NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL

K053553 · Polymedco, Inc. · DCF · Mar 9, 2006 · Immunology

Device Facts

• Record ID: K053553
• Device Name: NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
• Applicant: Polymedco, Inc.
• Product Code: DCF · Immunology
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

The NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. The NycoCard U-Albumin Control Kit consists of two control materials based on human urine. The controls should be used to confirm the efficacy of the MycoCard U-Albumin reagents and correct performance of the test.

Device Story

NycoCard U-Albumin is an immunochemical test system for quantitative measurement of albumin in human urine. Device aids clinicians in diagnosing kidney and intestinal diseases. System includes test reagents and control materials (human urine-based) to verify performance. Operation involves immunochemical reaction; results provide diagnostic information regarding protein levels in urine. Used in clinical laboratory settings by trained personnel. Output assists healthcare providers in assessing renal or intestinal function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-phase, sandwich-format immunometric assay. Components: membrane with immobilized monoclonal anti-albumin antibodies, gold-particle labeled antibody conjugate, phosphate/borate buffers. Quantitative measurement via NycoCard READER II color densitometer. Storage: 2-8°C. Shelf life: 12 months.

Indications for Use

Indicated for the measurement of albumin in urine to aid in the diagnosis of kidney and intestinal diseases. Intended for use with NycoCard U-Albumin Control to verify reagent efficacy and test performance.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 9 2006

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

k053553 Re:

> Trade/Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control Regulation Number: 21 CFR§ 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF, JJX Dated: December 16, 2005 Received: December 23, 2005

Dear Ms. Landicho:

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 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/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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): K053553

Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control

Indications For Use:

NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

NycoCard U-Albumin Control consists of two control materials based on human urine and is intended to be used to confirm the efficacy of the NycoCard U-Albumin reagents and correct performance of the test.

Prescription Use V (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 Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k053553