CardioChek Plus Test System

K151530 · Polymer Technology Systems, Inc. · CGA · Jul 7, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151530
• Device Name: CardioChek Plus Test System
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CardioChek Plus Test System is a small portable analyzer and test strip system intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (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. 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.

Device Story

Portable analyzer system for professional healthcare settings; uses analyte-specific test strips (glucose, lipids) and ChekMate strips for system verification. Input: venous or capillary whole blood applied to test strips. Operation: analyzer measures reflectance/optical signals from strips; calculates Chol/HDL ratio and estimates LDL/non-HDL cholesterol. Output: quantitative blood analyte concentrations displayed to clinician. Use: point-of-care testing by healthcare professionals. Benefit: rapid diagnostic assessment of metabolic and lipid disorders; ChekMate strips verify optics, calibration, and result handling algorithms without replacing liquid quality control.

Clinical Evidence

Bench testing only. Intermediate precision evaluation performed over 20 days per CLSI EP5-A2; within-run, between-run, between-day, and total % CV for all results were <3.0%. Stability studies support 18-month shelf life and 500-use re-use stability for ChekMate strips.

Technological Characteristics

Portable analyzer; optical sensing system. Includes dry test strips for glucose and lipids. ChekMate strips used for system verification of optics, calibration, and algorithms. Connectivity/software details not specified. Sterilization not applicable to analyzer; strips are single-use.

Indications for Use

Indicated for professional healthcare settings for quantitative determination of glucose, total cholesterol, HDL cholesterol, and triglycerides in venous or capillary whole blood. Used for diagnosis/treatment of lipid, lipoprotein, and carbohydrate metabolism disorders, including diabetes mellitus, atherosclerosis, liver/renal diseases, and hypoglycemia.

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) #: k151530

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.