TC MATRIX CLINICAL CHEMISTRY ANALYZER

K073370 · Teco Diagnostics · JJE · May 8, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073370
• Device Name: TC MATRIX CLINICAL CHEMISTRY ANALYZER
• Applicant: Teco Diagnostics
• Product Code: JJE · Clinical Chemistry
• Decision Date: May 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples. TECO MULTI Calibrator is intended for the calibration of quantitative assays. Teco Albumin reagent is intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. Teco ALT reagent is intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Teco Glucose reagent is intended for the quantitative determination of total glucose in human serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Teco BUN reagent is intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

TC Matrix Clinical Chemistry Analyzer is a discrete photometric system for clinical laboratory use. It automates manual analytical procedures including sample pipetting, heating, and colorimetric intensity measurement. The device processes serum and plasma samples to quantify specific analytes (Albumin, ALT, Glucose, BUN) using associated reagents and calibrators. Operated by laboratory personnel, the analyzer provides quantitative results to assist clinicians in diagnosing and managing liver, renal, and metabolic diseases. The system replaces manual benchtop methods with automated workflow to improve efficiency and consistency in clinical chemistry testing.

Clinical Evidence

No clinical data provided; device relies on bench testing and performance verification of analytical procedures.

Technological Characteristics

Discrete photometric chemistry analyzer; utilizes automated pipetting, heating, and colorimetric measurement modules. Designed for clinical laboratory environment. Connectivity and specific software architecture details not provided.

Indications for Use

Indicated for clinical use to measure analytes (Albumin, ALT, Glucose, BUN) in human serum and plasma samples for the diagnosis and treatment of liver, kidney, metabolic, and carbohydrate disorders.

Regulatory Classification

Identification

A discrete photometric 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. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Teco Diagnostics c/o Ms. Jian Vaeches R & D Department 1268 North Lakeview Avenue Anaheim, CA 92807

MAY - 8 2008

k073370 Re:

Trade Name: TC Matrix Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, CKA, CIX, CDQ, JJE, JIX Dated: March 12, 2008 Received: March 24, 2008

Dear Ms. Vaeches:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your booms in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manative to of the Medical Device American Drug commerce prof to May 20, 1770, the chaomen and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costletic Act (Act) that to not roquire approvine of the general controls provisions of the Act. The Act. The You may, merelore, market the device, basyon to me ments for annual registration, listing of general controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (soo aoove) inro . Existing major regulations affecting your device It may be subject to such additional comeonal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Codo of Federal resguents.
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 Please be advised that I DA s issualled of a but one complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a determination and Jour Stered by other Federal agencies. You must in and lisit of any Federal statutes and regulations annings, but not limited to: registration and listing (21 comply with an the Ace 3 requirements, includes 3).
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), laboning (21 Ce quality systems (QS) regulation (21 CFR Part 820).

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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-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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) :

## Device Name: TC Matrix Clinical Chemistry Analyzer

## Indications for Use:

The TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in serum, plasma samples.

TECO MULTI Calibrator is intended for the calibration of quantitative assays.

Teco Albumin reagent is intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Teco ALT reagent is intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Teco Glucose reagent is intended for the quantitative determination of total glucose in human serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Teco BUN reagent is intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Prescription Use J ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109)

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

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

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Office of In Vitro Diagnostic Device
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