ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

K170901 · Biosystems S.A. · CIX · Apr 13, 2018 · Clinical Chemistry

Device Facts

• Record ID: K170901
• Device Name: ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
• Applicant: Biosystems S.A.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

BA400 The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. ALBUMIN Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. ALKALINE PHOSPHASE (ALP) - AMP Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. GLUCOSE-HEXOKINASE Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Device Story

BA400 is an automated clinical chemistry analyzer; performs in vitro biochemical and turbidimetric measurements on human serum, urine, plasma, CSF, or whole blood. Replaces manual analytical procedures by automating pipetting, heating, and color intensity measurement. Operated by clinical laboratory personnel. Provides quantitative analyte concentrations to assist clinicians in diagnosing and monitoring liver, bone, and metabolic conditions like diabetes. System utilizes specific reagents (Albumin, ALP-AMP, Glucose-Hexokinase) for testing.

Clinical Evidence

No clinical data provided; device is an automated analytical instrument for in vitro diagnostic testing.

Technological Characteristics

Automated clinical chemistry analyzer; performs biochemical and turbidimetric measurements; includes automated pipetting, heating, and optical color intensity measurement modules. Designed for use with specific BioSystems reagents.

Indications for Use

Indicated for in vitro diagnostic measurement of albumin, alkaline phosphatase (ALP), and glucose in human serum, plasma, urine, or cerebrospinal fluid to aid in the evaluation of liver protein synthesis, nutritional status, hepatobiliary and bone disease diagnosis, and diabetes monitoring. For professional use in clinical laboratories.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 13, 2018

BioSystems S.A. Teresa Maria Cortes Quality Assurance Manager Costa Brava, 30. 08030 Barcelona Spain

Re: K170901

Trade/Device Name: ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX, CJE, CFR, JJE Dated: March 9, 2018 Received: March 12, 2018

Dear Teresa Maria Cortes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

#### 510(k) Number (if known) K170901

#### Device Name

BA400, ALBUMIN, ALKALINE-PHOSPHATASE (ALP) - AMP, GLUCOSE-HEXOKINASE

#### Indications for Use (Describe)

BA400

The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood.

This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.

#### ALBUMIN

Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

# ALKALINE PHOSPHATASE (ALP) - AMP

Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory. GLUCOSE-HEXOKINASE

Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus.

This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

| Type of Use (Select one or both, as applicable) | |
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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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