CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM

K140068 · Polymer Technology Systems, Inc. · NBW · May 22, 2015 · Clinical Chemistry

Device Facts

• Record ID: K140068
• Device Name: CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CardioChek Plus Test System is intended for multiple patient use in professional healthcare settings. The CardioChek Home Test System is intended for single-patient use.

Device Story

CardioChek Plus/Home Test Systems; modifications to previously cleared BioScanner Plus System (K014099). Inputs: patient samples (implied blood chemistry). Transformations: analyzer processes samples; provides diagnostic results. Output: test results. Operational context: professional healthcare settings (Plus) or home (Home). Modifications: wireless/wired PC communication; software solutions; printer connectivity; MEMo chip appearance; battery type; multi-language support; analyzer dimensions; name change; validated cleaning/disinfection instructions. Benefit: enables point-of-care or home diagnostic monitoring with updated connectivity and maintenance protocols.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological similarities and performance comparisons to the predicate device.

Technological Characteristics

Portable analyzer using reflectance photometry and amperometry. Powered by 4 AA batteries. Features include MEMo chip for lot-specific calibration, wireless/wired PC/printer connectivity, and multi-language software. Analyzers are larger than the predicate. Uses dry-phase test strips for quantitative blood analysis.

Indications for Use

Indicated for quantitative determination of glucose, total cholesterol, HDL cholesterol, and triglycerides in capillary whole blood (Home/Professional) or venous whole blood (Professional). Used for diagnosis/treatment of lipid disorders, atherosclerosis, liver/renal diseases, diabetes mellitus, neonatal/idiopathic hypoglycemia, and pancreatic islet cell carcinoma. Home system for single-user self-testing; Professional system for multiple-patient use in healthcare settings.

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.

Predicate Devices

• BioScanner Plus System (K014099)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K140068

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) BioScanner Plus System k014099
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the following modifications to the original device:

a. Wireless communications capability (professional system)
b. Software solutions capability
c. Printer connectivity capability
d. MEMo chip appearance
e. Battery type
f. Multiple language software capability
g. Wired PC Communication
h. Analyzer dimensions
i. Device name change from the Bioscanner Plus to the CardioChek Plus Test System and the CardioChek Home Test System
j. The addition of validated cleaning and disinfection instructions to the labeling

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

Studies performed include device usability study, disinfection efficacy testing study, robustness testing study, post disinfection accuracy study, and readability study.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

{1}

The CardioChek Plus Test System is intended for multiple patient use in professional healthcare settings. The CardioChek Home Test System is intended for single-patient use. Disinfection efficacy studies were performed by an outside commercial testing laboratory demonstrated complete inactivation of duck hepatitis B virus (HBV) with the chosen disinfectant, Super Sani-Cloth (EPA Registration #9480-4). Robustness studies demonstrated that there was no change in performance, functionality or external materials after 11,001 cleaning and 11,001 disinfection cycles designed to simulate a 3 year use life of the device. Adequate instructions for the validated cleaning and disinfection procedures are provided in the labeling of the device.