ACCUWELL T4-EIA

K972974 · Neometrics, Inc. · KLI · Oct 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972974
• Device Name: ACCUWELL T4-EIA
• Applicant: Neometrics, Inc.
• Product Code: KLI · Clinical Chemistry
• Decision Date: Oct 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Neometrics' Accuwell™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.

Device Story

Accuwell™ T4 EIA is an enzyme immunoassay kit for quantitative measurement of Thyroxine (T4) in neonatal dried blood spot samples. Samples are collected on S&S grade 903 filter paper. The assay is performed in a clinical laboratory setting by trained personnel. The device provides a quantitative T4 concentration, which clinicians use to screen newborns for congenital hypothyroidism. The output assists in identifying infants requiring further diagnostic testing for thyroid function.

Technological Characteristics

Enzyme immunoassay (EIA) kit for quantitative measurement of Thyroxine. Utilizes S&S grade 903 filter paper for neonatal dried blood spot collection. In vitro diagnostic device.

Indications for Use

Indicated for the quantitative measurement of Thyroxine in neonatal dried blood spot samples collected on S&S grade 903 filter paper to screen newborns for congenital hypothyroidism.

Regulatory Classification

Identification

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid 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 the limitations in § 862.9.

Submission Summary (Full Text)

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OCT - 6 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David Schwartz . President Neometrics, Inc. 104 Bellerose Avenue E. Northport, New York 11731

Re : K972974 ACCUWELL™ T4-EIA Requlatory Class: II Product Code: KLI Dated: August 8, 1997 Received: August 11, 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labelinq, 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 Requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 [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™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.

(Division
Division of Clinical
510(k) Number
K972974

/Prescription Use