IND ONE STEP OCCULT BLOOD (FOB) TEST

K113506 · Ind Diagnostics, Inc. · KHE · Dec 19, 2012 · Hematology

Device Facts

• Record ID: K113506
• Device Name: IND ONE STEP OCCULT BLOOD (FOB) TEST
• Applicant: Ind Diagnostics, Inc.
• Product Code: KHE · Hematology
• Decision Date: Dec 19, 2012
• Decision: SESE
• Submission Type: Special
• 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 lateral flow, direct binding immunoassay designed for the rapid, qualitative detection of human hemoglobin in fecal samples. Used in clinical laboratories or physician offices by professional staff, the device provides a visual qualitative result. The presence of occult blood serves as an indicator for potential gastrointestinal disorders, aiding clinicians in the diagnostic process for gastrointestinal bleeding. The test is intended for professional use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's technological characteristics and intended use as a qualitative immunoassay for fecal occult blood.

Technological Characteristics

Lateral flow, direct binding immunoassay; qualitative visual readout; professional in vitro diagnostic use; manual test format.

Indications for Use

Indicated for use in clinical laboratories or physician offices for the qualitative detection of human occult blood in stool specimens to assist in diagnosing 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Date: December 19, 2012

IND Diagnostics Inc. C/O Kai Ming Lou 1629 Fosters Way Delta, B.C. V3M 6S7 Canada

Re: k113506

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 Codes: KHE

Dated: November 20, 2012 Received: November 21, 2012

Dear Mr. Lou:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Kai Ming Lou

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.

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 Diagnostics and Radiological Health 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,

## Reena Philip -S

for

Maria M. Chan, Ph.D.

Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_k113506

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

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 × (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 Diagnostics and Radiological Health (OIR)

Mon

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510k K113506

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