(133 days)
Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.
EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT
The provided text does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document is an FDA 510(k) clearance letter for the "Immunoturbidimetric Urinary Microalbumin Assay Kit," dating back to 1997. It primarily focuses on the regulatory approval, indicating that the device is substantially equivalent to previously marketed devices.
The only relevant information related to the device is its intended use, as stated in the "Indications for Use" section:
- Indications for Use: "Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine."
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, and data provenance based on the provided text.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Rinaldo Pagnucco, Ph.D. Vice President, Research and Development Diagnostic Specialties, Inc. P.O. Box 4338 Leonard Street 08840-4338 Metuchem, New Jersey
Re: K971458 Immunoturbidimetric Urinary Microalbumin Assay Kit Requlatory Class: I Product Code: JIQ Dated: July 16, 1997 Received: July 17, 1997
Dear Dr. Pagnucco:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbornoon 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):________ N/K
evice Name: EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT
Indications for Use:
Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Oif
Division of Clinical Laboratory Devic.
510(k) Number K971458
Prescription Use x (Per 21 CFR 801.109)
Over-The-Counter Use
OR
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.