IMMOCARE

K052598 · Care Diagnostic, Inc. · KHE · Mar 16, 2006 · Hematology

Device Facts

• Record ID: K052598
• Device Name: IMMOCARE
• Applicant: Care Diagnostic, Inc.
• Product Code: KHE · Hematology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

Device Story

ImmoCARE® is a rapid immunochromatographic assay for qualitative detection of human hemoglobin in fecal samples. Device functions as a diagnostic aid for gastrointestinal bleeding associated with conditions like colorectal carcinoma, Crohn's disease, ulcerative colitis, and polyps. Used by healthcare professionals or patients (OTC); provides visual qualitative results. Benefits include convenient, hygienic screening for occult blood to facilitate early clinical investigation of GI pathology.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunochromatographic lateral flow assay. Components: sampling bottle with extraction buffer, test cassette with membrane. Detection: anti-β-hHb monoclonal antibody-colloidal gold conjugate. Internal control: rabbit IgG/goat anti-rabbit IgG. Cut-off: 0.03 mg hHb/g stool. Standalone, non-electronic, visual readout.

Indications for Use

Indicated for qualitative detection of intact human hemoglobin in fecal specimens to identify fecal occult blood in humans. Used as an aid in detecting gastrointestinal diseases associated with bleeding, including colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps. Suitable for both professional and over-the-counter use.

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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Public Health Service

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Trade/Device Name: ImmoCARE® Regulation Number: 21 CFR § 864.6550 Regulation Name: Reagent Occult Blood

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Re:

Care Diagnostic, Inc. c/o Araceli C. Fancher-Ferreira Official Correspondent 1741 Wiard Street Klamath Falls, OR 97603

16 200

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dated: February 3, 2006 Received: February 9, 2006

Regulatory Class: II Product Code: KHE

Dear Ms Fancher-Ferreira:

k052598

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 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

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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/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PX. 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: K052598

Device Name: ImmoCARE®

Indications for Use:

The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.

ImmoCARE® is an immunological test for both professional and over the counter use..

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

Over the Counter Use (21 CFR 301 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)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052598

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