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510(k) Data Aggregation
(45 days)
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test
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 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 BioScamer Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood 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 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 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 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 diseases involving lipid metabolism or various endocrine disorders.
The above named test systems are for in vitro diagnostic use with the prescription use BioScanner Plus (CardioChek PA) reflectance photometer.
The above named test systems are modified in this submission by the addition of a CardioChek ChekMate strip for use only with the prescription use analyzer. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.
The provided document describes the BioScanner Plus Glucose Test System and related PTS PANELS test systems. The primary focus of the performance characteristics section is on the CardioChek ChekMate strips, which are a modification to the system. While the document mentions several test systems and their intended uses (glucose, cholesterol, triglycerides, HDL cholesterol), the performance data specifically addresses the ChekMate strips, which are used to check the analyzer's optics, calibration, and result handling. The information regarding the various analyte test systems largely defers to previously cleared strips and an unmodified analyzer, indicating their performance was established in prior submissions.
Here's a breakdown of the acceptance criteria and study information for the CardioChek ChekMate Strips:
Table of Acceptance Criteria and Reported Device Performance (for CardioChek ChekMate Strips)
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment: Range Appropriateness | Range (MAX – MIN) must be at least 5% R but not more than 10% R. | Not explicitly stated what the calculated ranges were, but the document states "The range is acceptable if it is at least 5% R, but not more than 10% R." |
| Value Assignment: Individual Strip Verification | Every ChekMate strip, when measured on a different CardioChek PA meter, must pass the established acceptable ranges. | The document states, "Every ChekMate strip is then measured...to verify that every strip will pass these ranges." Implies compliance. |
| Real-time Stability: Percent Recovery | Percent recovery ((Result - Result baseline) * 100) must be 100±20%. | All four lots at each of the two levels passed the criterion. |
| Re-use Stability: Failure Rate on First Test | Less than 2% failures on the first test. | The acceptance criteria was met for 1,253 uses. (Implying |
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(24 days)
PTS PANELS CHOL+GLU TEST PANEL
The Chol+Glu Test Panel 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 and individuals at home to measure blood cholesterol and glucose. 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 Chol+Glu Test Panel is a dry phase test strip that is constructed from a plastic ship holder that holds chemically heated membranes. When whole blood is placed on the test ship, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membrane and react to produce a color change. The Chol+Glu Test Panel is for in vitro diagnostic use with a CardioChek brand (BioScanner Plus) reflectance photometer.
The provided document describes the Chol+Glu Test Panel, a device intended to measure cholesterol and glucose in whole blood. However, the document does not contain explicit acceptance criteria or a dedicated study section detailing how the device meets such criteria in the format requested. Instead, it details the 510(k) submission process, a comparison with predicate devices, and general information about the device's intended use and technology.
Therefore, many of the requested fields cannot be directly extracted from the provided text. The information below is based on what can be inferred or directly stated in the document, acknowledging the limitations.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics like accuracy, precision, sensitivity, or specificity. However, it does provide the measuring ranges for the analytes, which serve as a de facto performance specification that the device must operate within.
| Acceptance Criteria (Inferred from Measuring Ranges) | Reported Device Performance |
|---|---|
| Cholesterol: | Cholesterol: |
| Operates within 100-400 mg/dL | Not explicitly stated as "performance results" in this document, but implied to meet these ranges based on 510(k) clearance. |
| Glucose: | Glucose: |
| Operates within 20-600 mg/dL | Not explicitly stated as "performance results" in this document, but implied to meet these ranges based on 510(k) clearance. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "The Chol+Glu Test Panel is for in vitro diagnostic use," but does not provide details about clinical study sample sizes, data provenance, or study design (retrospective/prospective). This information would typically be found in a more detailed clinical study report, not a 510(k) summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document does not describe the establishment of ground truth by experts for a test set. For these types of devices, ground truth is typically established using a reference laboratory method rather than expert consensus on readings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For a quantitative diagnostic device like this, ground truth is usually established by objective laboratory methods, not by expert adjudication of interpretations.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dry-phase test strip for measuring cholesterol and glucose, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. Therefore, an MRMC study or AI assistance parameters are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical assay test strip that produces a quantitative result read by a photometer. There isn't an "algorithm only" performance concept in the way it applies to software-based diagnostic aids. The device itself generates the result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred to be laboratory reference methods. For in vitro diagnostic devices measuring analytes like glucose and cholesterol, "ground truth" or reference values are typically established using highly accurate and precise laboratory-based analyzer methods (e.g., enzymatic reference methods in a clinical chemistry laboratory). The document does not explicitly state this, but it is standard practice for such devices.
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The sample size for the training set:
- Not specified. The document does not distinguish between training and test sets or provide sample sizes for either. For a dry-phase chemical assay, the "training" aspect is more related to assay development and calibration rather than machine learning training.
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How the ground truth for the training set was established:
- Not specified. Similar to point 7, the document does not detail how ground truth (or reference values for calibration/development) was established. It is presumed to be through highly accurate laboratory reference methods.
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