OC-SENSOR DIANA IFOB TEST

K092330 · Polymedco Cancer Diagnostics, LLC · OOX · Jan 8, 2010 · Hematology

Device Facts

• Record ID: K092330
• Device Name: OC-SENSOR DIANA IFOB TEST
• Applicant: Polymedco Cancer Diagnostics, LLC
• Product Code: OOX · Hematology
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

“OC-Sensor DIANA iFOB Test” is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories.

Device Story

OC-Sensor DIANA iFOB Test is an automated immunoassay system for professional laboratory use. It detects human hemoglobin in fecal samples to identify gastrointestinal bleeding associated with conditions like colitis, polyps, and colorectal cancer. The system processes fecal samples to provide qualitative results, assisting clinicians in screening and monitoring patients. By automating the detection of occult blood, the device facilitates efficient diagnostic workflows for GI disorders.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Latex turbidimetry immunoassay. Reagents: polyclonal antibodies on polystyrene latex particles. Analyzer performs automated sampling, mixing, and multi-stage wash cycles. Connectivity: standalone instrument. Standards: IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101, IEC 61326-1, IEC 61326-2-6, ISO 14971, ISO 62304, ISO 17511, CLSI EP5-A2, CLSI EP6-A, CLSI EP17-A.

Indications for Use

Indicated for the determination of gastrointestinal (GI) bleeding associated with conditions such as colitis, polyps, and colorectal cancer. Recommended for routine physical examinations, monitoring patient bleeding, and screening for colorectal cancer or gastrointestinal bleeding. For prescription use only.

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-G609 Silver Spring, MD 20993-0002

Eiken Chemical Co., Ltd. c/o TUV SUD America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

JAN 0 8 2010

Re: k092330

Trade/Device Name: OC-Sensor DIANA IFOB Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: OOX Dated: October 16, 2009 Received: October 19, 2009

Dear Mr. Preiss:

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 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

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Page 2 - Mr. Preiss

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 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,

i m cham

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

510(k) Number (if known):

Device Name: OC-SENSOR DIANA iFOB Test

Indications for Use:

"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer.

The OC-Sensor DIANA iFOB test is recommended for use in:

- 1. Routine physical examinations
- 2. Monitoring bleeding in patients
- 3. Screening for colorectal cancer or gastrointestinal bleeding

Prescription Use र (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1 Office of In Vitro Diagnostic Section 4.0 - Indications for Use Page 1 of 1 Device Evaluation and Safety