LIASYS 450

K113131 · Ams · CFR · Mar 8, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113131
• Device Name: LIASYS 450
• Applicant: Ams
• Product Code: CFR · Clinical Chemistry
• Decision Date: Mar 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The "LIASYS 450 SAT 450" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Other various chemistry assays are 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. 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 450 SAT 450 is a random-access, computer-controlled, countertop clinical chemistry analyzer. Device processes serum samples to provide quantitative measurements of glucose, sodium, potassium, and chloride. System is designed for clinical laboratory use by trained personnel. Instrument automates chemistry assays; results are displayed for healthcare providers to assist in diagnosing and monitoring metabolic and electrolyte disorders. Device supports additional adaptable chemistry assays.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use as a clinical chemistry analyzer.

Technological Characteristics

Random-access, computer-controlled, countertop clinical chemistry analyzer. Performs in vitro quantitative measurements of glucose, sodium, potassium, and chloride in serum. System architecture supports adaptable chemistry assays.

Indications for Use

Indicated for in vitro quantitative measurement of glucose, sodium, potassium, and chloride in serum for patients requiring diagnosis or treatment monitoring of carbohydrate metabolism disorders, electrolyte imbalances, or metabolic disorders.

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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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling the image. The central element is a stylized representation of a human figure, composed of three curved lines, symbolizing health and well-being.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

AMS c/o Stefano Corradi OA & Regulatory Affairs Director 17/A Via E. Barsanti, Guidonia. Rome. I-00012 Italv

## Re: k113131

Trade/Device Name: LIASYS 450 SAT 450 Regulation Number: 21CFR Sec.862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: CFR, CEM, CGZ, JGS, JJE Dated: February 8, 2012 Received: February 9, 2012

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

- 8 2012

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## Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

N

Counney H. Lias, Ph.D. Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): _

Device Name: LIASYS 450 SAT 450

Indication for Use:

The "LIASYS 450 SAT 450" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Other various chemistry assays are 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. 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Concurrence of CDRH, O

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

510(k) K-113131

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