FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

K061065 · Teco Diagnostics · KHE · Jul 14, 2006 · Hematology

Device Facts

• Record ID: K061065
• Device Name: FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
• Applicant: Teco Diagnostics
• Product Code: KHE · Hematology
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physician’s offices. It is useful to determine gastrointestinal bleeding founding a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis.

Device Story

Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay for qualitative detection of human hemoglobin in fecal samples. Device used in professional laboratories or physician offices by healthcare personnel. Sample applied to test card; hemoglobin presence indicated by visual color change on test strip. Results assist clinicians in identifying gastrointestinal bleeding associated with conditions like colorectal cancer, polyps, diverticulitis, or ulcerative colitis. Provides rapid diagnostic information to guide further clinical investigation or patient monitoring.

Clinical Evidence

No clinical studies were performed. Evidence is based on analytical performance testing. Precision/reproducibility studies (n=120) showed 98.3% to 100% agreement across physician office laboratories. Method comparison against the predicate device using 120 spiked specimens demonstrated 98.3% total agreement, 96.3% positive percent agreement, and 100% negative percent agreement. Analytical specificity testing confirmed no interference from various animal hemoglobins or horseradish peroxidase at specified concentrations. Limit of detection is 50 ng/ml in buffer or 5 µg/g in feces.

Technological Characteristics

Lateral flow immunochromatographic sandwich assay. Employs monoclonal and polyclonal antibodies for human hemoglobin detection. Sample matrix: feces in PBS extraction buffer. Sensitivity: 50 ng/ml. Visual readout via rose-pink dye-conjugate bands. Procedural control included. Standalone, non-instrumented test device.

Indications for Use

Indicated for routine physical examination, hospital monitoring for bleeding, and screening for colorectal cancer or gastrointestinal bleeding from any source in patients requiring fecal occult blood testing.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 2006

Mr. Jian Vaeches R & D Department Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, California 92807

Re: k061065

> Trade/Device Name: Teco Rapid Fecal Occult Blood (FOB) Card Test Regulation Number: 21 CFR § 864.6550 Regulation Name: Occult blood test Regulatory Class: II Product Code: KHE Dated: May 26, 2006 Received: June 7, 2006

Dear Mr. Vaeches:

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. Iisting 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.

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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 (if known): _ K061065

## Device Name: Teco Rapid Fecal Occult Blood (FOB) Card Test

Indications for Use: Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis.

Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

Robert M. Becker
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Prescription Use V

510(k) K06/065

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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