HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

K041202 · W.H.P.M., Inc. · KHE · Aug 12, 2004 · Hematology

Device Facts

• Record ID: K041202
• Device Name: HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
• Applicant: W.H.P.M., Inc.
• Product Code: KHE · Hematology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

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

Device Story

The Hemosure™ One-Step FOB Test is a lateral flow sandwich immunoassay used in clinical laboratories or physician offices to detect human hemoglobin (hHb) in fecal samples. The device consists of a test cassette and a fecal collection tube containing extraction buffer. The user collects a fecal sample, mixes it with the buffer, and applies the extract to the test cassette. The device utilizes monoclonal and polyclonal antibodies conjugated to colloidal gold to capture hHb as the sample migrates via capillary action. A positive result is indicated by a pink-rose color band at the test line (hHb ≥50 ng/mL), while a control line confirms proper reagent function. The test provides a qualitative result that aids healthcare providers in identifying potential gastrointestinal bleeding, facilitating further diagnostic investigation for conditions like colorectal cancer or polyps.

Clinical Evidence

Bench testing using 150 spiked stool samples (50 in initial study, 100 in multi-site study). Sensitivity established at 50 ng hHb/mL. Multi-site evaluation (physician office, reference lab, manufacturer lab) showed 97-99% agreement with expected results; overall accuracy 98%. No cross-reactivity with non-human hemoglobin or common dietary/toilet substances.

Technological Characteristics

Lateral flow sandwich immunoassay. Components: nitrocellulose strip, mouse anti-hHb antibodies conjugated to colloidal gold, test line (anti-hHb antibodies), control line (goat anti-mouse IgG). Sensitivity: 50 ng hHb/mL. Format: Cassette. Qualitative visual readout (pink-rose band).

Indications for Use

Indicated for the qualitative determination of fecal occult blood to assist in the detection of gastrointestinal bleeding associated with 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

• Instant-View Fecal Occult Blood (FOB) II Test (Cassette) (Alfa Scientific Designs, Inc.)

Submission Summary (Full Text)

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510(k) Submission Hemosure™ One-Step Fecal Occult Blood (FOB) Test WHPM, Inc.

K04/202

Page 24 of 38

AUG 1 2 2004

# 510 (k) Summary

Date of Summary: 5 May 2004

#### Product Name

Hemosure™ One-Step Fecal Occult Blood (FOB) Test

### Sponsor and Manufacturer

WHPM. Inc. 9440 Telstar Avenue, Unit 1 El Monte, CA 91731

## Correspondent

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

### Substantially Equivalent Devices

Manufacturer: Alfa Scientific Designs, Inc. Instant-View Fecal Occult Blood (FOB) II Test (Cassette). Product:

#### Product Description

The Hemosure™ One-Step FOB Test is a lateral flow immunoassays intended for the detection of fecal occult blood.

#### Intended Use

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

#### Performance Characteristics

Neither dietary substances nor toilet water fresheners or cleansers interfere with the Hemosure™ One-Step FOB Test.

The Hemosure™ One-Step FOB Test gives positive results only when human hemoglobin with sufficient concentration is present. The Hemosure™ One-Step FOB Test does not crossreact with hemoglobin from other species.

Fifty extracted stool samples, free of human hemoglobin, were collected in house and then spiked with human hemoglobin (hHb) to the following concentrations: 0ng hHb/mL, 37.5ng hHb/mL (25% lower than cutoff), 50ng hHb/mL (cutoff), 62.5ng hHb/mL (25% higher than cutoff), and 2,000ng hHb/mL. All samples with concentrations of 50 ng hHb/mL or greater gave positive results. The results agreed 100% with predicate device. This indicates

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510(k) Submission Hemosure™ One-Step Fecal Occult Blood (FOB) Test WHPM, Inc.

Page 25 of 38

Hemosure™ One-Step FOB Test has a sensitivity of 50 ng hHb/mL. 100 extracted stool samples, free of human hemoglobin, were collected in house and then spiked with human hemoglobin (hHb) to the following concentrations: 0ng hHb/mL, 37.5ng hHb/mL (25% lower than cutoff), 50ng hHb/mL (cutoff), 62.5ng hHb/mL (25% higher than cutoff), and 2,000ng hHb/mL. The samples were then blinded and tested with the Hemosure™ One-Step FOB Test. The studies were performed in three sites including a physician's office laboratory, a reference laboratory, and the W.H.P.M. Inc. laboratory. The test results obtained from Physician's Office Laboratory agreed 97% with the expected results. The results obtained from the Reference Laboratory and W.H.P.M., Inc.'s Laboratory both agreed 99% with the expected results. Accordingly, the overall accuracy of the Hemosure One-Step Fecal Occult Blood Test is 98%.

## Conclusion

The Hemosure™ One-Step FOB Test is substantially equivalent to Alfa Scientific Designs' Instant-View Fecal Occult Blood (FOB) II Test.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized image of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

W.H.P.M., Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

AUG 1 2 2004

k041202 Re:

R041202
Trade/Device Name: Hemosure™ One-Step Fecal Occult Blood Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: July 13, 2004 Received: July 14, 2004

Dear Ms. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your beetier broom processorially equivalent (for the indications for use stated in the above and have devices marketed predicate devices marketed in interstate commerce prior to May 28, 1976, Che enactment date of the Medical Device Amendments, or to devices that have been reclassified in the chacmient date of the Frederal Food, Drug, and Cosmetic Act (Act) that do not require accordation with the provisions of molication (PMA). You may, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general coff. 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 IT your device is elassified (oo as e vy isting major regulations affecting your device can be found in Title Subject to suen architens (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 I loase of artistion that your device complies with other requirements of the Act or any Federal statues and regulations administered by other Federal agencies. You must comply with all the t carrar states and regarding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Acr 3 requirements, movements as a good manufacturing practice 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 (Qurregulation (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, rr you atons 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).

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Page 2

If you desire specific information about the application of labeling requirements to your device, r you don't 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 rou may other 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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D. 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

K041202 510(k) Number:

Hemosure™ One-Step Fecal Occult Blood Test Device Name:

#### Indication for Use:

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

#### For professional use only.

Prescription Use >< (21 CFR 801 Subpart D)

AND/OR

Over The Counter Use _________________________________________________________________________________________________________________________________________________________ (21CFR807 Subpart C)

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041202