Hemosure Accu-Reader A100

• K Number: K200754
• Device Name: Hemosure Accu-Reader A100
• Manufacturer: W.H.P.M., Inc
• Date Cleared: 2022-06-02 ( 801 days)
• Product Code: OOX
• Regulation Number: 864.6550

Intended Use

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit. For in vitro diagnostic use. For Prescription use.

Device Description

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit. The principle of measurement is an automated sandwich dye conjugate immunoassay that employs a combination of monoclonal antibodies to selectively identify and provide qualitative determination of human hemoglobin in feces. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen, forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. The throughput of the instrument is 100 samples are collected in the sample collection tube "Sample Collection tube". The sample tube and test cartridge are assembled and placed on the sample tray. The instrument positions the plunger station to initiate the test cartridge testing by plunging the sample collection buffer tube into the chamber of the cartridge and thereby piercing its aluminum seal. The test fecal sample buffer is released into the test cartridge and fecal sample buffer will migrate on the enclosed test strip affixed on the test cartridge. Results are read after the tray makes one full rotation, which takes 5 minutes. Immediately after sample reading, the result (positive, negative or invalid) is displayed on the touchscreen and printed on paper whose dispensing slot is situated at the top of the Accu-Reader™ A100.

Predicate Devices

K041408

Reference Devices

K041202 Hemosure™ One-Step Fecal Occult Blood (FOB) Test, Occult Blood Test

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions digital imaging for analysis but does not indicate the use of AI or ML algorithms for interpretation or decision-making. The analysis appears to be based on a standard immunoassay principle and reading of color bands.

Therapeutic

No.
The device is used for diagnostic purposes (detection of fecal occult blood) and not for treating a condition or disease.

Diagnostic

Yes

Explanation: The device is explicitly stated as "intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories," and its intended use section states "For in vitro diagnostic use." These phrases directly indicate its function as a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of hardware components including a "Hemosure® Accu-Reader™ A100 Reader with Sample Tray", "Hemosure Accu-Reader™ A100 Test Cartridge", and "Sample Collection tube". While it uses digital imaging and likely software for analysis, it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
• Nature of the Test: The device performs a test on a human specimen (feces) in vitro (outside the body) to detect a specific substance (fecal occult blood) for diagnostic purposes.
• Intended Use: The intended use is for the qualitative detection of fecal occult blood in human feces by clinical laboratories, which is a typical application for IVD devices.
• Components: The system includes components like test cartridges, controls, and calibration cartridges, which are common elements of IVD test systems.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.

Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartirige, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

For in vitro diagnostic use. For Prescription use.

Product codes

OOX

Device Description

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

The principle of measurement is an automated sandwich dye conjugate immunoassay that employs a combination of monoclonal antibodies to selectively identify and provide qualitative determination of human hemoglobin in feces. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen, forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly.

The throughput of the instrument is 100 samples are collected in the sample collection tube "Sample Collection tube". The sample tube and test cartridge are assembled and placed on the sample tray. The instrument positions the plunger station to initiate the test cartridge testing by plunging the sample collection buffer tube into the chamber of the cartridge and thereby piercing its aluminum seal. The test fecal sample buffer is released into the test cartridge and fecal sample buffer will migrate on the enclosed test strip affixed on the test cartridge. Results are read after the tray makes one full rotation, which takes 5 minutes. Immediately after sample reading, the result (positive, negative or invalid) is displayed on the touchscreen and printed on paper whose dispensing slot is situated at the top of the Accu-Reader™ A100.

Components of Hemosure Accu-Reader™ A100 Test System:
Hemosure Accu-Reader™ A100 Reader: Automated Camera-based reader. Digital imaging is used to analyze the intensity of the Test and Control lines resulting from the introduction of the sandwich dye conjugate immunoassay. The results (positive, negative, or invalid) are provided on a display screen as well as a printout.
Hemosure Accu-Reader™ A100 Sample Tray: Sample tray which comprises a turntable motor with a mechanism that positions and controls the sample diluent with the test strip.
Hemosure Accu-Reader™ A100 Test Cartridge: The Accu-Reader™ A100 adopts a patented test cartridge system which is comprised of:

1. Test cartridge: The test cartridge is a polystyrene plastic case that contains a test strip composed of a plastic plate, a water absorption plate, a nitrocellulose film, colloidal gold, and water absorption paper; The nitrocellulose membrane consists of a control line (line C) coated with sheep antimouse polyclonal antibody and a reaction line (line T) coated with mouse anti-human hemoglobin monoclonal antibody 1. Colloidal gold is prepared by labeling mouse anti-human hemoglobin monoclonal antibody 2.
2. Sample Collection Tube: contains Phosphate-buffered saline.

The sample is collected by the patient inserted into the test cartridge (molded for correct insertion), placed into the Reader sample tray.

Individual Test Calibration: Each time a test is run, the reader calibrates by using a specified blank zone of the test strip that is unaffected by the immunological reaction of the test. This calibration is conducted to mitigate any interference that could be caused by abnormal sample color.

Hemosure Accu-Reader™ A100 Test Positive and Negative Control Solutions:
Positive Control – 5mL or 2mL contains purified human hemoglobin, Tris buffer, bovine serum albumin, and 0.05% sodium azide. Store product at 2°C-8°C.
Negative Control - 5mL or 2mL contains Tris buffer, bovine serum albumin, and 0.05% sodium azide. Store product at 2°C-8°C.

Hemosure Accu-Reader™ A100 Calibration Cartridges:
Optical System Calibration: The Hemosure® Accu-Reader™ A100 is supplied with a Calibration Cartridge Kit to check the assay reading performance. A calibration check verifies that the internal digital camera is functioning correctly, the lens is free from debris, and the Hemosure® Accu-Reader™ A100 is working to specification.

Mentions image processing

Digital imaging is used to analyze the intensity of the Test and Control lines resulting from the introduction of the sandwich dye conjugate immunoassay.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Feces / human feces

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratories, Professional Laboratories, Laboratory technician

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

Precision/Reproducibility Studies:
Test Set: 21 replicates across 7 concentrations (0 ng/mL, 80 ng/mL, 100 ng/mL, 110 ng/mL, 120 ng/mL, 140 ng/mL, and 1000 ng/mL).
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Assessed by evaluating the positive percentage agreement (PPA) and negative percentage agreement (NPA) of the observed results with expected result values.

Assay Cut-off Study:
Test Set: Not explicitly stated, implied to be fecal samples.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Executed side-by-side with the predicate device to compare test results.

Prozone Effect Study:
Test Set: 21 replicates across eight increasing concentrations of fecal samples containing human blood, up to 3000 ng/mL.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Expected zero false negatives.

Analytic Sensitivity Study: Human Hemoglobin Variant:
Test Set: 21 replicates of fecal samples spiked with Hb-S for each concentration: 0, 12, 16, 17, 19, 22, and 156 µg HbS/g stool, equivalent to 0, 80, 100, 110, 120, 140, and 1000 ng HbS/ml.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Not explicitly stated, implied to be qualitative detection.

Cross Reactivity - Animal Hemoglobin Analytical Specificity/Exclusivity:
Test Set: 21 replicates of fecal samples spiked with human hemoglobin (at 0, 80, 100, 110, 120, 140, and 1000 ng/mL) and 500 µg/mL of animal hemoglobin (Bovine, Poultry, Fish, Horse/Equine, Goat, Pig, Rabbit, and Sheep).
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Looked for significant cross-reactivity.

Interfering Substances:
Test Set: 21 replicates of fecal samples spiked with human hemoglobin at concentrations of 0, 80, 100, 110, 120, 140, and 1000 ng/mL. Tested with Animal Meat Extracts, Dietary Substances, Vegetable Extracts, Toilet Water, and Contaminants.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Looked for significant interference.

Sample Collection Study:
Test Set: 200 samples (100 positive and 100 negative) collected by 20 laypersons (5 positive and 5 negative per layperson). Hemoglobin negative and hemoglobin positive human fecal samples were prepared.
Data Source: Human fecal samples collected by laypersons.
Annotation Protocol: Samples tested on the Accu-Reader™ A100 after weighing and calculating the weight of feces in sample collection tubes.

Specimen Stability Studies:
Test Set: Stool samples spiked with several concentrations of human hemoglobin (0 ng/mL, 100 nq/mL, 110 ng/mL, 120 ng/mL, 140 ng/mL, and 1000 ng/mL). 21 replicates for each concentration. Three kit lots included.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Samples stored at different temperatures (2-8ºC, -10- (-)20ºC, 30 ºC, and 40 ºC) for up to 30 days after sampling, then tested on the Accu-Reader™ A100. Looked for results within acceptable criteria and agreement over 95%.

Shipping Studies:
Test Set: 21 replicates at each of the seven concentrations. Fecal samples contained in sample collection buffer tubes and unused Accu-Reader™ A100 sample collection buffer tubes and cartridges.
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Samples stored under extreme temperatures (-10°C, 2~8°C, 25°C, and 40°C) for 0, 3, and 6 days. Evaluated to pass acceptance criteria, with agreement more than 95%.

Stability Studies - Accelerated Stability Studies:
Test Set: Three lots of Accu-Reader™ A100 test kits. 21 aliquots for each of seven known human hemoglobin levels (0 ng/mL, 80 ng/mL, 100 ng/mL, 110 ng/mL, 120 ng/mL, 140 ng/mL, and 1000 ng/mL).
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Test kits stored at 45℃ for 75 days, with six test points (0, 40, 55, 65, and 76 days). Data supported shelf life translation to 24 months at room temperature (25°C).

Stability Studies - Real Time:
Test Set: 3 different lots of Hemosure® Accu-Reader™ A100 test kits (test cartridge and sample tube). Samples measured in 21 replicates. Stool samples spiked with seven known concentrations of human hemoglobin (0, 80, 100, 110, 120, 140, and 1000 ng/ml).
Data Source: Not explicitly stated, implied to be internal laboratory testing.
Annotation Protocol: Measurements performed at day 0, after 12 months, 24 months, and 30 months. Test kits stored at temperatures between 4°C and 30°C.

Clinical Performance: Method Comparison Study:
Test Set: A total of 377 clinical fecal samples.
Data Source: Clinical fecal samples collected from individuals who had previously been screened by colonoscopy.
Annotation Protocol: Patient samples tested side-by-side in the Accu-Reader™ A100 and a predicate device. Samples were human stool samples reconstituted in buffer.

Summary of Performance Studies

Precision/Reproducibility Studies:
Study Type: Repeatability and Reproducibility studies (intra-assay, inter-site, between-run, between-instrument, lot-to-lot).
Sample Size: 21 replicates per concentration level for each study.
Key Results: Achieved high Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) across various concentrations and study factors. For example, Overall Percent Agreement (OPA) for repeatability was 98.63%, between-run reproducibility 99.09%, between-instrument 99.09%, lot-to-lot 99.32%, and between-site 99.32%.

Assay Cut-off Study:
Study Type: Performance evaluation.
Key Results: Overall percent agreement of the Accu-Reader™ A100 is more than 95%, performing similarly to the predicate device with an analytical cut-off of 100ng/mL.

Prozone Effect Study:
Study Type: Evaluation for Hook effect susceptibility.
Sample Size: 21 replicates.
Key Results: No false negatives observed up to a concentration of 3000ng/mL, indicating not susceptible to the Hook effect.

Analytic Sensitivity Study: Human Hemoglobin Variant:
Study Type: Detection ability for human hemoglobin-s variant.
Sample Size: 21 replicates for each concentration.
Key Results: Accu-Reader™ A100 was found to be sensitive to abnormal hemoglobin associated with sickle cell anemia (Hb-S variant).

Cross Reactivity - Animal Hemoglobin Analytical Specificity/Exclusivity:
Study Type: Cross-reactivity testing.
Sample Size: 21 replicates for each animal hemoglobin sample.
Key Results: Accu-Reader™ A100 did not show significant cross-reactivity with any of the animal hemoglobin proteins tested.

Interfering Substances:
Study Type: Interference testing.
Sample Size: 21 replicates for each substance.
Key Results: No significant interference observed with Animal Meat Extracts, Dietary Substances, Vegetable Extracts, Toilet Water, and Contaminants.

Sample Collection Study:
Study Type: Evaluation of layperson sample collection.
Sample Size: 20 laypersons, total of 200 samples (100 positive, 100 negative).
Key Results: High degree of accuracy of results and consistency of stool amount collected.

Specimen Stability Studies:
Study Type: Sample stability at different temperatures.
Sample Size: 21 replicates for each concentration.
Key Results: Devices are within acceptable criteria and agreement over 95%. Fecal sample storage at 40°C showed false negatives after 15 days; recommended storage at 30°C and 40°C for no more than 14 days.

Shipping Studies:
Study Type: Evaluation of shipping stress on samples and test kits.
Sample Size: 21 replicates at each of the seven concentrations.
Key Results: Sample results passed acceptance criteria, agreement more than 95%.

Stability Studies - Accelerated Stability Studies:
Study Type: Shelf life determination.
Key Results: Data supported a shelf life of up to 24 months at room temperature (25°C).

Stability Studies - Real Time:
Study Type: Ongoing real-time stability study.
Key Results: Test kits (cartridge and sample tube) are stable for 24 months at 4-30°C.

Clinical Performance: Method Comparison Study:
Study Type: Comparison with a predicate device.
Sample Size: 377 clinical fecal samples.
Key Results: Overall percent agreement (OPA) was 98.67% (96.93%-99.43%), positive percent agreement (PPA) 98.63% (93.51%-99.97%), and negative percent agreement (NPA) 98.71% (96.87%-99.76%). Accu-Reader™ A100 showed good agreement in sensitivity to hemoglobin relative to the predicate device.

Key Metrics

• Positive Percentage Agreement (PPA)
• Negative Percentage Agreement (NPA)
• Overall Percent Agreement (OPA)
• Sensitivity (implied by analytic sensitivity study)
• Cross-reactivity (analytical specificity/exclusivity)
• Interference (analytical specificity/exclusivity)

Specific values:
Precision/Reproducibility Studies - Overall Percent Agreement:

• Repeatability: 98.63%
• Between-run Reproducibility: 99.09% (97.69%~99.75% CI)
• Between-Instrument Reproducibility: 99.09% (97.69%~99.75% CI)
• Lot-to-Lot Reproducibility: 99.32%
• Between-site Reproducibility: 99.32%

Clinical Performance: Method Comparison Study:

• Overall Percent Agreement (OPA): 98.67% (96.93%~99.43% CI)
• Positive Percent Agreement (PPA): 98.63% (93.51%~99.97% CI)
• Negative Percent Agreement (NPA): 98.71% (96.87%~99.76% CI)

Predicate Device(s)

K041408 OC AUTO MICRO FOB Test and OC Auto Micro 80 Analyzer

Reference Device(s)

K041202 Hemosure™ One-Step Fecal Occult Blood (FOB) Test; Occult Blood Test

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

0

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

June 2, 2022

W.H.P.M., Inc % Farokh Etemadieh Manager of Regulatory Affairs and Ouality Assurance W.H.P.M., Inc 5358 North Irwindale Avenue Irwindale. California 91706

Re: K200754

Trade/Device Name: Hemosure Accu-Reader A100 Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: OOX Dated: December 13, 2021 Received: December 13, 2021

Dear Farokh Etemadieh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Min Wu. Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known)

K200754

Device Name

Hemosure® Accu-Reader™ A100

Indications for Use (Describe)

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.

Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartirige, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

For in vitro diagnostic use. For Prescription use.

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

510(k) Submitter Information:

Name:	W.H.P.M., Inc.
Chief Executive:	John Wan, CEO
Address	5358 North Irwindale Avenue
Irwindale, California 91706
Phone:	626-443-8480
Fax:	626-443-8065
Contact name:	Farokh Etemadieh, Regulatory and Quality Manager

Application Correspondent:

Name:	Farokh Etemadieh
Contact:	Farokh Etemadieh
Address:	5358 North Irwindale Avenue
Irwindale, California 91706
Phone:	626-443-8480
Fax:	626-443-8065

Date Prepared: June 1, 2022

Device Information:

| Trade Name:
Common Name:
Classification Name:
Product Code: | Hemosure® Accu-Reader™ A100
Automated Occult Blood Reader
Occult Blood Test (21 CLR 864.6550)
OOX |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| 510(k) Number: | K200754 |

Predicate Device Information:

K Number	Device Trade Name	Manufacturer
Primary
K041408	OC AUTO MICRO FOB Test and OC Auto Micro
80
Analyzer	POLYMEDCO,
Inc.
Reference
K041202	Hemosure™ One-Step Fecal Occult Blood (FOB)
Test;
Occult Blood Test	WHPM, Inc.

Intended Use:

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.

4

Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

For in vitro diagnostic use. For Prescription use.

Device Description:

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

The principle of measurement is an automated sandwich dye conjugate immunoassay that employs a combination of monoclonal antibodies to selectively identify and provide qualitative determination of human hemoglobin in feces. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen, forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly.

The throughput of the instrument is 100 samples are collected in the sample collection tube "Sample Collection tube". The sample tube and test cartridge are assembled and placed on the sample tray. The instrument positions the plunger station to initiate the test cartridge testing by plunging the sample collection buffer tube into the chamber of the cartridge and thereby piercing its aluminum seal. The test fecal sample buffer is released into the test cartridge and fecal sample buffer will migrate on the enclosed test strip affixed on the test cartridge. Results are read after the tray makes one full rotation, which takes 5 minutes. Immediately after sample reading, the result (positive, negative or invalid) is displayed on the touchscreen and printed on paper whose dispensing slot is situated at the top of the Accu-Reader™ A100.

Components of Hemosure Accu-Reader™ A100 Test System

Hemosure Accu-Reader™ A100 Reader

Automated Camera-based reader. Digital imaging is used to analyze the intensity of the Test and Control lines resulting from the introduction of the sandwich dye conjugate immunoassay. The results (positive, negative, or invalid) are provided on a display screen as well as a printout.

Hemosure Accu-Reader™ A100 Sample Tray

Sample tray which comprises a turntable motor with a mechanism that positions and controls the sample diluent with the test strip.

Hemosure Accu-Reader™ A100 Test Cartridge

The Accu-Reader™ A100 adopts a patented test cartridge system which is comprised of:

• 1. Test cartridge The test cartridge is a polystyrene plastic case that contains a test strip composed of a plastic plate, a water absorption plate, a nitrocellulose film, colloidal gold, and water absorption paper; The nitrocellulose membrane consists of a control line (line C) coated with sheep antimouse polyclonal antibody and a reaction line (line T) coated with mouse anti-human hemoglobin

5

monoclonal antibody 1. Colloidal gold is prepared by labeling mouse anti-human hemoglobin monoclonal antibody 2.

2. Sample Collection Tube - contains Phosphate-buffered saline.

The sample is collected by the patient inserted into the test cartridge (molded for correct insertion), placed into the Reader sample tray.

Individual Test Calibration - Each time a test is run, the reader calibrates by using a specified blank zone of the test strip that is unaffected by the immunological reaction of the test. This calibration is conducted to mitigate any interference that could be caused by abnormal sample color.

Hemosure Accu-Reader™ A100 Test Positive and Negative Control Solutions

Positive Control – 5mL or 2mL contains purified human hemoglobin, Tris buffer, bovine serum albumin, and 0.05% sodium azide. Store product at 2°C-8°C.

Negative Control - 5mL or 2mL contains Tris buffer, bovine serum albumin, and 0.05% sodium azide. Store product at 2°C-8°C.

Hemosure Accu-Reader™ A100 Calibration Cartridges

Optical System Calibration

The Hemosure® Accu-Reader™ A100 is supplied with a Calibration Cartridge Kit to check the assay reading performance. A calibration check verifies that the internal digital camera is functioning correctly, the lens is free from debris, and the Hemosure® Accu-Reader™ A100 is working to specification.

Predicate Comparison Table- Primary Predicate

| Description | New Device
W.H.P.M.,
Inc. | Predicate Device
POLYMEDCO,
Inc. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| K Number | K200754 | K041408 |
| Brand name | Hemosure® Accu-Reader™ A100 | OC AUTO MICRO FOB Test and OC
Auto Micro 80 Analyzer TEST |
| Intended Use | Hemosure® Accu-Reader™ A100 is
an automated immunochemical fecal
occult blood test system intended for
the qualitative detection of fecal
occult blood in human feces by
clinical laboratories.
Hemosure® Accu-Reader™ A100 is
comprised of Hemosure® Accu-
Reader™ A100 Reader with Sample
Tray, Hemosure Accu-Reader™
A100 Test Cartridge, Sample
Collection tube, Hemosure® Accu-
Reader™ A100 Control and | The Polymedco OC Auto Micro 80
Analyzer and OC Auto Micro FOB Test
are designed to be used together as
an immunological test system intended
for the qualitative detection of fecal
occult blood in feces by professional
laboratories. The automated test is
useful for the determination of
gastrointestinal (GI) bleeding, found in
a number of gastrointestinal (GI)
disorders, e.g., colitis, polyps, and
colorectal cancer. |
| Description | New Device
W.H.P.M.,
Inc. | Predicate Device
POLYMEDCO,
Inc. |
| | Hemosure® Accu-Reader™ A100
Calibration Cartridge Kit.
For in vitro diagnostic use. | |
| | For Prescription use. | |
| Product Code | OOX | OOX |
| Intended use
environment | Professional Laboratories | Professional Laboratories |
| Intended user | Laboratory technician | Laboratory technician |
| Test Sample | Feces in an extraction buffer | Feces in an extraction buffer |
| Test Principle | Automated sandwich dye conjugate
immunoassay for qualitative
detection of fecal occult blood in
feces | Automated immunoassay using latex
fixation for qualitative detection of fecal
occult blood in feces |
| Sampling and
Sample
Processing | Sampling is done with the help of the
stool collection rod which is a part of
the Sample Collection tube. The fecal
sample is delivered into the sampling
tube containing the buffer which
extracts it. | Sampling is done with the help of
the Sampling Probe which is a part
of the OC-Auto Sampling Bottle.
The fecal sample is delivered into
the sampling bottle containing the
buffer which extracts it. |
| Assay Results | Qualitative | Qualitative |
| Assay Cut-off | 100ng/mL
(Human hemoglobin in feces
processed in extraction buffer) | 100 ng/mL
(Human hemoglobin in feces
processed in extraction buffer) |
| Test Time | 5-10 minutes | 5-10 minutes |
| Presentation of
Test results | Qualitative (Positive or Negative) | Qualitative (Positive or Negative) |
| Differences | | |
| Description | New Device
W.H.P.M.,
Inc. | Predicate Device
POLYMEDCO,
Inc. |
| Test Principle | Automated sandwich dye conjugate
immunoassay that employs a
combination of monoclonal and
polyclonal antibodies to selectively
identify and provide qualitative
determination of human hemoglobin
in feces. As the test sample flows up
through the absorbent device, the
labeled antibody-dye conjugate binds
to the hemoglobin in the specimen
forming an antibody-antigen complex.
This complex binds to anti-
hemoglobin antibody in the positive
test reaction zone and produces a
pink-rose color band. In the absence
of hemoglobin, there is no line in the
positive test reaction zone. The pink-
rose color bands in the control
reaction zone demonstrate that the
reagents and devices are functioning
correctly. | Automated immunoassay using latex
fixation for qualitative detection of fecal
occult blood in feces. |
| Detection
Mechanism | Camera-based analysis of a
sandwich dye conjugate
immunoassay. | Optical measurement of agglutination
of latex particles |
| Test
Throughput/Time | 100 samples/hour | 80 samples/hour |
| Calibration | A test cartridge with defined
standard gray color intensity on its T
zone is read by the Accu-Reader™
A100 and adjustment is made
according to this standard gray scale
intensity. | Calibrator containing hHb A0 is
serially diluted prior to analysis to
construct a calibration curve. |

Table 1: Comparison Table - Primary Predicate

6

7

Reference Predicate

The reference predicate, K041202, is included for the similarities in its technological characteristics of the test cartridge, buffer and controls to support safety claims for the device. The test principle is the same but modifications to the design were made to the test cartridge for the automated processing of samples.

8

Table 2: Reference Comparison Chart

| Description | Subject Device | Reference Device
K041202 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Brand name | Hemosure® Accu-Reader™ A100 Test
Cartridge | Hemosure™ One-Step Fecal Occult
Blood (FOB) Test; Occult Blood
Test |
| Intended
Use/Indications
for Use | Hemosure® Accu-Reader™ A100 is
an automated immunochemical fecal
occult blood test system intended for
the qualitative detection of fecal
occult blood in human feces by
clinical laboratories.
Hemosure® Accu-Reader™ A100 is
comprised of Hemosure® Accu-
Reader™ A100 Reader with Sample
Tray, Hemosure Accu-Reader™
A100 Test Cartridge, Sample
Collection tube, Hemosure® Accu-
Reader™ A100 Control and
Hemosure® Accu-Reader™ A100
Calibration Cartridge Kit.
For in vitro diagnostic use.
For Prescription use. | The Hemosure™ One-Step Fecal
Occult Blood (FOB) Test is an
immunochemical device intended for
the qualitative detection of Fecal
Occult Blood by laboratories or
physicians offices. It is useful to
determine gastrointestinal
(GI)
bleeding found in a number of GI
disorders, e.g. diverticulitis, colitis,
polyps, and colorectal cancer. |
| Classification
Code | OOX | KHE |
| Description | Subject Device | Reference Device |
| | | K041202 |
| Test principle | Qualitative, sandwich dye conjugate
immunoassay and employs a
combination of monoclonal and
polyclonal antibodies to selectively
identify hemoglobin in test samples.
As the test sample flows up through
the absorbent device, the labeled
antibody- dye conjugate binds to the
hemoglobin in the specimen forming
an antibody- antigen complex. This
complex binds to anti-hemoglobin
antibody in the positive test reaction
zone and produces a pink-rose color
band. In the absence of hemoglobin,
there is no line in the positive test
reaction zone. The pink-rose color
bands in the control reaction zone
demonstrate that the reagents and
devices are functioning correctly | Qualitative, sandwich dye conjugate
immunoassay and employs a
combination of monoclonal and
polyclonal antibodies to selectively
identify hemoglobin in test samples. As
the test sample flows up through the
absorbent device, the labeled antibody-
dye conjugate binds to the hemoglobin in
the specimen forming an antibody-
antigen complex. This complex binds to
anti-hemoglobin antibody in the positive
test reaction zone and produces a pink-
rose color band. In the absence of
hemoglobin, there is no line in the
positive test reaction zone. The pink-rose
color bands in the control reaction zone
demonstrate that the reagents and
devices are functioning correctly |
| Test Device | Test Cartridge (test strip enclosed in a
plastic housing) and sample tube. | Test Cassette (test strip enclosed in a
plastic housing) and sample tube. |
| Test
Components | Accu-Reader™ A100 Test
Cartridge;
Sample Collection Tube;
Controls- Positive and Negative
Solutions | Test Cassette individually sealed in a foil
packet pouch, containing mouse MAB and
sheep PAB, directed against human
Hemoglobin (hHb) and;
Buffer, "Limit Fecal Sample Collection"
extraction buffer, 2.0 mL.
Controls- Positive and Negative Solutions |
| Sampling and
Sample
Processing | Samplings is done with the
applicator stick which is part of the
Sample Collection Tube | Samplings is done with the applicator stick
which is part of the
Buffer, "Limit Fecal Sample Collection"
tube |
| Assay results | Qualitative | Qualitative |
| Assay Cut-off | 100 ng/mL
(Human hemoglobin in feces
processed in extraction buffer) | 100 ng/mL
(Human hemoglobin in feces processed
in extraction buffer) |
| Detection
mechanism | Camera-based analysis of a
sandwich dye conjugate | Manual observation of a pink-rose
color band |
| Description | Subject Device | Reference Device
K041202 |
| Test cassette | Individually sealed in a foil pouch,
containing a combination of mouse
MAB and sheep or goat PAB,
directed against human
hemoglobin (hHb); | Individually sealed in a foil pouch,
containing a combination of mouse
MAB and sheep or goat PAB, directed
against human hemoglobin (hHb); |
| Specimen
collector | Fecal Collection Tube of
extraction buffer. (2.0 mL) | Fecal Collection Tube of extraction
buffer. (2.0 mL) |
| Controls,
Positive and
Negative | Same | Same |

9

10

Performance Characteristics

Precision/Reproducibility Studies

The Accu-Reader™ A100 was tested between test kit lots (one instrument and different lots), between instruments (one lot and different instruments), between sites (different instruments and lots), and between runs with different operators. Testing included 21 replicates across 7 concentrations at 0 ng/mL, 80 ng/mL, 100 ng/mL, 120 ng/mL, 140 ng/mL, and 1000 ng/mL for all studies across repeatability and reproducibility. Precision/reproducibility was assessed by evaluating the positive percentage agreement (PPA) and negative percentage agreement (NPA) of the observed results with expected result values.

Concentration	Expected Results	Observed Results			Positive Percent	Negative Percent
		Positive	Negative	Total	(95% CI)	(95% CI)
0 ng/ml	0% Positive	0	21	21	0	100%
(84.5-100)
80 ng/ml	5% Positive	1	20	21	4.8%
(0.9-22.7)	95.2%
(77.3-99.2)
100 ng/ml	50% Positive	10	11	21	47.6%
(28.3-67.6)	52.4%
(32.4-71.7)
110 ng/ml	C95 - 20%	15	6	21	71.4%
(50.1-86.2)	28.6%
(13.8-50)
120 ng/ml	95% Positive	20	1	21	95.2%
(77.3-99.2)	4.8%
(0.9-22.7)
140 ng/ml	C95 + 20%	21	0	21	100%
(84.5-100)	0
1000 ng/ml	100% Positive	21	0	21	100%
(84.5-100)	0

Table 3: Intra-Assay Precision/Repeatability Data Summary

Table 4A: Inter-site Repeatability/Reproducibility Data Summary

| Site | Sample
concentration | Observed Results | | | Positive
Percent
(95% CI) | Negative
Percent
(95% CI) | Overall
Percentage
Agreement |
|--------------|-------------------------|------------------|----------|-------|---------------------------------|---------------------------------|------------------------------------|
| Site 1 | 0 ng/ml | 0 | 21 | 21 | 0 | 100%
(84.5%-100%) | 100% |
| | 80 ng/ml | 0 | 21 | 21 | 0 | 100% | 100% |
| Site | Sample
concentration | Observed Results | | | Positive
Percent
(95% CI) | Negative
Percent
(95% CI) | Overall
Percentage
Agreement |
| | | Positive | Negative | Total | | (84.5%-100%) | |
| Site 1 | 100 ng/ml | 11 | 10 | 21 | 52.4%
(32.4%-
71.7%) | 47.6%
(28.3%-67.6%) | 52.4% |
| | 110 ng/ml | 15 | 6 | 21 | 71.4%
(50.1%-
86.2%) | 28.6%
(13.8%-50%) | 71.4% |
| | 120 ng/ml | 20 | 1 | 21 | 95.2%
(77.3%-
99.2%) | 4.8%
(0.9%-22.7%) | 95.2% |
| | 140 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 1000 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 0ng/ml | 0 | 21 | 21 | 0 | 100%
(84.5%-100%) | 100% |
| | 80 ng/ml | 0 | 21 | 21 | 0 | 100%
(84.5%-100%) | 100% |
| | 100 ng/ml | 11 | 10 | 21 | 52.4%
(32.4%-
71.7%) | 47.6%
(28.3%-67.6%) | 52.4% |
| Site 2 | 110 ng/ml | 15 | 6 | 21 | 71.4%
(50.1%-
86.2%) | 28.6%
(13.8%-50%) | 71.4% |
| | 120 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 140 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 1000 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 0ng/ml | 0 | 21 | 21 | 0 | 100%
(84.5%-100%) | 100% |
| Site 3 | 80 ng/ml | 1 | 20 | 21 | 4.8%
(0.9%-22.7%) | 95.2%
(77.3%-99.2%) | 95.2% |
| | 100 ng/ml | 12 | 9 | 21 | 57.1%
(32.4%-
75.5%) | 42.9%
(24.5%-63.5%) | 57.1% |
| | 110 ng/ml | 15 | 6 | 21 | 71.4%
(50.1%-
86.2%) | 28.6%
(13.8%-50%) | 71.4% |
| Site 3 | 120 ng/ml | 20 | 1 | 21 | 95.2%
(77.3%-
99.2%) | 4.8%
(0.9%-22.7%) | 95.2% |
| | 140 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 1000 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 0ng/ml | 0 | 21 | 21 | 0 | 100%
(84.5%-100%) | 100% |
| | 80 ng/ml | 1 | 20 | 21 | 4.8%
(0.9%-22.7%) | 95.2%
(77.3%-99.2%) | 95.2% |
| Site 4 | 100 ng/ml | 12 | 9 | 21 | 57.1%
(28.3%-
67.6%) | 42.9%
(32.4%-71.7%) | 57.1% |
| | 110 ng/ml | 15 | 6 | 21 | 71.4%
(47.8%-
88.7%) | 28.6%
(11.3%-52.2%) | 71.4% |
| | Sample
concentration | Observed Results | | | Positive
Percent
(95% CI) | Negative
Percent
(95% CI) | Overall
Percentage
Agreement |
| Site | | Positive | Negative | Total | | | |
| | 120 ng/ml | 20 | 1 | 21 | 95.2%
(77.3%-
99.2%) | 4.8%
(0.9%-22.7%) | 95.2% |
| | 140 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| | 1000 ng/ml | 21 | 0 | 21 | 100%
(84.5%-100%) | 0 | 100% |
| All
sites | 0ng/ml | 0 | 84 | 84 | 0 | 100%
(95.7%-100%) | 100% |
| | 80 ng/ml | 2 | 82 | 84 | 2.4%
(0.3%-8.3%) | 97.6%
(91.7%-99.75) | 97.6% |
| | 100 ng/ml | 46 | 38 | 84 | 54.8%
(43.5%-
65.7%) | 45.2%
(34.3%-56.5%) | 54.8% |
| | 110 ng/ml | 60 | 24 | 84 | 71.4%
(60.5%-
80.8%) | 24%
(19.2%-39.5%) | 71.4% |
| | 120 ng/ml | 82 | 2 | 84 | 97.6%
(91.7%-99.75) | 2.4%
(0.3%-8.3%) | 97.6% |
| | 140 ng/ml | 84 | 0 | 84 | 100%
(95.7%-100%) | 0 | 100% |
| | 1000 ng/ml | 84 | 0 | 84 | 100%
(95.7%-100%) | 0 | 100% |

11

12

Table 4B: Summary of Repeatability/Reproducibility Studies Data

| Sample
Concentration | Factor | | Number Positive (%),
95%CI | | | Number Negative (%),
95%CI | | |
|-------------------------|--------|------------------------|-------------------------------|------------------------|------------------------|-------------------------------|------------------------|--|
| | | 1 | 2 | 3 | 1 | 2 | 3 | |
| 0 ng/mL | Run | 0 | 0 | 0 | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | |
| 0 ng/mL | Device | 0 | 0 | 0 | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | |
| 0 ng/mL | Lot | 0 | 0 | 0 | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | |
| 80 ng/mL | Run | 1 (4.8),
0.9-22.7 | 0 | 1 (4.8),
0.9-22.7 | 20(95.2),
77.3-99.2 | 21(100),
84.5-100 | 20(95.2),
77.3-99.2 | |
| 80 ng/mL | Device | 0 | 1 (4.8),
0.9-22.7 | 1 (4.8),
0.9-22.7 | 21(100),
84.5-100 | 20(95.2),
77.3-99.2 | 20(95.2),
77.3-99.2 | |
| 80 ng/mL | Lot | 1 (4.8),
0.9-22.7 | 1 (4.8),
0.9-22.7 | 0 | 20(95.2),
77.3-99.2 | 20(95.2),
77.3-99.2 | 21(100),
84.5-100 | |
| 100 ng/mL | Run | 11(52.4),
32.4-71.7 | 11(52.4),
32.4-71.7 | 11(52.4),
32.4-71.7 | 10(47.6),
28.3-67.6 | 10(47.6),
28.3-67.6 | 10(47.6),
28.3-67.6 | |
| 100 ng/mL | Device | 11(52.4),
32.4-71.7 | 10(47.6),
28.3-67.6 | 11(52.4),
32.4-71.7 | 10(47.6),
28.3-67.6 | 11(52.4),
32.4-71.7 | 10(47.6),
28.3-67.6 | |
| 100 ng/mL | Lot | 12(57.1),
36.5-75.5 | 11(52.4),
32.4-71.7 | 11(52.4),
32.4-71.7 | 9(42.9),
24.5-63.5 | 10(47.6),
28.3-67.6 | 10(47.6),
28.3-67.6 | |
| 110 ng/mL | Run | 15(71.4),
50.1-86.2 | 16(76.2),
54.9-89.4 | 15(71.4),
50.1-86.2 | 6(28.6),
13.8-50 | 5(23.8),
10.6-45.1 | 6(28.6),
13.8-50 | |
| 110 ng/mL | Device | 15(71.4),
50.1-86.2 | 15(71.4),
50.1-86.2 | 15(71.4),
50.1-86.2 | 6(28.6),
13.8-50 | 6(28.6),
13.8-50 | 6(28.6),
13.8-50 | |
| 110 ng/mL | Lot | 16(76.2),
54.9-89.4 | 15(71.4),
50.1-86.2 | 15(71.4),
50.1-86.2 | 5(23.8),
10.6-45.1 | 6(28.6),
13.8-50 | 6(28.6),
13.8-50 | |

13

| Sample
Concentration | Factor | | Number Positive (%),
95%CI | | | Number Negative (%),
95%CI | | |
|-------------------------|--------|--|-------------------------------|------------------------|------------------------|-------------------------------|-----------------------|----------------------|
| | | | 1 | 2 | 3 | 1 | 2 | 3 |
| 120 ng/mL | Run | | 20(95.2),
77.3-99.2 | 20(95.2),
77.3-99.2 | 21(100),
84.5-100 | 1 (4.8%),
0.9-22.7 | 1 (4.8%),
0.9-22.7 | 0 |
| | Device | | 20(95.2), 77.3-
99.2 | 21(100),
84.5-100 | 20(95.2),
77.3-99.2 | 1 (4.8%),
0.9-22.7 | 0 | 1 (4.8),
0.9-22.7 |
| | Lot | | 21(100),
84.5-100 | 20(95.2),
77.3-99.2 | 21(100),
84.5-100 | 0 | 1 (4.8),
0.9-22.7 | 0 |
| 140 ng/mL | Run | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |
| | Device | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |
| | Lot | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |
| 1000 ng/mL | Run | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |
| | Device | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |
| | Lot | | 21(100),
84.5-100 | 21(100),
84.5-100 | 21(100),
84.5-100 | 0 | 0 | 0 |

Results: Statistical analysis of repeatability and reproducibility studies of the Accu-Reader™ A100.

Table 5: PPA/NPA

| Precision
Study | Observed
Results | Expected Results | | | Overall Percent
Agreement | Positive Percent
Agreement
(95% CI) | Negative
Percent
Agreement
(95% CI) |
|------------------------------------------|---------------------|---------------------|---------------------|------------------|------------------------------|-------------------------------------------|----------------------------------------------|
| | | Positive
Results | Negative
Results | Total
Results | | | |
| Repeatability | Positive
Results | 87 | 1 | 88 | 98.63% | 98.86%
(93.84%~99.80%) | 98.31%
(90.91%~99.70%) |
| | Negative
Results | 1 | 58 | 59 | | | |
| | Total Results | 88 | 59 | 147 | | | |
| Between-run
Reproducibility | Positive
Results | 266 | 2 | 268 | 99.09%
(97.69%~99.75%) | 99.25%
(97.33%~99.91%) | 98.84%
(95.89%~99.86%) |
| | Negative
Results | 2 | 171 | 173 | | | |
| | Total Results | 268 | 173 | 441 | | | |
| Between
Instrument
Reproducibility | Positive
Results | 264 | 2 | 266 | 99.09%
(97.69%~99.75%) | 99.25%
(97.31%~99.78%) | 98.86%
(95.93%~99.86%) |
| | Negative
Results | 2 | 173 | 175 | | | |
| | Total Results | 266 | 175 | 441 | | | |
| Lot-to-Lot
Reproducibility | Positive
Results | 268 | 2 | 270 | 99.32% | 99.63%
(97.92%~99.93%) | 98.84%
(95.86%~99.69%) |
| | Negative
Results | 1 | 170 | 171 | | | |
| | Total Results | 269 | 172 | 441 | | | |

14

| Precision
Study | Observed
Results | Expected Results | | | Overall Percent
Agreement | Positive Percent
Agreement
(95% CI) | Negative
Percent
Agreement
(95% CI) |
|---------------------------------|---------------------|------------------|-----|-----|------------------------------|-------------------------------------------|----------------------------------------------|
| Between-site
Reproducibility | Positive
Results | 356 | 2 | 358 | 99.32% | 99.44%
(98.00%~99.93%) | 99.13%
(96.89%~99.89%) |
| Between-site
Reproducibility | Negative
Results | 2 | 228 | 230 | | | |
| Between-site
Reproducibility | Total Results | 358 | 230 | 588 | | | |

Assay Cut-off Study

The assay cut-off performance evaluation for the Accu-Reader™ A100 was executed side-by-side with the predicate device to compare the test results of both devices. Based on the results, the overall percent agreement of the Accu-Reader™ A100 is more than 95%; thus, this agreement describes the validity of the data collection and analysis. The data indicates that the Accu-Reader™ A100 performs similarly to the predicate device, with the analytical cut-off of 100ng/mL results (hemoglobin in fecal mixed with the detection buffer), which is equivalent to 0.0156 mg Hb per gram of human stool.

Prozone Effect Study

The Accu-Reader™ A100 was found to not be susceptible to the Hook effect up to a concentration of 3000ng/mL as 21 replicates across eight increasing concentrations of fecal samples containing human blood were tested, which resulted in zero false negatives.

Analytic Sensitivity Study: Human Hemoqlobin Variant

The ability to detect human hemoglobin-s variant was determined by testing a series of concentrations of Hemoglobin-S spiked with human stool samples. Twenty-one (21) replicates of fecal samples spiked with Hb-S for each concentration were prepared. The concentrations were at 0. 12, 16, 17, 19, 22 and 156 µg HbS/g stool, and equivalent to 0, 80, 100, 110, 120, 140 and 1000 ng HbS/ml. The Accu-Reader™ A100 was found to be sensitive to the abnormal hemoglobin associated with sickle cell anemia (Hb-S variant).

| Concentration | 0ng/ml
Pos/Neg
(% Pos) | 80ng/mL
Pos/Neg
(% Pos) | 100ng/mL
Pos/Neg
(% Pos) | 110ng/mL
Pos/Neg
(% Pos) | 120ng/mL
Pos/Neg
(% Pos) | 140ng/mL
Pos/Neg
(% Pos) | 1000ng/mL
Pos/Neg
(% Pos) |
|---------------|------------------------------|-------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|---------------------------------|
| Test Result | 0/21
(0%) | 1/20
(5%) | 10/11
(48%) | 14/7
(67%) | 20/1
(95%) | 21/0
(100%) | 21/0
(100%) |

Table 6: hHb variant summary

Cross Reactivity - Animal Hemoglobin Analytical Specificity/Exclusivity

The cross-reactivity of the Accu-Reader™ A100 was tested with eight (8) animal hemoglobin samples by testing21 replicates of fecal samples spiked with human hemoglobin at several concentrations (0, 80, 100, 110, 120, 140 and 1000ng/mL). Each contrived fecal sample was prepared with 500 µg/mL of animal hemoglobin and included the following animals: Bovine, Poultry, Fish, Horse/Equine, Goat, Pig, Rabbit and Sheep. The Accu-Reader™ A100 did not show significant cross-reactivity with any of the animal hemoglobin proteins tested.

15

| Analytical Specificity | Observed Results | Expected Results | | | Overall
Percent
Agreement | Positive
Percent
Agreement | Negative
Percent
Agreement |
|---------------------------------|----------------------|---------------------|---------------------|------------------|---------------------------------|----------------------------------|----------------------------------|
| | Accu-Reader™
A100 | Positive
Results | Negative
Results | Total
Results | | | |
| Bovine Hemoglobin 500
µg/ml | Positive Results | 84 | 1 | 85 | 98.6% | 98.8% | 98.4% |
| | Negative Results | 1 | 61 | 62 | | | |
| | Total Results | 85 | 62 | 147 | | | |
| Equine Hemoglobin 500
µg/ml | Positive Results | 88 | 1 | 89 | 98.6% | 98.9% | 98.3% |
| | Negative Results | 1 | 57 | 58 | | | |
| | Total Results | 89 | 58 | 147 | | | |
| Goat Hemoglobin
500 µg/ml | Positive Results | 88 | 0 | 88 | 100% | 100% | 100% |
| | Negative Results | 0 | 59 | 59 | | | |
| | Total Results | 88 | 59 | 147 | | | |
| Porcine Hemoglobin 500
µg/ml | Positive Results | 88 | 1 | 89 | 98.6% | 98.9% | 98.3% |
| | Negative Results | 1 | 57 | 58 | | | |
| | Total Results | 89 | 58 | 147 | | | |
| Sheep Hemoglobin 500
µg/ml | Positive Results | 89 | 0 | 89 | 99.3% | 98.9% | 100% |
| | Negative Results | 1 | 57 | 58 | | | |
| | Total Results | 90 | 57 | 147 | | | |
| Turkey Hemoglobin 500
µg/ml | Positive Results | 89 | 1 | 90 | 98.6% | 98.9% | 98.2% |
| | Negative Results | 1 | 56 | 57 | | | |
| | Total Results | 90 | 57 | 147 | | | |
| Fish Hemoglobin
500 µg/ml | Positive Results | 89 | 1 | 90 | 99.3% | 100% | 98.3% |
| | Negative Results | 0 | 57 | 57 | | | |
| | Total Results | 89 | 58 | 147 | | | |
| Rabbit Hemoglobin 500
µg/ml | Positive Results | 88 | 0 | 88 | 99.3% | 98.9% | 100% |
| | Negative Results | 1 | 58 | 59 | | | |
| | Total Results | 89 | 58 | 147 | | | |

Table 7: Cross Reactivity Summary

Interfering Substances

The Interference substances studies for Accu-Reader™ A100 test kit were conducted with Animal Meat Extracts, Dietary Substances, Vegetable Extracts, Toilet Water and Contaminants by testing 21 replicates of fecal samples spiked with human hemoglobin at concentrations of 0, 80, 100, 110, 120, 140 and 1000 ng/mL. No significant interference was observed with the substances listed above.

| Meat
Extracts | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall
percentage
agreement |
|------------------------------------|---------------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|-----------------------------------------------|------------------------------------|
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 10 | 11 | 21 | 10(47.6)
28.3-67.6 | 11(52.4)
32.4-71.7 | 47.6% |
| Meat
Extracts | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall
percentage
agreement |
| Beef Meat
Extract
2.5% | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Pork Meat
Extract
2.5% | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Fish Meat
Extract 2.5% | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Meat
Extracts | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall
percentage
agreement |
| Horse
Meat
Extract
2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1 (4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Goat Meat
Extract
2.5% | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1 (4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 12 | 9 | 21 | 12(57.1)
36.6-75.5 | 9(42.9)
24.5-63.4 | 57.1% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Rabbit
Meat
Extract | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 16 | 5 | 21 | 16(76.2)
50.1-86.2 | 6(23.8)
10.6-45.1 | 76.2% |
| Meat
Extracts | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall
percentage
agreement |
| 2.5% | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | Lamb
Meat
Extract
2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 |
| 80 ng/ml | | 5%positive | 1 | 20 | 21 | 1 (4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| 100 ng/ml | | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| 110 ng/ml | | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| 120 ng/ml | | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| 140 ng/ml | | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| 1000 ng/ml | | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Chicken
Meat
Extract
2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1 (4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 12 | 9 | 21 | 12(57.1)
36.6-75.5 | 9(42.9)
24.5-63.4 | 57.1% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |

16

17

18

Table 9: Summary - Vegetable Extracts
---------------------------------------	--	--

19

| Vegetable
Extracts | Sample
concentration n | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall
percentage
agreement |
|-------------------------------|---------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|-----------------------------------------------|------------------------------------|
| Broccoli
Extract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| Broccoli
Extract 2.5% | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-
100 | 95.2% |
| Broccoli
Extract 2.5% | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-
67.6 | 52.4% |
| Broccoli
Extract 2.5% | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| Broccoli
Extract 2.5% | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| Broccoli
Extract 2.5% | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Broccoli
Extract 2.5% | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Cantaloupe
Extract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| Cantaloupe
Extract 2.5% | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| Cantaloupe
Extract 2.5% | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Cantaloupe
Extract 2.5% | 110 ng/ml | C95-20% | 15 | 0 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| Cantaloupe
Extract 2.5% | 120 ng/ml | 95%positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Cantaloupe
Extract 2.5% | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Cantaloupe
Extract 2.5% | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Cantaloupe
Extract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| Cantaloupe
Extract 2.5% | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| Cantaloupe
Extract 2.5% | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Cauliflower | | | | | | 16(76.2) | 6(23.8) | |
| Extract 2.5% | 110 ng/ml | C95-20% | 16 | 5 | 21 | 50.1-86.2 | 10.6-45.1 | 76.2% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Horseradish
Extract 2.5% | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Parsnip | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| Extract 2.5% | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 16 | 5 | 21 | 16(76.2)
50.1-86.2 | 6(23.8)
10.6-45.1 | 76.2% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| Red radish
Extract
2.5% | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 16 | 5 | 21 | 16(76.2)
50.1-86.2 | 6(23.8)
10.6-45.1 | 76.2% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Turnip
Extract
2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |

20

21

Table 10: Summary - Drugs and Dietary Supplements

| Dietary
Supplements | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative
percent
agreement
(95 % CI) | Overall percentage
agreement |
|-------------------------------------------------|---------------------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|-----------------------------------------------|---------------------------------|
| Iron 0.5% | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positiv
e | 10 | 11 | 21 | 10(47.6)
28.3-67.6 | 11(52.4)
32.4-71.7 | 47.6% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%
positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5% positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%
positive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| Sodium
Lascorbate
0.5% | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% |
| | 120 ng/ml | 95%
positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5% positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%
positive | 12 | 9 | 21 | 12(57.1)
36.6-75.5 | 9(42.9)
24.5-63.4 | 57.1% |
| Bisacodyl
Enteric-
coated tablets
2.5% | 110 ng/ml | C95-20% | 16 | 5 | 21 | 16(76.2)
50.1-86.2 | 6(23.8)
10.6-45.1 | 76.2% |
| | 120 ng/ml | 95%
positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%
positive | 10 | 11 | 21 | 10(47.6)
28.3-67.6 | 11(52.4)
32.4-71.7 | 47.6% |
| Sennoside
tablets
2.5% | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| | 120 ng/ml | 95%
positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Glycerol
enema
2.5% | Ong/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positive | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%positive | 9 | 12 | 21 | 9(42.9)
24.5-63.5 | 12(57.1)
36.5-75.5 | 42.9% |
| | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| | 120 ng/ml | 95%positive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% |
| | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | Hydrogen
peroxide
enema
2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 |
| 80 ng/ml | | 5%positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| 100 ng/ml | | 50%positive | 10 | 11 | 21 | 10(47.6)
28.3-67.6 | 11(52.4)
32.4-71.7 | 47.6% |
| 110 ng/ml | | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| 120 ng/ml | | 95%positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| 140 ng/ml | | C95+20% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| 1000 ng/ml | | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |

22

23

Table 11: Summary - Other Contaminants

| Contaminants | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative percent
agreement
(95 % CI) | Overall
percentage
agreement |
|----------------------|-------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|--------------------------------------------|------------------------------------|
| | 0ng/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positi
ve | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 100 ng/ml | 50%posit
ive | 11 | 10 | 21 | 11(52.4)
32.4-
71.7 | 10(47.6)
28.3-
67.6 | 52.4% |
| Lime-A-Way
5mg/ml | 110 ng/ml | C95-20% | 16 | 5 | 21 | 16(76.2)
50.1-86.2 | 6(23.8)
10.6-45.1 | 76.2% |
| | 120 ng/ml | 95%posit
ive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |

24

| Contaminants | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative percent
agreement
(95 % CI) | Overall
percentage
agreement | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------|-------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|--------------------------------------------|------------------------------------|-------|------------|------------------|----|---|----|---------------------|---|------|--|--------|----------------|---|----|----|---|---------------------|------|--|----------|----------------|---|----|----|--------------------|----------------------|-------|
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 0ng/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 80 ng/ml | 5%positi
ve | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 100 ng/ml | 50%posit
ive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clorox 5mg/ml | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 120 ng/ml | 95%posit
ive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 0ng/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Lysol
Bleach
5mg/ml | 80 ng/ml | 5%positi
ve | 1 | 20 | 21 | 1 (4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 100 ng/ml | 50%posit
ive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4% | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 120 ng/ml | 95%posit
ive | 20 | 1 | 21 | 20(95.2)
77.3-99.2 | 1(4.8)
0.9-22.7 | 95.2% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | Ong/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% | | 80 ng/ml | 5%positi
ve | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% |
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Ong/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 80 ng/ml | 5%positi
ve | 1 | 20 | 21 | 1(4.8)
0.9-22.7 | 20(95.2)
84.5-100 | 95.2% | | | | | | | | | | | | | | | | | | | | | | | | | | | |

25

| Contaminants | Sample
concentration | Expected
result | Observed
positive
results | Observed
negative
results | Total
number | Positive
percent
agreement
(95 % CI) | Negative percent
agreement
(95 % CI) | Overall
percentage
agreement |
|--------------------------------|-------------------------|--------------------|---------------------------------|---------------------------------|-----------------|-----------------------------------------------|--------------------------------------------|------------------------------------|
| Lysol
Cleaner
5mg/ml | 100 ng/ml | 50%posit
ive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4% |
| | 110 ng/ml | C95-20% | 14 | 7 | 21 | 14(66.7)
50.1-86.2 | 7(33.3)
13.8-50 | 66.7% |
| | 120 ng/ml | 95%posit
ive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| Scrubbing
Bubbles
5mg/ml | 0ng/ml | 0%
positive | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 80 ng/ml | 5%positi
ve | 0 | 21 | 21 | 0 | 21(100)
84.5-100 | 100% |
| | 100 ng/ml | 50%posit
ive | 11 | 10 | 21 | 11(52.4)
32.4-71.7 | 10(47.6)
28.3-67.6 | 52.4
% |
| | 110 ng/ml | C95-20% | 15 | 6 | 21 | 15(71.4)
50.1-86.2 | 6(28.6)
13.8-50 | 71.4
% |
| | 120 ng/ml | 95%posit
ive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 140 ng/ml | C95+20
% | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |
| | 1000 ng/ml | 100%
positive | 21 | 0 | 21 | 21(100)
84.5-100 | 0 | 100% |

26

Sample Collection Study

Twenty Laypersons were recruited to collect the human fecal samples of negative (Hemoglobin-free) and positive (known Hemoglobin concentration: 1000ng/mL) into the fecal sample collection tube of Accu-Reader™ A100 according to the Instructions For Use (IFU). Hemoglobin negative and hemoglobin positive human fecal samples were prepared. Five positive and five negative samples were collected by each layperson for a total of 200 samples (100 positive and 100 negative). The sample collection tubes loaded with the fecal sample were tested on the Accu-Reader™ A100 after weighing and calculating the weight of feces in sample collection tubes. The results of the sample collection study show a high degree of accuracy of results and consistency of the amount of stool collected.

Specimen Stability Studies

Stool samples were spiked with several concentrations of human hemoglobin and stored in the Sample Collection tube at different temperatures for up to 30 days after sampling. Testing was then performed on the Accu-Reader™ A100 according to the instructions for use. Twenty-one replicates of each of the following hemoglobin concentrations were tested: 0 ng/mL, 100 nq/mL, 110 ng/mL, 120 ng/mL, 140 ng/mL and 1000 ng/mL. Three kit lots were included in the testing. The temperature at which the samples were stored were 2-8ºC, -10- (-)20ºC, 30 ºC and 40 ºC.

Based on the test results, the data demonstrates that the devices of Accu-Reader are within acceptable criteria and the agreement over 95%. It is noted that sample storage at 40°C did begin to show false negative results when stored for 15 days. The fecal sample in collection tube will be stored at 30°C and 40°C no more than 14 days after sampling.

Shipping Studies

The shipping study was conducted to evaluate the shipping stress to the sample and test kit and their endurance under extreme temperatures. Fecal samples contained in sample collection buffer tubes and unused Accu-Reader™ A100 sample collection buffer tubes and cartridges (containing no fecal samples) were stored under extreme temperatures up to 5 days. Test point 0 days, 3 days and 6 days. The four temperature points of -10°C, 2~8°C, 25°C and 40°C were adopted in this shipping study. There were 21 replicates at each of the seven concentrations. There was one operator, one site, one device, and one lots of the Accu-Reader™ A100 test kits employed in this study.

The tested data demonstrates that the sample result passed the acceptance criteria and the agreement is more than 95%.

Stability Studies - Accelerated Stability Studies

The study was conducted to support the shelf life of Accu-Reader™ A100 test kits up to 24 months at room temperature. Accelerated stability study was conducted with three lots of Accu-Reader™ A100 test kits. Test kits were stored at 45℃ for 75 days and six test points adopted: 0 days, 40 days, 55 days, 65 days and 76 days. The 21 replicates for each concentration with seven known levels (0 ng/mL, 80 ng/mL, 100 ng/mL, 120 ng/mL, 140 ng/mL, 1000 ng/mL, 1000 ng/mL) of human hemoglobin were prepared for using to the study. Device test kits were stored at 45℃ for 75 days duration and temperature translate to 24 months of stability at room temperature (25°C). Hemoglobin standard concentration: 0, 80, 100, 110, 120, 140 and 1000 ng/mL, with 21 aliquots respectively.

Based on the tested results, the data supported the shelf life of Accu-Reader™ A100 test kits up to 24 months at room temperature.

27

Stability Studies - Real Time

The real time stability study was conducted to verify the test kits are stable up to 36 months when stored at temperatures between 4°C and 30°C. The on-going real time study has completed studies up to 18 months.

The study was conducted with 3 different lots of Hemosure® Accu-Reader™ A100 test kits (test cartridge and sample tube). Measurements were performed at day 0, after 12 months, 24 months, and 30 months using stool samples spiked with the seven known concentrations of human hemoglobin (0, 80, 100, 110, 120, 140, and 1000 ng/ml). The samples were measured in 21 replicates. The test results showed that the Hemosure® Accu-Reader™ A100 test kits (test cartridge and sample tube) are stable for 24 months at 4-30°C.

Clinical Performance: Method Comparison Study

A clinical method comparison study was performed in order to demonstrate the equivalency between Hemosure Accu-Reader™ A100 automated fecal occult blood detection device and a predicate device.

A total of 377 clinical fecal samples were collected from individuals who had previously been screened by colonoscopy in the recent past. The Accu Reader™ A100's capability and consistency were tested and compared against a predicate device. Patient samples were tested side-by-side in the Accu Reader™ A100 and the predicate device with human stool samples reconstituted in buffer. The machines processed these samples screening for human hemoglobin in the stools, and the Accu Reader™ A100 has shown to be well in agreement regarding its sensitivity to hemoglobin relative to the predicate device.

Table 12: Number of clinical fecal samples tested during clinical method comparison study of Accu-Reader A100

Study Site	Clinical samples tested by site & unique operator
	Operator 1			Operator 2			Operator 3			Operator 1+2+3
	Positive	Negative	Total	Positive	Negative	Total	Positive	Negative	Total	Positive	Negative	Total
Site 1	31	11	42	17	6	23	13	40	53	60	58	118
Site 2	36	29	65	25	25	50	19	5	24	80	59	139
Site 3	2	38	40	5	35	40	0	40	40	7	113	120
Total										147	230	377

Table 13: Statistical analysis of clinical method comparison study of Accu-Reader™ A100

| Study site | OC-Auto
Micro FOB | Accu-Reader™ A100 | | | Overall Percent
Agreement | Positive Percent
Agreement (95% CI) | Negative Percent
Agreement (95% CI) |
|------------|----------------------|-------------------|----------|-------|------------------------------|----------------------------------------|----------------------------------------|
| | | Positive | Negative | Total | | | |
| Site 1 | Positive | 59 | 1 | 60 | 98.31%
(94.03%~99.54%) | 98.33%
(91.15%~99.70%) | 98.27%
(90.76%~99.96%) |
| | Negative | 1 | 57 | 58 | | | |
| | Total | 60 | 58 | 118 | | | |
| Site 2 | Positive | 78 | 1 | 79 | 97.84%
(94.21%~98.90%) | 97.5%
(90.14%~99.31%) | 93.22%
(91.01%~99.70%) |

28

| Study site | OC-Auto
Micro FOB | Accu-Reader™ A100 | | | Overall Percent
Agreement | Positive Percent
Agreement (95% CI) | Negative Percent
Agreement (95% CI) |
|------------|----------------------|-------------------|-----|-----|------------------------------|----------------------------------------|----------------------------------------|
| | Negative | 2 | 58 | 60 | | | |
| | Total | 80 | 59 | 139 | | | |
| | | | | | | | |
| Site 3 | Positive | 7 | 0 | 7 | 100%
(96.23%~100%) | 100%
(56.96%~100%) | 100%
(96.01%100%) |
| | Negative | 0 | 113 | 113 | | | |
| | Total | 7 | 113 | 120 | | | |
| Total | Positive | 144 | 2 | 146 | 98.67%
(96.9399.43%) | 98.63%
(93.51%~99.97%) | 98.71%
(96.87%~99.76%) |
| | Negative | 3 | 228 | 231 | | | |
| | Total | 147 | 230 | 377 | | | |
| | | | | | | | |

The Accu-Reader™ A100's capability and consistency were tested and compared against a predicate device. Patient samples were tested side-by-side in the Accu-Reader™ A100 and the predicate device with human stool samples reconstituted in buffer. For a total of 377 samples between the results obtained with the device and the predicate, the overall percent agreement (OPA) was 98.67% (96.93%-99.43%), with positive percent agreement (PPA) 98.63% (93.51%-99.97%), and negative percent acreement (NPA) 98.71% (96.87%-99.76%). As our agreements are above 98%, the machines processed these samples screening for human hemoglobin in the stools, and the Accu-Reader™ A100 has shown to be well in agreement regarding its sensitivity to hemoglobin relative to the predicate device.

Cybersecurity

Hemosure® Accu-Reader™ A100 reader has USB and network capabilities. Data security vulnerability was evaluated and mitigation to risks were incorporated into the device software.

Electromagnetic Compatibility (EMC)

IEC 61326-1:2005, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements. Edition 2.0 was published in 2012. It was also tested to the IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests.

29

Clause	Description	Test	Results
4.1.1	Harmonics on AC Mains	IEC 61000-3-2:2005+A1+A2	Pass
4.1.2	Voltage Changes, Voltage Fluctuations and
Flicker on AC Mains	IEC 61000-3-3:2008	Pass
4.1.3	Mains Terminal Continuous Disturbance
Voltage	IEC61326-1:2012, IEC 61326-2-
6:2012	Pass
4.2.1	Radiated Electromagnetic Field Emission	IEC 61326-1:2012, IEC 61326-2-
6:2012	Pass
5.1.1	Electrostatic Discharge	IEC 61000-4-2:2008	Pass
5.1.2	Radio Frequency Electromagnetic Field Immunity Test	IEC 61000-4-3:2006+A1+A2	Pass
5.1.3	Proximity Fields From RF Wireless Communication
Equipment	IEC 61000-4-8:2009	Pass
5.1.4	Power Frequency Magnetic Field	IEC 61000-4-8:2009	Pass
5.2.1	Electrical Fast Transients on AC Power Line, Signal
Line and Interconnecting Line	IEC 61000-4-4:2004+A1	Pass
5.2.2	Conducted Disturbances Induced by RF Fields Into
AC Power Line, Signal Line and Patient
Coupling Line	IEC 61000-4-5:2005	Pass
5.2.3	Surges to AC Power Port. Signal Line and
Interconnecting Line	IEC 61000-4-6: 2008	Pass
5.2.4	Voltage Dips and Interruptions to AC Power Port	IEC 61000-4-11:2004	Pass
5.2.5	Safety Standard For Medical Devices	IEC 60601-1:2010+
CORR.1(2011)+CORR.2(2013)
ANSI/AAMI ES 60601 1:2005+
A2(R2012)+A1	Pass
5.2.6	Radiated Electromagnetic Field Emission	IEC 60601-1-2:2014	Pass

Table 14: EMC Testing Summary

Conclusion

Hemosure Accu-Reader™ A100 does not constitute a new intended use and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and as effective as the predicate and does not raise new questions of safety and effectiveness.