The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Device Description

Device is a one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with mouse anti-human hemoglobin monoclonal antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti-human hemoglobin antibodies, and the C line is coated with goat anti-mouse IgG antibodies. The proposed device has only cassette format. The cassette is a device that contains a dip-strip in a plastic housing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Test, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Accuracy	Correlation of 100% with the predicate device (Hemoccult®) for spiked samples.	100 samples (20 each at 0, 37.5, 50, 62.5, and 2000 ng/ml human hemoglobin) were tested. The correlation between the FOB and the predicate device was 100%.
Reproducibility (POL)	Not explicitly stated, but based on results, high agreement with expected.	Evaluations at three Physician's Office Laboratories (POL) showed 97.7% agreement with expected results.
Reproducibility (Med Lab)	Not explicitly stated, but based on results, high agreement with expected.	Results obtained from one Medical Laboratory showed 99% agreement with expected results.
Reproducibility (Lay Users)	Not explicitly stated, but implied to be high enough for OTC use.	95% of 120 professional and non-professional lay individuals were able to follow package insert instructions and obtain accurate results (matching professional results).
Sensitivity	50 ng/ml	The sensitivity of the proposed device is 50 ng/ml.
Specificity	Specific for human hemoglobin (avoiding false positives from red meats).	It is specific for human hemoglobin. Unlike the predicate (Hemoccult®), it does not give false positive results due to consumption of red meats, etc.
Consumer Study (Accuracy)	Consumer results within accepted range for self-test products.	Consumer results agreed 95% with expected results (four false negatives and two false positives). This was deemed within the accepted range.
Consumer Study (Usability)	Highly positive feedback on simplicity, speed, convenience, and accuracy.	Over 98% of consumers found the device to be simple, fast, convenient, and accurate.
Stability	2 years at 15-30°C (59-86°F)	The test device is stable when stored in a controlled environment at 15-30°C (59-86°F) for up to two years following manufacturing or until the expiration date, whichever comes first.

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

Accuracy Study (Spiked Samples): 100 samples. The text states these were "collected in-house" so the provenance details beyond that are not specified, but they were artificially spiked with human hemoglobin - suggesting a controlled laboratory setting rather than patient data.
Reproducibility Study:
- POL Sites: Not explicitly stated, but "three Physician's Office Laboratories" were used. The number of tests performed at these sites isn't detailed, only the agreement rate.
- Medical Laboratory: Not explicitly stated, but "one Medical Laboratory" was used. The number of tests performed isn't detailed.
- Lay Individuals: 120 professional and non-professional lay individuals.
Consumer Study: Likely the same 120 individuals mentioned in the reproducibility study for lay users.

The provenance is mixed:

Accuracy: Likely laboratory-controlled specimens (feces extraction specimens spiked with hemoglobin).
Reproducibility: Involved external POLs and a Medical Laboratory, and a group of "professional and non-professional lay individuals." The data collection seems prospective for the reproducibility and consumer studies, as individuals were actively performing tests.

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense for the test set.

For the Accuracy study, the ground truth was based on the known concentrations of human hemoglobin spiked into the samples. The predicate device (Hemoccult®) was also used for comparison, implying its results (for those concentrations) served as a reference.
For the Reproducibility study, the "expected results" were used. For the lay user portion, professionals also tested the samples, so their results served as a comparative ground truth.
For the Consumer study, the "expected results" and "results obtained by professionals" served as the ground truth against which consumer performance was compared.

4. Adjudication Method for the Test Set

The document does not specify a formal adjudication method (like 2+1 or 3+1). For reproducibility and consumer studies, consumer/lay results were compared against "expected results" or "results obtained by professionals," implying a simple comparison rather than a multi-reader adjudication process.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) self-test, not an AI-assisted diagnostic tool for human readers. Therefore, there's no mention of how human readers improve with AI assistance.

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

This refers to a diagnostic device, not an algorithm. The device itself (the immunoassay) performs the diagnostic function. The "standalone" performance here refers to the device's ability to accurately detect FOB. The accuracy, sensitivity, and specificity studies essentially demonstrate the standalone performance of the device.

7. The Type of Ground Truth Used

Accuracy: Known concentrations of spiked human hemoglobin. Comparison to a predicate device (Hemoccult®).
Reproducibility: "Expected results" (likely determined by the manufacturer or expert testing in a controlled environment). For lay users, professional results served as the reference.
Consumer Study: "Expected results" and "results obtained by professionals."

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional IVD device, not an AI-based one. All sample sizes mentioned pertain to validation/testing or performance evaluation.

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

As there is no mention of a training set, this question is not applicable.

Summary

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Alfa Scientific Designs, Inc.

FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM

Image /page/0/Picture/5 description: The image shows the number 0660 at the top. Below the numbers is the NSAI logo, which is a stylized eye shape. Underneath the logo are the text labels "I.S. EN ISO 9001" and "I.S. EN 46001".

JUN 2 1 2007

510(k) Summary

Safety and Effectiveness as Required by 21 CFR 807.92

Manufacture andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064
	Telephone	(858) 513-3888 x 324
	Fax:	(858) 513-8388
	Contact Person:	Majid Pajouh, Ph.D.E-mail: mpajouh@alfascientific.com
Device Name	Trade Name:	INSTANT-VIEW ® Fecal Occult Blood (FOB) Self-TestFecal Occult Blood (FOB) Self-Test
	Common Name:	Immunoassay, FOB Test
	Classification:	Occult Blood Test
	Product Code:	NGK
Date of SummaryPreparation	December 25, 2006
Predicate Device	510K Number: K880499	Hemoccult® test by Beckman Coulter, Inc.
Device Description	Device is a one-step lateral flow chromatographic immunoassay.The test strip in the device consists of 1) a burgundy-coloredconjugate pad containing colloidal gold coupled with mouse anti-human hemoglobin monoclonal antibodies, and 2) nitrocellulosemembrane containing a test line (T line) and a control line (C line).The T line is coated with anti-human hemoglobin antibodies, and theC line is coated with goat anti-mouse IgG antibodies.
Intended Use		The Fecal Occult Blood (FOB) Self-Test is a qualitativeimmunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurementof FOB is useful as an aid to detect human blood in stool as
	found in a number of gastrointestinal disorders, e.g. diverticulitis,colitis, polyps and colorectal cancer. It is intended for over thecounter use.
Similarity to thePredicate Device	Both are one-step rapid tests. Both are intended to provide qualitative detection of humanhemoglobin in the fecal specimen. Both are in-vitro diagnostic devices. The proposed device has a built-in quality control feature butpredicate does not. Since FOB is an immunologically based rapid test for thedetection of human hemoglobin in the fecal samples, it hasinherent advantages compared to the currently marketedchemically based fecal occult blood rapid tests including thepredicate Hemoccult®. FOB is more specific than Hemoccult® since it is specific forhuman hemoglobin and unlike Hemoccult® does not give falsepositive results due to consumption of red meats, etc.
Sensitivity andSpecificity	The sensitivity of the proposed device is 50 ng/ml and it is specificfor human hemoglobin.
Accuracy	One hundred (100) samples of hemoglobin free feces extractionspecimens collected in-house were divided into 5 groups of 20each. The five groups of extraction samples were spiked withhuman hemoglobin at five different concentrations (0, 37.5, 50,62.5 and 2000 ng/ml. Those 100 specimens were tested inhouse with FOB and predicate device. The correlation betweenthe FOB and the predicate device was 100%.
Reproducibility	This study was carried out at four (4) sites outside Alfa, threePhysician's Office Laboratories (POL) and one MedicalLaboratory. Evaluations at the POL sites were performed bypersonnel with different educational backgrounds and workingexperience and agreed 97.7% with the expected results. Theresults obtained from the Medical Laboratory agreed 99% with theexpected results. FOB was also tested by 120 professional and non-professional lay individuals of different education, age andbackgrounds 95% of which were able to follow the package insertinstructions and obtain accurate results obtained by professionals.
Stability	The test device is stable when stored in controlled environment at15-30° C 59-86° F) for up to two years following themanufacturing or until the expiration date printed on the label,whichever comes first.
Formats of theDevice	The proposed device has only cassette format. The cassette is adevice that contains a dip-strip in a plastic housing.
Conclusion	The results of accuracy, specificity, sensitivity, reproducibility,cross reactivity, and interference studies demonstrate that theproposed test is substantially equivalent to the predicate device.
Consumer study	Conclusion of the comparison between professionals andconsumer studies: Professional results agreed 100% with theexpected results whereas consumer results agreed 95% with theexpected results (four false negatives and two false positives).Consumer results are within the accepted range. The responsesfrom consumers are very positive. Over 98% of the consumersfound the INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Testto be simple, fast, convenience and accurate.The results of the consumer study demonstrated that it iscompatible and similar to the results obtained by professionalsand as a result INSTANT-VIEW® Fecal Occult Blood (FOB)Self-Test is safe and effective device for over the counter use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1 2007

Majid Pajouh, Ph.D. Alfa Scientific Designs, Inc. 13200 Gregg Street Poway, California 92064

Re: K070660

Trade/Device Name: INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Test Fecal Occult Blood (FOB) Self-Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: May 17, 2007 Received: May 21, 2007

Dear Dr. Pajouh:

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

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Page 2 - Majid Pajouh, Ph.D.

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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) 276-0450. 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 L. Becker, Jr., MD, PhD

Ms. PhDs.

Director Division of Immunology and Hematology 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): K070660

Device Name:

INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Test

Indications For Use:

The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occuit Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Prescription Use (Pert 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDR/Office/of/In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K.070440

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Indications for Use

510(k) Number (if known): K070660 ·

Device Name:

Fecal Occult Blood (FOB) Self-Test

Indications For Use:

The Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Prescription Use (Pert 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Hughine Brutha
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

10(K) K070460

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.