MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR

{0} 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k093492 B. Purpose for Submission: New devices C. Measurand: Quality control and calibrator material for multiple constituents listed in the indications for use H. 2. below. D. Type of Test: Not applicable E. Applicant: Diamond Diagnostics Inc. F. Proprietary and Established Names: Mission CliniCheck Assayed Chemistry Control I and II Mission CliniCAL Calibrator G. Regulatory Information: 1. Regulation Section: 21 CFR 862.1660 21 CFR 862.1150 2. Classification: Class II, Class I, reserved 3. Product Code: {1} JJY, JIT 4. Panel: 75 Clinical Chemistry ## H. Intended Use: 1. Intended use(s): See indications for use below 2. Indication(s) for use: **Mission ClinCheck Controls** is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Amylase, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), Calcium, Carbon Dioxide (CO₂), Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatinine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Iron, Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, sodium, Transferrin, Triglycerides, Urea, Urea Nitrogen, and Uric Acid which are listed in the expected values chart. **Mission CliniCAL Calibrator** is an *in vitro* diagnostic product intended for use as a calibration serum in clinical chemistry assays. Mission CliniCAL is a single level calibrator based on lyophilized human serum which contains the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Amylase, Aspartate Aminotransferase (AST/GOT), Bicarbonate (CO₂), Bilirubin (Direct), Bilirubin (Total), Calcium, Chloride, Cholesterol (Total), Cholinesterase, Creatinine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Iron, Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Sodium, Triglycerides, Urea, Urea Nitrogen and Uric Acid. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on various automatic analyzers. 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: Abbott chemistry analyzers, ROCHE Hitachi and Cobas Mira analyzers, Beckman chemistry analyzers, and Olympus chemistry analyzers. The package insert lists the 2 {2} specific analyzers for each analyte. I. Device Description: Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. It is packaged into a glass amber bottle, each containing 5ml of product. The product is packaged in single level boxes (10 x 5mL) or multiple level boxes (5 x 2 x 5mL). Mission ClinCAL Calibrator is a single level calibrator based on lyophilized human serum containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. It is packaged in a glass amber bottle, each containing 3mL of product. The product is packaged in multiple level boxes (5 x 2 x 3mL). All human source material was tested and found negative by FDA approved methods for HBsAG, HCV, and HIV-1/2. J. Substantial Equivalence Information: 1. Predicate device name(s): BioRad Lyphochek Assayed Chemistry Control (Level 1, 2) Randox Level 3 Calibrator 2. Predicate 510(k) numbers: k040273 k053153 3. Comparison with Predicate | Similarities | | | | --- | --- | --- | | Characteristics | Mission CliniCheck Assayed Chemistry Control | Predicate Device BioRad Lyphochek Assayed Chemistry Control k040273 | | Intended Use | For in vitro diagnostic use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Amylase, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), | Same | {3} 4 | Differences | | | | --- | --- | --- | | Characteristics | Mission CliniCheck Assrayed Chemistry Control | Predicate Device BioRad Lyphochek Assayed Chemistry Control k040273 | | Constituents | Does not contain values for Acetominophen, Alpha Hydroxybytryate Dehydrogenase (α-HBDH), Alpha-1-Antitrypsin, Alpha-Fetoprotein, Amylase (Alpha), Amylase (Pancreatic), Apolipoprotein B, Bilirubin (Indirect), C3 Complement, C4 Complement, Calcium (ionized) Carbamazepine, Carcinoembryonic Antigen, Ceruloplasmin, Copper, Cortisol, Digoxin, Gentamicin, Globulin, Glutamate Dehydrogenase (GLDH), Haptoglobin, hCG-Beta Subunit, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron Binding Capacity, Total (TIBC), LAP-Arylamidase, Osmolality, Phenobarbital, Phenytoin, Prostate Specific Antigen (PSA), Prostatic Acid Phosphatase (PAP), protein Electrophoresis, T3 Free, T3 Total, T3 Uptake/T Uptake, T4 Free, T4 Total, Theophylline, Thyroid Stimulating Hormone (TSH), Thyroxine Binding Globulin (TBG), Tobramycin, Valproic Acid, Vancomycin, Vitamin B12 and Zinc. | Does contain values for the analytes listed to the left. | | Reconstituted Stability | 20 days at -20°C | 30 days at -20°C | | Similarities | | | | --- | --- | --- | | Characteristics | Mission CliniCAL Calibrator | Predicate Device Randox Level 3 Calibrator k053153 | | Intended Use | For in vitro diagnostic use as a calibration serum in clinical chemistry assays. Mission CliniCAL is based on lyophilized human serum which contains the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline | Same | {4} 5 | Differences | | | | --- | --- | --- | | Characteristics | Mission ClinCAL Calibrator | Predicate Device Randox Level 3 Calibrator k053153 | | Constituents | Does not contain values for Acid Phosphatase (non-prostatic), Acid Phosphatase (prostatic), Bile Acids, Copper, D-3 Hydroxybutyrate, Glutamate Dehydrogenase (GLDH), Alpha Hydroxybutyrate Dehydrogenase, (α-HBDH), Leucine Aminopeptidase (LAP), Osmolality, Iron Binding Capacity, Total (TIBC), and Zinc | Does contain values for the analytes listed to the left. | | Volume | 3 mL per bottle | 5 mL per bottle | | Reconstitution Diluent | Bicarbonate Buffer | DI Water | | Shelf Life | 24 months | 36 months | | Reconstituted Stability | 3 days at 2-8°C, 20 days at -20°C | 7 days at 4°C, 30 days at -20°C | | Levels | One | Two | K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA Staff-Assayed and Unassayed Quality Control Material Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final Guidance for Industry L. Test Principle: Not applicable M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: {5} Not applicable b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Mission Clinicheck Assayed Chemistry Control and Mission Clinical Calibrator | Analyte | Traceability | | --- | --- | | Sodium Chloride, lithium acetate, sodium lactate, BUN (Urea), calcium acetate, creatinine, dextrose, magnesium chloride, NaHPO4, uric acid, potassium chloride, iron, sodium acetate, transferring, conjugated bilirubin, bilirubin | ACS or Reagent grade | | LD, AST, ALT, CK, GGT, Amylase, Lipase, Alkaline Phosphatase, Cholinesterase, Acid Phosphatase | Animal or plant derived from commercial vendors | | Triglyceride | In house preparation | | Albumin, Cholesterol, HDL Cholesterol, LDL Cholesterol | Commercial vendors | | Salicylate | ACS or Reagent Grade | Mission Clinicheck Assayed Chemistry Control Target values for each analyte were obtained by analyzing multiple replicates of each analyte over several days. Multiple replicates of each analyte were tested daily. An average of the values obtained was used to establish the target concentration. Range is assigned based upon pre-determined intervals. Value assignment for the Mission Clinicheck controls is lot specific. Lot to lot variation is determined by testing new lot versus previous lot normalized to either a serum standard made with corresponding analyte NIST (National Institute of Standards and Technology) material or predetermined intervals. Shelf-Life, Open Vial and Accelerated Stability testing protocols and acceptance criteria were described and found to be adequate. The Mission Clinicheck Assayed Chemistry controls have an estimated shelf life of 24 months when stored at 2-8°C. The Mission Clinicheck Assayed Chemistry controls are stable for 7 days when stored at 2-8°C with the following exception: Acid Phosphatase will be stable for 3 days when stored tightly capped at 2-8°C. The labeling states that the Mission {6} Clinicheck Assayed Chemistry controls are stable up to 20 days after reconstitution when stored tightly capped at -10 to -20°C. The labeling states that the control material should not be refrozen. Once thawed the remaining material should be discarded. Real time stability testing is ongoing. ## Mission CliniCAL Calibrator The mean values listed in the package insert were derived from multiple determinations performed on randomly selected samples from that particular lot. Multiple replicates of test samples and a master calibrator lot were measured for the analytes on consecutive days. The mean analyte values were calculated using the master lot of calibrator and target values assigned. To substantiate the new values created, the new lots of Mission CliniCAL calibrator were tested against predetermined intervals on selected chemistry analyzers using 2 levels of commercially available quality control material. Shelf-Life, Open Vial, and Accelerated Stability testing protocols and acceptance criteria were described and found to be adequate. The Mission CliniCAL calibrator has an estimated shelf life of 24 months when stored at 2-8°C. Once reconstituted, with the diluent provided, the Mission CliniCAL is stable for 72 hours at 2-8°C with the following exception: Total Alkaline Phosphatase is stable for at least one day when stored tightly capped at 2-8°C. The labeling states that the Mission ClinCAL calibrator is stable for at least 20 days after reconstitution when stored tightly capped at -20°C. The labeling also states that the control material should not be refrozen. Once thawed the remaining material should be discarded. Real time stability testing is ongoing. d. Detection limit: Not Applicable e. Analytical specificity: Not Applicable f. Assay cut-off: Not Applicable 2. Comparison studies: a. Method comparison with predicate device: Not Applicable b. Matrix comparison: {7} Not Applicable 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): Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: The values for each analyte are provided in the package insert. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.