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510(k) Data Aggregation
(562 days)
The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
- o 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.
A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home Analyzer.
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is 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.
- o 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.
A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.
The CardioChek PA Test System (consisting of the CardioChek PA analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood from the fingertip and is 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.
- 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.
A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Analyzer.
The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek Home Livid Panel test strips) is for the quantitative determination of total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
- Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol o 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.
A Chol/HDL ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Home Analyzer.
The PTS Panels Lipid Panel test strips and the CardioChek Home Lipid Panel test strips are used with the CardioChek Plus, CardioChek PA, CardioChek Home and CardioChek PA Home analyzers to measure total cholesterol and triglycerides in whole blood. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. These test strips are for in vitro diagnostic use only.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CardioChek Test Systems (CardioChek Plus, CardioChek Home, CardioChek PA, CardioChek PA Home) involve demonstrating accuracy and precision for HDL cholesterol measurements within a modified dynamic range of 20-120 mg/dL. The reported performance is based on comparison to a reference laboratory method (Roche Cobas Integra 400 plus) and precision studies.
| Performance Metric | Acceptance Criteria (Implied by equivalence claim and historical device performance) | Reported Device Performance |
|---|---|---|
| Accuracy (Correlation to Reference Method) | High correlation (r ≥ 0.90 typically expected for clinical agreement, though not explicitly stated as a statistical threshold) | CardioChek Plus Home: y = 0.99x + 0.55, r = 0.98 |
| CardioChek Plus: y = 0.99x + 0.55, r = 0.98 | ||
| CardioChek PA: y = 0.93x + 0.98, r = 0.98 | ||
| CardioChek PA Home: y = 0.93x + 0.98, r = 0.98 | ||
| Precision (Coefficient of Variation, CV%) | Generally, CV% values for clinical chemistry analytes are expected to be low, typically < 5-10% depending on the analyte and concentration level. No explicit numerical criteria are given in the document. | CardioChek PA HDL: |
| Level 1 (38.3 mg/dL): CV = 4.3% | ||
| Level 2 (62.4 mg/dL): CV = 3.6% | ||
| Level 3 (106.0 mg/dL): CV = 4.0% | ||
| CardioChek PA Home HDL: | ||
| Level 1 (38.3 mg/dL): CV = 4.3% | ||
| Level 2 (62.4 mg/dL): CV = 3.6% | ||
| Level 3 (106.0 mg/dL): CV = 4.0% | ||
| CardioChek Plus HDL: | ||
| Level 1 (39.5 mg/dL): CV = 4.1% | ||
| Level 2 (63.3 mg/dL): CV = 4.2% | ||
| Level 3 (108.3 mg/dL): CV = 4.8% | ||
| CardioChek Home HDL: | ||
| Level 1 (39.5 mg/dL): CV = 4.1% | ||
| Level 2 (63.3 mg/dL): CV = 4.2% | ||
| Level 3 (108.3 mg/dL): CV = 4.8% | ||
| Measuring Range (Dynamic Range) | 20-120 mg/dL HDL cholesterol | Demonstrated with samples in the range of 21 to 112 mg/dL HDL cholesterol (for accuracy study) and various levels within the range for precision. |
2. Sample Size and Data Provenance for the Test Set
- Accuracy Test Set:
- Sample Size: 80 samples for each analyzer type (CardioChek Plus Home, CardioChek Plus, CardioChek PA, CardioChek PA Home).
- Data Provenance: Not explicitly stated, but based on the nature of medical device studies for FDA submission, it would typically be prospective data collected for the purpose of the study. The country of origin is not specified, but the submission is to the U.S. FDA.
- Precision Test Set:
- Sample Size: 80 observations for Level 1 and Level 2 for all analyzers, and 80 observations (CardioChek PA/PA Home) or 78 observations (CardioChek Plus/Home) for Level 3. These observations were obtained by "three operators tested three levels of whole blood samples on five analyzers... over three time periods."
- Data Provenance: Not explicitly stated, but likely prospective data collected in a controlled laboratory setting.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- This relates to a diagnostic device for quantitative measurement, not an AI classification system requiring expert interpretation for ground truth.
- For Accuracy: The ground truth for HDL cholesterol measurements was established using a Roche Cobas Integra 400 plus HDL Cholesterol instrument, which is a recognized reference method in clinical chemistry. This is a laboratory analyzer, not an expert panel.
- For Precision: The "ground truth" is the mean value obtained from repeated measurements of the same whole blood samples.
4. Adjudication Method for the Test Set
- Not applicable as this is a quantitative measurement device study, not an AI diagnostic study requiring human expert adjudication of interpretations. The "ground truth" is derived from a reference laboratory instrument.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a study for a quantitative measurement device (lipid panel test system), not an AI algorithm intended for interpretation by human readers. The context is not one of human-in-the-loop performance improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, the accuracy and precision studies performed can be considered standalone performance of the device (analyzer with test strips), as it evaluates the device's ability to accurately and precisely measure HDL cholesterol compared to a reference method, without human interpretation as part of the primary output.
7. Type of Ground Truth Used
- Accuracy: The ground truth for the accuracy study was established using a reference laboratory instrument (Roche Cobas Integra 400 plus HDL Cholesterol). This is considered a highly reliable, objective, and standardized method for clinical chemistry analytes.
- Precision: The ground truth for precision is the central tendency (mean) of repeated measurements of controlled samples.
8. Sample Size for the Training Set
- This document describes performance testing for a medical device (CardioChek Test System) that determines quantitative values using enzymatic methods on dry strips read by reflectance photometry. It is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for model development. The device's calibration parameters are programmed into a lot-specific memory chip. Therefore, there is no "training set" in the context of machine learning model development. The calibration and manufacturing processes would involve internal quality control and standardization.
9. How the Ground Truth for the Training Set Was Established
- As there is no "training set" for an AI/machine learning model, this question is not applicable. The device's operational parameters and calibration are established through manufacturing processes and validated through studies like those described (accuracy and precision).
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