IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

K100031 · Ind Diagnostic, Inc. · KHE · Jul 19, 2010 · Hematology

Device Facts

• Record ID: K100031
• Device Name: IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
• Applicant: Ind Diagnostic, Inc.
• Product Code: KHE · Hematology
• Decision Date: Jul 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician’s offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

Device Story

The IND One Step Fecal Occult Blood (FOB) Test is a rapid, qualitative immunoassay designed for professional use in clinical laboratories or physician offices. It detects the presence of occult blood in fecal samples, which serves as an indicator of gastrointestinal bleeding related to various disorders. The device functions as a direct binding immunoassay; it provides a visual qualitative result to the healthcare provider. This diagnostic tool assists clinicians in identifying patients who may require further investigation for gastrointestinal pathology, potentially facilitating earlier diagnosis and management of underlying conditions.

Clinical Evidence

No clinical data provided; the document is a 510(k) clearance letter focusing on regulatory status and intended use.

Technological Characteristics

The device is a lateral flow or direct binding immunoassay for qualitative detection of fecal occult blood. It is intended for professional in vitro diagnostic use. No specific materials, energy sources, or software algorithms are detailed in the provided text.

Indications for Use

Indicated for professional in vitro diagnostic use in laboratories or physician's offices for the rapid, qualitative detection of fecal occult blood to assist in the determination of gastrointestinal bleeding associated with gastrointestinal disorders.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring. MD 20993-0002

IND Diagnostic Inc. c/o Mr. Jason Peng Regulatory Affairs Manager 1629 Fosters Way Delta, BC, Canada V3M6S7

JUL 1 9 2010

Re: k100031

Trade/Device Name: IND 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 2, 2010 Received: July 7, 2010

Dear Mr. Peng:

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, Jrug 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 - Mr. Jason Peng

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 Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mana m Chan

Maria M. Chan. 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 Form

K100031 510(k) Number (if known): __

IND One Step Fecal Occult Blood (FOB) Test Device Name:

Indications for Use:

The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

Prescription Use X Over-The-Counter Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

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

Leake R. S.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100031

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