FASTPACK TSH IMMUNOASSAY

K101390 · Qualigen, Inc. · JLW · Aug 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101390
• Device Name: FASTPACK TSH IMMUNOASSAY
• Applicant: Qualigen, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Device Story

FastPack TSH Immunoassay is a paramagnetic particle-based immunoassay used with the FastPack System. It measures TSH levels in human serum or plasma samples. The system automates the immunoassay process to provide quantitative results. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing thyroid or pituitary disorders, facilitating appropriate patient management.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of new sample collection tube on assay performance, including precision, method comparison, limit of detection, interference, and linearity.

Technological Characteristics

Paramagnetic particle immunoassay; quantitative measurement of TSH; designed for use with the FastPack System; in-vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of thyroid stimulating hormone (TSH) in human serum to aid in the diagnosis of thyroid disease.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Qualigen, Inc. c/o Michael S. Poirier, Senior Vice President 2042 Carte Del Nogal, Suite B Carlsbad, CA 92011

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AUG 1 3 2010

Trade Name

Re:

k101390

Trade Name: FastPack TSH Immunoassay Regulation Number: 21 CFR 8862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Codes: JLW Dated: July 12, 2010 Received: July 14, 2010

Dear Mr. Poirier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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, 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm1

Sincerely yours,

C.A.

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(K) Number (if known): k101390

## Device Name:

## Indications for Use:

The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Prescription Use XX (Part 21 CFR 801 Subpart D) C)

AND/OR

Over -the-Counter Use (Part 21 CFR 801 Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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