DATAPRO CLINICAL CHELISTRY ANALYZER

K042767 · Thermo Electron Corporation · CFR · Apr 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042767
• Device Name: DATAPRO CLINICAL CHELISTRY ANALYZER
• Applicant: Thermo Electron Corporation
• Product Code: CFR · Clinical Chemistry
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories. The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid. The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.

Device Story

DataPro™/DataPro Plus™ is a fully automated clinical chemistry analyzer for in vitro diagnostic use in clinical laboratories. Device processes patient samples to measure clinical assays (e.g., glucose, proteins, enzymes, lipids). System features automated maintenance monitoring, replaceable parts, and data backup capabilities. Throughput up to 230 tests/hour. Operated by laboratory personnel to assist in disease diagnosis and health status monitoring. Output provides quantitative assay results used by clinicians to inform treatment and diagnostic decisions.

Clinical Evidence

No clinical data. Performance established via bench testing per CLSI standards (EP5, EP6, EP9). Precision (CVs reported for 15 analytes), linearity (reportable ranges defined), and method comparison (N=40-60 samples per analyte, correlation coefficients R=0.9254-0.9952) were evaluated against predicate methods.

Technological Characteristics

Fully automated clinical chemistry analyzer; throughput up to 230 tests/hour; includes automated maintenance monitoring and data backup systems. Designed for in vitro diagnostic use.

Indications for Use

Indicated for use in clinical laboratories for the diagnosis of disease or health status assessment via measurement of clinical assays including Albumin, ALP, ALT, AST, BUN, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Bilirubin, Total Protein, Triglyceride, and Uric Acid. Intended for small to medium-sized laboratories or as a backup in large-volume facilities.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Re:

APR 2 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bola Nicholson MT (ASCP) Technical Manager Thermo Electron Corporation Clinical Chemistry 331 South 104th Street Louisville, CO 80027

> k042767 Trade/Device Name: DataPro™/ DataPro Plus™ Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, CJE, CIX, CIT, CIG, CIC, CGX, CDQ, CEK, CEO, CHH, CDT, CDO,CKA, JJE Dated: March 4, 2005 Received: March 7, 2005

Dear Ms. Nicholson:

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); and good manufacturing practice requirements as set forth in the 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 http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, 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 STATEMENT

### 510(K) Number K042767

# Device Name: DataPro™/DataPro Plus™ Clinical Chemistry Analyzer

#### Indications for Use:

The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataPro™ has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataPro™ is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories.

The DataPro™/DataPro Plus™ Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BJ N), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Billirubin, Total Protein, Triglyceride, and Uric Acid.

## The DataPro™, and all of the reagents included in this test system are for in vitro diagnostic use only.

Prescription Use V (Per 21 CFR 801.109)

OR

Over-the Counter-Use

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

oncurrence of CDRH, Office of Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042767