DOCUMENT TDM ULTRA ASSAYED CONTROL

{0} K96C344 MAR 22 13:51 Exhibit 15. 510(k) Summary FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT™ TDM ULTRA Assayed Control, Levels I, II, III 1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096 Attention: Christine V. Beach Manager, Regulatory Affairs (207) 878-7550 (207) 878-7578 FAX January 5, 1996 2. Product Name: Proprietary Name: DOCUMENT™ TDM ULTRA Assayed Control Classification Name: Control, multiple analyte, assayed. Page • 80 • {1} Page • 81 • # 3. Predicate Device: Product: Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3 Catalog: Level 1 (B5700-6), Level 2 (B5700-7), Level 3 (B5700-8) Manufacturer: BaxterDiagnostics, Inc., Deerfield, IL 60015-4633 Analytes: ACET, AMI, CARB, DIG, DISO, ETHO, GENT, LIDO, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, SAL, THEO, hTSH, T4, TOB, T3, TU, VAL Product: Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels Catalog: Low (2841-31), High (2842-31) Manufacturer: Instrumentation Laboratory Company, Lexington, MA 02173-3190 Analytes: METH, VANCO Product: Abbott REA Ethanol Serum Control, Levels L, M, and H Catalog: 9545-11 Manufacturer: Abbott Laboratories, Abbott Park, IL 60064 Analytes: ETOH # 4. Product Description: **DOCUMENT® TDM ULTRA Assayed Controls** consist of three levels of a human serum matrix containing 25 commonly monitored analytes. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT), lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO). # 5. Intended Use: This product is intended for *in vitro* diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies. {2} 6. Comparison to the Predicate Device: | Characteristic | DOCUMENT® TDM ULTRA Assayed Control | Dade Immunoassay Comprehensive Tri-Level Control | Instrumentation Laboratories TheraChem TDC Therapeutic Drug Control | Abbott REA Ethanol Serum Control | | --- | --- | --- | --- | --- | | Intended Use | To assess the analytical performance of analytical systems in the quantitative measurement of therapeutic drugs, thyroid function, and ethanol | Assist in monitoring accuracy and precision in clinical assays | Control material for procedures used to quantitate levels of therapeutic drugs and thyroid hormones in serum specimens | Controls for the validation of calibration of the REA Ethanol assay on the TDxFLx, TDx, or ADx | | Number of Levels | Three (3): Level I, Level II Level III | Three (3): Level 1, Level 2, Level 3 | Two (2): Low, High | Three (3): L, M, H | | Type | Assayed | Assayed | Assayed | Assayed | | Analytes | 25 | 64 | 30 | 1 | | Volume | 5 mL | 5 mL | 5 mL | 4 mL | | Matrix | Human serum, Liquid | Human source, Lyophilized | Bovine serum, Lyophilized | Human blood components, Liquid | | Dilution | None required | None required | None required | None required | | Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date | | Open Stability | 30 Days | Varies with analyte following reconstitution | Up to four weeks after reconstitution | Until expiration date | | Container | Plastic, Dropper Tip | Glass | Glass | Plastic | Page • 82 • {3} Page • 83 • # 7. Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the **DOCUMENT™** TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control. The results show that the **DOCUMENT™** TDM ULTRA Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes.