AIA-PACK TSH 3RD-GEN ASSAY

K972586 · Tosoh Medics, Inc. · JLW · Aug 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972586
• Device Name: AIA-PACK TSH 3RD-GEN ASSAY
• Applicant: Tosoh Medics, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of thyroid stimulating hormone (thyrotrophin) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid or pituitary disorders.

Device Story

In vitro diagnostic assay for quantitative measurement of thyroid stimulating hormone (TSH) in human serum; performed on TOSOH AIA System analyzers. Used by clinical laboratory personnel to assist in diagnosing and monitoring thyroid or pituitary disorders. Provides TSH concentration values to healthcare providers to inform clinical decision-making regarding thyroid function and endocrine health.

Technological Characteristics

In vitro diagnostic immunoassay for use on automated TOSOH AIA System analyzers. Measures TSH via quantitative serum analysis.

Indications for Use

Indicated for the quantitative measurement of thyroid stimulating hormone (thyrotrophin) in human serum to aid in the diagnosis and treatment of thyroid or pituitary disorders in patients.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Submission Summary (Full Text)

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AUG 2 9 100:

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lori Robinson Manager, Quality Assurance Tosoh Medics, Jnc. 373 D Vintage Park Drive Foster City, California 94404

K972586 Re : AIA-PACK TSH 3rd-Gen Assay Requlatory Class: II Product Code: JLW, JIS Dated: August 12, 1997 Received: August 13, 1997

Dear Ms. Robinson:

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, Druq, 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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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## TOSOH MEDICS, INC.

## PREMARKET NOTIFICATION

## INDICATION FOR USE STATEMENT

## AIA-PACK TSH 3rd-Gen Assay

AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for AIA-PACK TSH Stu-Gen is interiod of thyroid stimulating hormone (thyrotrophin) in
the quantitative measurement of thyroid stimulating horners obtained by the quantitative measurement of thyrou valimans. Measurements obtained by
human serum on TOSOH AIA System analyzers. Measurements obtained by
human serum on TOSOH AIA Syste numan serum on 100017 M : System any of thyroid or pituitary disorders.

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(Division Sign-Off)
Division of Clinical Laboratarevices
510(k) Number. 0912586

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