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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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