IMMAGE IMMUNOCHEMISTRY SYSTEM

{0} 200 South Kraemer Boulevard, Box 8000, Brea CA 92622-8000 • (714) 993-5321 # BECKMAN Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System ## 1.0 Submitted By K962294 Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea, California 92622-8000 Telephone: (714) 993-8916 FAX: (714) 961-4457 AUG 21 1996 ## 2.0 Date Submitted 15 June 1996 ## 3.0 Device Name(s) ### 3.1 Proprietary Names IMMAGE™ Immunochemistry System ### 3.2 Classification Names Nephelometer for clinical use (21 CFR 862.2700) Discrete photometric chemistry analyzer for clinical use (21 CFR 862.2160) ## 4.0 Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328) ## 5.0 Description The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 analytes per sample. Major hardware components include a reagent compartment, sample and reagent cranes, reaction module, sample carousel and crane, hydropheumatics, electronics, and power supplies. ## 6.0 Intended Use The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids. file: imgsystm.sse Beckman Instruments, Inc. twx: 910-592-1260 • telex: 06-78413 {1} Beckman Instruments Inc. Section 510(k) Notification IMMAGE™ Immunochemistry Systems Summary of Safety & Effectiveness # 7.0 Comparison to Predicate(s) The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. | Aspect/Characteristic | Comments | | --- | --- | | SIMILARITIES | | | Intended for: in vitro diagnostic quantitation of components of biological fluids by rate nephelometry and nephometric inhibition | same as ARRAY System | | Measures nephelometric increase in light scatter due to immunoprecipitin formation between antigen and antibody | same as ARRAY System | | Uses nephelometric inhibition immunoassay to measure drugs and small molecular weight constituents | same as ARRAY System | | Uses non-linear math models to describe standard curve determined during reagent manufacturing and a single point calibration for routine instrument operation | same as ARRAY System | | Uses plastic reaction cuvettes which are washed between samples | same as ARRAY System | | Measures turbidimetric decrease in transmitted light due to immunoprecipitin formation between antigen and antibody where one is coupled to latex particles | same as LPIA 100 | | Mathematically calculated absorbance units from the measured transmitted light intensity and calculated rate of change of absorbance during reaction | same as LPIA 100 | | Measures turbidimetric transmitted light scatter in the forward direction (0°- 15°) | same as LPIA 100 | | Cuvette light path 7 mm and reaction incubation temperature controlled at 37°C | same as LPIA 100 | | DIFFERENCES | | | IMMAGE System uses visible laser diode at 670 nm as the light source for nephelometry | ARRAY System uses a tungsten halogen lamp at 400-620 | | IMMAGE System detects light scatter at 90° from the incident beam angle | ARRAY System detects light scatter at 70° angle | | IMMAGE System maintains reaction temperature at 37°C | ARRAY System maintains reaction temperature at 26.7°C | | IMMAGE System uses a LED at 940 nm as light source for turbidimetry | LPIA-100 uses a tungsten halogen light source at 950 nm | | IMMAGE uses non-linear math models to describe standard curves during reagent manufacture and a single point calibration for routine instrument operation | LPIA-100 uses linear and quadratic math models with a multipoint calibration during operation | | IMMAGE uses washable plastic reaction cuvettes | LPIA-100 uses disposable plastic reaction cuvettes | file: imgsystm.sse {2} Beckman Instruments Inc. Section 510(k) Notification IMMAGE™ Immunochemistry Systems Summary of Safety & Effectiveness ## 8.0 Summary of Performance Data The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to *in vitro* diagnostic test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments that relate results obtained from the IMMAGE Immunochemistry System to selected predicate methods. ### Method Comparison Study Results IMMAGE Immunochemistry System vs Selected Predicate Methods | Analyte | Slope | Intercept | r | Predicate | | --- | --- | --- | --- | --- | | Apolipoprotein A | 0.9958 | 1.78 | 0.985 | ARRAY System | | Complement C3 | 0.9789 | 8.05 | 0.990 | ARRAY System | | Digoxin | 1.0637 | -0.02 | 0.968 | Abbott TDx* | | Immunoglobulin A | 1.0281 | -4.61 | 0.995 | ARRAY System | | Rheumatoid Factor | 1.0545 | 0.41 | 0.940 | Behring N Latex RF | | Theophylline | 0.9917 | 0.12 | 0.955 | Abbott TDx | | Transferrin/serum | 1.0316 | -10.06 | 0.985 | ARRAY System | | Transferrin/urine | 1.1108 | -0.04 | 0.998 | ARRAY System | *TDx is a registered trademark of Abbott Diagnostics* ### Estimated Within-run Imprecision | MATERIAL | MEAN | SD | %CV | N | | --- | --- | --- | --- | --- | | Apolipoprotein A (mg/dL) | | | | | | Level 1 | 56.0 | 1.92 | 3.4 | 80 | | Level 2 | 103 | 2.6 | 2.5 | 80 | | Level 3 | 163 | 2.5 | 1.5 | 80 | | Complement C3 (mg/dL) | | | | | | Level 1 | 67.1 | 1.3 | 1.9 | 80 | | Level 2 | 102 | 2.2 | 2.1 | 80 | | Level 3 | 395 | 8.7 | 2.2 | 80 | | Digoxin (ng/mL) | | | | | | Level 1 | 1.18 | 0.063 | 5.3 | 80 | | Level 2 | 2.47 | 0.177 | 7.2 | 80 | | Level 3 | 4.16 | 0.109 | 2.6 | 80 | file: imgsystm.sse {3} Beckman Instruments Inc. Section 510(k) Notification IMMAGE™ Immunochemistry Systems Summary of Safety & Effectiveness | Immunoglobulin A (mg/dL) | | | | | | --- | --- | --- | --- | --- | | Level 1 | 123 | 2.1 | 1.7 | 80 | | Level 2 | 261 | 3.4 | 1.3 | 80 | | Level 3 | 599 | 19.2 | 3.2 | 80 | | Rheumatoid Factor (IU/mL) | | | | | | Level 1 | 123 | 1.5 | 1.2 | 80 | | Level 2 | 290 | 3.1 | 1.1 | 80 | | Level 3 | 613 | 8.7 | 1.4 | 80 | | Theophylline (μg/mL) | | | | | | Level 1 | 8.12 | 0.17 | 2.2 | 80 | | Level 2 | 19.9 | 0.30 | 1.5 | 80 | | Level 3 | 32.4 | 0.46 | 1.4 | 80 | | Transferrin/serum (mg/dL) | | | | | | Level 1 | 241 | 6.8 | 2.8 | 80 | | Level 2 | 364 | 15.2 | 4.2 | 80 | | Level 3 | 680 | 17.9 | 2.6 | 80 | | Transferrin/urine (mg/dL) | | | | | | Level 1 | 0.38 | 0.008 | 2.2 | 80 | | Level 2 | 1.56 | 0.042 | 2.7 | 80 | | Level 3 | 3.06 | 0.124 | 4.1 | 80 | This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. file: imgsystm.sse