CHEMWELL, ALSO KNOWN AS PROJECT 2900

K013420 · Awareness Technology, Inc. · JLW · Jul 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013420
• Device Name: CHEMWELL, ALSO KNOWN AS PROJECT 2900
• Applicant: Awareness Technology, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

Device Story

ChemWell (Project 2900) is an automated laboratory analyzer used by technologists to process patient serum samples. The device performs quantitative analysis using United Biotech, Inc. (UBI) ELISA kits for thyroid hormones (TSH, T3, T4). It automates the biochemical assay process, providing quantitative hormone measurements to assist clinicians in diagnosing thyroid disorders. The system functions as a clinical laboratory instrument, streamlining the testing workflow for diagnostic hormone panels.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the performance of the specified UBI ELISA kits on the ChemWell analyzer.

Technological Characteristics

Automated laboratory analyzer for ELISA-based hormone assays. System is designed for use with specific UBI reagent kits for TSH, T3, and T4 measurement. Operates as a clinical laboratory instrument.

Indications for Use

Indicated for use by laboratory technologists to obtain blood chemistry information from patient serum samples for the diagnosis of thyroid disorders via quantitative measurement of TSH, total T3, and total T4 using UBI ELISA kits.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings forming three curved lines. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 1 9 2002

Mr. Glen Van Slooten Research Chemist Awareness Technology, Inc. 1995 S.W. Martin Hwy. P.O. Box 1679 Palm City, FL 34990

Re: k013420

Trade/Device Name: ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW; CDP; KLI` Dated: May 8, 2002 Received: May 9, 2002

Dear Mr. Van Slooten:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Putman

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

{2}------------------------------------------------

510 (k) Number: K013420

Device Name: ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.

Indications For Use: ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

Sean Coopn

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KO13420°

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use