The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.

Device Description

The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a simple operation and a number of specimen can be treated in minimal time.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OcculTech Fecal Occult Blood Rapid Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria tied to clinical endpoints with specific thresholds. Instead, the performance is reported as agreement with the predicate device or expected results.

Study Type	Acceptance Criteria (Implicit/Implied)	Reported Device Performance
Sensitivity (hHb detection)	Detect human hemoglobin (hHb) at levels close to or higher than 50ng/mL.	Can detect hHb at the level close to or higher than 50ng/mL in extraction buffer.
Prozone Effect	No interference from prozone effect up to 2000ng hHb/mL.	No interference from prozone effect observed up to 2000ng hHb/mL.
Specificity (Cross-reactivity)	100% agreement with predicate device (Instant-View™) for absence/presence of hHb with other species' hemoglobin.	100% agreement with predicate device. Negative for other species' Hb when hHb absent. Positive when hHb present.
Specificity (Interference)	100% agreement with predicate device (Instant-View™) regarding tested interfering substances.	100% agreement with predicate device. Negative for interfering substances when hHb absent. Positive when hHb present.
Reproducibility & Repeatability	High agreement with expected results and predicate device. Aim for >95% agreement.	98% agreement with expected results by three professionals. 99% agreement with expected results from Reference Laboratory. 99% agreement with Instant-View™ Fecal Occult Blood Rapid Test.
Specimen Stability	Maintain performance after storage at specific conditions.	Up to 6 months at 4℃ and 24 months at -20℃.
Test Strip Stability (after opening)	Maintain performance after opening at room temperature.	Up to 28 days at room temperature.

2. Sample Sizes Used for the Test Set and Data Provenance

Sensitivity and Prozone effect: 40 stool extraction samples. The text does not specify the country of origin or whether this was retrospective or prospective data.
Specificity (Cross-reactivity): Not explicitly stated as a number of samples, but implied to be multiple tests with various animal hemoglobin types.
Specificity (Interference): Not explicitly stated as a number of samples, but implied to be multiple tests with various interfering substances. Each test was performed as duplicates.
Reproducibility and Repeatability: The study involved "tests performed by the three professionals" and "results obtained from the Reference Laboratory." The number of "expected results" or cases used for comparison isn't specified, but implies a collection of results against which the performance was measured.
Training Set: Not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Reproducibility and Repeatability: "three professionals with diverse education backgrounds and work experiences" were involved in performing tests and achieving agreement with "expected results." Their specific qualifications (e.g., medical doctors, lab technicians) or years of experience are not detailed.
Reference Laboratory: "the Reference Laboratory" provided "expected results," but the number and qualifications of experts within this laboratory are not given.
Other studies (Sensitivity, Specificity): The ground truth for these studies appears to be based on the known controlled concentrations of human hemoglobin (hHb) or the absence/presence of hHb, rather than expert judgment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1).
For Reproducibility and Repeatability, it states "the results obtained from the tests performed by the three professionals... agreed 98% with expected results (average)." This suggests a comparison against a predetermined or established "expected result" rather than an adjudication process among the professionals themselves.

5. 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 a rapid diagnostic test, not an AI-powered image analysis or diagnostic tool that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone rapid immunochromatography test. The results are "visually determined without using any special instrument." There is no "algorithm" in the modern sense of AI or automated interpretation. The performance reported (sensitivity, specificity, reproducibility) are for the device's standalone operation.

7. The Type of Ground Truth Used

Sensitivity and Prozone effect: Known concentrations of human hemoglobin (hHb) spiked into a buffer.
Specificity (Cross-reactivity): Known presence or absence of human hemoglobin and various animal hemoglobins.
Specificity (Interference): Known presence or absence of human hemoglobin and various interfering substances.
Reproducibility and Repeatability: "Expected results" which likely refer to the known state of control samples or a pre-established gold standard for the samples tested, possibly determined by reference methods or the predicate device.

8. The Sample Size for the Training Set

The document does not provide information on a specific "training set" for the device. This type of diagnostic test usually undergoes development and internal validation, but a formal "training set" in the context of machine learning or AI is not applicable. The studies described are performance evaluations.

9. How the Ground Truth for the Training Set was Established

As no training set is described, the method for establishing its ground truth is also not provided.

Summary

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SEP 1 8 2006

K060953

510(k) summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

User Fee Payment ID. No.: MD6025264-956733

Submitter :

YD Diagnostics 2F, Keukdong A Building, 228-8, Chamsil-Dong Songpa-Gu, Seoul, Korea Tel.82-31-333-3827, Fax.82-31-339-0176 Contact : Young Nam Park Date Prepared : March 5, 2004

Contact Person :

Dusic Kwak, Esq. Kwak & Associates, P. C. 4304 Evergreen Lane, Suite 101 Annandale, Virginia 22003 Tel: 703-658-6347 Fax: 703-658-9807 e-mail: annandalelawfirm@yahoo.com

Device name :

OcculTech Fecal Occult Blood Rapid Test Common or usual name : Fecal Occult Blood (FOB) Test

Predicate Device :

Instant-View™ Fecal Occult Blood Rapid Test, 510(k) number K021423

Device Description:

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extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a
simple operation and a number of specimen can be treated in minimal time.

The following types of tests for fecal occult blood (FOB) testing are commercially available Guaiac, Hemoporphyrin and immunochemical. The guaiac test is widely available but lacks in accuracy. The hemoporphyrin test can cause false positive result for patients who have gastric or duodenal ulcers. The immunochemical FOB rapid test is much more sensitive and has been designed to specifically detect low levels of human fecal occult blood.

Intended Use:

The OcculTech Fecal Occult Blood Rapid test is a card type rapid test and an immunochromatography-based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g., diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.

Statement of how the technology characteristics of the device Compare to the predicate device:

The technology characteristics of the OcculTech Fecal Occult Blood Rapid Test is same as the legally marked predicate device (Instant-View™ Fecal Occult Blood Rapid Test).

Sensitivity and Prozone effect :

In study of 40 stool extraction samples, the OcculTech Fecal Occult Blood Rapid test can detect the human hemoglobin(hHb) at the level close to or higher than 50ng/mL in extraction buffer. No interference from prozone effect was observed when the hHb level reached up to 2000ng hHb/mL, which is equivalent to 2mg hHb/g feces.

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Human hemoglobin level performed this study are as following : 0, 37.5, 50, 62.5, 2000ng hHb/mL.

Specificity (cross-reactivity)

In study of cross-reactivity for hemoglobin from other species, both Devices (Occul Tech, Instant-View™) indicated negative test results when tested with the Hb of other species when hHb was absent(Negative solution) and positive test results in all cases when hHb was present(Positive solution, 50ng/mL).

This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% with predicate device.

Hemoglobin of other species used this test are as following : Horse hemoglobin, Rabbit hemoglobin, Fish hemoglobin, Beef hemoglobin, Chicken Hemoglobin, Goat hemoglobin, Pig hemoglobin, Sheep hemoglobin.

Specificity (Interference)

In study of Interference substances Both Devices (OcculTech, Instant-View™) indicated negative test results when tested with the substances when hHb was absent (Negative solution)and positive test results in all cases when hHb was present(Positive solution, 50ng/mL). Each test was performed as duplicates.

This test results showed that OcculTech Fecal Occult Blood Rapid Test agrees 100% agreed with predicate device.

Interference substances tested are as following :

Horseradish perosidase, Red radish, Raw turnip, Cauliflower, Broccoli, Parsnip, Cantaloupe, Ascorbic acid, Iron, Human Serum Albumin.

Reproducibility and Repeatability

In study of reproducibility and repeatability, the results obtained from the tests performed by the three professionals with diverse education backgrounds and work experiences agreed 98% with expected results(average). The results obtained from the Reference Laboratory agreed 99% with expected results. And OcculTech Fecal Occult Blood Rapid Test agreed 99% with Instant-View™ Fecal Occult Blood Rapid Test.

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Stability

- For specimen

The test result showed that specimen can store up to 6 months at 4℃ and 24 months at -20 ℃.

- For test strip after opening

The test result showed that test strip after opening can store up to 28 days at room temperature.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2006

YD Diagnostics Corporation c/o Kwak & Associates 4304 Evergreen Lane Suite 101 Annandale, VA 22003 ATTN: Dusic Kwak

Re: K060953

Trade/Device Name: OcculTech Fecal Occult Blood Rapid Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: II Product Code: KHE Dated: April 4, 2006 Received: April 6, 2006

Dear Mr. Kwak:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert Zseckaf

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K060953

Device Name:

OcculTech Fecal Occult Blood Rapid Test

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert Becker
Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K060953

Page 1 of 1

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.