(79 days)
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.
Not Found
The provided text is an FDA 510(k) clearance letter for the NycoCard U-Albumin and NycoCard U-Albumin Control devices. It does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a study proving device adherence to acceptance criteria.
The document primarily focuses on:
- Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control
- Regulation Number and Name: 21 CFR § 866.5040, Albumin immunological test system
- Regulatory Class: Class II
- Product Code: DCF, JJX
- Indications For Use: To measure albumin in urine by immunochemical techniques, aiding in the diagnosis of kidney and intestinal diseases. The control material confirms the efficacy of reagents and correct test performance.
- FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.
Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the requested study-specific questions.
The document states FDA's determination of "substantial equivalence" based on "indications for use stated in the enclosure." A full 510(k) submission would contain data demonstrating this equivalence, but that data is not included in the provided snippets.
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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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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)
Division Sign Off
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K053553
§ 866.5040 Albumin immunological test system.
(a)
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.(b)
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.