COLOSCREEN-ES

K980671 · Helena Laboratories · KHE · May 12, 1998 · Hematology

Device Facts

• Record ID: K980671
• Device Name: COLOSCREEN-ES
• Applicant: Helena Laboratories
• Product Code: KHE · Hematology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

ColoScreen-ES is designed for the qualitative detection of fecal occult blood. It is an aid in the diagnosis of gastrointestinal disorders such as hemorrhoids, diverticulitis, fissures, colitis or colorectal cancer. The test can be used in mass health screens, doctors offices or hospitals.

Device Story

ColoScreen-ES is an in vitro diagnostic test for qualitative detection of fecal occult blood. Used in clinical settings, mass screenings, or hospitals to assist in diagnosing gastrointestinal conditions like colorectal cancer, diverticulitis, or hemorrhoids. Device functions via chemical reaction to detect occult blood in stool samples. Healthcare providers interpret results to guide further diagnostic investigation. Benefits include early detection of gastrointestinal bleeding associated with various pathologies.

Technological Characteristics

In vitro diagnostic test for qualitative detection of fecal occult blood. Chemical-based detection method. Standalone diagnostic kit.

Indications for Use

Indicated for qualitative detection of fecal occult blood in patients as an aid in diagnosing gastrointestinal disorders including hemorrhoids, diverticulitis, fissures, colitis, or colorectal cancer. Suitable for use in mass health screenings, physician offices, or hospitals.

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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MAY

1 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Patricia Franks Assistant Director of Regulatory Affairs HELENA LABORATORIES 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 77704-0752

Re: K980671 Trade Name: ColoScreen-ES Regulatory Class: II Product Code: KHE Dated: February 19, 1998 Received: February 20, 1998

Dear Ms. Franks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone],or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

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510(k) Number (if known): 1) 980(p

Device Name: ColoScreen-ES

Indications for Use:

ColoScreen-ES is designed for the qualitative detection of fecal occult blood. It is an aid in the diagnosis of gastrointestinal disorders such as hemorrhoids, diverticulitis, fissures, colitis or colorectal cancer.

The test can be used in mass health screens, doctors offices or hospitals.

Peter E. Madson

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

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