"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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the OC-Auto Sensor io iFOB Test are largely demonstrated through its equivalence to the predicate device and robust validation of its performance characteristics. The specific acceptance criteria themselves are not explicitly listed in a table format with quantitative targets for each category. However, the performance characteristics studies confirm that the device meets implied acceptance levels by showing high agreement with expected values and the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Precision/Reproducibility	Consistent and accurate detection across a range of hemoglobin concentrations, both negative and positive. High percentage agreement (95% CI) with expected values.	Overall Precision:- Negative Samples (0, 50, 80 ng/mL): 100.0% Negative Percentage Agreement (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined).- Positive Samples (120, 450, 700 ng/mL): Very high Positive Percentage Agreement. - 120 ng/mL: 99.8% - 100.0% PPA (99.1% ~ 99.9% CI to 99.5% ~ 100.0% CI for individual sites, 99.7% ~ 100.0% CI for all clinical sites combined). - 450 ng/mL: 100.0% PPA (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined). - 700 ng/mL: 100.0% PPA (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined).- The negative/positive threshold (100 ng/mL) showed variable distribution of positive/negative results, which is expected at the cutoff. Overall Percentage Agreement for this range was 100.0% (99.9% ~ 100.0% CI).- All test results satisfied the acceptance criteria (stated in the text).
Linearity	Measured values should align with theoretical values across the reported detection range.	Measured values were treated as regression values and compared against theoretical values (intended hemoglobin concentration from dilution). The test results satisfied the criteria. (Specific quantitative results not provided, but deemed acceptable).
Prozone Effect	No susceptibility to prozone effect within the specified concentration range.	Device is not susceptible to prozone effect up to 1953 ng/mL.
Limit of Detection (LoD)	Ability to detect hemoglobin at a specific low concentration.	20 ng/mL was determined as the limit of detection.
Hemoglobin Variants	Equivalence in sensitivity to common hemoglobin variants (S, C, F).	Device is equally sensitive to hemoglobin S, C, and F.
Cross Reactivity	No false positives or interference from animal hemoglobin, vegetable extracts, or meat extracts.	Animal Hemoglobin: No cross reactivity with bovine, equine, porcine, goat, sheep, rabbit, turkey, and fish hemoglobin.Vegetable Extracts: No cross reactivity with broccoli, cauliflower, cantaloupe, horseradish, red radish, parsnip, and turnip extracts.Animal Meat Extracts: No interference with beef, pork, chicken, lamb, and fish extracts.
Interference	No interference from common toilet cleaners, drugs, and dietary supplements.	Toilet Cleaners: No interference with Nuriper, Lysol Bleach, and Blue Enzyme.Drugs and Dietary Supplements: No interference with Iron, Vitamin C, laxative, glycerol concentration for enema, and peroxidase.
Stability (Reagents)	Reagents maintain performance over their labeled shelf life.	Stable for 12 months at 2-8°C (Latex Reagent and Buffer).
Stability (Calibrator)	Calibrator maintains performance over its labeled shelf life.	Stable for 12 months at 2-8°C.
Stability (Controls)	Controls maintain performance over their labeled shelf life.	Stable for 12 months at 2-8°C (Positive and Negative Controls).
Stability (Sampling Bottle)	Sampling bottle maintains integrity and sample stability over its labeled shelf life and under simulated extreme shipping conditions.	Stable for 18 months at 2-30°C.Inoculated Native Sample Stability: Samples stable for 15 days at room temperature, and 30 days when refrigerated.Inoculated Sample Shipping Test: Samples stable for 15 days during shipment under simulated extreme heat conditions.
Reagent Open Bottle Stability	Reagents maintain performance after opening for a specified period on-board the analyzer.	Stable for 7 days after opening and kept on-board.
Humidity Effect	No adverse effect of humidity on reagent stability.	No effect of humidity (25%, 50%, 80% at 23°C) on reagents (latex, buffer, calibrator, controls).
Method Comparison	Substantial equivalence to the predicate device in terms of diagnostic performance (PPA, NPA, OPA).	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 %). For CRC patients' samples, PPA was 100% (95% CI 79.6% - 100%) and NPA was 100% (95% CI 56.6% - 100%), with OPA 100% (95% CI 83.9% - 100%). The study demonstrated that the analytical performance of the device is substantially equivalent to the predicate.
Cybersecurity	Immune to cyberattacks via network, secure USB/RS-232C terminals.	No network connecting function. USB memory and RS-232C terminals are for data output only and have no read functions.
Electromagnetic Compatibility (EMC)	Meets relevant EMC standards.	Passed tests 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.

Study Information:

1. Sample sizes used for the test set and the data provenance:

Precision/Reproducibility:
- For each of the seven known concentrations (0, 50, 80, 100, 120, 450, 700 ng/mL): 21 replicates were measured.
- This was performed daily (morning and afternoon) over 20 days.
- Total individual measurements per concentration per site = 21 (replicates) * 2 (times/day) * 20 (days) = 840 measurements.
- Total measurements across 3 clinical sites for each concentration = 2520 measurements.
- Data Provenance: Not explicitly stated, but performed "in-house and in three intended use sites." The "intended use sites" typically imply clinical laboratories, likely in Japan (country of origin of manufacturer) or the US (for regulatory submission). The study is prospective in nature as samples were intentionally prepared and tested.
Linearity, Prozone Effect, Limit of Detection, Hemoglobin Variants, Cross Reactivity, Interference:
- For each specific condition/concentration tested: 21 replicates were measured.
- Data Provenance: In-house studies. Prospective.
Stability Studies (Reagents, Calibrator, Controls, Open Bottle):
- For each time point and condition: 21 replicates of stool samples spiked with the seven known hemoglobin concentrations were measured.
- Data Provenance: In-house studies. Prospective.
Inoculated Native Sample Stability:
- Not explicitly stated, but samples were prepared with 6 hemoglobin concentrations similar to the 7 known concentrations (excluding 0, presumably, or similar). Replicates are implied.
- Data Provenance: In-house studies. Prospective.
Inoculated Sample Shipping Test:
- Samples prepared in the same way as the native sample stability study (implying similar replicates/conditions).
- Data Provenance: In-house simulated study. Prospective.
Method Comparison:
- Total samples: 425 samples.
- This included 20 CRC patients samples.
- Data Provenance: Performed at "one professional medical laboratory in the U.S. and two international professional medical laboratories." This indicates prospective collection of samples used for the comparison study, though the samples themselves might have been collected retrospectively from patients or prepared for the study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the Precision/Reproducibility, Linearity, Prozone Effect, Limit of Detection, Hemoglobin Variants, Cross Reactivity, Interference, Stability studies, and Inoculated Native Sample Stability/Shipping tests, the ground truth was established by preparation of controlled samples with known concentrations of hemoglobin or interfering substances. No human expert consensus was required for these analytical performance studies.
For the Method Comparison study, the ground truth was the predicate device's result. The predicate device (OC-Sensor DIANA iFOB Tes, K092330) itself would have been validated against a clinical ground truth (e.g., colonoscopy, pathology) in its own clearance process, but for this specific study, the predicate served as the reference standard. Thus, no new experts were used to establish ground truth in this comparative effectiveness study.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No explicit adjudication method (like 2+1, 3+1) is mentioned. This is typical for in vitro diagnostic (IVD) devices where results are quantitative or qualitative (positive/negative) based on pre-defined cutoffs, rather than subjective interpretations by multiple readers.
For the precision studies, the "expected value" (negative/positive) served as the reference for agreement. For the method comparison, the predicate device result served as the reference.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done.
This device is an automated in vitro diagnostic (IVD) test system. It performs qualitative detection of fecal occult blood using immunoassay, meaning the results are determined by the analyzer itself, not through human interpretation of images or complex data that AI would assist with. The "AI" would be the automated algorithm within the device for analysis, and its performance is evaluated as a standalone system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the entire set of performance studies (Precision, Linearity, Prozone Effect, LoD, Stability, Cross-reactivity, Interference) represents a standalone performance evaluation. The device (OC-Auto Sensor io iFOB Test system, including the analyzer and reagents) performs the analysis and provides results automatically without human interpretation in the decision-making loop for individual sample outcomes. The method comparison also evaluates the standalone performance against a predicate standalone device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For most analytical performance studies (Precision, LoD, etc.): The ground truth was controlled samples with known, spiked concentrations of human hemoglobin or interfering substances.
For the method comparison study: The ground truth was the results obtained from the predicate device (OC-Sensor DIANA iFOB Tes). While the predicate's original clearance would have relied on clinical correlation (potentially pathology or outcomes data), for this specific 510(k) submission, the predicate itself served as the reference.

7. The sample size for the training set:

The document describes performance studies and comparisons, but does not explicitly mention a "training set" or "validation set" in the context of machine learning. This is because the device is an immunoassay system, not an AI/ML-based diagnostic software. Its underlying principles are based on known chemical reactions and optical density measurements, which are "trained" through calibration curves rather than an algorithm trained on large datasets.
The "calibration curve" is established using 5 points: 0, 50, 200, 500, 1000 ng Hb/mL.

8. How the ground truth for the training set was established:

As above, there isn't a traditional "training set" as understood in AI/ML. The device is calibrated.
The ground truth for calibration is established using purified hemoglobin in buffer at precisely known concentrations (0, 50, 200, 500, 1000 ng Hb/mL). The 1000 ng/mL calibrator is derived from human blood and tested to be negative for HBS antigens, HIV, and HCV antibodies.

Summary

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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

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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)

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 YasudaRegulatory Affairs Departmentregulatoryaffairs@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:

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 qualitativedetection of fecal occult blood infeces by professional laboratories.The automated test is used formeasurement of fecal occultblood and is useful as an aid todetect blood in stool when lowergastrointestinal bleeding may besuspected.	Intendedfor the qualitativedetection of fecal occult blood infeces by professional laboratories.
Indications forUse	Same as intended use	The automated test is used for thedetermination of gastrointestinal(GI) bleeding, found in a numberof gastrointestinal disorders (GI),e.g. colitis, polyps, and colorectalcancer. The OC-Sensor DIANAiFOB Test is recommended foruse in 1) routine physicalexaminations, 2) monitoring forbleeding in patients, and 3)screening for colorectal cancer orgastrointestinal bleeding.
Sample Type	Feces in an extraction buffer	Feces in an extraction buffer
Test Principle	Measurement of hemoglobinantibody-antigen reaction by latexturbidimetry.	Measurement of hemoglobinantibody-antigen reaction by latexturbidimetry.
Detection Level	20 ug hHb/g stool(100 ng hHb/mL buffer)	100 ng/mL hHb in fecalextraction buffer
Latex Reagent	Anti-human HbA0 antibodiessensitized to polystyrene latexparticles	Anti-human HbA0 antibodiessensitized to polystyrene latexparticles

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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:

	Sampleconcentration	Expectedvalue	Observedpositivenumber	Observednegativenumber	Totalnumber	positivepercentageagreement		Negativepercentageagreement			Overallpercentageagreement
						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(inhousenot 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 PercentAgreement(95 % CI)	Positive PercentAgreement(95 % CI)	NegativePercentAgreement(95 % CI)
	OC-SENSOR io	PositiveResults	NegativeResults	OC-SENSOR DIANA	PositiveResults	NegativeResults				TotalResults
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 PercentAgreement(95% CI)	Positive PercentAgreement(95% CI)	NegativePercentAgreement(95% CI)
		OC-SENSOR io	OC-SENSOR DIANA
			PositiveResults	NegativeResults	TotalResults
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 samplescombined	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.

Regulation Number and Section

§ 864.6550 Occult blood test.

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