LIASYS WITH MODELS LIASYS

K080468 · Ams S.R.L. Analyzer Medical System · CFR · Jul 25, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080468
• Device Name: LIASYS WITH MODELS LIASYS
• Applicant: Ams S.R.L. Analyzer Medical System
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides the In Vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST in serum, and for sodium, potassium and chloride in serum. Other various chemistry assays may be adaptable to this instrument. 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. Urea Nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Measurements of Creatinine are used in the diagnosis and treatment of muscle diseases and endocrine disorders. Aspartate amino transferase (AST) quantitative measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Measurements of Potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

Liasys is a random-access, computer-controlled, countertop clinical chemistry analyzer. It processes serum samples to perform quantitative diagnostic measurements for glucose, urea nitrogen, creatinine, AST, sodium, potassium, and chloride. The device is intended for professional use in clinical laboratory settings. It automates the analysis of clinical chemistry assays, providing quantitative results that assist healthcare providers in diagnosing and monitoring various metabolic, renal, and electrolyte-related conditions. The system is designed to be adaptable for additional chemistry assays.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing, including precision/reproducibility (within-run and total), linearity, limit of detection (LOD), limit of quantitation (LOQ), and analytical specificity (interference studies). Method comparison studies were conducted against similar methodologies using 64-85 serum samples per analyte, showing high correlation (r > 0.99) for all analytes.

Technological Characteristics

Countertop, random-access clinical chemistry analyzer. Computer-controlled system for automated in vitro diagnostic testing. Performs photometric and/or ion-selective electrode measurements for serum analytes. Operates as a standalone laboratory instrument.

Indications for Use

Indicated for quantitative in vitro diagnostic measurement of glucose, urea nitrogen, creatinine, AST, sodium, potassium, and chloride in serum. Used for diagnosis and monitoring of metabolic, renal, liver, heart, and electrolyte disorders in patients.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 5 2008

AMS S.R.L. Analyzer Medical System C/O Stefano Corradi 17/A Via E. Barsanti Guidonia (Rome), IT I-00012

Re: k080468

Trade/Device Name: Liasys Regulation Number: 21 CFR Sec .- 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Code: CFR, CDN, CGX, CIT, CEM, CGZ, JGS, JJE Dated: June 10, 2008 Received: June 13, 2008

Dear Mr. Corradi:

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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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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 your device of your device to a legally marketed predicate device results in a classification for your device and this, 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 fire number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yéan 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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## Indication for Use

510(k) Number (if known): K080468

Device Name: Liasys

Indication For Use:

The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides the In Vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST in serum, and for sodium, potassium and chloride in scrum. Other various chemistry assays may be adaptable to this instrument.

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. Urea Nitrogen measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Measurements of Creatinine are used in the diagnosis and treatment of muscle diseases and endocrine disorders. Aspartate amino transferase (AST) quantitative measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Measurements of Potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080468