(247 days)
Not Found
No
The description focuses on a standard immunoassay test system using latex agglutination and turbidimetry/nephelometry for measurement. There is no mention of AI/ML in the device description, intended use, or performance studies. The calculations are based on changes in light intensity, which is a direct measurement, not an interpretation or prediction using AI/ML.
No
The device is an in vitro diagnostic (IVD) test intended for the qualitative detection of fecal occult blood, which aids in detecting blood in stool when lower gastrointestinal bleeding is suspected. It does not directly treat or prevent a disease but rather provides diagnostic information.
Yes
The device is intended for the "qualitative detection of fecal occult blood in feces," which is used as an "aid to detect blood in stool when lower gastrointestinal bleeding may be suspected." This perfectly fits the definition of a diagnostic device as it provides information about a disease or condition.
No
The device description explicitly states the system is comprised of test reagents, sample collection bottles, and an analyzer, indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of fecal occult blood in feces by professional laboratories." This is a diagnostic test performed on a biological sample (feces) outside of the body (in vitro).
- Device Description: The description details a "test system" comprised of reagents, sample collection bottles, and an analyzer. It describes the principle of measurement (latex agglutination) and how it's used to measure components in the sample. This aligns with the definition of an IVD.
- In Vitro: The term "in vitro" is used multiple times in the description, specifically stating "automated in vitro qualitative detection."
- Professional Laboratories: The intended user is professional laboratories, which is a common setting for IVD testing.
The information provided clearly indicates that this device is designed to perform a diagnostic test on a biological sample outside of the body, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitye detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.
Product codes
OOX
Device Description
OC-Auto Sensor io iFOB Test is intended for the automated in vitro qualitative detection of fecal occult blood in feces by professional laboratories. The test system is comprised of test reagents (latex, diluent buffer, wash concentrate, calibrator, negative and positive controls), sample collection bottles and analyzer.
The principle of measurement employed for the reagent system is latex agglutination. A latex agglutination reaction is the clumping of antibody-sensitized polystyrene latex particles through an antigen-antibody reaction. A light beam is passed through the reaction liquid to measure changes in the intensity of the transmitted light beam (latex turbidimetry), and changes in the intensity of the scattered light beam (latex nephelometry). With OC-Auto Sensor io iFOB Test analyzer, latex turbidimetry is used to measure the amount of an antigen or an antibody by measuring changes in scattered light rays in latex agglutination.
The throughput of the instrument is 88 samples per hour. The samples are collected in the sample collection bottles that are sent home with the patient. The sample collection bottles are then returned to the laboratory. The inverted sample collection bottles are racked and placed onto the instrument platform. The sample collection bottle is punctured and a sample is pipet into the cuvette followed by the latex reagent and mixed. Measurements are taken between the mixing cycles. After a series of washes the blank is read and the final results calculated and printed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Four test sites, including in-house and three intended use sites.
Samples used were control stool samples with added hemoglobin concentrations at 0, 50, 80, 100, 120, 450 and 700 ng/mL.
The samples were measured in replicates of 21.
Personnel at each site performed the tests, and concentrations were blinded from operators to exclude bias.
The same measurement was done in the morning and in the afternoon in one day for a total of 20 days.
For method comparison: One professional medical laboratory in the U.S. and two international professional medical laboratories. 425 samples, including 20 CRC patient samples. Two sampling bottles, one for the device and one for the predicate, were used per fecal sample, and measurements were performed on their respective analyzers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility Study:
Type: In-house and multi-site study.
Sample Size: Control stool samples with seven known concentrations (0, 50, 80, 100, 120, 450, and 700 ng/mL). Each concentration was tested in 21 replicates, twice a day for 20 days (total of 840 measurements per concentration per site).
Key Results:
- In-house: 100.0% NPA for 0, 50, 80 ng/mL; 99.8% PA for 120 ng/mL; 100.0% PA for 450, 700 ng/mL. Overall percentage agreement of 100.0% for 0, 50, 80 ng/mL; 100.0% for 100 ng/mL; 100.0% for 100 ng/mL.
- Study Site 1: 100.0% NPA for 0, 50, 80 ng/mL; 100.0% PA for 120, 450, 700 ng/mL. Overall percentage agreement 100.0% for 0, 50, 80 ng/mL; 100.0% for 100 ng/mL.
- Study Site 2: 100.0% NPA for 0, 50, 80 ng/mL; 99.9% PA for 120 ng/mL; 100.0% PA for 450, 700 ng/mL. Overall percentage agreement 100.0% for 0, 50, 80 ng/mL; 100.0% for 100 ng/mL.
- Study Site 3: 100.0% NPA for 0, 50, 80 ng/mL; 99.8% PA for 120 ng/mL; 100.0% PA for 450, 700 ng/mL. Overall percentage agreement 100.0% for 0, 50, 80 ng/mL; 100.0% for 100 ng/mL.
- All sites (in-house not included): 100.0% NPA for 0, 50, 80 ng/mL; 99.9% PA for 120 ng/mL; 100.0% PA for 450, 700 ng/mL.
Linearity Study:
Type: Dilution series.
Sample Size: Hemoglobin dilution in 100 ng/mL increments from 100-1,000 ng/mL. Each sample measured in triplicate.
Key Results: Measured values as regression values compared against theoretical values satisfied the criteria.
Prozone Effect Study:
Type: Susceptibility evaluation.
Sample Size: Stool samples with hemoglobin concentrations at 975, 1953, 3906, 7813, 15625, 31250, 125000, 250000, 500000 ng/mL. Each sample measured in triplicate.
Key Results: Device not susceptible to prozone effect up to 1953 ng/mL.
Limit of Detection Study:
Type: Determination of LoD.
Sample Size: Hemoglobin negative samples and samples with 10 ng/mL increments up to 60 ng/mL, 21 replicates each, tested for three days using three reagent lots.
Key Results: 20 ng/mL was determined as the limit of detection.
Hemoglobin Variants Study:
Type: Cross-reactivity.
Sample Size: Negative stool samples spiked with seven known concentrations of hemoglobin S, C, and F, measured in 21 replicates respectively.
Key Results: Device equally sensitive to hemoglobin S, C, and F.
Cross Reactivity - Animal Hemoglobin Study:
Type: Cross-reactivity.
Sample Size: Stool samples spiked with seven known concentrations of human hemoglobin, with 600 ng/mL of animal hemoglobin (bovine, equine, porcine, goat, sheep, rabbit, turkey, and fish) added. Measured in 21 replicates.
Key Results: No cross reactivity with tested animal hemoglobin.
Cross Reactivity - Vegetable Extracts Study:
Type: Cross-reactivity.
Sample Size: Stool samples spiked with seven known concentrations of human hemoglobin, with vegetable extracts (broccoli, cauliflower, cantaloupe, horseradish, red radish, parsnip, turnip) added. Measured in 21 replicates.
Key Results: No cross reactivity with tested vegetable extracts.
Interference – Animal Meat Extracts Study:
Type: Interference.
Sample Size: Stool samples spiked with seven known concentrations of human hemoglobin, with meat extracts (beef, pork, chicken, lamb, fish, rabbit) added. Measured in 21 replicates.
Key Results: No interference with tested meat extracts.
Interference - Toilet Cleaners Study:
Type: Interference.
Sample Size: Stool samples spiked with seven known concentrations of human hemoglobin, with toilet cleaners (Nuriper, Lysol Bleach, Blue Enzyme) added. Measured in 21 replicates.
Key Results: No interference with tested toilet cleaners.
Interference - Drugs and Dietary Supplements Study:
Type: Interference.
Sample Size: Stool samples spiked with seven known concentrations of human hemoglobin, with drugs and dietary supplements (Iron, Vitamin C, laxative, glycerol, peroxidase) added. Measured in 21 replicates.
Key Results: No interference with tested drugs and dietary supplements.
Stability Studies:
Type: Real Time Stability (Reagents, Calibrator, Controls, Sampling Bottle), Reagent - Open Bottle Stability, Inoculated Native Sample Stability, Inoculated Sample Shipping Test, Humidity Effect on Stability.
Key Results:
- Reagents stable for 12 months at 2-8°C.
- Calibrator stable for 12 months at 2-8°C.
- Controls stable for 12 months at 2-8°C.
- Sampling bottle stable for 18 months at 2-30°C.
- Open reagents stable on-board for 7 days.
- Samples in sampling bottles stable for 15 days at room temperature and 30 days refrigerated.
- Samples stable for 15 days during simulated extreme heat shipment condition.
- No effect of humidity on reagents.
Method Comparison Study:
Type: Comparison with predicate device.
Sample Size: 425 samples (including 20 CRC patients) from one U.S. and two international professional medical laboratories.
Key Results:
- Overall Percent Agreement (OPA): 100% (95% CI 99.1 - 100%) for all samples combined with CRC patient sample data. For combined non-CRC samples: 100% (95% CI 98.7% - 100%)
- Positive Percent Agreement (PPA): 100% (95% CI 96.9 - 100%) for all samples combined. For combined non-CRC samples: 100% (95% CI 96.5% - 100%).
- Negative Percent Agreement (NPA): 100% (95% CI 98.8 - 100%) for all samples combined. For combined non-CRC samples: 100% (95% CI 99.1% - 100%).
The study demonstrated that the analytical performance of the device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Precision: Positive Percentage Agreement (PPA), Negative Percentage Agreement (NPA), Overall Percentage Agreement.
Method Comparison: Overall Percent Agreement (OPA), Positive Percent Agreement (PPA), Negative Percent Agreement (NPA).
Overall Precision:
- Inhouse: 100.0% NPA for 0, 50, 80 ng/mL; 99.8% PPA for 120 ng/mL; 100.0% PPA for 450, 700 ng/mL; OPA up to 100.0%.
- Study Site 1: 100.0% NPA for 0, 50, 80 ng/mL; 100.0% PPA for 120, 450, 700 ng/mL; OPA up to 100.0%.
- Study Site 2: 100.0% NPA for 0, 50, 80 ng/mL; 99.9% PPA for 120 ng/mL; 100.0% PPA for 450, 700 ng/mL; OPA up to 100.0%.
- Study Site 3: 100.0% NPA for 0, 50, 80 ng/mL; 99.8% PPA for 120 ng/mL; 100.0% PPA for 450, 700 ng/mL; OPA up to 100.0%.
- All sites (inhouse not included): 100.0% NPA for 0, 50, 80 ng/mL; 99.9% PPA for 120 ng/mL; 100.0% PPA for 450, 700 ng/mL.
Method Comparison (Combined Results from 3 Study Sites excluding CRC patients):
- Overall Percent Agreement (OPA): 100% (95% CI 98.7% - 100%)
- Positive Percent Agreement (PPA): 100% (95% CI 96.5% - 100%)
- Negative Percent Agreement (NPA): 100% (95% CI 99.1% - 100%)
Method Comparison (CRC patients' sample):
- Overall Percent Agreement (OPA): 100% (95% CI 83.9% - 100%)
- Positive Percent Agreement (PPA): 100% (95% CI 79.6% - 100%)
- Negative Percent Agreement (NPA): 100% (95% CI 56.6 % - 100%)
Method Comparison (All samples combined):
- Overall Percent Agreement (OPA): 100% (95% CI 99.1% - 100%)
- Positive Percent Agreement (PPA): 100% (95% CI 96.9% - 100%)
- Negative Percent Agreement (NPA): 100% (95% CI 98.8% - 100%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 2, 2020
Eiken Chemical Co., Ltd. Tadashi Yasuda Manager 4-19-9. Taito Taito-ku, Tokyo 110-8408 Japan
Re: K191147
Trade/Device Name: OC-Auto Sensor io iFOB Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: OOX Dated: April 26, 2019 Received: April 30, 2019
Dear Tadashi Yasuda:
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,
Lea Carrington Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191147
Device Name OC-Auto Sensor io iFOB Test
Indications for Use (Describe)
"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitye detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo features a red circular design with the word "Eiken" written below it. The text provides the company's name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
"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: | Tadashi Yasuda |
| Regulatory Affairs Department | |
| regulatoryaffairs@eiken.co.jp |
Date Prepared: December 19, 2019
Device Information:
| Trade Name: | OC-Auto Sensor io iFOB Test |
|---|---|
| Common Name: | Automated Occult Blood Analyzer |
| Classification Name: | Occult Blood Test (21 CFR 864.6550, Product Code: OOX) |
| Device Class: | Class II |
| 510(k) Number: | K191147 |
| Manufacturer: | Eiken Chemical Co., Ltd. |
Predicate Device Information:
| Trade Name: | OC-Sensor DIANA iFOB Tes |
|---|---|
| 510(k) Number: | K092330 |
| 510(k) Applicant: | Eiken Chemical Co., Ltd. |
| Manufacturer: | Eiken Chemical Co., Ltd. |
| Repackager/Relabeler: | Polymedco Inc. |
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Image /page/4/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo features a red circular design with the word "Eiken" written below it. The text provides the company's address as 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and their website is listed as http://www.eiken.co.jp.
Intended Use:
"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitve detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.
Device Description:
OC-Auto Sensor io iFOB Test is intended for the automated in vitro qualitative detection of fecal occult blood in feces by professional laboratories. The test system is comprised of test reagents (latex, diluent buffer, wash concentrate, calibrator, negative and positive controls), sample collection bottles and analyzer.
The principle of measurement employed for the reagent system is latex agglutination. A latex agglutination reaction is the clumping of antibody-sensitized polystyrene latex particles through an antigen-antibody reaction. A light beam is passed through the reaction liquid to measure changes in the intensity of the transmitted light beam (latex turbidimetry), and changes in the intensity of the scattered light beam (latex nephelometry). With OC-Auto Sensor io iFOB Test analyzer, latex turbidimetry is used to measure the amount of an antigen or an antibody by measuring changes in scattered light rays in latex agglutination.
The throughput of the instrument is 88 samples per hour. The samples are collected in the sample collection bottles that are sent home with the patient. The sample collection bottles are then returned to the laboratory. The inverted sample collection bottles are racked and placed onto the instrument platform. The sample collection bottle is punctured and a sample is pipet into the cuvette followed by the latex reagent and mixed. Measurements are taken between the mixing cycles. After a series of washes the blank is read and the final results calculated and printed.
Components of OC-Auto Sensor io iFOB Test System:
Analyzer
The analyzer can be operated by selecting the icons displayed on the operation panel. Operators are encouraged to follow the accompanied instruction manual.
Latex Reagent
Prepared by sensitizing anti-human HbA0 antibodies to polystyrene latex particles. When the reagent is mixed with sample, the anti-human HbA0 antibodies that were sensitized to latex react with the hemoglobin in the sample, resulting in a latex agglutination reaction. The
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Image /page/5/Picture/0 description: The image shows the logo of EIKEN CHEMICAL CO., LTD. The logo consists of a red circular symbol with three interconnected circles and the text 'Eiken' in a stylized font. Below the logo is the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
reaction is then analyzed by optical density, with the amount of the change increasing in proportion to higher concentration of HbA0 in the sample.
Latex Reagent contains latex sensitized with polyclonal antibodies to human hemoglobin. One vial contains 7 mL of reagent. It shall be stored at 2-8 °C and is stable through its labeled shelf-life.
Diluent Buffer
One vial contains 200 mL of buffer. One vial contains 2.38 g of HEPES. It shall be stored at 2-8 ℃ and is stable through its labeled shelf-life.
Wash Concentrate
Aqueous detergent capable of dissolving protein deposits within the fluid path during the cleaning routine. The wash concentrate contains 120 mL of a concentrated wash that is diluted to 500 mL prior to use. The final wash solution concentration contains less than 5 % Sodium Hypochlorite. It shall be stored at room temperature and is stable through its labeled shelf life.
Calibrator
Contains 3 mL of 1,000 ng/mL purified hemoglobin in buffer. The HbA0 is derived from human blood. The blood is tested for HBS antigens, HIV (HIV-1 and HIV-2) antibodies and HCV antibodies, and only blood that tests negative for the presence of these agents is used. The Calibrator is serially diluted prior to analysis with Diluent Buffer to construct a calibration curve. It shall be stored at 2-8 °C and is stable through its labeled shelf-life.
Positive Control
Contains 5 mL of purified hemoglobin targeted around 150 ng/mL and 450 ng/mL in buffer. It shall be stored at 2-8 ℃ and is stable through its labeled shelf-life.
Negative Control
Contains 1 mL of buffer. It shall be stored at 2-8 °C and is stable through its labeled shelflife.
Sampling Bottle
Plastic bottle for collecting fecal sample. It contains 2 mL of extraction buffer.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for EIKEN CHEMICAL CO., LTD. The logo features a red circular design with the word 'Eiken' written in cursive below it. The text provides the company's name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
Device Characteristics in Comparison with the Predicate Device:
The table below provides a summary of the device characteristics for OC-Auto Sensor io iFOB Test and the predicate device.
| Similarities | |||||
|---|---|---|---|---|---|
| Device | OC-Auto Sensor io iFOB Test | Predicate (K092330) | |||
| (K191147) | |||||
| Manufacturer | Eiken Chemical Co., Ltd. | Eiken Chemical Co., Ltd. | |||
| Intended Use | Intended for the qualitative | ||||
| detection of fecal occult blood in | |||||
| feces by professional laboratories. | |||||
| The automated test is used for | |||||
| measurement of fecal occult | |||||
| blood and is useful as an aid to | |||||
| detect blood in stool when lower | |||||
| gastrointestinal bleeding may be | |||||
| suspected. | Intended | ||||
| for the qualitative | |||||
| detection of fecal occult blood in | |||||
| feces by professional laboratories. | |||||
| Indications for | |||||
| Use | Same as intended use | The automated test is used for the | |||
| determination of gastrointestinal | |||||
| (GI) bleeding, found in a number | |||||
| of gastrointestinal disorders (GI), | |||||
| e.g. colitis, polyps, and colorectal | |||||
| cancer. The OC-Sensor DIANA | |||||
| iFOB Test is recommended for | |||||
| use in 1) routine physical | |||||
| examinations, 2) monitoring for | |||||
| bleeding in patients, and 3) | |||||
| screening for colorectal cancer or | |||||
| gastrointestinal bleeding. | |||||
| Sample Type | Feces in an extraction buffer | Feces in an extraction buffer | |||
| Test Principle | Measurement of hemoglobin | ||||
| antibody-antigen reaction by latex | |||||
| turbidimetry. | Measurement of hemoglobin | ||||
| antibody-antigen reaction by latex | |||||
| turbidimetry. | |||||
| Detection Level | 20 ug hHb/g stool | ||||
| (100 ng hHb/mL buffer) | 100 ng/mL hHb in fecal | ||||
| extraction buffer | |||||
| Latex Reagent | Anti-human HbA0 antibodies | ||||
| sensitized to polystyrene latex | |||||
| particles | Anti-human HbA0 antibodies | ||||
| sensitized to polystyrene latex | |||||
| particles |
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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 features a red circular design with three interconnected circles and the text 'Eiken' below it. The contact information includes the address 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and the website URL http://www.eiken.co.jp.
| Differences | ||
|---|---|---|
| Device | OC-Auto Sensor io iFOB Test | Predicate (K092330) |
| Analyzer | ||
| Dimension | W360 x D560 x H425 (mm) | W630 x D560 x H560 (mm) |
| Weight | 35 kg | 60 kg |
| Power Required | AC100-240V, 150 VA | AC100-240V, 500VA |
| Operating System | NORTI Ver.4.0 | Windows XP Embedded Adv. |
| Through-put | 88 samples / hour | 280 samples / hour |
| Sample Rack | 20 samples: 5 samples x 4 racks | 150 samples: 10 samples x 15 racks |
| Reaction Cuvette | Disposable acrylic cuvette (10 serial cell cuvette) | Semi-disposable acrylic cuvette (11 serial cells x 5 cuvettes) |
| Cell Cleaning Units | Not included | Included |
| Buffer Bottle Volume | 200 mL | 500 mL |
| Latex Reagent Bottle Volume | 7 mL | 15 mL |
| Calibrator Concentration (top) | 1000 ng Hb/mL | 2000 ng Hb/mL |
| # of Calibration Points | 5 points | 6 points |
| Hb Conc. of Calibration Points | 0, 50, 200, 500, 1000 ng Hb/mL | 0, 62.5, 125, 250, 500, 1000 ng Hb/mL |
Performance Characteristics
Precision/Reproducibility
The tests were performed in-house and in three intended use sites using different lots of reagents, and different analyzers. The samples measured were control stool samples with added hemoglobin concentrations at 0, 50, 80, 100, 120, 450 and 700 ng/mL (hereafter, the seven known concentrations). The tests were performed by personnel in each site and to exclude bias, the concentrations of the samples were kept blind from the operators.
Calibrators are prepared by diluting with calibrator diluent, then they are measured in triplicate. This calibration curve is used throughout the procedure of 20 days. The samples are measured in replicates of 21. The same measurement is done in the morning and in the afternoon in one day for total of 20 days. All test results satisfied the acceptance criteria.
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Image /page/8/Picture/0 description: The image shows the logo of EIKEN CHEMICAL CO., LTD. The logo consists of a red circular symbol with three dots inside a triangle, along with the company name in bold, dark blue 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.
Overall Precision:
| | Sample
concentration | Expected
value | Observed
positive
number | Observed
negative
number | Total
number | positive
percentage
agreement | | Negative
percentage
agreement | | | | Overall
percentage
agreement | | | |
|----------------------------------------|-------------------------|-------------------|--------------------------------|--------------------------------|-----------------|-------------------------------------|----------------|-------------------------------------|--|--------|----------------|------------------------------------|----------------|----------------|--|
| | | | | | | 95%CI | | 95%CI | | | | 95%CI | | | |
| inhouse | 0ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 50ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 80ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | 100.0% | 99.9% ~ 100.0% | | |
| | 100ng/mL | negative/positive | 466 | 374 | 840 | | | | | | | | 100.0% | 99.9% ~ 100.0% | |
| | 120ng/mL | positive | 838 | 2 | 840 | 99.8% | 99.1% ~ 99.9% | | | | | | | | |
| | 450ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| | 700ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| Study Site 1 | 0ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 50ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 80ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 100ng/mL | negative/positive | 395 | 445 | 840 | | | | | | | | 100.0% | 99.9% ~ 100.0% | |
| | 120ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| | 450ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| | 700ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| Study Site 2 | 0ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 50ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 80ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 100ng/mL | negative/positive | 80 | 760 | 840 | | | | | | | | 100.0% | 99.9% ~ 100.0% | |
| | 120ng/mL | positive | 839 | 1 | 840 | 99.9% | 99.3% ~ 100.0% | | | | | | | | |
| | 450ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| | 700ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| Study Site 3 | 0ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 50ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 80ng/mL | negative | 0 | 840 | 840 | | | | | 100.0% | 99.5% ~ 100.0% | | | | |
| | 100ng/mL | negative/positive | 39 | 801 | 840 | | | | | | | | 100.0% | 99.9% ~ 100.0% | |
| | 120ng/mL | positive | 838 | 2 | 840 | 99.8% | 99.1% ~ 99.9% | | | | | | | | |
| | 450ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| | 700ng/mL | positive | 840 | 0 | 840 | 100.0% | 99.5% ~ 100.0% | | | | | | | | |
| all sites
(inhouse
not included) | 0ng/mL | negative | 0 | 2520 | 2520 | | | | | 100.0% | 99.9% ~ 100.0% | | | | |
| | 50ng/mL | negative | 0 | 2520 | 2520 | | | | | 100.0% | 99.9% ~ 100.0% | | | | |
| | 80ng/mL | negative | 0 | 2520 | 2520 | | | | | 100.0% | 99.9% ~ 100.0% | | | | |
| | 100ng/mL | negative/positive | 514 | 2006 | 2520 | | | | | | | | 100.0% | 99.9% ~ 100.0% | |
| | 120ng/mL | positive | 2517 | 3 | 2520 | 99.9% | 99.7% ~ 100.0% | | | | | | | | |
| | 450ng/mL | positive | 2520 | 0 | 2520 | 100.0% | 99.9% ~ 100.0% | | | | | | | | |
| | 700ng/mL | positive | 2520 | 0 | 2520 | 100.0% | 99.9% ~ 100.0% | | | | | | | | |
Linearity
Hemoglobin dilution in series, 100 ng/mL increments of the range 100-1,000 ng/mL, was prepared by diluting a calibrator that has concentration of 1,000 ng/mL with the diluent. The samples were measured in triplicate. The measured values were treated as regression values and compared against theoretical values (intended hemoglobin concentration from dilution). The test results satisfied the criteria.
Prozone Effect
Susceptibility to prozone effects was evaluated by testing stool samples with hemoglobin concentration at 975, 1953, 3906, 7813, 15625, 31250, 125000, 250000, 500000 ng/mL. Each sample was measured in triplicate. The test results showed that the device is not susceptible to prozone effect up to 1953 ng/mL.
Limit of Detection
Hemoglobin negative samples and samples with 10 ng/mL increments up to 60 ng/mL of 21 replicates are measured for three days (Day 1, 2, and 3), using three lot sets of reagents. From the study, 20 ng/mL was determined as the limit of detection.
Hemoglobin Variants
Negative stool samples spiked with the seven known concentrations of hemoglobin S, C, and F were measured in 21 replicates respectively. The test results showed that the device is
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Image /page/9/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo includes a red circular graphic with three circles connected by lines, along with the text 'Eiken' in a stylized font. Below the logo, the company's name is written in bold, followed by their address: 4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan, and their website: http://www.eiken.co.jp.
equally sensitive to hemoglobin S. C. and F.
Cross Reactivity - Animal Hemoglobin
600 ng/mL of animal hemoglobin (bovine, equine, porcine, goat, sheep, rabbit, turkey, and fish) were added to stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed no cross reactivity with the tested animal hemoglobin.
Cross Reactivity - Vegetable Extracts
Vegetables known to have peroxidase activities, broccoli, cauliflower, cantaloupe, horseradish, red radish, parsnip, and turnip were tested. Extracts with 2.5% concentration of broccoli, cantaloupe, horseradish, red radish, and parsnip and 3.3% concentration of cauliflower and turnip were added to stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed no cross reactivity with the tested vegetable extracts.
Interference – Animal Meat Extracts
Extracts with 2.0% concentration of beef, pork, chicken, lamb, and fish, and 2.5% concentration of rabbit were added to stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed no interference with the tested meat extracts.
Interference - Toilet Cleaners
10 mg/mL concentration of Nuriper, and Lysol Bleach, and 1.3 mg/mL concentration of Blue Enzyme were added to stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed no interference with the tested toilet cleaners.
Interference - Drugs and Dietary Supplements
3.1 ug/mL of Iron, 2 ug/mL of Vitamin C, 0.2 ug/mL of laxative, 2 mg/mL of glycerol concentration for enema, and 25 ug/mL of peroxidase were added to stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed no interference with the tested drugs and dietary supplements.
Stability Studies
Real Time Stability - Reagents (Latex Reagent and Buffer)
Reagents (latex reagent and buffer) were stored at 2℃ and 8℃, respectively for 13 months. Measurements were performed initially (at day 0), after 6 months, and 13 months of storage, using stool samples spiked with the seven known concentrations of human hemoglobin. The samples were measured in 21 replicates. The test results showed that the reagents are stable for 12 months at 2-8°C.
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Image /page/10/Picture/0 description: The image shows the logo and contact information for Eiken Chemical Co., LTD. The logo features a red circular design with interconnected lines and the word "Eiken" in cursive. Below the logo, the company name "EIKEN CHEMICAL CO., LTD." is displayed in bold, followed by the address "4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan" and the website URL "http://www.eiken.co.jp".
Real Time Stabilitv – Calibrator
Calibrator was stored at 2ºC and 8ºC, respectively for 13 months. Measurements were performed initially (at day 0), after 6 months, 12 months, and 13 months of storage. The test results showed that the calibrator is stable for 12 months at 2-8°C.
Real Time Stability – Controls
Positive and negative controls were stored at 2℃ and 8℃, respectively for 13 months. Measurements were performed initially (at day 0), after 6 months, and 13 months of storage. The test results showed that the controls are stable for 12 months at 2-8°C.
Real Time Stability - Sampling Bottle
Sampling bottles were stored at 2°C and 30°C, respectively for 19 months. Measurements were performed initially (at day 0), after 9 months, 18 months, and 19 months of storage. At each time point, stored bottles were taken out of incubator, let to come to room temperature, and stool samples with the seven known hemoglobin concentration were added for 21 replicates. The test results showed that the sampling bottle is stable for 18 months at 2-30°C.
Reagent - Open Bottle Stability
Reagents (latex reagent and buffer) were opened and kept at 25°C for eight days. Stool samples with the seven known hemoglobin concentration were measured in 21 replicates at day 0, 4, 7, and 8 using the reagents. The test results showed that the reagents are stable after opened and kept on-board for 7 days.
Inoculated Native Sample Stability
Hemoglobin positive stool from two donors was mixed and positive pool sample was prepared. It was mixed with hemoglobin negative stool in sampling buffer to make 0.5 % stool sample with 6 hemoglobin concentrations that are close to 50, 80, 100, 120, 450, 700 ng/mL. Hemoglobin negative sample was made by mixing hemoglobin negative stool in sampling buffer with same percentage of stool. One set of samples consists of seven concentration levels and each set is stored at 25, 28, 30 and 33°C, respectively to test stability in room temperature at 7, 15, and 16 days for a 15-day claim. Another set was stored at 1, 4, 8, and 10℃, respectively to test stability in refrigerated temperature at 15, 30 and 31 days for a 30-day claim. The test results showed that samples collected in the sampling bottles are stable for 15 days when stored at room temperature, and 30 days when they are refrigerated.
Inoculated Sample Shipping Test
Sample shipment under extreme heat condition was simulated based on the temperature log taken in summer from a home mailbox to a medical laboratory where the measurement takes place. The test simulation is made at 110 % of the actual temperature, and the end point is set at 16 days from the sampling to cover the 15-day sample stability claim at room temperature. The tested samples were prepared in the same ways as described in the sample stability study. The test results showed that the samples collected in the sampling bottles are stable for 15 days during shipment under the simulated extreme heat condition.
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Image /page/11/Picture/0 description: The image shows the logo and contact information for Eiken Chemical Co., LTD. The logo is on the left and features a red circle with a triangle inside. The text on the right includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
Humidity Effect on Stability
The reagents (latex, buffer, calibrator, and controls) were stored under three humidity condition (25%, 50%, and 80%, all at 23°C for 15 days which corresponds to 13 months storage at 8°C by Arrhenius equation) to evaluate the effect of humidity to the reagents. The test results showed that there were no effect of humidity to the reagents.
Method Comparison
Two sampling bottles, one for the device and one for the predicate were used for sampling per a fecal sample and the measurements were performed on their analyzers, respectively. The method comparison study was performed at one professional medical laboratory in the U.S. and two international professional medical laboratories. For total of 425 samples with which included 20 CRC patients samples, between the results obtained with the device and the predicate, the overall percent agreement (OPA) was 100 % (95 % CI 99.1 - 100 %), with positive percent agreement (PPA) 100 % (95 % CI 96.9 - 100 %), and negative percent agreement (NPA) 100 % (95 % CI 98.8 - 100 %). The study demonstrated that the analytical performance of the device is substantially equivalent to the predicate.
| Study site | New Test | | | Predicate Test | | | Overall Percent
Agreement
(95 % CI) | Positive Percent
Agreement
(95 % CI) | Negative
Percent
Agreement
(95 % CI) | |
|--------------|------------------|---------------------|---------------------|-----------------|---------------------|---------------------|-------------------------------------------|--------------------------------------------|-----------------------------------------------|------------------|
| | OC-SENSOR io | Positive
Results | Negative
Results | OC-SENSOR DIANA | Positive
Results | Negative
Results | | | | Total
Results |
| Study site 1 | Positive Results | 50 | 0 | | 50 | 0 | 50 | 100% | 100% | 100% |
| | Negative Results | 0 | 100 | | 0 | 100 | 100 | | | |
| | Total Results | 50 | 100 | | 50 | 100 | 150 | (97.5 % - 100 %) | (92.9 % - 100 %) | (96.3 % - 100 %) |
| Study site 2 | Positive Results | 25 | 0 | | 25 | 0 | 25 | 100% | 100% | 100% |
| | Negative Results | 0 | 100 | | 0 | 100 | 100 | | | |
| | Total Results | 25 | 100 | | 25 | 100 | 125 | (97.0 % - 100 %) | (86.7 % - 100 %) | (96.3 % - 100 %) |
| Study site 3 | Positive Results | 30 | 0 | | 30 | 0 | 30 | 100% | 100% | 100% |
| | Negative Results | 0 | 100 | | 0 | 100 | 100 | | | |
| | Total Results | 30 | 100 | | 30 | 100 | 130 | (97.1 % - 100 %) | (88.6 % - 100 %) | (96.3 % - 100 %) |
| Combined | Positive Results | 105 | 0 | | 105 | 0 | 105 | 100% | 100% | 100% |
| | Negative Results | 0 | 300 | | 0 | 300 | 300 | | | |
| | Total Results | 105 | 300 | | 105 | 300 | 405 | (99.1 % - 100 %) | (96.5 % - 100 %) | (98.7 % - 100 %) |
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Image /page/12/Picture/0 description: The image shows the logo for Eiken Chemical Co., LTD. The logo includes a red circular graphic with three circles inside a triangle. The text includes the company name, address (4-19-9, Taito, Taito-ku, Tokyo 110-8408, Japan), and website (http://www.eiken.co.jp).
| Description | | New Test | Predicate Test | | | Overall Percent
Agreement
(95% CI) | Positive Percent
Agreement
(95% CI) | Negative
Percent
Agreement
(95% CI) |
|-------------------------|------------------|--------------|---------------------|---------------------|------------------|------------------------------------------|-------------------------------------------|----------------------------------------------|
| | | OC-SENSOR io | OC-SENSOR DIANA | | | | | |
| | | | Positive
Results | Negative
Results | Total
Results | | | |
| CRC patients'
sample | Positive Results | 15 | 0 | 0 | 15 | 100% | 100% | 100% |
| | Negative Results | 0 | 5 | 5 | 5 | | | |
| | Total Results | 15 | 5 | 5 | 20 | (83.9 % - 100 %) | (79.6 % - 100 %) | (56.6 % - 100 %) |
| All samples
combined | Positive Results | 120 | 120 | 0 | 105 | 100% | 100% | 100% |
| | Negative Results | 0 | 0 | 305 | 300 | | | |
| | Total Results | 120 | 120 | 305 | 425 | (99.1 % - 100 %) | (96.9 % - 100 %) | (98.8 % - 100 %) |
Cybersecurity:
OC-Auto Sensor io analyzer has no network connecting function, therefore from cyberattacks via network. The analyzer is equipped with USB memory terminal and RS-232C terminal, however these terminals can only be used for data output and have no read functions.
Electromagnetic Compatibility (EMC):
OC-Auto Sensor io analyzer passed the tests performed at Power Frequency Magnetic Field 30 A/m and Electrostatic Discharge ±2 kV, ±4 kV, ±8 kV contact; ±2 kV, ±8 kV, ±15 kV air.
Conclusion:
OC-Auto Sensor io iFOB Test 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.