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The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood.

· Cholesterol measurements are used in the diagnosis and treatments 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 mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.

The PTS Professional Chemistry Kit combines devices that are already cleared and packages them together for the convenience of the user.

There are two CardioChek® Analyzers: the CardioChek® PA Analyzer and the CardioChek® Plus Analyzer. These analyzers are part of portable test systems. The CardioChek® PA test system and the CardioChek® Plus test system consist of their respective analyzer and PTS Panels® Test Strips with a lotspecific MEMo® Chip.

The CardioChek® PA and Plus test systems 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 and are intended for multiple patient uses in professional healthcare settings. These systems are for in vitro diagnostic use only.

The PTS Panels® Test Strips consist of varying amounts of test strips packed into a vial and a lot-specific MEMo® Chip. PTS Panels® Test Strips include reflectance and electrochemical test strips. The reflectance assays include quantitative determination of glucose, total cholesterol. HDL (high density lipoprotein) cholesterol and triglycerides. The electrochemical assay is for glucose measurement. The reflectance test strips are available with one, two, and three assays and come in various combinations of assays. The included PTS Panels® Test Strips include: PTS Panels® Lipid Panel Test Strips, PTS Panels® Chol+HDL+Glu Test Strips, PTS Panels® Chol+HDL Test Strips, PTS Panels® Chol+Clu Test Strips, PTS Panels® eGlu Test Strips, PTS Panel® Glucose Test Strips, and CardioChek Plus Smart Bundle™ Pack. The PTS Panels® Test Strips are single-use.

PTS Panels® Controls contain chemicals that react with test strips to produce color or an electrical current depending on the test strips used. Controls should be run to verify the test system performance, when results are questionable, to comply with a facility's quality control requirements, or as required by local accrediting and regulatory bodies. They contain two vials of control solution that have two levels of each analyte. Controls included in this kit are the PTS Panels® HDL Cholesterol Controls and PTS Panels® Multi-Chemistry Controls.

The PTS Collect™ Capillary Tubes are a glass and plastic tube capable of dispensing an exact volume of blood from the capillary tube to a test strip. The tubes are available with volumes of 15, 20, 30, and 40 uL.

The A1CNow + test provides quantitative measurement of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. A1CNow®+ consists of three components: a semi-disposable plastic-encased device (the analyzer), a plastic cartridge enclosing dry reagent strips, and a shaker kit. The units of the analyzer are pre-programmed on the analyzer and are available in either percentage of glycated hemoglobin (%A1C) or millimoles per mole (mmol/mol). The analyzers are lot specific and intended to be discarded once the provided cartridges are consumed.

The Unistik® 3 Pre-set Single Use Safety Lancets are sterile, single-use, auto-disabling lancets to perform finger sticks to obtain capillary blood.

The PTS Connect™ Dock and PTS Connect® ProLink are included to transfer data from the CardioChek® Plus Analyzer, CardioChek® PA Analyzer, and the A1CNow®+ to computer systems. The CardioChek® Printer interfaces with the CardioChek® Plus and CardioChek® PA Analyzer to print results onto paper and self-adhesive labels.

The PTS Professional Chemistry Kit contents are customizable according to user needs. Individual kits may not contain all the devices described in this submission.

The provided text describes the 510(k) premarket notification for the "PTS Professional Chemistry Kit." However, it does not contain a study demonstrating the device meets specific acceptance criteria in the format requested.

Instead, the document states that the "PTS Professional Chemistry Kit" is a convenience kit combining previously cleared devices. Therefore, the performance criteria and studies for each individual component refer to their original 510(k) clearances.

The available information is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria for the kit itself. Instead, it refers to the performance established for its individual components in their respective prior 510(k) clearances. The "Similarities" table indicates the analytes measured and the intended use are the same as the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given document for the "PTS Professional Chemistry Kit." It would be found within the detailed clinical and non-clinical testing reports for the individual predicate devices (K140068, K090413, K151545, K162282, K071507, K041750, K014099).

3. 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):

This information is not provided in the given document. It is relevant for image-based diagnostic AI, not typically for chemical test kits like this. The ground truth for chemical analytes is established through laboratory reference methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided in the given document. Adjudication methods are typically used in clinical studies involving interpretation of results, often for imaging or subjective assessments, not for quantitative chemical measurements.

5. 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:

This information is not applicable and not provided in the given document. MRMC studies are relevant for human-in-the-loop AI systems that assist human readers in interpreting complex data (e.g., radiology images). This device is a quantitative chemical test kit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device measures chemical analytes directly. The performance described (precision, linearity, limit of detection, analytical specificity, method comparison) for the predicate devices would inherently be "standalone" performance for the instrument measuring the analytes. The "PTS Professional Chemistry Kit" itself is a collection of these standalone devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For chemical measurement devices, the ground truth is typically established using reference laboratory methods (e.g., standardized assays on high-precision lab equipment). The document mentions "method comparison" studies, implying comparison against such reference methods.

8. The sample size for the training set:

This information is not provided in the given document. For traditional chemical test kits, a "training set" in the machine learning sense is not typically used. Instead, methods are developed and validated through extensive analytical testing and calibration curves.

9. How the ground truth for the training set was established:

As mentioned, a "training set" as understood in AI/ML is not directly applicable here. For the development and validation of these chemical assays, the "ground truth" (i.e., true concentration values) would be established using reference laboratory methods for calibrating the devices and evaluating their accuracy against known standards.

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PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

PTS PANELS HDL Cholesterol Test Strips consist of chemical reagents in dry form. When whole blood is placed on the test strip, only the HDL cholesterol fraction passes through to the reaction layer. The HDL cholesterol reacts with a dried cholesterol reagent to produce color. The HDL concentration is proportional to the intensity of the color developed and is measured by a CardioChek brand analyzer.

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. It is a 510(k) summary for the PTS PANELS HDL Cholesterol Test Strips, focusing on its substantial equivalence to predicate devices and its intended use.

However, I can extract information related to the device and its intended use based on the provided text.

Here's an analysis of what is and is not available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available: The document does not explicitly state acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds) nor does it provide detailed performance data from a specific study against such criteria. The "Measuring Range" of 25-85 mg/dL HDL Cholesterol is mentioned, but this is a device specification, not an acceptance criterion related to a study outcome.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Available: The document does not describe any specific test set, its sample size, or its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Available: Since no specific clinical or performance study is detailed, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method:

• Not Available: No adjudication method is mentioned as there's no described study involving expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable/Not Available: This type of study is typically for image-based diagnostic aids involving human readers. The PTS PANELS HDL Cholesterol Test Strips are a dry chemistry test strip for quantitative measurement, not an imaging device requiring human interpretation in this context. Therefore, an MRMC study is not relevant, and no such study is described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

• Partially Addressed by Nature of Device: The device itself is a standalone diagnostic tool, as it directly measures HDL cholesterol. However, the document does not describe a study explicitly proving its standalone performance against a defined set of acceptance criteria. The entire 510(k) submission process inherently evaluates the standalone performance of the device against predicate devices, but specific details of such a study (sample size, methods, results) are not in this summary.

7. Type of Ground Truth Used:

• Implied (Not Explicitly Stated for a Study): For a device like this, the "ground truth" would typically be established by a reference laboratory method (e.g., a standardized enzymatic assay or a CDC-certified method) against which the device's measurements are compared. The document states the "Chemistry Method" is "Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol," which suggests a well-established biochemical principle. However, it does not detail how this ground truth was applied in a specific performance study for the modified device.

8. Sample Size for the Training Set:

• Not Available: The document does not describe any training set or its sample size. This device is a chemical assay, not an AI/ML algorithm that typically requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Not Available: As no training set is described, there's no information on how its ground truth was established.

Summary of what is available from the document:

• Device Name: PTS PANELS HDL Cholesterol Test Strips
• Intended Use: To measure high density lipoprotein cholesterol in whole blood for the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.
• Technology: Dry chemistry test strip for use with PTS reflectance photometer.
• Measuring Range: 25-85 mg/dL HDL Cholesterol.
• Chemistry Method: Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.
• Key Modification: Change in chemistry fractionation method from Phosphotungstic acid precipitation to Dextran sulfate inhibiting method, and removal of glass fiber from the blood separation membrane.
• Predicate Devices: K990247 and K993377, the unmodified PTS PANELS HDL Cholesterol Test Strips from the same company.
• Regulatory Class: Class I.

To answer the prompt fully, more detailed study reports (e.g., analytical and clinical validation studies) would be required, which are typically found in the full 510(k) submission, not just the summary provided here. The provided text is a summary focusing on substantial equivalence to predicate devices, not a detailed performance study report.

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