PTS Professional Chemistry Kit

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k182781 B. Purpose for Submission: Combination of previously cleared test systems into a convenience kit C. Measurand: Hemoglobin A1c, glucose, triglycerides, high density lipoprotein, cholesterol D. Type of Test: Convenience Kit E. Applicant: Polymer Technology Systems, Inc. d/b/a PTS Diagnostics F. Proprietary and Established Names: PTS Professional Chemistry Kit G. Regulatory Information: 1. Regulation section: | Regulation Section | Classification | Product Code | Panel | | --- | --- | --- | --- | | Glycosylated Hemoglobin Assay (21 CFR 864.7470) | Class II | LCP | Hematology (81) | | Glucose Test System (21 CFR 862.1345) | Class II | CGA | Chemistry (75) | | Cholesterol (Total) Test System (21 CFR 862.1175) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | CHH | | | Lipoprotein Test System (21 CFR 862.1475) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | LBR | | {1} | Regulation Section | Classification | Product Code | Panel | | --- | --- | --- | --- | | Triglyceride Test System (21 CFR 862.1705) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | JGY | | H. Intended Use: 1. Intended use(s): See Indications for use. 2. Indication(s) for use: 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 mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. - 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 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. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. The Glucose and HbA1c test systems in this kit are not intended for use in screening for diabetes. {2} 4. Special instrument requirements: This convenience kit may include up to three different analyzers, the Cardiochek PA, the Cardiochek Plus and the A1cNow analyzer. Users should follow the instructions on each test strip package insert to determine which analyzer is appropriate for use with that strip. I. Device Description: The PTS Professional Chemistry Kit combines the previously cleared test systems listed below: The CardioChek® PA test system that consists of the CardioChek® PA Analyzer and certain PTS Panels® Test Strips. The CardioChek® Plus test system that consists of the CardioChek® Plus Analyzer and certain PTS Panels® Test Strips. The PTS Panels® Test Strips consist of varying amounts of test strips packed into a vial and a lot-specific MEMo® Chip. The PTS Panels® Test Strips for use with this kit include: PTS Panels® Lipid Panel Test Strips, PTS Panels® Chol+HDL+Glu Test Strips, PTS Panels® Chol+Glu Test Strips, PTS Panels® eGlu Test Strips and PTS Panel® Glucose Test Strips. The PTS Panels® Test Strips are single-use. PTS Panels® Controls 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. 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 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 of the devices described in this submission. J. Substantial Equivalence Information: {3} 1. Predicate device name(s) and 510(k) numbers: CardioChek® Plus Test System (k140068) A1CNow®+ (k090413) 2. Comparison with predicate: | Similarity | | | | | --- | --- | --- | --- | | Item | PTS Professional Chemistry Kit (Candidate Device) | CardioChek® Plus Analyzer (k140068) | A1CNow®+ (k090413) | | Intended Use | Quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in whole blood. | Quantitatively measures total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in whole blood. | Quantitatively measures the percent of glycated hemoglobin (%Alc) in whole blood | | Difference | | | | | Analyte | Percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose | Total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose | Percent of glycated hemoglobin (%Alc), | ## K. Standard/Guidance Document Referenced (if applicable): None referenced. ## L. Test Principle: PTS Panels® Test Strips include reflectance and electrochemical test strips. The reflectance assays include quantitative determination of glucose, total cholesterol, HDL cholesterol and triglycerides. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. A single application of whole blood flows laterally to dose each set of analyte specific membranes once the blood is applied to the test strip. The red blood cells are separated by the test strip such that only the serum or plasma reaches the reaction membranes. The color resulting from the enzymatic reaction is read by the analyzers by reflectance. The reflectance is compared to the calibration curve stored in the memory chip {4} and converted into concentration and displayed by the analyzer. PTS Panels eGLU glucose test strips use electrochemical (amperometric) technology to produce a glucose result. When the blood is applied to the test strip, the blood starts a chemical reaction that produces an electrical current. The current is converted into a glucose result and is displayed on the analyzer screen. The A1CNow+ analyzer utilizes both immunoassay and chemistry technology to measure A1C and total hemoglobin, respectively. Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-A1C antibodies migrate along the reagent strips. The amount of blue microparticles captured on the strips reflects the amount of A1C in the sample. For the total hemoglobin (Hb) portion of the test, the sample diluent converts Hb to met-Hb. The intensity of met-Hb color measured on the reagent strips is proportional to the concentration of hemoglobin in the sample. Test results are expressed as % A1C (A1C ÷ total Hb x 100). ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: All devices included in this kit are previously cleared and are being combined into a kit without modification. a. Precision/Reproducibility: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. b. Linearity/assay reportable range: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. c. Traceability, Stability, Expected values (controls, calibrators, or methods): The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. d. Detection limit: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. e. Analytical specificity: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. f. Assay cut-off: Not applicable. {5} 2. Comparison studies: a. Method comparison with predicate device: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. b. Matrix comparison: Not applicable. Appropriate sample types previously established for the test systems in this kit. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.