood samples. No specific country mentioned.
Reproducibility Study:
- Sample Size: Tri-level quality control material (Low, Normal, High). A total of 60 measurements per level per site (3 sites x 2 operators/site x 2 runs/day x 6 replicates/run x 5 days = 360 measurements per level across all sites).
- Data Provenance: Quality control material. Multi-center study (3 sites). No specific country mentioned.
Detection Limits Studies:
- Limit of Blank: 5 centrifuged venous blood samples, each assayed 6 times on 2 QScout Labs and 2 RLD lots (total 60 measurements for WBC per RLD lot).
- Limit of Detection: 5 low WBC concentration samples, each assayed 6 times on 2 QScout Labs and 2 RLD lots (total 60 measurements for WBC per RLD lot).
- Limit of Quantitation: 4 low WBC concentration samples, each assayed 5 times on 2 QScout Labs and 2 RLD lots (total 40 measurements for WBC per RLD lot).
- Data Provenance: Venous whole blood samples (diluted or depleted). No specific country mentioned.
Linearity Studies:
- Sample Size: 2 venous whole blood samples manipulated to create 10 concentrations. Each concentration measured at least 4 times.
- Data Provenance: Venous whole blood samples. No specific country mentioned.
Analytical Specificity/Interference Studies:
- Sample Size: Not explicitly stated as a total number of samples, but tests were performed using samples spiked with various interferents.
- Data Provenance: No specific country mentioned.
Sample Stability:
- Sample Size: 11 venous whole blood samples (6 normal, 5 around medical decision levels).
- Data Provenance: Venous whole blood samples. No specific country mentioned.
QScout RLD Test Stability & QScout BCS Stability:
- Sample Size: 6 lots of RLD tests for real-time stability; 3 lots of BCS for shelf-life stability.
- Data Provenance: Manufacturing lots of the device components.
Clinical Sensitivity/Flagging Study:
- Sample Size: 200 samples.
- Data Provenance: Samples from one clinical laboratory and seven point-of-care sites. Included distributional and morphological abnormal samples. Implicitly retrospective collection (existing samples with known abnormalities) or prospective collection of samples with known characteristics. No specific country mentioned.
Reference Interval Study:
- Sample Size: 265 apparently healthy adults (139 female, 126 male).
- Data Provenance: Venous whole blood samples from healthy adults (≥ 18 years). No specific country mentioned.
Matrix Comparison Study (K2EDTA vs K3EDTA):
- Sample Size: 40 paired samples.
- Data Provenance: Venous whole blood samples. No specific country mentioned.

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

The document does not specify the number or qualifications of experts used to establish ground truth.

For the Method Comparison Study, the QScout system was compared against a "predicate device" (Beckman Coulter UniCel® DxH 800 Coulter® Cellular Analysis System), which serves as the reference standard. The predicate device's output is assumed to be the "ground truth" for comparison purposes.
For the Clinical Sensitivity/Flagging Study, the reference method was a "400-cell manual differential reference method." While this implies human experts (e.g., experienced medical technologists or hematopathologists) performed the manual differential, the number and specific qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the test set.

For the Method Comparison study, it's a comparison against a single predicate device output.
For the Clinical Sensitivity/Flagging Study, it explicitly states a "400-cell manual differential reference method," implying that this manual method itself was considered the ground truth, rather than an adjudicated consensus of multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this 510(k) summary. This device is an automated hematology analyzer designed to perform cell counting and differentiation automatically, rather than to assist human readers in image interpretation. Its primary comparison is to a predicate automated device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (Method Comparison, Repeatability, Reproducibility, Detection Limits, Linearity, Analytical Specificity, Stability) are all measurements of the standalone performance of the QScout system (the QScout Lab analyzer and QScout RLD assay) without human intervention in the analysis process itself. The data in Tables 1-9 represent the algorithm's output directly compared to reference methods or statistical performance metrics. The device is an automated analyzer, so its core function is algorithm-only.

7. The Type of Ground Truth Used

The ground truth varied depending on the study:

Method Comparison Study: The output of the predicate device (Beckman Coulter UniCel® DxH 800 Coulter® Cellular Analysis System) was used as the reference/ground truth for comparison.
Clinical Sensitivity/Flagging Study: A "400-cell manual differential reference method" was used as the ground truth. This is typically performed by highly trained laboratory professionals based on microscopic examination.
Precision, Detection Limits, Linearity, Analytical Specificity, Stability Studies: These studies typically use predefined reference materials, spiked samples, or expected values based on known concentrations or manipulations of samples (e.g., diluted samples for low WBC, samples treated with specific interferents). The performance is evaluated against these known or expected values.
Reference Interval Study: The ground truth for health was based on samples collected from apparently healthy adults, and the intervals were statistically derived from these measurements.

8. The Sample Size for the Training Set

The document does not provide information on the training set for the machine vision algorithm. The provided text is a 510(k) summary for device clearance, which focuses on validation studies against a predicate and clinical standards, not necessarily the development or training of the internal algorithms. This information would typically be considered proprietary and might be part of an internal V&V report, but not usually released in a public summary.

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

Since information on the training set itself is not provided, the method for establishing its ground truth is also not described in this document. Given that the device uses a "machine vision algorithm to identify cells from the images in real time," it's highly probable that the training involved extensive datasets of annotated cell images where the cell types (neutrophil, lymphocyte, monocyte, etc.) were identified and labeled by human experts (e.g., highly experienced hematologists or medical technologists).

Summary

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November 14, 2023

Ad Astra Diagnostics, Inc. Jasper Pollard Cto 633 Davis Drive Suite 460 Morrisville, North Carolina 27560

Re: K230878

Trade/Device Name: QScout Lab; QScout RLD Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: October 12, 2023 Received: October 12, 2023

Dear Jasper Pollard:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Min Wu

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices

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OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230878

Device Name OScout™ Lab; QScout™ RLD

Indications for Use (Describe)

White blood cell count (WBC)
· Neutrophils (NEUT#)
· Lymphocytes (LYMPH#)
· Monocytes (MONO#)
· Eosinophils (EOS#)
· Basophils (BASO#)
· Immature Granulocytes (IG#)
· Percent Neutrophils (NEUT%)
Percent Lymphocytes (LYMPH%)
· Percent Monocytes (MONO%)
· Percent Eosinophils (EOS%)
· Percent Basophils (BASO%)
· Percent Immature Granulocytes (IG%)
· Neutrophil to Lymphocyte Ratio (NLR)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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

Jasper Pollard, CTO Ad Astra Diagnostics, Inc. 633 Davis Drive Suite 460 Morrisville, NC 27560 Tel: 919-491-9643 E-mail: JPollard@aadiagnostics.com

Date Prepared

November 14, 2023

Name of Device QScout™ Lab (analyzer) and QScout™ RLD (assay)

Common or Usual Name Automated Differential Cell Counter

Classification 21 CFR 864.5220, Class II, Product Code: GKZ

Predicate Device Beckman Coulter UniCel® DxH 800 Coulter® Cellular Analysis System (K140911)

Device Description

The QScout RLD test includes a microfluidic chamber of predetermined volume containing a dried reagent of organic compounds to stain and fluoresce white blood cells. Once venous whole blood is transferred to the QScout RLD test, white blood cells mix with the reagent. The QScout RLD test is inserted into the QScout Lab, a quantitative multi-parameter automated hematology analyzer, where an optical imaging system takes images of the test chamber. A machine vision algorithm identifies cells from the images in real time. When analysis is complete, the results are displayed on the screen and can be printed.

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Intended Use/ Indications for Use

The QScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K₂/K₃EDTA whole blood:

White blood cell count (WBC)
. Neutrophils (NEUT#)
Lymphocytes (LYMPH#)
Monocytes (MONO#)
Eosinophils (EOS#)
Basophils (BASO#)
Immature Granulocytes (IG#)
Percent Neutrophils (NEUT%)
Percent Lymphocytes (LYMPH%)
. Percent Monocytes (MONO%)
Percent Eosinophils (EOS%)
Percent Basophils (BASO%)
Percent Immature Granulocytes (IG%)
. Neutrophil to Lymphocyte Ratio (NLR)

Summary of Substantial Equivalence

The QScout™ system has the same intended use and similar technological characteristics to the Beckman Coulter UniCel® DxH800 Coulter® Cellular Analysis System. Both devices are quantitative, multi-parameter, automated in vitro diagnostic hematology analyzers. Both devices screen venous whole blood samples.

The QScout system includes the QScout Lab (an analyzing device with optical imaging system) and the QScout RLD test (a disposable test with a microfluidic chamber and self-contained reagent). Similarly, the predicate device includes a specimen processing module that aspirates, and analyzes whole blood (including reagents). The predicate device also includes a unit that processes data from the analyzing unit and provides the operator interface with the system. The QScout Lab integrates the different units (data processing and operator interface) within the device and carries out all processes automatically after the sample has been manually loaded into the disposable QScout RLD test. The general components and functions of the QScout Lab are similar to the predicate device: a sample is provided, a sample is processed, and a sample is analyzed.

The QScout Lab is factory calibrated prior to shipping to the end user and does not require further calibration. The predicate device is calibrated as needed. Both devices use a three-level control to monitor system performance of WBC and differential parameters. Both devices use a second control to monitor system performance based on test principle; a control monitors counting capability and optical system performance of the QScout Lab, and a control monitors electrical processing and fluidic flow rate systems of the UniCel® DxH800 Coulter® Cellular Analysis System.

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For both devices, questions of safety and effectiveness are concerned with the ability to provide white blood cell counts and differentials accurately and reproducibly. Minor differences in features between the QScout Lab and the predicate device do not present new questions of safety and effectiveness.

	QScout™ Lab, QScout™ RLDK230878	Beckman Coulter UniCel® DxH 800 Coulter®Cellular Analysis SystemK140911
Regulation	21 CFR 864.5220	21 CFR 864.5220
Product Code	GKZ	GKZ
Class	Class II	Class II
Intended Use	Quantitative, multi-parameter, automatedhematology analyzer	Quantitative, multi-parameter, automatedhematology analyzer
Intended Use Sites	Clinical Laboratory, Point of Care	Clinical Laboratory
Indications for Use	In vitro diagnostic use	In vitro diagnostic use
Target Population	Patient populations found in clinicallaboratories and point-of-care (POC) settings	Patient populations found in clinicallaboratories
Test Parameters	WBC, NEUT%/#, LYMPH%/#, MONO%/#,EOS%/#, BASO%/#, IG%/#, Neutrophil toLymphocyte Ratio (NLR)	WBC, RBC, HGB, HCT, MCV, MCH, MCHC,RDW, RDW-SD, PLT, MPV, NE%/#, LY%/#,MO%/#, EO%/#, BA%/#, NRBC%/#, RET%/#,MRV, IRF, TNC
SpecimenType/Collection	Venous anticoagulated whole blood samplescollected into K2/K3EDTA tubes	Venous or capillary whole blood samplescollected into K2/K3EDTA microtubes/tubes
Calibration	Factory Calibrated	As needed by the operator
Quality Control	3 Level Biological Controls2 Level Synthetic Controls	3 Level Whole Blood ControlElectrical processing/flow rate Control
Test Principle	White blood cells are stained within amicrofluidic chamber and scanned with anoptical imaging system. Each image is analyzedby a machine vision algorithm to count anddifferentiate the white blood cells.	1. Coulter principle of automated cellcounting and sizing.2. Photometric measurement of HgB.3. VCSn technology for WBC differential,NRBC, and RET. Cells are mixed withreagent and the prepared sample isdelivered to a flow cell where lightscatter, cell volume, and cell conductivityare measured.
Throughput	25 samples/hour	≥ 72 samples/hour depending on mode
Sample Volume	10 μL	165 μL (aspiration volume)

Performance Data

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

Method Comparison Study with the Predicate Device (CLSI EP09c, H20-A2, and H26-A2)

Method comparison studies were conducted to assess the performance of the QScout system compared to the predicate device. The testing was conducted at a clinical laboratory and seven point-of-care sites using a total of 396 K₂EDTA/K₃EDTA whole blood samples.

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The studies included normal and pathological samples to assess the QScout Lab performance across the analytical measuring range. The pathological samples included the following conditions: allergic reaction, anemia, autoimmune / rheumatological diseases, B12 or folate deficiency, bacterial infection, cardiovascular diseases, chronic inflammation, hemoglobinopathies / hereditary RBC diseases, iron deficiency, acute and chronic leukemias (lymphocytic), lymphoma, liver disease, myelodysplastic syndromes, respiratory diseases, severe trauma or bleeding due to surgery or childbirth, solid tumor or other oncological conditions, and viral infections.

The results demonstrated that all parameters met the pre-defined acceptance criteria for correlation, slope, and bias. A summary of the results is presented in Table 1.

Parameter	N	Sample range	Slope(95% CI)	Intercept(95% CI)	Pearson's r
WBC	396	0.51 - 59.45	1.008(0.998, 1.020)	0.020(-0.033, 0.087)	0.996
NEUT#	396	0.00 - 45.87	0.976(0.963, 0.987)	0.078(0.040, 0.125)	0.985
LYMPH#	396	0.08 - 41.15	1.036(1.018, 1.053)	-0.004(-0.027, 0.018)	0.972
MONO#	396	0.00 - 13.06	1.100(1.050, 1.146)	-0.007(-0.030, 0.015)	0.907
EOS#	396	0.00 - 1.82	0.900(0.867, 0.995)	0.010(0.004, 0.017)	0.883
BASO#	396	0.00 - 1.61	0.720(0.644, 0.861)	0.010(0.010, 0.010)	0.922
IG#	139	0.00 - 7.55	1.194(1.004, 1.538)	-0.003(-0.011, 0.003)	0.926
NEUT%	396	0.3 - 96.0	0.954(0.939, 0.968)	1.830(0.882, 2.860)	0.981
LYMPH%	396	0.7 - 99.0	0.983(0.968, 0.997)	0.719(0.430, 1.018)	0.979
MONO%	396	0.0 - 75.1	0.985(0.931, 1.033)	0.603(0.264, 1.008)	0.928
EOS%	396	0.0 - 25.3	0.897(0.860, 0.929)	0.129(0.092, 0.200)	0.949
BASO%	396	0.0 - 4.9	0.889(0.800, 1.000)	-0.056(-0.100, 0.000)	0.690
IG%	139	0.0 - 21.5	0.862(0.713, 1.010)	0.471(0.272, 0.671)	0.896
NLR	396	0.00 - 120.71	0.914(0.891, 0.934)	0.089(0.060, 0.146)	0.947

Table 1 Method Comparison Study Combined Sites Results

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Repeatability Study (CLSI H26-A2)

Within-in run repeatability studies were performed to evaluate the precision of the QScout system using K₂EDTA/K₃EDTA whole blood samples around medical decision levels and within the laboratory reference range. Each sample was measured at least 20 times using a single QScout Lab analyzer and single lot of QScout RLD tests. For each parameter, the mean, standard deviation (SD), and coefficient of variation (CV) were computed. The results of the study are summarized in Table 2.

						Pooled
Parameter	WBC Range	N Samples	N Replicates	Mean	Pooled SD	CV%
WBCx103/μL	WBC<4 x103 /μL	12	21-31	1.55	0.08	6.07
	WBC≥4 x103 /μL	19	20-31	10.84	0.42	3.64
NEUT#x103/μL	WBC<4 x103 /μL	12	21-31	0.79	0.05	15.05
	WBC≥4 x10³/μL	19	20-31	7.36	0.33	4.22
LYMPH#x103/μL	WBC<4 x10³/μL	12	21-31	0.54	0.05	11.45
	WBC≥4 x103 /μL	19	20-31	2.06	0.13	6.01
MONO#x103/μL	WBC<4 x10³/μL	12	21-31	0.17	0.02	25.17
	WBC≥4 x10³/μL	19	20-31	0.93	0.08	9.87
EOS#x103/μL	WBC<4 x103/μL	12	21-31	0.03	0.01	N/A
	WBC≥4 x103 /μL	19	20-31	0.11	0.02	28.14
BASO#x103/μL	WBC<4 x103 /μL	12	21-31	0.01	0.01	N/A
	WBC≥4 x103 /μL	19	20-31	0.03	0.01	N/A
IG#x103/μL	WBC<4 x103 /μL	12	21-31	0.02	0.01	N/A
	WBC≥4 x103 /μL	19	20-31	0.34	0.07	33.42
NEUT%	WBC<4 x10³/μL	12	21-31	42.89	2.31	13.21
	WBC≥4 x103 /μL	19	20-31	65.13	1.31	2.34
LYMPH%	WBC<4 x10³/μL	12	21-31	41.69	2.37	8.84
	WBC≥4 x10³/μL	19	20-31	21.78	0.80	5.22
MONO%	WBC<4 x10³/μL	12	21-31	11.90	1.94	23.54
	WBC≥4 x10³/μL	19	20-31	8.87	0.81	8.82
EOS%	WBC<4 x103 /μL	12	21-31	1.69	0.54	80.58
	WBC≥4 x103 /μL	19	20-31	1.09	0.24	28.26
BASO%	WBC<4 x10³/μL	12	21-31	0.66	0.45	93.77
	WBC≥4 x10³/μL	19	20-31	0.42	0.12	N/A
IG%	WBC<4 x103 /μL	12	21-31	1.17	0.69	67.87
	WBC≥4 x10³/μL	19	20-31	2.70	0.59	31.95
NLR	WBC<4 x103/μL	12	21-31	2.49	0.56	18.48
	WBC>4 x103 /ul	19	20-31	6.15	0.62	6.21

Table 2 Pooled Results of Repeatability Study

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Reproducibility Study (CLSI EP05-A3 and H26-A2)

A reproducibility study of the QScout system was conducted at three sites. The study was performed over five days with three QScout Labs (one per site), six lots of QScout RLD tests, and one lot of tri-level quality control material (Low, Normal, and High). Two runs per day and six replicates per run were performed by two operators at each site for each control level. A total of 60 measurements were generated at each site for each level of control. The data generated was used to calculation (SD) and coefficient of variation (%CV) for within-run, betweenrun, between-day, between-lot, between-site, and total precision as shown in Table 3. The results demonstrated that the pre-defined acceptance criteria.

Parameter	ControlLevel	MeanValue	N	WithinRun		BetweenRun		BetweenDay		Between Lot		Between Site		Reproducibility
				SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%
WBC	Low	3.17	180	0.15	4.69	0.04	1.20	0.00	0.00	0.04	1.23	0.08	2.59	0.18	5.54
WBC	Normal	8.02	180	0.28	3.48	0.26	3.24	0.08	0.95	0.00	0.00	0.14	1.68	0.41	5.10
WBC	High	20.90	180	0.78	3.71	0.40	1.92	0.00	0.00	0.23	1.08	0.23	1.10	0.93	4.45
NEUT#	Low	1.52	180	0.09	6.20	0.00	0.00	0.00	0.00	0.03	1.84	0.02	1.12	0.10	6.45
NEUT#	Normal	4.64	180	0.19	3.99	0.14	2.95	0.04	0.86	0.00	0.00	0.07	1.44	0.24	5.23
NEUT#	High	13.22	180	0.59	4.46	0.22	1.63	0.04	0.30	0.15	1.15	0.12	0.87	0.66	4.98
LYMPH#	Low	1.09	180	0.08	6.88	0.04	3.21	0.02	1.83	0.00	0.00	0.04	3.85	0.10	8.66
LYMPH#	Normal	1.89	180	0.11	5.68	0.09	4.87	0.03	1.75	0.00	0.00	0.08	4.18	0.17	8.62
LYMPH#	High	3.17	180	0.17	5.44	0.13	4.10	0.04	1.36	0.00	0.00	0.09	2.87	0.24	7.44
MONO#	Low	0.35	180	0.04	12.68	0.01	3.14	0.00	0.57	0.01	2.29	0.03	8.57	0.06	15.79
MONO#	Normal	0.59	180	0.05	8.53	0.02	2.54	0.01	2.03	0.02	3.90	0.03	4.41	0.06	10.80
MONO#	High	1.10	180	0.09	7.88	0.04	4.00	0.00	0.00	0.00	0.00	0.08	7.00	0.12	10.91
EOS#	Low	0.14	180	0.02	16.17	0.01	7.14	0.00	0.00	0.00	0.00	0.00	0.00	0.03	18.27
EOS#	Normal	0.67	180	0.08	11.45	0.00	0.00	0.00	0.00	0.02	2.39	0.02	2.39	0.08	11.86
EOS#	High	2.62	180	0.25	9.70	0.03	1.07	0.00	0.00	0.06	2.14	0.03	0.95	0.26	9.91
BASO#	Low	0.03	180	0.01	39.89	0.00	10.00	0.00	3.33	0.00	0.00	0.00	6.67	0.01	42.28
BASO#	Normal	0.14	180	0.03	22.82	0.01	9.29	0.00	0.00	0.01	9.29	0.02	10.71	0.04	27.80
BASO#	High	0.52	180	0.08	14.47	0.00	0.00	0.00	0.00	0.03	4.81	0.02	4.04	0.08	15.60
Parameter	ControlLevel	MeanValue	N	WithinRun		BetweenRun		BetweenDay		Between Lot		Between Site		Reproducibility
				SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%	SD	CV%
IG#	Low	0.04	180	0.01	31.63	0.00	0.00	0.00	0.00	0.00	10.00	0.00	10.00	0.01	35.26
IG#	Normal	0.10	180	0.03	27.14	0.01	13.00	0.00	0.00	0.00	0.00	0.02	20.00	0.04	35.82
IG#	High	0.27	180	0.06	20.71	0.02	8.89	0.00	0.00	0.02	7.04	0.06	20.37	0.09	30.89
NEUT%	Low	48.06	180	1.74	3.62	0.78	1.62	0.47	0.97	0.00	0.00	0.78	1.61	2.11	4.36
NEUT%	Normal	57.81	180	1.35	2.34	0.23	0.40	0.32	0.55	0.00	0.00	0.25	0.44	1.43	2.44
NEUT%	High	63.25	180	1.45	2.29	0.14	0.22	0.40	0.63	0.00	0.00	0.00	0.00	1.51	2.40
LYMPH%	Low	34.49	180	1.65	4.79	0.57	1.66	0.59	1.71	0.00	0.00	0.46	1.34	1.90	5.48
LYMPH%	Normal	23.51	180	1.01	4.31	0.58	2.45	0.27	1.14	0.00	0.00	0.57	2.43	1.33	5.54
LYMPH%	High	15.18	180	0.67	4.44	0.44	2.87	0.24	1.56	0.00	0.00	0.28	1.83	0.88	5.65
MONO%	Low	10.96	180	1.39	12.70	0.00	0.00	0.08	0.68	0.25	2.32	0.65	5.90	1.56	14.21
MONO%	Normal	7.39	180	0.62	8.35	0.20	2.65	0.11	1.46	0.20	2.68	0.22	3.02	0.72	9.75
MONO%	High	5.24	180	0.42	8.08	0.15	2.90	0.11	2.12	0.00	0.00	0.31	5.84	0.56	10.42
EOS%	Low	4.47	180	0.69	15.43	0.23	5.08	0.00	0.00	0.00	0.00	0.12	2.60	0.74	16.62
EOS%	Normal	8.31	180	0.86	10.31	0.00	0.00	0.00	0.00	0.24	2.83	0.35	4.20	0.95	11.40
EOS%	High	12.53	180	1.08	8.65	0.00	0.00	0.14	1.13	0.20	1.60	0.14	1.11	1.12	9.06
BASO%	Low	0.87	180	0.33	37.51	0.11	12.76	0.04	4.37	0.00	0.00	0.10	10.80	0.36	41.29
BASO%	Normal	1.70	180	0.37	21.72	0.15	8.53	0.00	0.00	0.16	9.24	0.22	12.88	0.48	27.22
BASO%	High	2.48	180	0.35	14.04	0.03	1.37	0.00	0.00	0.10	4.15	0.13	5.36	0.39	15.67
IG%	Low	1.15	180	0.37	32.00	0.00	0.00	0.02	1.91	0.13	10.87	0.13	11.48	0.41	35.76
IG%	Normal	1.28	180	0.34	26.18	0.13	10.08	0.00	0.00	0.00	0.00	0.25	19.53	0.44	34.21
IG%	High	1.31	180	0.27	20.82	0.11	8.63	0.03	2.52	0.08	6.11	0.28	21.53	0.42	32.02
NLR	Low	1.40	180	0.11	7.48	0.05	3.57	0.04	2.86	0.00	0.00	0.04	3.07	0.13	9.10
NLR	Normal	2.47	180	0.14	5.72	0.09	3.48	0.05	1.82	0.00	0.00	0.07	2.87	0.19	7.32
NLR	High	4.18	180	0.20	4.85	0.14	3.37	0.09	2.03	0.00	0.00	0.09	2.13	0.28	6.36

Table 3 Reproducibility Study Results

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Detection Limits Studies including Limit of Blank, Limit of Detection, and Limit of Quantitation (CLSI EP17-A2 and CLSI H26-A2)

Limit of blank was determined using five centrifuged venous blood samples to deplete plasma of white blood cells, red blood cells, and platelets. Each of the five plasma samples was assayed six times on two QScout Labs and two RLD test lots for a total of 60 measurements of WBC per RLD test lot.

Limit of detection was determined using five low WBC concentration samples using diluted venous whole blood samples. Each of the low WBC samples was assayed six times on two QScout Lab and two RLD test lots for a total of 60 measurements of WBC per RLD test lot.

Limit of quantitation was determined using four low WBC concentration samples using diluted venous whole blood samples. Each of the low WBC samples was assayed five times on two QScout Labs and two RLD test lots for a total of 40 measurements of WBC per RLD test lot. The LoQ was defined as the lowest WBC concentration in which the predetermined total error accuracy goal was satisfied.

The LoB, LoD, and LoQ for WBC is shown in Table 4.

Table 4 Detection Limits of the QScout System

Parameter	Limit of Blank(LoB)	Limit of Detection(LoD)	Limit ofQuantitation (LoQ)	Units
WBC	0.02	0.08	0.38	x 103 /μL

Linearity Studies (CLSI EP06-Ed2 and H26-A2)

Two venous whole blood samples were manipulated to create linearity panels of 10 concentrations for WBC. Each concentration was measured at least four times using one QScout Lab and two RLD test lots. Determination of linearity was performed using weighted least squares regression. The linear range is shown in Table 5.

Table 5 Linear Range of the QScout System

Parameter	Linear Range
WBC	$0.5 – 60.0 \times 10^3 /\mu L$

Analytical Specificity/Interference Studies (CLSI EP07 and EP37)

Interference studies for glucose, hemolysate, lipemia (triglyceride-rich lipoproteins), conjugated bilirubin, unconjugated bilirubin, total protein, and thrombocytosis were performed on the QScout system. Paired-difference screening tests were conducted to evaluate whether WBC is susceptible to the presence of clinically high levels of each interferent. If susceptible, dose response tests were conducted to determine the critical concentration of the interferent.

The results of the interference studies demonstrated that:

1. There was no significant glucose interference at a concentration of 1000 mg/dL.
1. There was no significant hemolysate interference at a concentration of 1000 mg/dL.
1. There was no significant lipemia interference at a concentration of 1500 mg/dL.

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1. There was no significant conjugated bilirubin interference at a concentration of 40 mg/dL.
1. There was no significant unconjugated bilirubin interference up to a concentration of 20 mg/dL.
1. There was no significant total protein interference up to a concentration of 12.3 g/dL.
1. There was no significant thrombocytosis interference at a concentration of 750 x 103 platelets/pL.

Nucleated Red Blood Cells (nRBCs): For nRBCs the QScout system raises a flag in the presence of nRBCs ≥ 0.56 per 100 WBC. At levels lower than the threshold, there is no interference with WBC differential parameters. For levels above the threshold, nRBC is flagged and excluded from the WBC differential.

Sample Stability (CLSI EP25-A and H26-A2)

Sample stability was determined for 11 venous whole blood samples including six normal and five whole blood samples around medical decision levels. The samples were tested in replicate within one hour of collection, stored at room temperature, and tested in replicate again at two, three, four, five, and six hours after collection. The data support a sample stability claim of three hours.

QScout RLD Test Stability (CLSI EP09c and EP25-A)

A real-time stability study is being conducted to establish shelf-life stability of the QScout RLD test when it is stored at the recommended storage conditions. Six lots of RLD tests are tested. Each test lot is stored at 18 - 32ºC and tested at defined time points.

QScout BCS Stability

A real-time stability study was conducted using three lots of QScout BCS (biological control solution). The study verified 75 days of shelf-life stability when the control is stored upright at 2-8°C, protected from overheating and freezing.

Transportation Studies

The stability of the QScout Lab during transportation has been tested in accordance with ASTM D7386-16. The results of this testing indicate that the QScout Lab maintains performance specifications during shipping. The stability of the RLD test during shipping is being evaluated as part of the stability study in accordance with ASTM D7386-16.

Clinical Sensitivity/Flagging Study (CLSI H20-A2)

The clinical sensitivity, or flagging rate, of the QScout system was compared to a 400-cell manual differential reference method for 200 samples from one clinical laboratory and seven point-of-care sites. Two types of abnormalities were evaluated: (1) distributional abnormal samples, which are samples where the quantity of at least one of the parameters resided outside the reference interval, and (2) morphological abnormal samples that contain atypical forms of the normal cell types contained in ordinary blood. The ability to identify abnormal samples was evaluated by creation of predictive value tables for distributional and morphological abnormalities, separately and combined. From these tables, the overall agreement, sensitivity, and specificity were calculated. The overall flagging capability of the QScout system met the predefined acceptance criteria as seen in Table 8.

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Table 6 Distributional Flagging

	Overall Agreement %(95% CI)	Sensitivity % (95% CI)	Specificity % (95% CI)
Distributional Flagging	87.00(81.53, 91.33)	87.88(79.78, 93.58)	86.14(77.84, 92.21)

Table 7 Morphological Flagging

	Overall Agreement %(95% CI)	Sensitivity % (95% CI)	Specificity % (95% CI)
Morphological Flagging	97.50(94.26, 99.18)	81.25(54.35, 95.95)	98.91(96.13, 99.87)

Table 8 Overall Flagging

	Overall Agreement %(95% CI)	Sensitivity % (95% CI)	Specificity % (95% CI)
Overall Flagging	87.00(81.53, 91.33)	88.00(79.98, 93.64)	86.00(77.63, 92.13)

Reference Interval Study (CLSI EP28-A3c)

A reference interval study was conducted to establish adult reference intervals for all QScout system parameters. The study was performed using venous whole blood samples collected from 265 (139 female and 126 male) apparently healthy adults (≥ 18 years). The lower and upper limits of the 95% reference intervals were determined based on the 2.5th and 97.50 percentiles of measurements for each sex group, respectively.

Table 9 QScout System Reference Intervals

Parameter	Femalen=139	Malen=126	Units
WBC	4.00-11.30	3.78-12.12	x103/μL
NEUT#	1.68-7.42	1.56-7.89	x103/μL
LYMPH#	1.25-3.98	1.08-3.92	x103/μL
MONO#	0.27-0.92	0.25-1.08	x103/μL
EOS#	0.04-0.61	0.03-0.76	x103/μL
BASO#	0.01-0.11	0.01-0.16	x103/μL
IG#	0.00-0.04	0.00-0.06	x103/μL
NEUT%	33.8-71.4	33.7-75.0	%
LYMPH%	19.2-54.0	15.6-55.7	%
MONO%	4.8-13.2	4.6-13.1	%
EOS%	0.4-8.1	0.5-7.2	%
BASO%	0.2-1.5	0.1-2.2	%
IG%	0.0-0.5	0.0-0.7	%
NLR	0.63-3.76	0.62-4.89	N/A

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Matrix Comparison Study Between K2EDTA and K5EDTA (CLSI EP09c and H26-A2)

A matrix study was performed to demonstrate equivalence between K₂EDTA and K₃EDTA venous whole blood samples. A total of 40 paired samples were compared. The results show comparable performance characteristics and support the claim of using the two specimen types on the QScout system.

Device Testing

Electromagnetic compatibility, electrical safety testing, and software testing were conducted for the QScout system. In all instances, these tests demonstrate that the performance, functionality, and reliability the QScout system functioned as intended.

Conclusion

Through a range of clinical and nonclinical CLSI recommended studies, the QScout system, including the QScout Lab and QScout RLD test, has been shown to be substantially equivalent to the Beckman Coulter UniCel® DxH 800 Coulter® Cellular Analysis System. The conclusions drawn from the clinical and nonclinical data demonstrate that the QScout system is safe and effective for its intended use.

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.”