HEMA SCREEN SPECIFIC IFOBT

K060463 · Immunostics Inc., · KHE · Jun 6, 2006 · Hematology

Device Facts

• Record ID: K060463
• Device Name: HEMA SCREEN SPECIFIC IFOBT
• Applicant: Immunostics Inc.,
• Product Code: KHE · Hematology
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The hema-screen™ SPECIFIC is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examinations, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Device Story

Lateral flow chromatographic immunoassay for qualitative detection of human hemoglobin in fecal samples. Input: fecal specimen collected via wand or card, mixed with extraction buffer. Principle: sandwich immunoassay using mouse anti-human hemoglobin antibodies on colloidal gold particles and polyclonal anti-human hemoglobin antibodies fixed on membrane. Output: visual red/purple band in test zone indicates presence of human hemoglobin (≥50 μg/g); control zone confirms test validity. Used in professional/laboratory settings by clinicians. Results aid in identifying GI bleeding associated with conditions like diverticulitis, colitis, polyps, or colorectal cancer.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

Lateral flow immunoassay; utilizes monoclonal and polyclonal antibodies; colloidal gold conjugate; solid porous membrane matrix; qualitative visual readout; includes internal control zone; 50 μg/g detection limit.

Indications for Use

Indicated for rapid, qualitative detection of human blood in fecal samples. Intended for professional/laboratory use in screening for colorectal cancer or GI bleeding associated with conditions like diverticulitis, colitis, and polyps; used in routine physical exams and hospital patient monitoring.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN -6 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Immunostics, Inc. c/o Mr. Jeffrey Fleishman Manager, Regulatory Affairs 3505 Sunset Ave. Ocean, NJ 07712

Re: k060463

Trade/Device Name: hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler

Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: February 21, 2006 Received: February 22, 2006

Dear Mr. Fleishman:

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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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours,

Marie Chan for
Dr. Robert Becker

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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## Indication of Use Statement

K060463 510(k) Number (if known):

Device Name:

Hema-Screen™ Specific

Indications for Use:

The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Prescription Use (Part 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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert H. Becker
Division Sign-Off

Office of In Vitro Diagnostic Device

2004(k) K060463

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3505 Sunset Avenue, Ocean, New Jersey 07712 · 732-918-0770 · FAX [phone]