POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

K040332 · Arkray, Inc. · JJF · Jun 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040332
• Device Name: POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
• Applicant: Arkray, Inc.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

Intended Use

The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Device Story

SpotChem EZ Analyzer is an in vitro diagnostic instrument; measures ALT/SGPT enzyme activity in serum, plasma, or whole blood samples. Device utilizes photometric analysis to quantify enzyme activity; provides quantitative results to clinicians. Used in clinical settings for diagnostic and treatment monitoring of liver and heart conditions. Healthcare providers use output to assess liver function and cardiac health; aids in clinical decision-making regarding patient disease management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the ALT test system.

Technological Characteristics

In vitro diagnostic instrument; photometric sensing principle; measures ALT enzyme activity in serum, plasma, or whole blood. Standalone benchtop analyzer.

Indications for Use

Indicated for measurement of alanine amino transferase (ALT/SGPT) activity in serum, plasma, and whole blood to aid in diagnosis and treatment of liver diseases (e.g., viral hepatitis, cirrhosis) and heart diseases.

Regulatory Classification

Identification

A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2005

Mr. Yuji Yagi ARKRAY, Inc. 57 Nishiaketa-Cho. Higashi-Kujo, Minami-Ku Kyoto, Japan 601-8045

> k040332 Trade/Device Name: SpotChem EZ Analyzer and ALT Test Regulation Number: 21 CFR 862.1030 Regulation Name: Alanine amino transferase (ALT/SGPT) test system Regulatory Class: Class I Product Code: CKA, JJF Dated: April 6, 2004 Received: April 27, 2004

Dear Mr. Yagi:

Re:

This letter corrects our substantially equivalent letter of April 6, 2004 regarding the applicant/ owner which should be listed as Arkray and not Polymedco.

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 (Act 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 and to 895. In additions and to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 not 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 the more of [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Cornelia B. Pookt

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Cc: Polymedco, Inc Helen Landicho, RAC

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## Indications for Use

510(k) Number (if known): K040332

Device Name:_SpotChem EZ Analyzer and ALT Test

Indications For Use:

The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040332

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