This Fecal Occult Blood (FOB) Ravid Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determining gastrointestinal (GI) bleeding found in a number of gastrointestinal (GI) disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

This test is recommended for use in 1) routine physical examinations. when hospital patients are first admitted, 2) hospital monitoring for bleeding in patients. 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

Device Description

The Instant-View™ Fecal Occult Blood Rapid Test is an immunochemical device for the qualitative detection of Fecal Occult Blood.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Sensitivity	Detect human Hemoglobin (hHb) at or above 50 µg hHb/g feces (50 ng/ml extraction buffer).	Able to detect hHb at 50 ng/ml (100% agreement with predicate).
Prozone Effect	No interference observed up to a certain high hHb concentration.	No interference up to 2000 ng hHb/ml (equivalent to 2 mg hHb/g feces).
Specificity (Cross-reactivity)	No false positives with hemoglobin from other species (beef, chicken, fish, horse, goat, pig, rabbit, sheep).	Gave negative results with other species' Hb; positive when hHb was present.
Interference (Dietary Substances)	No false positives or interference from common dietary substances (broccoli, cantaloupe, cauliflower, horseradish, parsnip, red radish, turnip, horseradish peroxidases, dietary iron, Vitamin C).	Gave negative results with all extracts; positive when hHb was present. No interference observed with dietary iron/Vitamin C.
Interference (Toilet Water Additives)	No false positives from toilet bowl deodorizers/fresheners/cleaners. Sensitivity may vary, requiring removal for optimal performance.	No false positives. Some decreased sensitivity by over three-fold, others no effect.
Interference (Toilet Water Contaminants)	No false positives due to residual human blood in toilet if concentration below 50 ng/ml. Instructions for flushing before use and proper sample collection required.	False positives may occur if residual human blood is ≥ 50 ng/ml.
Reproducibility (POL)	High agreement with expected results across different users and sites.	97.7% agreement (average) with expected results at three Physician Office Laboratories (POLs).
Reproducibility (Reference Lab)	High agreement with expected results in a controlled lab setting.	99% agreement with expected results at a Reference Laboratory.
Overall Accuracy	High accuracy (composite of sensitivity, specificity, reproducibility).	98% overall accuracy.
Specimen Stability at 35°C (95°F)	Expected stability for a reasonable duration.	Stable for up to 8 days.
Specimen Stability at 4°C (39.2°F)	Expected stability for a longer duration.	Stable for up to 6 months.
Specimen Stability at -20°C (-4°F)	Expected stability for extended storage.	Stable for at least 2 years.

2. Sample Sizes and Data Provenance

Sensitivity Study (Test Set): 40 stool extraction samples, spiked with hHb at five concentration levels (0, 37.5, 50, 62.5, 2000 ng/ml), with 8 samples per level. The study was conducted in-house. Data provenance is implied to be internal (Alfa Scientific Designs, Inc.), likely U.S.-based as the manufacturer is in Poway, CA. It is a prospective, controlled spiking study.
Reproducibility and Repeatability Studies (Test Set):
- 100 human hemoglobin-free stool extraction specimens, divided into 5 groups (20 each), spiked with hHb at 0, 37.5, 50, 62.5, and 2000 ng/ml. These were collected in-house.
- 120 fresh human hemoglobin-free stool extraction specimens, divided into 5 groups (72 in each), spiked with hHb at 0, 37.5, 50, 62.5, and 2000 ng/ml. These were collected in-house.
- Data provenance is internal (Alfa Scientific Designs, Inc.), likely U.S.-based, and appears to be prospective, controlled spiking studies.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets. The ground truth for these studies appears to be based on the known spiked concentration of human hemoglobin, rather than expert consensus on clinical samples.

4. Adjudication Method for the Test Set

For the sensitivity study, "Results were compared with one lot of predicate device, the Hemoccult® Test." This suggests a comparative analysis rather than a formal adjudication of experts.
For the reproducibility and repeatability studies, "Every test result was read by two independent readers." This indicates a 2-reader independent reading. However, it doesn't specify an adjudication method for disagreements between readers, or how the "expected results" were determined beyond the known spiked concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus human readers without AI assistance, was not conducted. This device is a rapid diagnostic test, not an AI-powered image analysis system. The comparison was between the Instant-View™ FOB Rapid Test and the predicate device (Hemoccult®) in terms of analytical performance.

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

Yes, the studies described are essentially "standalone" in the context of the device itself. The device (a rapid test) provides a qualitative result, and the studies evaluated this result directly against known sample compositions. The "human-in-the-loop" aspect is the reading of the test result by a person, but the device's performance is assessed on its inherent ability to detect hHb.

7. The Type of Ground Truth Used

The primary type of ground truth used in these analytical studies is known spiked concentrations of human hemoglobin. This is a controlled, analytical ground truth, not pathology, clinical outcomes, or expert consensus on patient samples.

8. The Sample Size for the Training Set

The document does not specify a distinct "training set" or its sample size. This is typical for traditional rapid diagnostic tests, where the analytical performance is characterized rather than a model being "trained" on data. The studies described are performance validation/verification studies.

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

As no separate training set is mentioned in the context of machine learning, this question is not directly applicable. If considering the "training" of the device (i.e., its design and manufacturing to meet specifications), the ground truth would be established through internal R&D and analytical testing to ensure the reagents and test strip perform as intended to detect hHb at the specified cutoff.

Summary

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Instant-View™ Fecal Occult Blood Rapid Test

Description of the device

I. Product Name: Instant-View™ Fecal Occult Blood Rapid Test

II. Manufacturer:

Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway. CA 92064 (858) 513-3888 Telephone: Fax: (858) 513-8388 Email: info@alfascientific.com

III. Common Name of the Device: Fecal Occult Blood (FOB) Test

IV. Trade Name of the Device: Instant-View™ Fecal Occult Blood Rapid Test

V. Establishment Registration Number: 2060833.

VI. Classification of the Device:

The Test Device is classified as Class II (21 CFR 864.6550).

VII. Intended Use:

VIII. Predicate Product:

Hemoccult® test by Beckman Coulter, Inc., 510K# K880499.

IX. Performance Summary:

The Instant-View™ FOB Rapid Test is more accurate than the predicate device Hemoccult®. The performance of Instant-View™ FOB Rapid Test was verified by sensitivity, specificity, cross reactivity, interference, reproducibility and accuracy studies. Please refer the attached "Summary".

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Device specifications

I. BACKGROUND

The American Cancer Society and National Cancer Institute guidelines for early detection of colorectal cancer recommend an occult blood stool test annually every 3-5 years after age 50 years. There are three types of tests for FOB testing are commercially available: 1) Guaiac Dye: 2) Immunochemical: and 3) Hemoporphyrin. The Guaiac test is widely available, but lack of high accuracy. The Hemoporphyin test is not affected by dietary peroxidases, but false-positive results can occur in patients with upper gastrointestinal bleeding disorders. This Immunochemical FOB test has great advantage than the Guaiac and Hemoporphyrin method. It is highly accurate, and the results are not interfered by dietary peroxidases, animal blood and ascorbic acid.

II. PERFORMANCE CHARACTERISTICS

1. Sensitivity and prozone effect study

The Instant-View™ FOB Rapid Test is able to detect the human Hemoglobin (hHb) at the level close to or higher than 50μg hHb/g feces (50ng/ml extraction buffer) and no interference from prozone effect was observed when the human hHb level reached up to 2000ng hHb/ml, which is equivalent to 2mg hHb/g feces.

A sensitivity study was conducted in-house to evaluate the minimum concentration of the human hemoglobin that has a high probability of being detected with this devise.

Forty stool extraction samples were spiked with human hemoglobin at five levels of concentrations, 0. 37.5, 50. 62.5, and 2000ng/ml, in an evenly distributed number. 8 of each level. The samples were blind labeled and tested with three lots of Instant-View™Fecal Occult Blood Rapid Test. Results were compared with one lot of predicate device, the Hemoccult® Test.

Results indicated that the Instant-View™ Fecal Occult Blood Rapid Test has a sensitivity of 50 ng/ml. and 100% agreed with predicate device.

2. Specificity study

Cross reactivity

The Instant-View™ FOB Rapid Test was examined in vitro by adding hemoglobin (Hb) of beef, chicken, fish, horse, goat, pig, rabbit, and sheep to the human feces and applied to the test to determine the cross-reactivity of the test with the hemoglobin from other spices. The samples were added with and without diluted hHb at 50 ug hHb/g feces. Instant-View™ FOB Rapid Test gave negative test results when tested with the Hb of other spices and positive in all cases when hHb was present. Whereas the Hemoccult® test consistently gave false-positive results when tested with all hemoglobin of other spices.

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Abbreviated 510(k)

Interference of dietary substances .

Instant-View™ FOB Rapid Test does not require the patient to follow any special dietary restrictions. Aqueous extracts of raw broccoli, cantaloupe, cauliflower, horseradish, Parsnip, red radish and turnin were added to the Test device to determine if vegetable extracts cross react with the test. Test device was also tested with 20 mg/ml solution of horseradish peroxidases. The extracts were added with and without diluted hHb at 50 ug hHb/g feces (50ng/ml extraction buffer). Instant-View™ FOB Rapid Test gave negative results when tested with all of the extracts, and positive results when hHb was present. The Hemoccult® Test, a Guaiac FOB Test, consistently gave false-positive results to all the cases with or without human Hb. A dietary iron and Vitamin C supplement were added with and without diluted human Hb at 50 µg hHb/g feces (50ng/ml extraction buffer) to the test device. No interference was observed with the performance of the Instant-View™ FOB Rapist test.

Interference bv toilet water .

Additives:

No false positive test results were observed with toilet bowl deodorizers/fresheners or cleaners The effects of the toilet bowl deodorizers/fresheners or cleaners on the sensitivity of the test studied. are varying. Some decreased the sensitivity of the test by over three-fold, while others have no effect. Based on the results of these studies it is concluded that toilet bowl deodorizers/fresheners should be removed from the toilet bowl prior to collecting samples for the proposed test.

Contaminants:

Study on the contaminated toilet bowl with residual human blood indicated that the human blood left in the toilet bowl may induce false positive results, if the concentration of human blood is equal to or higher than 50ng/ml. Therefore, instructions were given that flush the toilet before use.

The specimen is suggested to be collected from the toilet paper or caught in a clean cup to avoid contacting toilet water.

3. Reproducibility and repeatability studies

One hundred (100) human hemoglobin free stool extraction specimens collected in house and divided into 5 groups in an evenly distributed number, 20 in each. The 5 groups of extraction samples were spiked with human hemoglobin for five different concentrations, respectively, 0, 37.5ng hHb/ml (25% lower than cut off), 50ng hHb/ml (cut off level), 62.5ng hHb/ml (25% higher than cut off), and 2000ng hHb/ml (equal to 2000ug hHb/g feces). Those specimens were tested with Instant-View™ Fecal Occult Blood Test at three (3) Physician Office Laboratories (POL) and a Reference Laboratory. All specimens were blind labeled.

The results obtained from three POL sites by persons with diverse education background and work experiences agreed 97.7 % (average) with the expected results. The results obtained from the Reference laboratory agreed 99% with the expected results. Overall, the accuracy of the Instant-View™ Fecal Occult Blood Rapid Test is 98%.

Specimen Collection and Handling 4.

Fresh human hemoglobin free stool extraction specimens, total 120 specimens, were collected in house and divided into 5 groups in an evenly distributed number, 72 in each group. Those 5 groups of

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extraction samples were spiked with human hemoglobin for five different concentrations. respectively, 0, 37.5ng hHb/ml (25% lower than cut off), 50ng hHb/ml (cut off level), 62.5ng hHb/ml (25% higher than cut off), and 2000ng hHb/ml (equal to 2000ug hHb/g feces).

The specimens in each group were further divided into three groups, A, B, and C, 8 specimens of each concentration in each group.

Specimens of Group A were stored at temperature 95°F (35°C) and tested at 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 days post preparation. Specimens of Group B were stored at 39.2°F (4 °C) and tested at 1, 2, 3, 4. 5. 6. 7 and 8 months post preparation. Specimens of Group C were stored at -40F (-20°C) and tested at 6, 12, 18, 20, 22, 24, 25, and 26 months post preparation. The samples were blind labeled and tested with three lots of Instant-View ™ FOB Rapid Test. Every test result was read by two independent readers.

Results observed indicated that specimens collected may be stored up to 8 days at temperature 95°F (35°C); 6months at 39.2°F (4 °C), and at least 2 years at -4°F (-20°C).

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right. The profiles are arranged in a way that they appear to be stacked on top of each other. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 7 2002

Naishu Wang, M.D., Ph.D. President Alpha Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064

Re: K021423

Trade/Device Name: Instant-View™ Fecal Occult Blood Rapid Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: April 30, 2002 Received: May 3, 2002

Dear Dr. Wang:

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 the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) NUMBER (IF KNOWN) : KO214 23

DEVICE NAME : Instant-View™ Fecal Occult Blood Rapid Test

INDICATIONS FOR USE:

This Fecal Occult Blood (FOB) Rapid Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determining gastrointestinal (GI) bleeding found in a number of gastrointestinal (GI) disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

This test is recommended for use in 1) routine physical examinations, when hospital patients are first admitted, 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Josephine Bautista

(Division Sign-Off) Division of Clinical Laborator 510(k) Number -

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.