(801 days)
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.
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.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Hemosure Accu-Reader A100 device:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state a single, overarching acceptance criterion as a numerical threshold (e.g., "accuracy > 95%"). Instead, it demonstrates acceptable performance across various studies (precision, cross-reactivity, interference, stability, clinical performance) by consistently achieving high levels of "agreement" and confirming expected results. The primary measure used to show effectiveness, particularly in the clinical method comparison, is the "Overall Percent Agreement (OPA)," "Positive Percent Agreement (PPA)," and "Negative Percent Agreement (NPA)" with a predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | High Positive Percentage Agreement (PPA) and Negative Percentage Agreement (NPA) across different conditions (intra-assay, inter-site, between-run, between-instrument, lot-to-lot). Consistent expected results for various hemoglobin concentrations. | Intra-Assay: PPA 98.86%, NPA 98.31%Between-run: OPA 99.09%, PPA 99.25%, NPA 98.84%Between-Instrument: OPA 99.09%, PPA 99.25%, NPA 98.86%Lot-to-Lot: OPA 99.32%, PPA 99.63%, NPA 98.84%Between-site: OPA 99.32%, PPA 99.44%, NPA 99.13%All concentrations showed expected positive/negative trends with high agreement. |
| Assay Cut-off Performance | Overall percent agreement of more than 95% with predicate device at the analytical cut-off. | Overall percent agreement > 95% with predicate device. |
| Prozone (Hook) Effect | No false negatives at high concentrations up to 3000 ng/mL. | No false negatives up to 3000 ng/mL. |
| Analytic Sensitivity (hHb variant) | Ability to detect human hemoglobin-S variant. | Found to be sensitive to Hb-S variant at various concentrations (e.g., 95% positive at 120 ng/mL, 100% positive at 140 ng/mL). |
| Cross-Reactivity (Animal Hemoglobin) | No significant cross-reactivity with common animal hemoglobin (ovine, poultry, fish, horse, goat, pig, rabbit, sheep). | No significant cross-reactivity observed, with high OPA, PPA, and NPA for all tested animal hemoglobins (e.g., OPA > 98% in all cases). |
| Interfering Substances | No significant interference from meat extracts, dietary substances, vegetable extracts, toilet water, and contaminants. | No significant interference observed for all tested substances, with high OPA, PPA, and NPA typically above 95%. |
| Sample Collection | High degree of accuracy of results and consistency of stool collected by laypersons. | Demonstrated high accuracy and consistency (specific quantitative metrics not provided but implied as acceptable). |
| Specimen Stability | Samples remain stable and device accuracy maintained over specified storage conditions and durations. | Agreement over 95% for samples stored at 2-8°C, -10-(-)20°C, 30°C for up to 30 days. Noted false negatives at 40°C after 15 days, leading to specific storage guidance (no more than 14 days at 30°C and 40°C). |
| Shipping Stability | Samples remain stable and device accuracy maintained after shipping stress under extreme temperatures. | Agreement over 95% for samples after shipping stress for up to 6 days at -10°C, 2-8°C, 25°C, and 40°C. |
| Accelerated Stability (Kit) | Support of a 24-month shelf life at room temperature. | Data supported 24-month shelf life at room temperature (based on 75 days at 45°C). |
| Real-Time Stability (Kit) | Test kits are stable up to 36 months when stored at 4-30°C. | Test kits stable for 24 months at 4-30°C (ongoing study for 36 months). |
| Clinical Performance | High overall, positive, and negative percent agreement with a legally marketed predicate device. | Overall: OPA 98.67% (96.93%-99.43%)Positive: PPA 98.63% (93.51%-99.97%)Negative: NPA 98.71% (96.87%-99.76%). Agreements are above 98%. |
| Cybersecurity | Data security vulnerability evaluated and risks mitigated. | Evaluation done, mitigations incorporated (details not provided). |
| EMC | Device meets international standards for electromagnetic compatibility. | Passed all specified IEC 61326-1 and IEC 60601-1-2 standards tests. |
2. Sample Size Used for the Test Set and Data Provenance:
-
Clinical Performance Study:
- Sample Size: A total of 377 clinical fecal samples were used.
- Data Provenance: The samples were collected from individuals who had previously been screened by colonoscopy. The study was conducted at three different sites, indicating a likely prospective or retrospective multi-center clinical study setup, although the document does not definitively state "prospective" or "retrospective." The samples are human fecal samples. The country of origin is not explicitly stated.
-
Other Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity):
- The test set for each of these studies used 21 replicates for each concentration (spanning various hemoglobin levels, including negative controls, around the cut-off, and high positive).
- Data Provenance: These studies generally involved contrived or spiked samples (e.g., human hemoglobin, animal hemoglobin, interfering substances spiked into fecal samples). The provenance of the base fecal samples or the location of these analytical studies is not explicitly stated, but they are laboratory-based analytical studies rather than clinical field studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
-
For the Clinical Performance Study, the ground truth appears to be based on a legally marketed predicate device (OC-Auto Micro FOB Test) and "individuals who had previously been screened by colonoscopy." The document does not specify the number or qualifications of experts (e.g., radiologists, gastroenterologists, pathologists) who established the ground truth from the colonoscopy results. It's implied that the findings from the colonoscopy were used to determine the true positive/negative status for fecal occult blood, which was then compared to the device and predicate.
-
For the Analytical Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity), the "ground truth" for the test samples was established by preparing samples with known concentrations of human hemoglobin (or other substances). This is a controlled laboratory setting, so "experts" in the sense of clinical reviewers for ground truth are not applicable here. The known concentrations themselves served as the ground truth.
4. Adjudication Method for the Test Set:
- The document does not describe an explicit adjudication method for the clinical study test set in terms of human expert review. The comparison is made against a "predicate device" and implied "colonoscopy" results.
- For the analytical studies, the "ground truth" was established by the known concentrations of spiked analytes, so adjudication was not necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No, a standard MRMC comparative effectiveness study, where human readers interpret cases with and without AI assistance to measure improvement, was not conducted.
- This device, the Hemosure Accu-Reader A100, is an automated immunochemical fecal occult blood test system. It is designed for qualitative detection of fecal occult blood in human feces by clinical laboratories, with results read by a camera-based reader and displayed as "positive, negative or invalid." It is an in vitro diagnostic device, not an image interpretation AI system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, this was a standalone performance study. The Hemosure Accu-Reader A100 is an automated system. Its "performance characteristics" (precision, analytical sensitivity, cross-reactivity, interference, stability, and clinical comparison to a predicate) reflect the algorithm's performance in analyzing the test cartridge without human intervention in the result interpretation. The reader (machine) identifies and provides qualitative determination of human hemoglobin.
7. The Type of Ground Truth Used:
- For the Clinical Performance Study: The ground truth was based on the performance of a predicate device (OC-Auto Micro FOB Test) and, implicitly, outcomes data from colonoscopy screenings.
- For Analytical Studies (Precision, Prozone, Analytic Sensitivity, Cross-Reactivity, Interfering Substances, Specimen and Shipping Stability, Accelerated and Real-Time Kit Stability): The ground truth was known concentrations of spiked human hemoglobin (or other substances like animal hemoglobin or interfering agents) in fecal samples. These are essentially controlled experimental conditions.
8. The Sample Size for the Training Set:
- The document does not provide information on a training set size. As an in vitro diagnostic device, this typically refers to a specific assay method and an automated reader. While the reader uses digital imaging to analyze lines, it's not described as a deep learning or traditional machine learning system requiring a large "training set" in the common sense for AI algorithms. The system's "training" would be more akin to calibration and optimization of its optical analysis and interpretation logic, rather than iterative learning from a large labeled dataset. The various analytical studies validate its performance but are not explicitly referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Since a "training set" in the context of an AI algorithm is not explicitly mentioned or implied for this device, the method for establishing its ground truth is not applicable/not provided. The device relies on a pre-defined sandwich dye conjugate immunoassay principle and a calibrated optical system.
{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
{3}------------------------------------------------
510(k) Summary
510(k) Submitter Information:
| Name: | W.H.P.M., Inc. |
|---|---|
| Chief Executive: | John Wan, CEO |
| Address | 5358 North Irwindale AvenueIrwindale, 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 AvenueIrwindale, 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™ A100Automated Occult Blood ReaderOccult Blood Test (21 CLR 864.6550)OOX |
|---|---|
| Device Class: | Class II |
| 510(k) Number: | K200754 |
Predicate Device Information:
| K Number | Device Trade Name | Manufacturer |
|---|---|---|
| PrimaryK041408 | OC AUTO MICRO FOB Test and OC Auto Micro80Analyzer | POLYMEDCO,Inc. |
| ReferenceK041202 | 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:
-
- 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 DeviceW.H.P.M.,Inc. | Predicate DevicePOLYMEDCO,Inc. |
|---|---|---|
| Similarities | ||
| K Number | K200754 | K041408 |
| Brand name | Hemosure® Accu-Reader™ A100 | OC AUTO MICRO FOB Test and OCAuto Micro 80 Analyzer TEST |
| Intended Use | Hemosure® Accu-Reader™ A100 isan automated immunochemical fecaloccult blood test system intended forthe qualitative detection of fecaloccult blood in human feces byclinical laboratories.Hemosure® Accu-Reader™ A100 iscomprised of Hemosure® Accu-Reader™ A100 Reader with SampleTray, Hemosure Accu-Reader™A100 Test Cartridge, SampleCollection tube, Hemosure® Accu-Reader™ A100 Control and | The Polymedco OC Auto Micro 80Analyzer and OC Auto Micro FOB Testare designed to be used together asan immunological test system intendedfor the qualitative detection of fecaloccult blood in feces by professionallaboratories. The automated test isuseful for the determination ofgastrointestinal (GI) bleeding, found ina number of gastrointestinal (GI)disorders, e.g., colitis, polyps, andcolorectal cancer. |
| Description | New DeviceW.H.P.M.,Inc. | Predicate DevicePOLYMEDCO,Inc. |
| Hemosure® Accu-Reader™ A100Calibration Cartridge Kit.For in vitro diagnostic use. | ||
| For Prescription use. | ||
| Product Code | OOX | OOX |
| Intended useenvironment | 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 conjugateimmunoassay for qualitativedetection of fecal occult blood infeces | Automated immunoassay using latexfixation for qualitative detection of fecaloccult blood in feces |
| Sampling andSampleProcessing | Sampling is done with the help of thestool collection rod which is a part ofthe Sample Collection tube. The fecalsample is delivered into the samplingtube containing the buffer whichextracts it. | Sampling is done with the help ofthe Sampling Probe which is a partof the OC-Auto Sampling Bottle.The fecal sample is delivered intothe sampling bottle containing thebuffer which extracts it. |
| Assay Results | Qualitative | Qualitative |
| Assay Cut-off | 100ng/mL(Human hemoglobin in fecesprocessed in extraction buffer) | 100 ng/mL(Human hemoglobin in fecesprocessed in extraction buffer) |
| Test Time | 5-10 minutes | 5-10 minutes |
| Presentation ofTest results | Qualitative (Positive or Negative) | Qualitative (Positive or Negative) |
| Differences | ||
| Description | New DeviceW.H.P.M.,Inc. | Predicate DevicePOLYMEDCO,Inc. |
| Test Principle | Automated sandwich dye conjugateimmunoassay that employs acombination of monoclonal andpolyclonal antibodies to selectivelyidentify and provide qualitativedetermination of human hemoglobinin feces. As the test sample flows upthrough the absorbent device, thelabeled antibody-dye conjugate bindsto the hemoglobin in the specimenforming an antibody-antigen complex.This complex binds to anti-hemoglobin antibody in the positivetest reaction zone and produces apink-rose color band. In the absenceof hemoglobin, there is no line in thepositive test reaction zone. The pink-rose color bands in the controlreaction zone demonstrate that thereagents and devices are functioningcorrectly. | Automated immunoassay using latexfixation for qualitative detection of fecaloccult blood in feces. |
| DetectionMechanism | Camera-based analysis of asandwich dye conjugateimmunoassay. | Optical measurement of agglutinationof latex particles |
| TestThroughput/Time | 100 samples/hour | 80 samples/hour |
| Calibration | A test cartridge with definedstandard gray color intensity on its Tzone is read by the Accu-Reader™A100 and adjustment is madeaccording to this standard gray scaleintensity. | Calibrator containing hHb A0 isserially diluted prior to analysis toconstruct 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 DeviceK041202 |
|---|---|---|
| Similarities | ||
| Brand name | Hemosure® Accu-Reader™ A100 TestCartridge | Hemosure™ One-Step Fecal OccultBlood (FOB) Test; Occult BloodTest |
| IntendedUse/Indicationsfor Use | Hemosure® Accu-Reader™ A100 isan automated immunochemical fecaloccult blood test system intended forthe qualitative detection of fecaloccult blood in human feces byclinical laboratories.Hemosure® Accu-Reader™ A100 iscomprised of Hemosure® Accu-Reader™ A100 Reader with SampleTray, Hemosure Accu-Reader™A100 Test Cartridge, SampleCollection tube, Hemosure® Accu-Reader™ A100 Control andHemosure® Accu-Reader™ A100Calibration Cartridge Kit.For in vitro diagnostic use.For Prescription use. | The Hemosure™ One-Step FecalOccult Blood (FOB) Test is animmunochemical device intended forthe qualitative detection of FecalOccult Blood by laboratories orphysicians offices. It is useful todetermine gastrointestinal(GI)bleeding found in a number of GIdisorders, e.g. diverticulitis, colitis,polyps, and colorectal cancer. |
| ClassificationCode | OOX | KHE |
| Description | Subject Device | Reference Device |
| K041202 | ||
| Test principle | Qualitative, sandwich dye conjugateimmunoassay and employs acombination of monoclonal andpolyclonal antibodies to selectivelyidentify hemoglobin in test samples.As the test sample flows up throughthe absorbent device, the labeledantibody- dye conjugate binds to thehemoglobin in the specimen formingan antibody- antigen complex. Thiscomplex binds to anti-hemoglobinantibody in the positive test reactionzone and produces a pink-rose colorband. In the absence of hemoglobin,there is no line in the positive testreaction zone. The pink-rose colorbands in the control reaction zonedemonstrate that the reagents anddevices are functioning correctly | Qualitative, sandwich dye conjugateimmunoassay and employs acombination of monoclonal andpolyclonal antibodies to selectivelyidentify hemoglobin in test samples. Asthe test sample flows up through theabsorbent device, the labeled antibody-dye conjugate binds to the hemoglobin inthe specimen forming an antibody-antigen complex. This complex binds toanti-hemoglobin antibody in the positivetest reaction zone and produces a pink-rose color band. In the absence ofhemoglobin, there is no line in thepositive test reaction zone. The pink-rosecolor bands in the control reaction zonedemonstrate that the reagents anddevices are functioning correctly |
| Test Device | Test Cartridge (test strip enclosed in aplastic housing) and sample tube. | Test Cassette (test strip enclosed in aplastic housing) and sample tube. |
| TestComponents | Accu-Reader™ A100 TestCartridge;Sample Collection Tube;Controls- Positive and NegativeSolutions | Test Cassette individually sealed in a foilpacket pouch, containing mouse MAB andsheep PAB, directed against humanHemoglobin (hHb) and;Buffer, "Limit Fecal Sample Collection"extraction buffer, 2.0 mL.Controls- Positive and Negative Solutions |
| Sampling andSampleProcessing | Samplings is done with theapplicator stick which is part of theSample Collection Tube | Samplings is done with the applicator stickwhich is part of theBuffer, "Limit Fecal Sample Collection"tube |
| Assay results | Qualitative | Qualitative |
| Assay Cut-off | 100 ng/mL(Human hemoglobin in fecesprocessed in extraction buffer) | 100 ng/mL(Human hemoglobin in feces processedin extraction buffer) |
| Detectionmechanism | Camera-based analysis of asandwich dye conjugate | Manual observation of a pink-rosecolor band |
| Description | Subject Device | Reference DeviceK041202 |
| Test cassette | Individually sealed in a foil pouch,containing a combination of mouseMAB and sheep or goat PAB,directed against humanhemoglobin (hHb); | Individually sealed in a foil pouch,containing a combination of mouseMAB and sheep or goat PAB, directedagainst human hemoglobin (hHb); |
| Specimencollector | Fecal Collection Tube ofextraction buffer. (2.0 mL) | Fecal Collection Tube of extractionbuffer. (2.0 mL) |
| Controls,Positive andNegative | 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 | Sampleconcentration | Observed Results | PositivePercent(95% CI) | NegativePercent(95% CI) | OverallPercentageAgreement | ||
|---|---|---|---|---|---|---|---|
| Site 1 | 0 ng/ml | 0 | 21 | 21 | 0 | 100%(84.5%-100%) | 100% |
| 80 ng/ml | 0 | 21 | 21 | 0 | 100% | 100% | |
| Site | Sampleconcentration | Observed Results | PositivePercent(95% CI) | NegativePercent(95% CI) | OverallPercentageAgreement | ||
| 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% | |
| Sampleconcentration | Observed Results | PositivePercent(95% CI) | NegativePercent(95% CI) | OverallPercentageAgreement | |||
| 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% | |
| Allsites | 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
| SampleConcentration | 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}------------------------------------------------
| SampleConcentration | 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
| PrecisionStudy | ObservedResults | Expected Results | Overall PercentAgreement | Positive PercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||
| Repeatability | PositiveResults | 87 | 1 | 88 | 98.63% | 98.86%(93.84%~99.80%) | 98.31%(90.91%~99.70%) |
| NegativeResults | 1 | 58 | 59 | ||||
| Total Results | 88 | 59 | 147 | ||||
| Between-runReproducibility | PositiveResults | 266 | 2 | 268 | 99.09%(97.69%~99.75%) | 99.25%(97.33%~99.91%) | 98.84%(95.89%~99.86%) |
| NegativeResults | 2 | 171 | 173 | ||||
| Total Results | 268 | 173 | 441 | ||||
| BetweenInstrumentReproducibility | PositiveResults | 264 | 2 | 266 | 99.09%(97.69%~99.75%) | 99.25%(97.31%~99.78%) | 98.86%(95.93%~99.86%) |
| NegativeResults | 2 | 173 | 175 | ||||
| Total Results | 266 | 175 | 441 | ||||
| Lot-to-LotReproducibility | PositiveResults | 268 | 2 | 270 | 99.32% | 99.63%(97.92%~99.93%) | 98.84%(95.86%~99.69%) |
| NegativeResults | 1 | 170 | 171 | ||||
| Total Results | 269 | 172 | 441 |
{14}------------------------------------------------
| PrecisionStudy | ObservedResults | Expected Results | Overall PercentAgreement | Positive PercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| Between-siteReproducibility | PositiveResults | 356 | 2 | 358 | 99.32% | 99.44%(98.00%~99.93%) | 99.13%(96.89%~99.89%) |
| Between-siteReproducibility | NegativeResults | 2 | 228 | 230 | |||
| Between-siteReproducibility | 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/mlPos/Neg(% Pos) | 80ng/mLPos/Neg(% Pos) | 100ng/mLPos/Neg(% Pos) | 110ng/mLPos/Neg(% Pos) | 120ng/mLPos/Neg(% Pos) | 140ng/mLPos/Neg(% Pos) | 1000ng/mLPos/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 | OverallPercentAgreement | PositivePercentAgreement | NegativePercentAgreement | ||
|---|---|---|---|---|---|---|---|
| Accu-Reader™A100 | PositiveResults | NegativeResults | TotalResults | ||||
| Bovine Hemoglobin 500µg/ml | Positive Results | 84 | 1 | 85 | 98.6% | 98.8% | 98.4% |
| Negative Results | 1 | 61 | 62 | ||||
| Total Results | 85 | 62 | 147 | ||||
| Equine Hemoglobin 500µg/ml | Positive Results | 88 | 1 | 89 | 98.6% | 98.9% | 98.3% |
| Negative Results | 1 | 57 | 58 | ||||
| Total Results | 89 | 58 | 147 | ||||
| Goat Hemoglobin500 µg/ml | Positive Results | 88 | 0 | 88 | 100% | 100% | 100% |
| Negative Results | 0 | 59 | 59 | ||||
| Total Results | 88 | 59 | 147 | ||||
| Porcine Hemoglobin 500µg/ml | Positive Results | 88 | 1 | 89 | 98.6% | 98.9% | 98.3% |
| Negative Results | 1 | 57 | 58 | ||||
| Total Results | 89 | 58 | 147 | ||||
| Sheep Hemoglobin 500µg/ml | Positive Results | 89 | 0 | 89 | 99.3% | 98.9% | 100% |
| Negative Results | 1 | 57 | 58 | ||||
| Total Results | 90 | 57 | 147 | ||||
| Turkey Hemoglobin 500µg/ml | Positive Results | 89 | 1 | 90 | 98.6% | 98.9% | 98.2% |
| Negative Results | 1 | 56 | 57 | ||||
| Total Results | 90 | 57 | 147 | ||||
| Fish Hemoglobin500 µg/ml | Positive Results | 89 | 1 | 90 | 99.3% | 100% | 98.3% |
| Negative Results | 0 | 57 | 57 | ||||
| Total Results | 89 | 58 | 147 | ||||
| Rabbit Hemoglobin 500µg/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.
| MeatExtracts | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overallpercentageagreement |
|---|---|---|---|---|---|---|---|---|
| 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% | |
| MeatExtracts | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overallpercentageagreement |
| Beef MeatExtract2.5% | 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 MeatExtract2.5% | 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 MeatExtract 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% | |
| MeatExtracts | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overallpercentageagreement |
| HorseMeatExtract2.5% | 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 MeatExtract2.5% | 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% | |
| RabbitMeatExtract | 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% | |
| MeatExtracts | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overallpercentageagreement |
| 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% | |
| LambMeatExtract2.5% | 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% | |
| ChickenMeatExtract2.5% | 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}------------------------------------------------
| VegetableExtracts | Sampleconcentration n | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overallpercentageagreement |
|---|---|---|---|---|---|---|---|---|
| BroccoliExtract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)84.5-100 | 100% |
| BroccoliExtract 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% |
| BroccoliExtract 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% |
| BroccoliExtract 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% |
| BroccoliExtract 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% |
| BroccoliExtract 2.5% | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
| BroccoliExtract 2.5% | 1000 ng/ml | 100%positive | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
| CantaloupeExtract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)84.5-100 | 100% |
| CantaloupeExtract 2.5% | 80 ng/ml | 5%positive | 0 | 21 | 21 | 0 | 21(100)84.5-100 | 100% |
| CantaloupeExtract 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% |
| CantaloupeExtract 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% |
| CantaloupeExtract 2.5% | 120 ng/ml | 95%positive | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
| CantaloupeExtract 2.5% | 140 ng/ml | C95+20% | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
| CantaloupeExtract 2.5% | 1000 ng/ml | 100%positive | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
| CantaloupeExtract 2.5% | 0ng/ml | 0% positive | 0 | 21 | 21 | 0 | 21(100)84.5-100 | 100% |
| CantaloupeExtract 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% |
| CantaloupeExtract 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% | |
| HorseradishExtract 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 radishExtract2.5% | 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% | |
| TurnipExtract2.5% | 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
| DietarySupplements | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negativepercentagreement(95 % CI) | Overall percentageagreement |
|---|---|---|---|---|---|---|---|---|
| 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%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% | 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% | |
| SodiumLascorbate0.5% | 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% | |
| BisacodylEnteric-coated tablets2.5% | 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% | |
| Sennosidetablets2.5% | 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% | |
| Glycerolenema2.5% | 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% | |
| Hydrogenperoxideenema2.5% | 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 | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negative percentagreement(95 % CI) | Overallpercentageagreement |
|---|---|---|---|---|---|---|---|---|
| 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% | |
| Lime-A-Way5mg/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%positive | 21 | 0 | 21 | 21(100)84.5-100 | 0 | 100% |
{24}------------------------------------------------
| Contaminants | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negative percentagreement(95 % CI) | Overallpercentageagreement | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% | ||||||||||||||||||||||||||||
| 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%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% | ||||||||||||||||||||||||||||
| LysolBleach5mg/ml | 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% | 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% | ||||
| 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% |
{25}------------------------------------------------
| Contaminants | Sampleconcentration | Expectedresult | Observedpositiveresults | Observednegativeresults | Totalnumber | Positivepercentagreement(95 % CI) | Negative percentagreement(95 % CI) | Overallpercentageagreement |
|---|---|---|---|---|---|---|---|---|
| LysolCleaner5mg/ml | 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 | 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% | |
| ScrubbingBubbles5mg/ml | 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% | |
| 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% |
{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-AutoMicro FOB | Accu-Reader™ A100 | Overall PercentAgreement | Positive PercentAgreement (95% CI) | Negative PercentAgreement (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-AutoMicro FOB | Accu-Reader™ A100 | Overall PercentAgreement | Positive PercentAgreement (95% CI) | Negative PercentAgreement (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%(96.93~99.43%) | 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 andFlicker on AC Mains | IEC 61000-3-3:2008 | Pass |
| 4.1.3 | Mains Terminal Continuous DisturbanceVoltage | 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 CommunicationEquipment | 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, SignalLine and Interconnecting Line | IEC 61000-4-4:2004+A1 | Pass |
| 5.2.2 | Conducted Disturbances Induced by RF Fields IntoAC Power Line, Signal Line and PatientCoupling Line | IEC 61000-4-5:2005 | Pass |
| 5.2.3 | Surges to AC Power Port. Signal Line andInterconnecting 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.
§ 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.