ACCUWELL PHENYLALANINE ASSAY

K974047 · Neometrics, Inc. · JNB · Dec 5, 1997 · Clinical Chemistry

Device Facts

• Record ID: K974047
• Device Name: ACCUWELL PHENYLALANINE ASSAY
• Applicant: Neometrics, Inc.
• Product Code: JNB · Clinical Chemistry
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1555
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 (PKU) disease.

Device Story

ACCUWELL™ Phenylalanine kit performs quantitative measurement of phenylalanine in neonatal dried blood spot samples; samples collected on S&S grade 903 filter paper. Device used in clinical laboratory settings for screening newborns for phenylketonuria (PKU). Healthcare providers use quantitative results to identify infants requiring further diagnostic testing for PKU. Benefits include early detection of metabolic disorders to facilitate timely clinical intervention.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

In vitro diagnostic kit for quantitative measurement of phenylalanine in neonatal dried blood spots. Utilizes S&S grade 903 filter paper for sample collection. Class II device, product code JNB.

Indications for Use

Indicated for quantitative measurement of phenylalanine in neonatal dried blood spot samples collected on S&S grade 903 filter paper to screen for phenylketonuria (PKU).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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