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510(k) Data Aggregation
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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(8 days)
BIOSCANNER PLUS
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' offices and in acute and convalescent care facility bedside testing and individuals at home. 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 BioScanner Plus, as modified, is an in vitro diagnostic device consisting of both a reflectance photometer and an 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 analysis. The test strips have not been modified. The unmodified BioScanner Plus contains a reflectance photometer. The modified BioScanner Plus has an additional amperometric circuit.
The provided 510(k) summary for the BioScanner Plus device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, the summary focuses on demonstrating substantial equivalence to predicate devices and describes the device's modification and intended use, rather than presenting a performance study with specific acceptance criteria and results.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, precision) that would typically be associated with a device performance study. The submission primarily focuses on the device's design, intended use, and its similarities to legally marketed predicate devices to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for a test set or the provenance of any data. This type of detail is typically found in a separate performance study section, which is not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of a ground truth establishment process, experts, or their qualifications in this 510(k) summary. This information would be relevant if a clinical or analytical performance study was detailed.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method, as no specific test set or study methodology is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. For a glucose meter, the focus is typically on the device's analytical accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The BioScanner Plus is a quantitative glucose measurement device. Its performance is inherently "standalone" in terms of its ability to measure glucose from a biological sample. A "human-in-the-loop" performance study in the context of interpretation (like with imaging) is not applicable here. The accuracy of the device itself would be evaluated. However, the summary does not detail such an evaluation.
7. The Type of Ground Truth Used
The summary does not explicitly state the type of ground truth used. For a glucose meter, the ground truth for an analytical performance study would typically be a reference laboratory method for glucose measurement (e.g., hexokinase method, YSI analyzer) known for its high accuracy and precision.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this 510(k) summary. This term is most often used in the development of machine learning or AI algorithms. The BioScanner Plus is described as a reflectance photometer and an amperometer, implying a more traditional analytical device with established chemical and optical principles, not one that relies on a machine learning model requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth might have been established.
Summary of Device and 510(k) Submission:
The 510(k) summary describes the BioScanner Plus, an in vitro diagnostic device for quantitative determination of glucose in human whole blood. The submission's primary purpose is to establish substantial equivalence for a modified BioScanner Plus compared to several predicate devices. The modification involves adding an amperometric circuit to the existing reflectance photometer, essentially combining the functionalities of two predicate devices (the BioScanner Plus with reflectance photometry and the BioScanner Beyond Glucose Analyzer with amperometry) into a single new device. The intended use remains the same: for use by healthcare professionals and individuals at home for the diagnosis and treatment of carbohydrate metabolism disorders.
The core of this 510(k) relies on the fact that both the reflectance photometry and amperometry technologies, as well as the test strips, are already cleared through previous 510(k)s (K013173, K972669, K013203). The argument for substantial equivalence is that by combining these already-cleared technologies, the modified device does not raise new questions of safety or effectiveness. Therefore, the submission focuses on comparing the features and technology of the modified device to its predicates, rather than presenting new, detailed performance studies with quantitative acceptance criteria.
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(28 days)
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner 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. 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 BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.
The BioScanner Plus is a reflectance photometer for in vitro diagnostic use with Polymer Technology System's (PTS) test strips to measure color developed in a chemical reaction that occurs when whole blood is placed on a test strip. The color is measured and converted into concentration for each analyte.
The Lipid Panel Test Strips are dry phase test strips that are constructed from a plastic strip holder that holds chemically treated membranes. When whole blood is placed on the test strip, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membranc and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus reflectance photometer.
The only modification that was made to the BioScanner to produce the BioScanner Plus was: A fourth optical read window was added to the three optical read windows in the BioScanner.
The only modification that was made to the Cholesterol, HDL Cholesterol and Triglycerides test strips to produce the Lipid Panel Test Strips is that the reaction membranes from the three individual test strips were assembled together on one test strip holder that holds all three at once.
Here's a breakdown of the acceptance criteria and study information for the BioScanner Plus Lipid Panel Test Strips, based on the provided 510(k) summary:
This document is a 510(k) summary for a medical device modification, not a standalone study report. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or a comprehensive study analysis of a novel device. Therefore, some information requested, particularly regarding detailed acceptance criteria, specific performance metrics, sample sizes for test sets, expert-derived ground truth, and MRMC studies, is not explicitly present in this type of submission. The focus is on comparing the modified device's performance to the predicate device's established performance.
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds). Instead, the criterion for acceptance is "substantial equivalence" to the predicate device. This implies that the modified device (BioScanner Plus and Lipid Panel Test Strips) must perform comparably to the predicate device (BioScanner and its individual Cholesterol, HDL Cholesterol, and Triglycerides Test Strips).
The "performance" described is the functionality and analytical method, with the implicit understanding that the analytical performance (accuracy, precision) would be equivalent to the predicate. The changes made were structural (four optical windows instead of three) and organizational (combining three test strips into one Lipid Panel Test Strip), not fundamental changes to the chemical reaction or measurement principle.
| Metric | Acceptance Criteria (Implicit, based on substantial equivalence) | Reported Device Performance |
|---|---|---|
| Determination of Total Cholesterol, HDL Cholesterol, and Triglycerides | Equivalent to predicate device | Determines Total Cholesterol, HDL Cholesterol, and Triglycerides concentrations in whole blood |
| Method of Red Blood Cell Separation | Equivalent to predicate device | Uses the same method of red blood cell separation |
| Reaction Membranes | Equivalent to predicate device | Uses the same reaction membranes for blood separation and color development |
| Measurement Principle | Equivalent to predicate device | Uses a reflectance photometer to convert the intensity of color produced in a colorimetric chemical reaction into results |
| EEPROM Chip Functionality | Equivalent to predicate device | Incorporates a lot-specific EEPROM chip for curve information and a failsafe feature |
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. 510(k) summaries for device modifications often do not include the detailed sample sizes of validation studies if the modifications are considered minor and don't significantly alter the fundamental performance. The focus is on demonstrating that the changes do not negatively impact performance compared to the predicate, often through bridging studies rather than full-scale clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given that this is an in vitro diagnostic device measuring standard analytes, ground truth would typically be established using validated laboratory reference methods, not necessarily by human expert consensus as might be the case for image-based diagnostic aids.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This type of study is typically performed for diagnostic aids where human interpretation is involved (e.g., radiology AI). The BioScanner Plus is an automated in vitro diagnostic device for quantitative measurements; direct human reader involvement in the measurement process for improvement with AI assistance is not applicable here.
6. Standalone Performance Study (Algorithm Only)
The 510(k) summary describes a standalone device (BioScanner Plus with Lipid Panel Test Strips). However, it does not detail a specific "algorithm only" study in the sense of comparing an AI algorithm's performance in isolation. The device itself is the "algorithm only" in the context of its chemical and optical measurement system. The performance is assessed by comparing its output (analyte concentrations) to accepted reference methods or the predicate device, not by comparing an AI algorithm's output to human expert readings.
7. Type of Ground Truth Used for the Test Set
The type of ground truth used would almost certainly be reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry, or other established analytical methods) for Cholesterol, HDL Cholesterol, and Triglycerides. This is standard practice for validating in vitro diagnostic devices. However, the specific methods are not detailed in this summary.
8. Sample Size for the Training Set
This information is not provided in the 510(k) summary. The BioScanner Plus is a reflectance photometer, which uses a chemical reaction and optical detection, not an AI or machine learning algorithm that typically requires a distinct "training set" in the common sense. The "training" in this context refers to the calibration curves established for each lot of test strips.
9. How the Ground Truth for the Training Set Was Established
The "ground truth" for the "training set" (calibration) in this device is established via a multipoint curve that is set for each lot of test strips. This involves measuring known concentrations of the analytes (standards) to generate a calibration curve. This curve information is then programmed into a lot-specific electronically erasable programmable read-only memory (EEPROM) chip. The exact methods for determining the "known concentrations" (standards) are not detailed in this summary but would involve highly accurate reference methods.
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