(273 days)
OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is a qualitative test intended for the immunochemical detection of fecal occult blood (FOB) by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected. OC-Light S FIT is recommended for use in routine physical examinations.
OC-Light S FIT is an in vitro diagnostic device, a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. OC-Light S FIT consists of a test strip, and a sampling bottle containing buffer solution. OC-Light S FIT test strip consists of a nitrocellulose membrane with immobilized mouse monoclonal antibodies specific to human hemoglobin at the test region and immobilized rabbit anti-mouse antibodies at the control region, a sample pad, a conjugate pad which contains human hemoglobin specific mouse monoclonal antibodies conjugated with colloidal gold, an absorption pad, and a plastic backing. OC-Light S FIT sampling bottle is a plastic bottle for collecting fecal sample containing 2.0 mL of extraction buffer. When the sample end of the test strip is dipped in the fecal extract, the liquid fecal extract wicks through a series of absorbent materials and contacts colloidal gold conjugated with monoclonal antibodies specific to hHb. If hHb is present in the sample, it reacts with the antibodies on the colloidal gold. When the gold conjugate with hHb reaches the test region of the membrane, it binds with the immobilized antibodies also specific to hHb to form a visible reddish/pink line. The procedural control region of the membrane contains immobilized anti-mouse antibodies that capture the conjugate independent of the presence of the hHb, thereby always producing a distinct reddish/pink line. The reddish/pink line in the procedural control region demonstrates the validity of the test, and assures the operator that the device is working properly.
Here's an analysis of the acceptance criteria and study details for the OC-Light S FIT device based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold but rather presents performance data and concludes substantial equivalence based on comparisons. For this table, I'll extract the key performance metrics and the overall conclusion of substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (OC-Light S FIT) |
|---|---|---|
| Cut-off Value | No significant difference from predicate (10 µg Hb/g stool or 50 ng/mL buffer) | Established at 10 µg Hb/g stool (50 ng/mL buffer). 100.0% positive at this cut-off. Overall agreement with expected results: 99.3% (95% CI 96.2 ~ 100.0%). |
| Reaction Time | Timely and accurate detection (e.g., 50 ng/mL positive at 5 minutes) | 50 ng/mL was 100% positive at 5 minutes. |
| Repeatability | High agreement with expected results, no invalid/indeterminate results | Overall Agreement: 99.3% (96.2% - 100.0%), Positive Agreement: 100.0% (96.2% - 100.0%), Negative Agreement: 98.1% (89.5% - 100.0%) |
| Reproducibility (Lot-to-Lot) | High agreement with expected results | Overall Agreement: 98.6% (Positive: 100.0%, Negative: 96.2%) |
| Reproducibility (Between-run) | High agreement with expected results | Overall Agreement: 99.8% (Positive: 99.6%, Negative: 100.0%) |
| Reproducibility (Between Device) | High agreement with expected results | Overall Agreement: 98.6% (Positive: 100.0%, Negative: 96.2%) |
| Reproducibility (Between-site) | High agreement with expected results | Overall Agreement: 98.4% (Positive: 99.6%, Negative: 96.2%) |
| Reproducibility (Combined) | High agreement with expected results | Overall Agreement: 98.9% (Positive: 99.8%, Negative: 97.1%) |
| Test Kit Stability (Accelerated) | Overall agreement > 90% | All tests showed overall agreement > 90%. Estimated stability: 19 months at 30°C. Claimed: 18 months at 30°C. |
| Sample Stability | Overall agreement > 90% for various temperatures/durations | All tests showed overall agreement > 90%. Stable for 30 days at 2-8°C, and 15 days at room temperature. |
| Test Kit Shipping Stress Test | Overall agreement > 90% | All tests showed overall agreement > 90%. Stable for 3 days at 45°C, and 3 freeze/thaw cycles. |
| Sample Shipping Stress Test | Overall agreement > 90% | All tests showed overall agreement > 90%. Stable for 3 days at 45°C, and 3 freeze/thaw cycles. |
| Hemoglobin Variants Detection | Equivalent detection of HbA0, HbS, HbC | Equivalently detected HbA0, HbS, and HbC. |
| Cross-Reactivity (Non-human Hb/Meat) | No interference | Not interfered by bovine, equine, goat, porcine, sheep, turkey, fish, rabbit Hb, or various meat extracts. |
| Interference (Dietary Substances) | No interference | Not interfered by broccoli, cantaloupe, cauliflower, horseradish, parsnip, red radish, turnip extracts, ascorbic acid, or iron. |
| Interference (Toilet Cleaners) | No interference | Not interfered by various toilet cleaners. |
| Prozone Effect | No prozone effect at elevated Hb levels | No prozone effect observed up to 400 µg/g stool (2000 ng/mL buffer). |
| Method Comparison (vs. Predicate) | Substantially equivalent performance to Polymedco OC Light FOB Test | Overall Agreement: 99.9% (95% CI: 99.4 ~ 100.0%). Positive Agreement: 100.0% (95% CI: 97.0 ~ 100.0%). Negative Agreement: 99.9% (95% CI: 99.3 ~ 100.0%). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several "test sets" for different studies:
- Cut-off Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
- Reaction Time Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
- Precision/Reproducibility Study: 147 samples (7 Hb concentrations x 21 replicates) per site, across three POL sites. Total for combined reproducibility: 1764 samples. Data provenance: Spiked Hb-free stool specimens shipped to US clinical coordinator for distribution to POL sites.
- Test Kit Stability (Accelerated): 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
- Sample Stability: 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
- Test Kit Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
- Sample Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
- Method Comparison Study: 953 specimens. Data provenance: Presumably clinical samples collected from Physician Office Laboratory (POL) and Professional Medical Laboratory (PML) settings. The document specifies "three POL sites and three PML sites." This suggests the data is prospective, collected at these clinical sites in the US (implied by POL/PML settings).
- Prozone Effect, Hemoglobin Variants, Cross-Reactivity, Interference: Various spiked concentrations as described. These are laboratory-prepared samples rather than patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for most of the foundational studies (cut-off, reaction time, precision, stability, interference) was established using spiked Hb-free stool specimens with known concentrations of human hemoglobin (hHb). This means the "ground truth" was inherently known by the experimental design, not determined by experts.
For the Method Comparison Study, the ground truth for clinical samples was established by the predicate device, Polymedco OC Light FOB Test. Therefore, no independent experts were used to determine the true presence or absence of FOB for these samples; the predicate device results served as the reference.
The "Intensity Reading" study involved 5 readers at one physician office laboratory grading the intensity of the test line. Their qualifications are not specified beyond being "live participant readers at a FOL." This is a qualitative assessment of the test line based on visual interpretation, not a determination of ground truth for fecal occult blood.
4. Adjudication Method for the Test Set
Given that the ground truth for most studies was based on spiked samples with known concentrations, or the predicate device in the method comparison, there was no need for an "adjudication method" in the sense of reconciling disagreements between multiple expert readers. The results were compared directly against the known concentrations or the predicate device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The primary clinical study was a method comparison study between the new device and a predicate device. This study assessed the agreement between the two devices, not the improvement of human readers with or without AI assistance. The OC-Light S FIT is a qualitative test strip, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The OC-Light S FIT is described as an "in vitro diagnostic device, a qualitative test" and a "lateral flow chromatographic immunoassay." It produces a visible reddish/pink line for positive results. This is a standalone diagnostic device where the result (presence or absence of a line) is visually interpreted by a human, but the device itself does not involve an "algorithm" or "AI" in the modern sense. Its performance as an independent assay is what was evaluated through the various studies (cut-off, precision, stability, interference, method comparison).
7. The Type of Ground Truth Used
- For Cut-off, Reaction Time, Precision/Reproducibility, Test Kit Stability, Sample Stability, Shipping Stress Tests, Hemoglobin Variants, Cross-Reactivity, Interference, Prozone Effect: The ground truth was known concentrations of human hemoglobin (hHb) in spiked, Hb-free stool specimens. This is a laboratory-controlled, artificial ground truth.
- For the Method Comparison Study: The ground truth was established by the predicate device, Polymedco OC Light FOB Test.
8. The Sample Size for the Training Set
The document does not describe a "training set" as it would for a machine learning model. This device is a traditional immunoassay, not an AI/ML product. All described samples are for validation/testing of the device's performance characteristics.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no "training set" or corresponding ground truth establishment process described for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
EIKEN CHEMICAL CO., LTD. Takashi Enomoto, Regulatory Affairs 4-19-9, Taito, Taito-ku Tokyo 110-8408, Japan
Re: K143325
Trade/Device Name: OC-Light S FIT Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: July 15, 2015 Received: July 16, 2015
Dear Mr. Enomoto:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| 510(k) Number (if known) | K143325 |
| Device Name | OC-Light S FIT |
| Indications for Use (Describe) | OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is aqualitative test intended for the immunochemical detection of fecal occult blood (FOB) by professional laboratories andphysician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI)bleeding may be suspected.OC-Light S FIT is recommended for use in routine physical examinations. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (1/14) | Page 1 of 1 PSC Publishing Services (301) 443-67-40 EF |
and the comments of the state of the states of the states of
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"510(k) Summary"
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
510(k) Submitter Information:
| Name: | EIKEN CHEMICAL CO., LTD |
|---|---|
| Address: | 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan |
| Phone: | 81-3-58463479 |
| Fax: | 81-3-58463474 |
| Contact Name & Info: | Takashi EnomotoRegulatory Affairs DepartmentTakashi Enomoto@eiken.co.jp |
Date Prepared: August 20, 2015
Device Information:
| Trade Name: | OC-Light S FIT |
|---|---|
| Common Name: | Fecal Immunochemical Test |
| Classification Name: | Occult Blood Test (21 CFR 864.6550, Product Code: KHE) |
| Device Class: | Class II |
| 510(k) Number: | K143325 |
| Manufacturer: | Eiken Chemical Co., Ltd. |
Predicate Device Information:
| Trade Name: | Polymedco OC Light FOB Test |
|---|---|
| 510(k) Number: | K041297 |
| 510(k) Applicant: | Polymedco Inc.(currently Polymedco Cancer Diagnostic Products LLC) |
| Manufacturer: | Eiken Chemical Co., Ltd. |
| Repackager/Relabeler: | Polymedco Cancer Diagnostic Products LLC |
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Image /page/4/Picture/0 description: The image shows the logo of Eiken Chemical Co., LTD. The logo includes a circular graphic with three dots connected by lines, followed by the company name and address. The address is 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and the website is http://www.eiken.co.jp.
Device Description:
OC-Light S FIT is an in vitro diagnostic device, a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens.
OC-Light S FIT consists of a test strip, and a sampling bottle containing buffer solution. OC-Light S FIT test strip consists of a nitrocellulose membrane with immobilized mouse monoclonal antibodies specific to human hemoglobin at the test region and immobilized rabbit anti-mouse antibodies at the control region, a sample pad, a conjugate pad which contains human hemoglobin specific mouse monoclonal antibodies conjugated with colloidal gold, an absorption pad, and a plastic backing. OC-Light S FIT sampling bottle is a plastic bottle for collecting fecal sample containing 2.0 mL of extraction buffer.
When the sample end of the test strip is dipped in the fecal extract, the liquid fecal extract wicks through a series of absorbent materials and contacts colloidal gold conjugated with monoclonal antibodies specific to hHb. If hHb is present in the sample, it reacts with the antibodies on the colloidal gold. When the gold conjugate with hHb reaches the test region of the membrane, it binds with the immobilized antibodies also specific to hHb to form a visible reddish/pink line. The procedural control region of the membrane contains immobilized anti-mouse antibodies that capture the conjugate independent of the presence of the hHb, thereby always producing a distinct reddish/pink line. The reddish/pink line in the procedural control region demonstrates the validity of the test, and assures the operator that the device is working properly.
Clinical cut-off
The clinical cut-off of OC-Light S FIT is 10 µg hemoglobin /g stool. (50 ng/mL buffer)
Controls
Internal Control: Procedural controls are included in the test device. A reddish/pink line appearing in the control region is serves as the internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
External Control: FOBT-CHEK positive and negative controls, cleared under 510(k) 041297, are available in a separate control kit. The controls are run in the FIT in the same manner as extracted fecal samples. It is recommended that positive and negative controls be performed to verify proper test performance.
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Image /page/5/Picture/0 description: The image shows the logo for EIKEN CHEMICAL CO., LTD. The logo consists of a circular graphic to the left of the company name and address. The address is 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan. The website address is http://www.eiken.co.jp.
Intended Use:
OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is an qualitative test intended for the immunochemical detection of fecal occult blood (FOB) in feces by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected.
OC-Light S FIT is recommended for use in routine physical examinations.
Device Characteristics in Comparison with the Predicate Device:
The table below provides a summary of the device characteristics for OC-Light S FIT and the predicate device.
| Device | OC-Light S FIT | Polymedco OC Light FOB Test(Predicate) |
|---|---|---|
| Similarities | ||
| Intended Use | A qualitative test intended for theimmunochemical detection of fecaloccult blood in feces byprofessional laboratories andphysician office laboratories.Measurement of FOB is useful asan aid to detect blood in stoolwhen gastrointestinal (GI) bleedingmay be suspected. | An immunological test intendedfor the detection of fecal occultblood in feces by professionallaboratories and physician officelabs The test is useful for thedetermination of gastrointestinal(GI) bleeding, found in a numberof gastrointestinal (GI) disorders,e.g., diverticulitis, colitis, polyps,and colorectal cancer. |
| Indications forUse | Recommended for use in routinephysical examinations. | Recommended for use in 1) routinephysical examinations, 2)monitoring for bleeding inpatients, and 3) screening forcolorectal cancer orgastrointestinal bleeding. |
| Sample Type | Feces in an extraction buffer | Feces in an extraction buffer |
| Test Principle | Qualitative test system intendedfor immunochemical detection offecal occult blood in feces. | Immunological test systemintended for qualitative detectionof fecal occult blood in feces. |
| DetectionMethod | Lateral flow chromatographicimmunoassay | Lateral flow chromatographicimmunoassay |
| Detection Level | 10µg hemoglobin/g stool(50ng/ml buffer) | 50ng/mL hHb in fecal extractionbuffer |
Comparison of technological characteristics
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Image /page/6/Picture/0 description: The image shows a geometric design with a circle and a triangle. The triangle is inscribed within the circle, with its vertices touching the circle's circumference. There is a dot at each vertex of the triangle and one in the center of the triangle.
CAL CO.. LTD
-ku. Tokvo 110-8408. Japan
| Differences | ||
|---|---|---|
| Detection Antibody Conjugate | Monoclonal anti-hHb conjugated to colloidal gold | Monoclonal and polyclonal anti-hHb conjugated to blue latex |
| Result Format | Visible reddish/pink line in procedural control region and test region | Visible blue line in procedural control region and test region |
Summary of Performance Data:
Cut-off
Cut-off study was conducted in-house with one operator. Hb-free stool specimen was spiked with known levels of hHb to obtain fecal samples with seven different Hb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL. Each sample was collected with twenty one OC-Light S FIT sampling bottles and twenty one Polymedco OC Light FOB Test (Predicate) sampling bottles to perform side-by-side tests for comparing the test results of the device with that of the predicate.
The test result of 50ng/mL using OC-Light S FIT was 100.0% positive. The overall agreement between the total results of OC-Light S FIT and the expected results was 99.3% (95% CI 96.2 ~ 100.0%), and the overall agreement between the total results of Polymedco OC Light FOB Test and the expected results was 97.3% (95% CI 93.1 ~ 99.3%)
The cut-off value of OC-Light S FIT was established as 10 µg hemoglobin/g stool (50 ng/mL buffer). No significant difference was observed between the results of OC-Light S FIT and the predicate Polymedco OC Light FOB Test.
| Cut off study | Agreement | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | |||
|---|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | ||||||
| PolymedcoOC LightFOB Test | Positive Results | 92 | 1 | 93 | 97.3%( 93.1% ~ 99.3% ) | 96.8%( 90.9% ~ 99.4% ) | 98.1%( 89.5% ~ 100.0% ) | |
| Negative Results | 3 | 51 | 54 | |||||
| Total Results | 95 | 52 | 147 | |||||
| OC-Light SFIT | Positive Results | 95 | 1 | 96 | 99.3%( 96.2% ~ 100.0% ) | 100.0%( 96.2% ~ 100.0% ) | 98.1%( 89.5% ~ 100.0% ) | |
| Negative Results | 0 | 51 | 51 | |||||
| Total Results | 95 | 52 | 147 |
Polymedco OC Light FOB Test/OC-Light S FIT test results in comparison with the expected results
Reaction Time
Reaction time study was conducted in-house with one operator to demonstrate that 5
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Eiken Chemical Co., LTD. The logo is a geometric design of a circle with three points inside. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
minutes is the appropriate reaction time for OC-Light S FIT. Hb-free stool specimen was spiked with known levels of hHb to obtain fecal samples with seven different Hb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL. Twenty-one replicates of each sample for a total of 147 samples were tested in a randomized and blinded fashion with results read at 3, 5, 10, and 30 minutes of reaction.
Positivity rate of 25ng/mL was 0%, positivity rate of 40ng/mL was 43%, and positivity rate of 50ng/mL was 100% at 5 minutes of reaction, and the appropriate reaction time of OC-Light S FIT was demonstrated as 5 minutes.
| Reaction time | Hb concentration (ng/ml) | |||||||
|---|---|---|---|---|---|---|---|---|
| 0 | 25 | 40 | 50 | 60 | 75 | 2000 | ||
| 3min | Positive | 0 | 0 | 0 | 19 | 21 | 21 | 21 |
| Negative | 21 | 21 | 21 | 2 | 0 | 0 | 0 | |
| Positive (%) | 0% | 0% | 0% | 90% | 100% | 100% | 100% | |
| Negative (%) | 100% | 100% | 100% | 10% | 0% | 0% | 0% | |
| 5min | Positive | 0 | 0 | 9 | 21 | 21 | 21 | 21 |
| Negative | 21 | 21 | 12 | 0 | 0 | 0 | 0 | |
| Positive (%) | 0% | 0% | 43% | 100% | 100% | 100% | 100% | |
| Negative (%) | 100% | 100% | 57% | 0% | 0% | 0% | 0% | |
| 10min | Positive | 0 | 0 | 17 | 21 | 21 | 21 | 21 |
| Negative | 21 | 21 | 4 | 0 | 0 | 0 | 0 | |
| Positive (%) | 0% | 0% | 81% | 100% | 100% | 100% | 100% | |
| Negative (%) | 100% | 100% | 19% | 0% | 0% | 0% | 0% | |
| 30min | Positive | 0 | 2 | 20 | 21 | 21 | 21 | 21 |
| Negative | 21 | 19 | 1 | 0 | 0 | 0 | 0 | |
| Positive (%) | 0% | 10% | 95% | 100% | 100% | 100% | 100% | |
| Negative (%) | 100% | 90% | 5% | 0% | 0% | 0% | 0% |
Reaction time: test results
Precision/Reproducibility
The repeatability and reproducibility of OC-Light S FIT was evaluated by testing twenty-one replicates of fecal samples spiked with hHb to obtain test samples with seven different Hb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL.
The repeatability and reproducibility studies were conducted at three POL sites in the US. The test samples were shipped frozen from our laboratory to the clinical coordinator, where they were collated, and then distributed to the POL sites. There were no cases of invalid or indeterminate results throughout the precision studies.
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Image /page/8/Picture/0 description: The image shows the logo and contact information for Eiken Chemical Co. The logo is a geometric design of a circle with a triangle inside, and three dots are placed at the vertices of the triangle. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo), and website (http://www.eiken.co.jp).
u Tokvo 110-8408 http://www.eiken.co.jp
Repeatability and reproducibility test results in comparison with the expected
| Type ofPrecision Study | Actual ResultsOC-Light S FIT | Expected Results | OverallPercentAgreement | Positive PercentAgreement(95% CI) | Negative PercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | Total | |||||
| Repeatability | Positive Results | 95 | 1 | 96 | 99.3% | 100.0%(96.2% - 100.0%) | 98.1%(89.5% - 100.0%) |
| Negative Results | 0 | 51 | 51 | ||||
| Total Results | 95 | 52 | 147 | ||||
| Lot-to-LotReproducibility | Positive Results | 284 | 6 | 290 | 98.6% | 100.0%(98.7% - 100.0%) | 96.2%(91.8% - 98.6%) |
| Negative Results | 0 | 151 | 151 | ||||
| Total Results | 284 | 157 | 441 | ||||
| Between-runReproducibility | Positive Results | 283 | 0 | 283 | 99.8% | 99.6%(98.0% - 100.0%) | 100.0%(97.7% - 100.0%) |
| Negative Results | 1 | 157 | 158 | ||||
| Total Results | 284 | 157 | 441 | ||||
| Between DeviceReproducibility | Positive Results | 284 | 6 | 290 | 98.6% | 100.0%(98.7% - 100.0%) | 96.2%(91.8% - 98.6%) |
| Negative Results | 0 | 151 | 151 | ||||
| Total Results | 284 | 157 | 441 | ||||
| Between-siteReproducibility | Positive Results | 283 | 6 | 289 | 98.4% | 99.6%(98.0% - 100.0%) | 96.2%(91.8% - 98.6%) |
| Negative Results | 1 | 151 | 152 | ||||
| Total Results | 284 | 157 | 441 | ||||
| CombinedReproducibility | Positive Results | 1134 | 18 | 1152 | 98.9% | 99.8%(99.4% - 100.0%) | 97.1%(95.5% - 98.3%) |
| Negative Results | 2 | 610 | 612 | ||||
| Total Results | 1136 | 628 | 1764 |
Test Kit Stability (Accelerated)
Accelerated stability study was conducted with 3 lots of OC-Light S FIT test strips and sampling bottles). The test kit was stored at 60°C for 1.04 months (31 days), 56°C for 1.49 months (45 days), and 50°C for 2.58 months (77 days), which are equivalent to 19 months of storage at 30°C when Arrhenius equation is applied. The test kits stored at above conditions were used to test Hb-free stool specimen spiked with seven different Hb
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Image /page/9/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo includes a circular graphic with three dots connected by lines inside a circle. To the right of the graphic is the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL.
Overall agreements between the test results and the expected results were statistically over 90% for all of the tests conducted. The results showed that OC-Light S FIT test kit is stable for an estimated period of 19 months at 30°C, enabling claim of 18 months test kit stability at 30°C (room temperature).
| Test kitstability(accelerated) | Actual Results | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | ||||
| initial | Positive Results | 283 | 2 | 285 | ( 98.0% ~ 99.9% ) | 99.6% | 98.7% |
| Negative Results | 1 | 155 | 156 | ( 98.0% ~ 100.0% ) | ( 95.4% ~ 99.9% ) | ||
| Total Results | 284 | 157 | 441 | ||||
| 60°C 31 days | Positive Results | 282 | 1 | 283 | ( 98.0% ~ 99.9% ) | 99.3% | 99.4% |
| Negative Results | 2 | 156 | 158 | ( 97.4% ~ 99.9% ) | ( 96.4% ~ 100.0% ) | ||
| Total Results | 284 | 157 | 441 | ||||
| 56°C 45 days | Positive Results | 282 | 0 | 282 | ( 98.3% ~ 100.0% ) | 99.3% | 100.0% |
| Negative Results | 2 | 157 | 159 | ( 97.4% ~ 99.9% ) | ( 97.7% ~ 100.0% ) | ||
| Total Results | 284 | 157 | 441 | ||||
| 50°C 77 days | Positive Results | 283 | 3 | 286 | ( 97.7% ~ 99.8% ) | 99.6% | 98.1% |
| Negative Results | 1 | 154 | 155 | ( 98.0% ~ 100.0% ) | ( 94.4% ~ 99.6% ) | ||
| Total Results | 284 | 157 | 441 | ||||
| 99.3% |
Test kit stability (accelerated); test results in comparison with the expected results
Sample Stability
Sample stability study was conducted with three lots of OC-Light S FIT test kit to evaluate the stability of fecal samples collected in OC-Light S FIT sampling bottles. OC-Light S FIT sampling bottles containing fecal samples with seven different Hb concentrations; 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL, were stored at 2, 4, 8, and 10°C for 31 days, and stored at 15, 25, 30, and 32°C for 16 days. The samples stored at 2, 4, 8, and 10°C were tested at day 30 and day 31, and the samples stored at 15, 25, 30, and 32°C were tested at day 15 and day 16, with OC-Light S FIT test strips stored under room temperature.
All analyzed overall agreements between the expected results of OC-Light S FIT utilizing fecal samples in OC-Light S FIT sampling bottles were statistically over 90%. The results showed that the collected fecal samples were stable for 31 days when
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo is a circular design with three interconnected triangles and dots at the vertices. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
stored at 2, 4, 8, 10°C, and were stable for 16 days when stored at 15, 25, 30, 32°C, enabling to claim that fecal sample collected in OC-Light S FIT sampling bottle is stable up to 30 days when stored at 2 to 8°C, and is stable up to 15 days when stored at room temperature.
| Actual Results | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 30SampleStability | OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | ||||||||||||
| Positive Results | 283 | 6 | 289 | 98.4%( 96.7% ~ 99.4% ) | 99.6%( 98.0% ~ 100.0% ) | 96.2%( 91.8% ~ 98.6% ) | ||||||||||
| 2°C | Negative Results | 1 | 151 | 152 | ||||||||||||
| Total Results | 284 | 157 | 441 | |||||||||||||
| Positive Results | 284 | 4 | 288 | 99.1%( 97.7% ~ 99.8% ) | 100.0%( 98.7% ~ 100.0% ) | 97.5%( 93.5% ~ 99.3% ) | ||||||||||
| 4°C | Negative Results | 0 | 153 | 153 | ||||||||||||
| Total Results | 284 | 157 | 441 | |||||||||||||
| Positive Results | 280 | 0 | 280 | 99.1%( 97.7% ~ 99.8% ) | 98.6%( 96.4% ~ 99.6% ) | 100.0%( 97.7% ~ 100.0% ) | ||||||||||
| 8°C | Negative Results | 4 | 157 | 161 | ||||||||||||
| Total Results | 284 | 157 | 441 | |||||||||||||
| Positive Results | 284 | 2 | 286 | 99.5%( 98.3% ~ 100.0% ) | 100.0%( 98.7% ~ 100.0% ) | 98.7%( 95.4% ~ 99.9% ) | ||||||||||
| 10℃ | Negative Results | 0 | 155 | 155 | ||||||||||||
| Total Results | 284 | 157 | 441 | |||||||||||||
Sample stability: test results in comparison with the expected results
| Actual Results | OverallPositiveNegative | PercentAgreement | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Day 31Sample | OC-Light S FIT | Expected Results | PercentPercentAgreementAgreement | |||||||
| Stability | Positive | Ne gative | Total | (95% CI)(95% CI)(95% CI) | ||||||
| Results | Results | Results | ||||||||
| Positive Results | 283 | 3 | 286 | 99.1%99.6%98.1% | ||||||
| 2°C | Negative Results | । ਟੋਕੇ | ારરિ | |||||||
| Total Results | 284 | 157 | 441 | 99.8%~ 99.6%98.0%~ 100.0%97.7%રે94.4% | ||||||
| Positive Results | 284 | 2 | 286 | 99.5%100.0%98.7% | ||||||
| 4°C | Negative Results | 0 | ારરિ | ારર | ||||||
| Total Results | 284 | 157 | 441 | 98.3%~ 100.0%98.7%~ 100.0%95.4%~ 99.9% | ||||||
| Positive Results | 283 | 3 | 286 | 99.1%99.6% | ||||||
| 8°C | Negative Results | । રત | ારર | 98.1% | ||||||
| Total Results | 284 | 157 | 441 | ~ 99.8%~ 99.6%~ 100.0%97.7%98.0%94.4% | ||||||
| Positive Results | 280 | 0 | 280 | 99.1%98.6%100.0% | ||||||
| 10℃ | Negative Results | 4 | 157 | 161 | ||||||
| Total Results | 284 | 157 | 441 | ~ 100.0%97.7%~ 99.8%96.4%~ 99.6%97.7% |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo of EIKEN CHEMICAL CO., LTD. The logo consists of a circular graphic with three dots connected by lines, followed by the company name in bold letters. Below the company name is the address: 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and the website address: http://www.eiken.co.jp.
| Actual Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||||
|---|---|---|---|---|---|---|---|
| Day 15SampleStability | OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | |||
| 15°C | Positive Results | 284 | 3 | 287 | 99.3%(98.0% ~ 99.9%) | 100.0%(98.7% ~ 100.0%) | 98.1%(94.4% ~ 99.6%) |
| Negative Results | 0 | 154 | 154 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 25°C | Positive Results | 284 | 2 | 286 | 99.5%(98.3% ~ 100.0%) | 100.0%(98.7% ~ 100.0%) | 98.7%(95.4% ~ 99.9%) |
| Negative Results | 0 | 155 | 155 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 30°C | Positive Results | 283 | 0 | 283 | 99.8%(98.7% ~ 100.0%) | 99.6%(98.0% ~ 100.0%) | 100.0%(97.7% ~ 100.0%) |
| Negative Results | 1 | 157 | 158 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 32°C | Positive Results | 284 | 2 | 286 | 99.5%(98.3% ~ 100.0%) | 100.0%(98.7% ~ 100.0%) | 98.7%(95.4% ~ 99.9%) |
| Negative Results | 0 | 155 | 155 | ||||
| Total Results | 284 | 157 | 441 |
| Actual Results | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||||
|---|---|---|---|---|---|---|---|---|
| Day 16SampleStability | OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | ||||
| 15°C | Positive Results | 284 | 284 | 2 | 286 | 99.5%( 98.3% ~ 100.0% ) | 100.0%( 98.7% ~ 100.0% ) | 98.7%( 95.4% ~ 99.9% ) |
| Negative Results | 0 | 0 | 155 | 155 | ||||
| Total Results | 284 | 284 | 157 | 441 | ||||
| 25°C | Positive Results | 283 | 283 | 2 | 285 | 99.3%( 98.0% ~ 99.9% ) | 99.6%( 98.0% ~ 100.0% ) | 98.7%( 95.4% ~ 99.9% ) |
| Negative Results | 1 | 1 | 155 | 156 | ||||
| Total Results | 284 | 284 | 157 | 441 | ||||
| 30°C | Positive Results | 284 | 284 | 1 | 285 | 99.8%( 98.7% ~ 100.0% ) | 100.0%( 98.7% ~ 100.0% ) | 99.4%( 96.4% ~ 100.0% ) |
| Negative Results | 0 | 0 | 156 | 156 | ||||
| Total Results | 284 | 284 | 157 | 441 | ||||
| 32°C | Positive Results | 284 | 284 | 5 | 289 | 98.9%( 97.4% ~ 99.6% ) | 100.0%( 98.7% ~ 100.0% ) | 96.8%( 92.7% ~ 99.9% ) |
| Negative Results | 0 | 0 | 152 | 152 | ||||
| Total Results | 284 | 284 | 157 | 441 |
Test Kit Shipping Stress Test
Test kit shipping stress test was conducted to evaluate the effect of exposure to transportation stress during product shipping on OC-Light S FIT test kit. Unused OC-Light S FIT test strips and sampling bottles (containing no fecal samples) were stored under extreme temperature conditions. The measurements were then performed using stressed test strips after fecal samples with seven different Hb concentrations were collected with stressed sampling bottles.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo is a circular design with three interconnected triangles. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website address (http://www.eiken.co.jp).
All analyzed overall agreements between the test results of OC-Light S FIT and the expected results were statistically over 90%. The results showed that the test kit was stable for 4 days when stored at -40, -20, 30, 45, and 50°C, enabling to claim that OC-Light S FIT test kit is stable for 3 days of storage at 45°C, and is stable for 3 days of with 3 freeze/thaw cycles.
| Day 2Test kitshippingstress test | Actual ResultsOC-Light S FIT | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||
| -40°C | Positive Results | 283 | 4 | 287 | 98.9% | 99.6% | 97.5% |
| Negative Results | 1 | 153 | 154 | ||||
| Total Results | 284 | 157 | 441 | (97.4% ~ 99.6%) | (98.0% ~ 100.0%) | (93.5% ~ 99.3%) | |
| -20°C | Positive Results | 284 | 0 | 284 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 157 | 157 | ||||
| Total Results | 284 | 157 | 441 | (99.2% ~ 100.0%) | (98.7% ~ 100.0%) | (97.7% ~ 100.0%) | |
| 30°C | Positive Results | 283 | 3 | 286 | 99.1% | 99.6% | 98.1% |
| Negative Results | 1 | 154 | 155 | ||||
| Total Results | 284 | 157 | 441 | (97.7% ~ 99.8%) | (98.0% ~ 100.0%) | (94.4% ~ 99.6%) | |
| 45°C | Positive Results | 284 | 4 | 288 | 99.1% | 100.0% | 97.5% |
| Negative Results | 0 | 153 | 153 | ||||
| Total Results | 284 | 157 | 441 | (97.7% ~ 99.8%) | (98.7% ~ 100.0%) | (93.5% ~ 99.3%) | |
| 50°C | Positive Results | 282 | 0 | 282 | 99.5% | 99.3% | 100.0% |
| Negative Results | 2 | 157 | 159 | ||||
| Total Results | 284 | 157 | 441 | (98.3% ~ 100.0%) | (97.4% ~ 99.9%) | (97.7% ~ 100.0%) |
Test kit shipping stress test: test results in comparison with the expected results
| Day 3Test kitshippingstress test | Actual Results | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | ||||||||||
| -40°C | Positive Results | 283 | 2 | 285 | 99.3% | 99.6% | 98.7% | ||||||
| Negative Results | 1 | 155 | 156 | ( 98.0% ~ 99.9% ) | ( 98.0% ~ 100.0% ) | ( 95.4% ~ 99.9% ) | |||||||
| Total Results | 284 | 157 | 441 | ||||||||||
| -20°C | Positive Results | 284 | 0 | 284 | 100.0% | 100.0% | 100.0% | ||||||
| Negative Results | 0 | 157 | 157 | ( 99.2% ~ 100.0% ) | ( 98.7% ~ 100.0% ) | ( 97.7% ~ 100.0% ) | |||||||
| Total Results | 284 | 157 | 441 | ||||||||||
| 30°C | Positive Results | 284 | 5 | 289 | 98.9% | 100.0% | 96.8% | ||||||
| Negative Results | 0 | 152 | 152 | ( 97.4% ~ 99.6% ) | ( 98.7% ~ 100.0% ) | ( 92.7% ~ 99.0% ) | |||||||
| Total Results | 284 | 157 | 441 | ||||||||||
| 45°C | Positive Results | 284 | 2 | 286 | 99.5% | 100.0% | 98.7% | ||||||
| Negative Results | 0 | 155 | 155 | ( 98.3% ~ 100.0% ) | ( 98.7% ~ 100.0% ) | ( 95.4% ~ 99.9% ) | |||||||
| Total Results | 284 | 157 | 441 | ||||||||||
| 50°C | Positive Results | 279 | 0 | 279 | 98.9% | 98.2% | 100.0% | ||||||
| Negative Results | 5 | 157 | 162 | ( 97.4% ~ 99.6% ) | ( 95.9% ~ 99.4% ) | ( 97.7% ~ 100.0% ) | |||||||
| Total Results | 284 | 157 | 441 |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo consists of a circular design with three dots inside a triangle, which is enclosed in a circle. Next to the logo is the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
| Dav 4 | Actual Results | Expected Results | OverallPercent | PositivePercent | NegativePercent | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test kitshipping | OC-Light S FIT | Positive | Agreement(95% CI) | Agreement | Agreement | ||||||||||||||
| stress test | Results | NegativeResults | TotalResults | (95% CI) | (95% CI) | ||||||||||||||
| Positive Results | 273 | 0 | 273 | 97.5%95.6%રે98.8% | 96.1% | 100.0% | |||||||||||||
| -40°C | Negative Results | 11 | 157 | 168 | |||||||||||||||
| Total Results | 284 | 157 | 441 | 93.2% | ん | 98.1% | 97.7% | ん | 100.0% | ||||||||||
| Positive Results | 281 | 0 | 281 | 99.3% | 98.9% | 100.0% | |||||||||||||
| -20℃ | Negative Results | 3 | 157 | 160 | 99.9%98.0%રે | ||||||||||||||
| Total Results | 284 | 157 | 441 | 96.9% | રે | 99.8% | 97.7% | રે | 100.0% | ||||||||||
| Positive Results | 284 | 2 | 286 | 99.5% | 100.0% | 98.7% | |||||||||||||
| 30℃ | Negative Results | 0 | ારરે | ારરે | |||||||||||||||
| Total Results | 284 | 157 | 441 | 98.3% | ~ 100.0% | 98.7% | ~ 100.0% | 95.4% | ん | 99.9% | |||||||||
| Positive Results | 278 | 0 | 278 | 98.6% | 97.9% | 100.0% | |||||||||||||
| 45°C | Negative Results | б | 157 | 163 | |||||||||||||||
| Total Results | 284 | 157 | 441 | 99.5%97.0%ર | 95.4% | રે | 99.2% | 97.7% | રે | 100.0% | |||||||||
| Positive Results | 280 | 0 | 280 | 99.1% | |||||||||||||||
| 50℃ | Negative Results | 4 | 157 | 161 | 98.6% | 100.0% | |||||||||||||
| Total Results | 284 | 157 | 441 | 97.7% | રે | 99.8% | 96.4% | રે | 99.6% | 97.7% | ん | 100.0% |
Sample Shipping Stress Test
Sample shipping stress test was conducted to evaluate the effect of exposure to transportation stress during sample shipping on the stability of fecal samples collected in OC-Light S FIT sampling bottles. OC-Light S FIT sampling bottles containing fecal samples with seven different Hb concentrations were stored under extreme temperature conditions. The measurements were then performed on the stressed samples with unstressed OC-Light S FIT test strips.
All analyzed overall agreements between the test results using OC-Light S FIT and the expected results were statistically over 90% for all of the tests conducted. The results showed that fecal sample in OC-Light S FIT sampling bottle was stable for 4 days when stored at -40, -20, 30, 45, and 50°C, enabling to claim that fecal sample collected in OC-Light S FIT sampling bottle is stable for 3 days of storage at 45℃, and is stable for 3 days of with 3 freeze/thaw cycles.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for EIKEN CHEMICAL CO., LTD. The logo includes a circular graphic with three dots connected by lines. The text below the graphic provides the company's address as 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan. The website address, http://www.eiken.co.jp, is listed below the address.
Sample shipping stress test: test results in comparison with the expected results
| Day 2Sampleshippingstress test | Actual ResultsOC-Light S FIT | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||
| -40°C | Positive Results | 284 | 3 | 287 | 99.3%(98.0% ~ 99.9%) | 100.0%(98.7% ~ 100.0%) | 98.1%(94.4% ~ 99.6%) |
| Negative Results | 0 | 154 | 154 | ||||
| Total Results | 284 | 157 | 441 | ||||
| -20°C | Positive Results | 284 | 5 | 289 | 98.9%(97.4% ~ 99.6%) | 100.0%(98.7% ~ 100.0%) | 96.8%(92.7% ~ 99.0%) |
| Negative Results | 0 | 152 | 152 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 30°C | Positive Results | 284 | 3 | 287 | 99.3%(98.0% ~ 99.9%) | 100.0%(98.7% ~ 100.0%) | 98.1%(94.4% ~ 99.6%) |
| Negative Results | 0 | 154 | 154 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 45°C | Positive Results | 284 | 6 | 290 | 98.6%(97.0% ~ 99.5%) | 100.0%(98.7% ~ 100.0%) | 96.2%(91.8% ~ 98.6%) |
| Negative Results | 0 | 151 | 151 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 50°C | Positive Results | 284 | 6 | 290 | 98.6%(97.0% ~ 99.5%) | 100.0%(98.7% ~ 100.0%) | 96.2%(91.8% ~ 98.6%) |
| Negative Results | 0 | 151 | 151 | ||||
| Total Results | 284 | 157 | 441 |
| Day 3Sampleshippingstress test | Actual ResultsOC-Light S FTT | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||||||||
| -40°C | Positive Results | 283 | 0 | 283 | 99.8% | 99.6% | 100.0% | ||||||
| Negative Results | 1 | 157 | 158 | ||||||||||
| Total Results | 284 | 157 | 441 | ( 98.7% ~ 100.0% ) | ( 98.0% ~ 100.0% ) | ( 97.7% ~ 100.0% ) | |||||||
| -20°C | Positive Results | 282 | 0 | 282 | 99.5% | 99.3% | 100.0% | ||||||
| Negative Results | 2 | 157 | 159 | ||||||||||
| Total Results | 284 | 157 | 441 | ( 98.3% ~ 100.0% ) | ( 97.4% ~ 99.9% ) | ( 97.7% ~ 100.0% ) | |||||||
| 30°C | Positive Results | 283 | 3 | 286 | 99.1% | 99.6% | 98.1% | ||||||
| Negative Results | 1 | 154 | 155 | ||||||||||
| Total Results | 284 | 157 | 441 | ( 97.7% ~ 99.8% ) | ( 98.0% ~ 100.0% ) | ( 94.4% ~ 99.6% ) | |||||||
| 45°C | Positive Results | 284 | 4 | 288 | 99.1% | 100.0% | 97.5% | ||||||
| Negative Results | 0 | 153 | 153 | ||||||||||
| Total Results | 284 | 157 | 441 | ( 97.7% ~ 99.8% ) | ( 98.7% ~ 100.0% ) | ( 93.5% ~ 99.3% ) | |||||||
| 50°C | Positive Results | 284 | 7 | 291 | 98.4% | 100.0% | 95.5% | ||||||
| Negative Results | 0 | 150 | 150 | ||||||||||
| Total Results | 284 | 157 | 441 | ( 96.7% ~ 99.4% ) | ( 98.7% ~ 100.0% ) | ( 91.0% ~ 98.2% ) |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo includes a circular graphic with three interconnected triangles and dots at the vertices. To the right of the graphic is the company name, "EIKEN CHEMICAL CO., LTD.", followed by the address "4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan" and the website URL "http://www.eiken.co.jp".
| Day 4Sampleshippingstress test | Actual ResultsOC-Light S FIT | Expected Results | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||
| -40°C | Positive Results | 284 | 3 | 287 | 99.3%(98.0% ~ 99.9%) | 100.0%(98.7% ~ 100.0%) | 98.1%(94.4% ~ 99.6%) |
| Negative Results | 0 | 154 | 154 | ||||
| Total Results | 284 | 157 | 441 | ||||
| -20°C | Positive Results | 284 | 4 | 288 | 99.1%(97.7% ~ 99.8%) | 100.0%(98.7% ~ 100.0%) | 97.5%(93.5% ~ 99.3%) |
| Negative Results | 0 | 153 | 153 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 30°C | Positive Results | 284 | 7 | 291 | 98.4%(96.7% ~ 99.4%) | 100.0%(98.7% ~ 100.0%) | 95.5%(91.0% ~ 98.2%) |
| Negative Results | 0 | 150 | 150 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 45°C | Positive Results | 284 | 4 | 288 | 99.1%(97.7% ~ 99.8%) | 100.0%(98.7% ~ 100.0%) | 97.5%(93.5% ~ 99.3%) |
| Negative Results | 0 | 153 | 153 | ||||
| Total Results | 284 | 157 | 441 | ||||
| 50°C | Positive Results | 284 | 4 | 288 | 99.1%(97.7% ~ 99.8%) | 100.0%(98.7% ~ 100.0%) | 97.5%(93.5% ~ 99.3%) |
| Negative Results | 0 | 153 | 153 | ||||
| Total Results | 284 | 157 | 441 |
Hemoglobin Variants
The ability of OC-Light S FIT to detect human hemoglobin variants was determined by testing hemoglobin-S (HbS) and hemoglobin-C (HbC) of known concentrations (0, 25, 40, 50, 75, 100, 500, 750, 1000, 1250, 1500, and 2000 ng/mL). OC-Light S FIT equivalently detected variants of hemoglobin (HbA0, HbS and HbC).
Cross-Reactivity
The following non-human hemoglobin and meat extracts were added to fecal samples with seven different hHb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL. OC-Light S FIT was not interfered by any of the added substances.
| Substance | Concentration |
|---|---|
| Bovine Hb | 500 µg/mL |
| Equine Hb | 500 µg/mL |
| Goat Hb | 500 µg/mL |
| Porcine Hb | 500 µg/mL |
| Sheep Hb | 500 µg/mL |
| Turkey Hb | 500 µg/mL |
| Fish Hb | 500 µg/mL |
| Rabbit Hb | 200 µg/mL |
Potentially cross-reactive substances
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows a geometric design with a circle enclosing a triangle. The triangle has a dot at each of its three vertices. There is also a dot in the center of the triangle. The circle and the lines of the triangle are thick and black, and the dots are solid black.
EIKEN CHEMICAL CO., LTD.
4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan
http://www.eiken.co.jp
| Beef meat extract | 2.5% |
|---|---|
| Pork meat extract | 2.5% |
| Chicken meat extract | 2.5% |
| Rabbit meat extract | 2.5% |
| Fish meat extract | 2.5% |
| Goat meat extract | 2.5% |
| Horse meat extract | 2.5% |
| Lamb meat extract | 2.5% |
Interference of Other Dietary Substances
The following dietary substances were added to fecal samples with seven different hHb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL. OC-Light S FIT was not interfered by any of the added substances.
| Substance | Concentration |
|---|---|
| Broccoli extract | 2.5% |
| Cantaloupe extract | 2.5% |
| Cauliflower extract | 2.5% |
| Horseradish extract | 2.5% |
| Parsnip extract | 2.5% |
| Red radish extract | 2.5% |
| Turnip extract | 2.5% |
| Ascorbic acid (Vitamin C) | 0.5 % (w/v) |
| Iron | 0.5 % (w/v) |
Potentially interfering substances
Interference of Substances Contained in Toilet Cleaners
A variety of toilet cleaners was added to fecal samples with seven different hHb concentrations: 0, 5, 8, 10, 12, 15, and 400 µg/ g stool, that are equivalent to 0, 25 (C5), 40 (C50, C95-20%), 50 (C95, clinical cutoff), 60 (C95+20%), 75 and 2000 ng/mL. OC-Light S FIT was not interfered by any of the added substances.
Prozone Effect
Samples with elevated levels of hHbA0, hHbS and hHbC at the concentrations of 0, 20, 100, 150, 200, 250, 300, and 400 µg/ g stool, that are equivalent to 0, 100, 500, 750, 1000, 1250, 1500, and 2000 ng/mL, were tested for prozone effect determination. The test results
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Image /page/17/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo includes a circular graphic with three dots connected by lines inside a circle. Next to the graphic is the company name, followed by the address: 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan. The website address, http://www.eiken.co.jp, is printed below the address.
of all samples were positive, demonstrating that there is no prozone effect at these hemoglobin levels.
Intensity Reading
Reader variability of OC-Light S FIT test results was characterized. Hb-free stool suspension was spiked with hHb to prepare seven different concentrations: 0, 25, 37.5, 50, 62.5, 75, and 2000 ng/mL. 35 replicates were prepared for each concentration, and were tested in a randomized and blinded fashion by 5 readers at one physician office laboratory. Each reader graded the intensity of the test line from 6 levels (Negative, Faint, 1+, 2+, 3+, and 4+). Intensity of the test line increased in correlation with the Hb concentration of samples.
| Intensity grading by live participant readers at a FOL | ||||||
|---|---|---|---|---|---|---|
| Intensity Levels | ||||||
| Hb Concentrations | N | F | 1+ | 2+ | 3+ | 4+ |
| 0 ng/mL | 35 | 0 | 0 | 0 | 0 | 0 |
| 25 ng/mL | 35 | 0 | 0 | 0 | 0 | 0 |
| 37.5 ng/mL | 30 | 5 | 0 | 0 | 0 | 0 |
| 50 ng/mL | 0 | 22 | 12 | 1 | 0 | 0 |
| 62.5 ng/mL | 0 | 9 | 22 | 3 | 1 | 0 |
| 75 ng/mL | 0 | 3 | 15 | 14 | 3 | 0 |
| 2000 ng/mL | 0 | 0 | 0 | 0 | 0 | 35 |
Intensity grading hy five narticinant readers at a POI
FOBT-CHEK (external control) Repeatability
The repeatability study of FOBT-CHEK controls were conducted with OC-Light S FIT test kit for over twenty days. The results of all positive controls tested were positive, and the results of all negative controls tested were negative, demonstrating that FOBT-CHEK indicates satisfactory repeatability. None of the tests showed invalid results.
FOBT-CHEK (external control) Reproducibility
The reproducibility study of FOBT-CHEK controls were conducted with OC-Light S FIT test kit at three POL sites for over five days. The results of all positive controls tested were positive, and the results of all negative controls tested were negative, demonstrating that FOBT-CHEK indicates satisfactory reproducibility. None of the tests showed invalid results.
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Image /page/18/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo is a geometric design featuring a circle with three points connected by lines. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
Method Comparison Study with the Predicate Device
Method comparison study was conducted to determine the performance of OC-Light S FIT in Physician Office Laboratory (POL) and Professional Medical Laboratory (PML) settings. OC-Light S FIT was compared with a commercially available device, Polymedco OC Light FOB Test, using 953 specimens. The study was performed at three POL sites and three PML sites.
The overall percent agreement between the results obtained by OC-Light S FIT and the results obtained by Polymedco OC Light FOB Test was 99.9% (95% CI: 99.4 ~ 100.0%), with positive percent agreement 100.0% (95% CI: 97.0 ~ 100.0%) and negative percent agreement 99.9% (95% CI: 99.3 ~ 100.0%), demonstrating that analytical performance of OC-Light S FIT is substantially equivalent to the predicate Polymedco OC Light FOB Test.
| POLsMethodcomaprisonstudy | New TestOC-Light S FIT | Predicate TestPolymedco OC LightFOB Test | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| PositiveResults | NegativeResults | TotalResults | |||||
| POL 1 | Positive Results | 17 | 0 | 17 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 90 | 90 | ||||
| Total Results | 17 | 90 | 107 | ( 96.6% ~ 100.0% ) | ( 83.8% ~ 100.0% ) | ( 96.0% ~ 100.0% ) | |
| POL 2 | Positive Results | 13 | 1 | 14 | 99.1% | 100.0% | 99.0% |
| Negative Results | 0 | 95 | 95 | ||||
| Total Results | 13 | 96 | 109 | ( 94.9% ~ 100.0% ) | ( 79.4% ~ 100.0% ) | ( 94.2% ~ 100.0% ) | |
| POL 3 | Positive Results | 15 | 0 | 15 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 85 | 85 | ||||
| Total Results | 15 | 85 | 100 | ( 96.4% ~ 100.0% ) | ( 81.8% ~ 100.0% ) | ( 95.8% ~ 100.0% ) | |
| POLscombined | Positive Results | 45 | 1 | 46 | 99.7% | 100.0% | 99.6% |
| Negative Results | 0 | 270 | 270 | ||||
| Total Results | 45 | 271 | 316 | ( 98.2% ~ 100.0% ) | ( 92.1% ~ 100.0% ) | ( 97.9% ~ 100.0% ) |
Method comparison study: test results
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Image /page/19/Picture/0 description: The image shows the logo for EIKEN CHEMICAL CO., LTD. The logo consists of a circular graphic with a triangle inside, and the text "EIKEN CHEMICAL CO., LTD." is written in bold letters. Below the company name is the address: 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and the website address: http://www.eiken.co.jp.
| PMLs | New Test | Predicate TestPolymedco OC LightFOB Test | OverallPercentAgreement(95% CI) | PositivePercentAgreement(95% CI) | NegativePercentAgreement(95% CI) | ||
|---|---|---|---|---|---|---|---|
| Methodcomparisonstudy | OC-Light S FIT | PositiveResults | NegativeResults | TotalResults | |||
| PML 1 | Positive Results | 21 | 0 | 21 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 194 | 194 | ||||
| Total Results | 21 | 194 | 215 | ( 98.3% ~ 100.0% ) | ( 86.7% ~ 100.0% ) | ( 98.1% ~ 100.0% ) | |
| PML 2 | Positive Results | 18 | 0 | 18 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 193 | 193 | ||||
| Total Results | 18 | 193 | 211 | ( 98.3% ~ 100.0% ) | ( 84.6% ~ 100.0% ) | ( 98.1% ~ 100.0% ) | |
| PML 3 | Positive Results | 37 | 0 | 37 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 174 | 174 | ||||
| Total Results | 37 | 174 | 211 | ( 98.3% ~ 100.0% ) | ( 90.5% ~ 100.0% ) | ( 97.9% ~ 100.0% ) | |
| PMLscombined | Positive Results | 76 | 0 | 76 | 100.0% | 100.0% | 100.0% |
| Negative Results | 0 | 561 | 561 | ||||
| Total Results | 76 | 561 | 637 | ( 99.4% ~ 100.0% ) | ( 95.3% ~ 100.0% ) | ( 99.3% ~ 100.0% ) |
| POLs&PMLscombined | Positive Results | 121 | 1 | 122 | 99.9% | 100.0% | 99.9% | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Negative Results | 0 | 831 | 831 | |||||||
| Total Results | 121 | 832 | 953 | ( 99.4% ~ 100.0% ) | ( 97.0% ~ 100.0% ) | ( 99.3% ~ 100.0% ) |
Conclusion:
OC-Light S FIT 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 effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.
§ 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.