POLYMEDCO OC AUTO MICRO 80 FOB TEST

K041408 · Polymedco, Inc. · OOX · Oct 21, 2004 · Hematology

Device Facts

• Record ID: K041408
• Device Name: POLYMEDCO OC AUTO MICRO 80 FOB TEST
• Applicant: Polymedco, Inc.
• Product Code: OOX · Hematology
• Decision Date: Oct 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer. The OC Auto Micro FOB Test is recommended for use in 1. Routine physical examinations 2. Monitoring for bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

Device Story

The Polymedco OC Auto Micro 80 is an automated immunological test system for fecal occult blood (FOB) detection. It processes fecal samples in professional laboratory settings to identify GI bleeding associated with conditions like colitis, polyps, and colorectal cancer. The system utilizes an analyzer and specific test reagents to perform qualitative analysis. Healthcare providers use the resulting output to screen for colorectal cancer or monitor patients for GI bleeding, aiding in clinical diagnostic decision-making.

Clinical Evidence

Bench testing only. Precision studies (intra-assay, inter-assay, instrument-to-instrument) showed CVs <5% and <10%. Analytical specificity confirmed no cross-reactivity with animal hemoglobins, dietary substances, or common toilet cleaners. Method comparison with predicate using 63 positive samples showed 100% agreement; 106 asymptomatic patient samples showed 99% agreement. Cut-off of 100 ng/mL established with 96.11% sensitivity and 99.33% specificity.

Technological Characteristics

Immunological test system consisting of an automated analyzer and FOB test reagents. Designed for professional laboratory use. Qualitative detection method.

Indications for Use

Indicated for routine physical examinations, monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding.

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 Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 6, 2016

Polymedco, Inc. Helen Landicho, RAC Director, Regulatory Affairs 510 Furnace Dock Road Cortlandt Manor, New York 10567

Re: K041408

Trade/Device Name: The Polymedco OC Auto Micro 80 FOB Test Regulation Number: 21 CFR § 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: 00X Dated: August 31, 2004 Received: September 1, 2004

Dear Ms. Landicho:

This letter corrects our substantially equivalent letter of October 21, 2004.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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 Part 803); good manufacturing practice requirements as set 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

## Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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): k041408

Device Name: The Polymedco OC Auto Micro 80 FOB Test

Indications For Use: The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.

The OC Auto Micro FOB Test is recommended for use in

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

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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(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 Evauation and Safety

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