INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST

K070660 · Alfa Scientific Designs, Inc. · KHE · Jun 21, 2007 · Hematology

Device Facts

• Record ID: K070660
• Device Name: INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: KHE · Hematology
• Decision Date: Jun 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as an over-the-counter product for home use. Measurement of FOB is a useful as an aid to detect 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. The Fecal Occult Blood (FOB) Rapid Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as an over-the-counter product for home use. Measurement of FOB is a useful as an aid to detect 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 Story

The INSTANT-VIEW FOB Self-Test is a one-step lateral flow chromatographic immunoassay; detects human hemoglobin in fecal specimens. Device consists of a test strip in a plastic cassette housing; strip contains a conjugate pad with colloidal gold-labeled mouse anti-human hemoglobin monoclonal antibodies and a nitrocellulose membrane with test (T) and control (C) lines. User applies fecal sample; if human hemoglobin is present, it binds to the conjugate and is captured at the T line. Results are visually interpreted by the user. Intended for over-the-counter, home use by lay individuals. Provides a qualitative result to aid in detecting gastrointestinal bleeding; enables early identification of potential conditions like colorectal cancer. Offers higher specificity than traditional chemical-based tests by targeting human hemoglobin specifically, avoiding false positives from dietary red meat consumption.

Clinical Evidence

Bench testing only. Analytical performance established via spiked stool samples (0–500 ng/ml hHb). Precision/reproducibility confirmed across three lots. Analytical specificity verified against various dietary substances (meats, vegetables, iron, Vitamin C) with no interference. Method comparison study (n=40) showed 100% agreement with expected results. Multi-site evaluation (n=100) at physician office and medical laboratories showed 98% overall agreement. Consumer study (n=120) using spiked PBS samples showed 95% agreement with expected results compared to 100% for professional testers.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: colloidal gold-conjugated mouse anti-human hemoglobin monoclonal antibodies; nitrocellulose membrane coated with anti-human hemoglobin (test line) and goat anti-mouse IgG (control line). Detection limit: 50 ng/ml hHb in buffer or 50 µg hHb/g in stool. Standalone, single-use cassette format. No external energy source required.

Indications for Use

Indicated for non-professional, lay individuals for the qualitative detection of human blood in stool as an aid in identifying gastrointestinal disorders such as diverticulitis, colitis, polyps, and colorectal cancer.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Hemoccult® test by Beckman Coulter, Inc. (K880499)

Submission Summary (Full Text)

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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

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JUN 2 1 2007

# 510(k) Summary

Safety and Effectiveness as Required by 21 CFR 807.92

| Manufacture and<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 13200 Gregg Street<br>Poway, CA 92064 |
| | Telephone | [phone] x 324 |
| | Fax: | [phone] |
| | Contact Person: | Majid Pajouh, Ph.D.<br>E-mail: [e-mail] |
| Device Name | Trade Name: | <i>INSTANT-VIEW</i> ® Fecal Occult Blood (FOB) Self-Test<br>Fecal Occult Blood (FOB) Self-Test |
| | Common Name: | Immunoassay, FOB Test |
| | Classification: | Occult Blood Test |
| | Product Code: | NGK |
| Date of Summary<br>Preparation | 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.<br>The test strip in the device consists of 1) a burgundy-colored<br>conjugate pad containing colloidal gold coupled with mouse anti-<br>human hemoglobin monoclonal antibodies, and 2) nitrocellulose<br>membrane containing a test line (T line) and a control line (C line).<br>The T line is coated with anti-human hemoglobin antibodies, and the<br>C line is coated with goat anti-mouse IgG antibodies. | |
| Intended Use | | The Fecal Occult Blood (FOB) Self-Test is a qualitative<br>immunoassay for the detection of Fecal Occult Blood by non-<br>professional, lay individuals as a self-test product. Measurement<br>of FOB is useful as an aid to detect human blood in stool as |
| | found in a number of gastrointestinal disorders, e.g. diverticulitis,<br>colitis, polyps and colorectal cancer. It is intended for over the<br>counter use. | |
| Similarity to the<br>Predicate Device | Both are one-step rapid tests. Both are intended to provide qualitative detection of human<br>hemoglobin in the fecal specimen. Both are in-vitro diagnostic devices. The proposed device has a built-in quality control feature but<br>predicate does not. Since FOB is an immunologically based rapid test for the<br>detection of human hemoglobin in the fecal samples, it has<br>inherent advantages compared to the currently marketed<br>chemically based fecal occult blood rapid tests including the<br>predicate Hemoccult®. FOB is more specific than Hemoccult® since it is specific for<br>human hemoglobin and unlike Hemoccult® does not give false<br>positive results due to consumption of red meats, etc. | |
| Sensitivity and<br>Specificity | The sensitivity of the proposed device is 50 ng/ml and it is specific<br>for human hemoglobin. | |
| Accuracy | One hundred (100) samples of hemoglobin free feces extraction<br>specimens collected in-house were divided into 5 groups of 20<br>each. The five groups of extraction samples were spiked with<br>human hemoglobin at five different concentrations (0, 37.5, 50,<br>62.5 and 2000 ng/ml. Those 100 specimens were tested in<br>house with FOB and predicate device. The correlation between<br>the FOB and the predicate device was 100%. | |
| Reproducibility | This study was carried out at four (4) sites outside Alfa, three<br>Physician's Office Laboratories (POL) and one Medical<br>Laboratory. Evaluations at the POL sites were performed by<br>personnel with different educational backgrounds and working<br>experience and agreed 97.7% with the expected results. The<br>results obtained from the Medical Laboratory agreed 99% with the<br>expected results. FOB was also tested by 120 professional and non-<br>professional lay individuals of different education, age and<br>backgrounds 95% of which were able to follow the package insert<br>instructions and obtain accurate results obtained by professionals. | |
| Stability | The test device is stable when stored in controlled environment at<br>15-30° C 59-86° F) for up to two years following the<br>manufacturing or until the expiration date printed on the label,<br>whichever comes first. | |
| Formats of the<br>Device | The proposed device has only cassette format. The cassette is a<br>device that contains a dip-strip in a plastic housing. | |
| Conclusion | The results of accuracy, specificity, sensitivity, reproducibility,<br>cross reactivity, and interference studies demonstrate that the<br>proposed test is substantially equivalent to the predicate device. | |
| Consumer study | Conclusion of the comparison between professionals and<br>consumer studies: Professional results agreed 100% with the<br>expected results whereas consumer results agreed 95% with the<br>expected results (four false negatives and two false positives).<br>Consumer results are within the accepted range. The responses<br>from consumers are very positive. Over 98% of the consumers<br>found the INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Test<br>to be simple, fast, convenience and accurate.<br>The results of the consumer study demonstrated that it is<br>compatible and similar to the results obtained by professionals<br>and as a result INSTANT-VIEW® Fecal Occult Blood (FOB)<br>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 [phone]. 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 [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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