(494 days)
The CardioChek Home Test System is a small portable analyzer and test strip system for self-testing by lay users. It is intended to be used by a single person and should not be shared. 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 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 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.
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 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.
The CardioChek Plus professional test system consists of the CardioChek Plus professional analyzer and analyte specific test strips and is intended for professional use. The CardioChek Plus professional analyzer is an in vitro diagnostic device consisting of both a reflectance photometer and amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric (electrochemical) analysis.
The CardioChek Home test system consists of the CardioChek Home analyzer and analyte specific test strips. The CardioChek Home analyzer is an in vitro diagnostic device consisting of both a reflectance photometer and amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric (electrochemical) analysis.
The CardioChek Plus professional and CardioChek Home test systems are a modification of the original device (cleared as BioScanner Plus, K014099) to include the following modifications:
- · Wireless communications capability (professional system)
- · Software solutions capability
- · Printer connectivity capability
- · MEMo chip appearance
- · Battery type
- · Multiple language software capability
- · Wired PC Communication
- · Analyzer dimensions
The provided text is a 510(k) summary for the CardioChek Plus and CardioChek Home Test Systems. It describes the devices, their intended use, and states their substantial equivalence to a predicate device (BioScanner Plus System, K014099). However, it does not contain specific acceptance criteria, study data, or details about patient sample sizes, training sets, or ground truth establishment methods.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study results.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on the device modifications and
the argument for substantial equivalence based on similarities and minor
differences from the predicate device (BioScanner Plus System K014099).
It states that "The CardioChek Plus and CardioChek Home test systems are as safe and effective and perform as well as our predicate device, the BioScanner Plus."
However, it does not provide the detailed study results that would
substantiate this claim in terms of specific performance metrics or
acceptance criteria.
Key information present in the document:
- Device Names: CardioChek Plus Test System, CardioChek Home Test System
- Intended Use: Quantitative determination of glucose, total cholesterol, HDL, and triglycerides in capillary whole blood (CardioChek Home) and venous/capillary whole blood (CardioChek Plus).
- Predicate Device: BioScanner Plus System (K014099)
- Modifications: Wireless communications, software solutions, printer connectivity, MEMo chip appearance, battery type, multi-language software, wired PC communication, analyzer dimensions. These are cosmetic, connectivity, and usability changes, not fundamental changes to the core measurement technology.
- Conclusion: The new devices are "as safe and effective and perform as well as our predicate device, the BioScanner Plus." This conclusion implies that the performance of the predicate device serves as the implicit "acceptance criteria" and that the modifications did not degrade this performance.
To answer your questions thoroughly, detailed study reports (e.g., analytical and clinical validation studies) would be required, which are not included in this 510(k) summary document.
§ 862.1345 Glucose test system.
(a)
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.(b)
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.