(42 days)
Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.
Not Found
I am sorry, but based on the provided document, I cannot answer questions 1-9. The document is a 510(k) clearance letter from the FDA for the ACCUWELL™ Phenylalanine device, dated December 5, 1997. It primarily discusses the regulatory approval and classification of the device.
The letter explicitly states that the FDA "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..."
This type of document does not contain specific details about:
- Detailed acceptance criteria and reported device performance (beyond the general statement of substantial equivalence).
- Sample sizes used for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or types of ground truth used in testing that informed the substantial equivalence.
- Training set details (sample size, ground truth establishment methods).
These details would typically be found in the 510(k) submission itself, which is not provided in this excerpt. The included "Statement of Indications for Use" only describes what the device is intended for.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
DEC - 5 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David Schwartz · President Neometrics, Inc. 104 Bellerose Avenue E. Northport, New York 11731
K974047 Re : ACCUWELL™ Phenylalanine Requlatory Class: II Product Code: JNB Dated: October 23, 1997 Received: October 24, 1997
Dear Mr. Schwartz:
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. A 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIN 00), Child dovice any active 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 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 Litman
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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Statement of Indications for Use
Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the Neometrics' ACCUWELL -- Fietiylalanine in neonatal dried blood spot samples which
quantitative measurement of phenylalanine in neonatal to screen quantitative measurement 'or prenyalalance'in nechanized on the many of the screen
have been collected onto S&S grade 903 filter paper. Results are used to screen
have been nave been concered (phenylketonuria) disease.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 4974047
Az
Prescription Use
§ 862.1555 Phenylalanine test system.
(a)
Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.(b)
Classification. Class II.