POLYMEDCO OC LIGHT FOBT TEST

K041297 · Polymedco, Inc. · KHE · Aug 12, 2004 · Hematology

Device Facts

• Record ID: K041297
• Device Name: POLYMEDCO OC LIGHT FOBT TEST
• Applicant: Polymedco, Inc.
• Product Code: KHE · Hematology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The OC Light 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

Poly stat OC Light FOBT is an immunochromatographic lateral flow dipstick test for qualitative detection of human hemoglobin in fecal samples. Input: fecal extract in HEPES buffer; sample applied to dipstick via capillary action. Principle: membrane-immobilized murine anti-Hb capture antibody binds human hemoglobin; latex-conjugated murine anti-hCG antibody facilitates visualization. Output: visible blue bands in test and control zones. Used in professional laboratories and physician office labs; operated by healthcare professionals. Results interpreted visually by user to determine presence of GI bleeding; aids clinical decision-making for GI disorders like polyps or colorectal cancer.

Clinical Evidence

No clinical data. Bench testing only. Reproducibility study conducted at three physician office labs (POLs) with 300 determinations across five hemoglobin concentrations (0-2000 ng/mL). Agreement between POL results and reference laboratory was 99.3%. Method comparison with predicate device showed 99.9% agreement. Analytical specificity testing confirmed no cross-reactivity with animal hemoglobins, dietary substances, or toilet cleaners.

Technological Characteristics

Lateral flow immunoassay dipstick. Components: membrane-immobilized murine anti-Hb capture antibody, conjugated murine anti-hCG antibody, goat anti-mouse IgG control antibody. Extraction buffer: HEPES. Form factor: dipstick in screw-cap bottle with desiccant. Qualitative visual readout.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 2 2004

Ms. Helen Landicho, RAC I)irector of Regulatory Affairs Polymedco Inc. 510 Furnace Dock Rd. Cortlandt Manor, NY 10567

Re: k041297

Trade/Device Name: The Polymedco OC Light FOB Test Regulation Number: 21 CFR 866.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: June 30, 2004 Received: July 9, 2004

Dear Ms. Landicho:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energe, 1976, the enactment date of the Medical Device Amendments, or to commerce province have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been that do not require approval of a premarket approval application (PMA). and Cosmetic Act (110) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of gencial controls proficturing 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 n may be buoject to back 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 r touse be actived a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any Feathall 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 OFF Part 807), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter rections as over 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert I.. Becker, Jr., M.D., 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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## SECTION 12.0 INDICATIONS FOR USE STATEMENT

Ke41297 510(k) Number: -

Device Name: The Polymedco OC Light FOB Test

Indications For Use:

The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of test is useral for the disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

The OC Light test is recommended for use in

- 1) routine physical examinations
- 2) monitoring for bleeding in patients
- 3) screening for colorectal cancer or gastrointestinal bleeding

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A.P. Reeve for S. Bautista

ision of Clinical Laboratory Devices

KO41997 510(k) Number -

V Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Polymedco, Inc.