PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS

K022072 · Precision Systems, Inc. · CIX · Aug 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022072
• Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
• Applicant: Precision Systems, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.

Device Story

Automated clinical chemistry analyzer; processes serum, plasma, or urine samples; utilizes open system architecture compatible with various commercial reagents (e.g., Medical Analysis Systems, Synermeds). Device performs quantitative analysis of analytes to monitor physiological diseases/conditions. Operated by laboratory personnel in clinical settings. Output provides quantitative analyte concentrations to healthcare providers for clinical decision-making regarding patient health status.

Clinical Evidence

Substantial equivalence established through comparative bench testing studies. No clinical trial data provided.

Technological Characteristics

Automated clinical chemistry analyzer; open system architecture; supports multiple analyte assays (e.g., Calcium, Creatinine, Glucose, Enzymes). Connectivity/software details not specified. Sterilization/materials not specified.

Indications for Use

Indicated for quantitative determination of various analytes (e.g., Calcium, Glucose, Cholesterol, Enzymes) in serum, plasma, or urine to monitor physiological diseases or conditions in patients.

Regulatory Classification

Identification

An albumin test system is a device 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.

Predicate Devices

• Precision Systems™, Inc, ANALETTE™ using Synermeds® reagents (K022072)

Submission Summary (Full Text)

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- G. Conclusions:
For the above reasons, we believe the ANALETTE™ clinical chemistry I of the acore reasons is analysis Systems Reagents to be substantially equivalent to the ANALETTE ™ clinical chemistry using Synermeds® 072 reagents.

Should you require further information or have questions, please contact me at: 508 655 7010. Bill Haden

| Summary of Safety and Effectiveness: June 14, 2002 | Classification<br>Name: | Chemistry analyzer, micro | 862.2500 | |
|----------------------------------------------------|-----------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Manufacturer: | Precision Systems™, Inc. | | Calcium | 862.1145 |
| | 16 Tech Circle | | Creatinine | 862.1225 |
| | Natick, MA. 01760 | | Phosphorus | 862.1580 |
| | Attention: Bill Haden | | Albumin | 862.1035 |
| | Medical Analysis Systems | | Total Protein | 862.1635 |
| | 5300 Adolfo Road | | Glucose | 862.1345 |
| | Camarillo, CA 93012 | | Urea Nitrogen | 862.1770 |
| Proprietary Name: | ANALETTE ™ | | Magnesium | 862.1495 |
| | Medical Analysis Systems Reagents | | Creatine Kinase | 862.1215 |
| | Calcium, | | Alkaline Phosphatase | 862.1050 |
| | Creatinine | | Carbon Dioxide | 862.1160 |
| | Phosphorus | | Amylase | 862.1070 |
| | Albumin | | Cholesterol(includes HDL) | 862.1175 |
| | Total Protein | | Triglycerides | 862.1705 |
| | Glucose | | Total Bilirubin | 862.1110 |
| | Urea Nitrogen | | Direct Bilirubin | 862.1110 |
| | Magnesium | | Uric Acid | 862.1775 |
| | Creatine Kinase | | Lactate Dehydrogenase L | 862.1440 |
| | Alkaline Phosphatase | | Lactate Dehydrogenase P | 862.1440 |
| | Carbon Dioxide | | Alanine Aminotransferase | 862.1030 |
| | Amylase | | Aspartate Aminotransferase | 862.1100 |
| | Cholesterol(includes HDL) | | Gamma Glutamyl Transferase | 862.1360 |
| | Triglycerides | | Lipase | 862.1465 |
| | Total Bilirubin | | Chloride | 862.1170 |
| | Direct Bilirubin | Intended Use: | An in vitro diagnostic automated clinical chemistry<br>analyzer for the analysis of analytes in solution. | |
| | Uric Acid | Predicate Device: | Precision Systems™, Inc, ANALETTE™ using<br>Synermeds® reagents | |
| | Lactate Dehydrogenase L | Performance: | Substantially equivalence was established in<br>comparative studies.<br>It was concluded from these results that this product<br>is safe and effective. | |
| | Lactate Dehydrogenase P | Safe Medical<br>Device Act 1990 | Precision Systems™ will make any additional safety<br>and effectiveness information for the ANALETTE ™<br>Clinical Chemistry Analyzer available to interested<br>persons upon request. | |
| | Alanine Aminotransferase | | | |
| | Aspartate Aminotransferase | | | |
| | Gamma Glutamyl Transferase | | | |
| | Chloride | | | |

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Lipase

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is composed of three curved lines that suggest movement and flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.

Public Health Service

AUG 2 3 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bill Haden VP Scientific and Regulatory Affairs Precision Systems Inc. 16 Tech Circle Natick, MA 01760

Re: k022072

> Trade/Device Name: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX; CKA; CIT; CGS; CGA; CJY; CGX; CFJ; CJE; KHS; CIG; CEK; · JFJ; CGZ; JQB; CDQ; CHH; JGJ; JGY; CET; CEO; KNK Dated: June 14, 2002 Received: June 26, 2002

Dear Mr. Haden:

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. Iisting 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

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510k K022072 PRODUCT: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS

## INDICATIONS FOR USE STATEMENT

The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.

R.Q. Hede

Bill Haden, Vice President June 12, 2002

Alberto Sarti for Jean

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

prescription use X
(for 21 CFR 801.109)