PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

K013654 · Precision Systems, Inc. · JJF · Jun 5, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013654
• Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
• Applicant: Precision Systems, Inc.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

Intended Use

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

Device Story

The Analette Chemistry Analyzer is an automated, open-system in vitro diagnostic device used in clinical laboratories. It processes liquid samples (serum, plasma, urine) to measure various analytes using commercially available reagents. As an open system, it allows for the use of a wide variety of reagents for tests including albumin, enzymes (ALT, AST, ALP, Amylase, CK, GGT, LDH), electrolytes (Calcium, CO2, Magnesium, Phosphorus, Chloride), metabolites (Glucose, Creatinine, Urea Nitrogen, Bilirubin, Triglycerides, Uric Acid, Iron), and proteins. The device automates the analytical process, providing quantitative results that assist healthcare providers in diagnosing and monitoring patient health. It functions as a laboratory instrument operated by trained laboratory personnel.

Clinical Evidence

Bench testing only; substantial equivalence established via comparative studies.

Technological Characteristics

Automated clinical chemistry analyzer; open-system architecture compatible with various commercial reagents; in vitro diagnostic instrumentation.

Indications for Use

Indicated for the quantitative determination of analytes in solutions, such as serum, plasma, or urine, in a clinical laboratory setting.

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.

Predicate Devices

• Synermed IR® 200 (K971491)

Reference Devices

• Hitachi® 705

Submission Summary (Full Text)

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JUN 5 2002

K013654

## PRECISION SYSTEMS INC

16 Tech Circle Natick MA USA

Phone [phone] E-mail: [e-mail]

Fax [phone]

Summary of Safety and Effectiveness: July 2, 2001

| Manufacturer: | Precision Systems TM, Inc.<br>16 Tech Circle<br>Natick, MA. 01760<br>Attention: Bill Haden |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | ANALETTE TM |
| Classification<br>Name: | 862.2500 |
| Intended Use: | An in vitro diagnostic automated clinical chemistry<br>analyzer for the analysis of analytes in solution. |
| Predicate Device: | Synermed IR® 200 manufactured by Precision<br>Systems TM, Inc, for Synermed® and as found in<br>Synermeds® 510(k) IR200 vs. the Hitachi® 705. |
| Performance: | Substantially equivalence was established in<br>comparative studies.<br>It was concluded from these results that this product<br>is safe and effective. |
| Safe Medical<br>Device Act 1990 Precision Systems TM will make any additional<br>safety and effectiveness information for the<br>ANALETTE TM Clinical Chemistry Analyzer<br>available to interested persons upon request. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

5 2002 "JUN

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

k013654 Re:

> Trade/Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test Regulatory Class: Class II; Product Code: JJF, CDQ, CEK, CEO, CFJ, CFM, CGA, CGS, CGX, CHG, CHH, CIG,CIT, CIX, CJE, CJE, CJY, CKA, JFJ, JGJ, JGY, JMO, JQB, KHS,KNK, LBR Dated: April 8, 2002 Received: April 8, 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, 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.

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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 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.

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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 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/cdrh/dsma/dsmamain.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

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510(k) Number (if known): K013654

Device Name: PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

Indications For Use:

The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, 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 Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013654

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)