BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System

K142302 · Polymer Technology Systems, Inc. · CGA · Oct 2, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142302
• Device Name: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' office and in acute and convalescent care facility bedside testing. 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. The Chol+Glu Test Panel system is intended to measure cholesterol and glucose in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure blood cholesterol and dlucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders. The Lipid Panel Test system is intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure three blood analytes: cholesterol and triglycerides. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. The PTS PANELS HDL Cholesterol Test system is intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The PTS PANELS CHOL+HDL Panel Test system is intended to be used by medical professionals to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. The PTS PANELS CHOL+HDL+GLU Panel Test system is intended to be used by medical professionals to measure cholesterol, high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders. The PTS PANELS Metabolic Chemistry Panel Test system is intended to be used by medical professionals to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

Device Story

BioScanner Plus (CardioChek PA) is a reflectance photometer for in vitro diagnostic testing of whole blood. This submission introduces 'CardioChek ChekMate' strips, which are dry strips used to verify analyzer optics, calibration, and result-handling algorithms. ChekMate strips are not for patient testing but serve as a quality check tool. The device is used by healthcare professionals in clinical settings. The system processes blood samples via test strips to provide quantitative analyte measurements. The addition of ChekMate strips allows for periodic system verification without substituting for liquid quality control materials. The output is displayed on the analyzer, assisting clinicians in diagnosing and managing metabolic and lipid disorders.

Clinical Evidence

Bench testing only. Stability studies performed on ChekMate strips: real-time stability confirmed for 18 months (100±20% recovery); re-use stability confirmed for 500 uses (acceptance criteria: <2% failures on first test, no failures on re-test).

Technological Characteristics

Reflectance photometer; dry chemistry test strips; ChekMate strips for optical/algorithm verification; 18-month shelf life; 500-use re-use limit for ChekMate strips.

Indications for Use

Indicated for healthcare professionals in physicians' offices and bedside care, and for home use by individuals with diabetes (specific panels), to quantitatively measure glucose, cholesterol, triglycerides, and HDL cholesterol in human whole blood for the diagnosis and management of carbohydrate metabolism, lipid, and lipoprotein 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k142302

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.