ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

{0}------------------------------------------------ ## Amylase (AMY) Method for the ADVIA IMS Systems Listed below is a comparison of the performance of the Bayer ADVIA Amylase (AMY) method and a similar device that was granted clearance of substantial equivalence (Bayer RA-XT Amylase method). The information was extracted from the Bayer ADVIA AMY method and Bayer RA-XT Amylase method sheet. ### INTENDED USE The Bayer ADVIA IMS Amylase (AMY) assay is an in-vitro diagnostic device intended to measure AMY in human serum, plasma or urine. Such measurements are used in the diagnosis and treatment of acute pancreatitis. This diagnostic method is not intended for -use on any other diagnostic system .- - - | AMY METHOD: | ADVIA IMS | | RA-XT | | | |------------------------------------------------|----------------------|------------------|----------------|------|--| | Part Number: | Reagents B41-3721-23 | | T01-3508-01 | | | | Analytical Range: | 0 to 1500 U/L | | 10 to 3400 U/L | | | | Precision (Total): | mean<br>(U/L) | % CV | mean<br>(U/L) | % CV | | | | 56 | 2.5 | 51 | 2.2 | | | | 113 | 2.1 | 179 | 1.0 | | | | 430 | 1.5 | 373 | 0.6 | | | Regression Equation:<br>(serum) | y = 1.01x - 5.7 | | | | | | | where: y | = ADVIA IMS | | | | | | x | = RA-XT | | | | | | n | = 72 | | | | | | r | = 0.999 | | | | | | Sy.x | = 11.9 | | | | | | range | = 19 to 1318 U/L | | | | | Regression Equation:<br>(plasma qualification) | y = 1.00x - 0.2 | | | | | | | where: y | = plasma | | | | | | x | = serum | | | | | | n | = 60 | | | | | | r | = 0.999 | | | | | | Sy.x | = 1.0 | | | | | | range | = 18 to 106 U/L | | | | {1}------------------------------------------------ # Interference | | Interfering Substance<br>Concentration | AMY<br>(U/L) | Effect<br>% Change | |--------------------------|----------------------------------------|--------------|--------------------| | Hemolysis (Hemoglobin) | 500 mg/dL | 112 | +2 | | Bilirubin (conjugated) | 20 mg/dL | 113 | -4 | | Bilirubin (unconjugated) | 25 mg/dL | 112 | -2 | | Lipemia (Triglycerides) | 500 mg/dL | 113 | 3 | Urine Samples: 1 | AMY METHOD: | ADVIA IMS | RA-XT | | | |--------------------|----------------------|----------------|------------|------| | Part Number: | Reagents B41-3721-23 | T01-3508-01 | | | | Analytical Range: | 0 to 1500 U/L | 10 to 3400 U/L | | | | Precision (Total): | mean (U/L) | % CV | mean (U/L) | % CV | | | 50 | 1.3 | 57 | 3.4 | | | 218 | 1.1 | 172 | 1.3 | | | 493 | 1.6 | 510 | 1.3 | (urine) | where: | y | = ADVIA IMS | |--------|-------|------------------| | | x | = RA-XT | | | n | = 72 | | | r | = 0.999 | | | Sy.x | = 9.7 | | | range | = 17 to 1465 U/L | Interference : | | Interfering Substance<br>Concentration | AMY<br>(U/L) | Effect<br>% Change | |---------------|----------------------------------------|--------------|--------------------| | Ascorbic Acid | 400 mg/dL | 115 | 1 | | Acetaminophen | 50 mg/dL | 116 | -1 | | Salicylate | 500 mg/dL | 116 | -2 | Rqm. Jr. RA 5/21/99 {2}------------------------------------------------ # Cortisol Method for Bayer ADVIA® IMSTM Listed below is a comparison of the performance between the ADVIA Cortisol method and a similar device that was granted clearance of substantial equivalence (Immuno 1 Cortisol assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA Cortisol method sheet and the Immuno 1 Cortisol method sheet. #### INTENDED USED This in viro method is intended to quantitatively measure cortisol, a hormone secreted by the human adrenal gland, in human serum using Bayer cortisol reagents on a Bayer ADVIA Modular System. Measurements of cortisol are used as a direct indicator of adrenal status or an indirect monitor of pituitary function. | METHOD | | Immuno 1 Cortisol<br>(predicate device) | ADVIA Cortisol | |--------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Part No. | | Reagents T01-2910-01<br>Calibrators T03-3252-01 | Reagents B42-3899-21<br>Calibrators B43-3931-01 | | Minimum Detectable Conc. | | 0.2 µg/dL | 0.1 µg/dL | | Precision (Total CV%) | | 3.2 µg/dL 7.9%<br>20.1 µg/dL 4.5%<br>33.3 µg/dL 4.7% | 4.4 µg/dL 6.0%<br>17.3 µg/dL 5.0%<br>37.5 µg/dL 3.8% | | Correlation | | y = 1.013 x - 0.142<br><br>where<br>y = Bayer ADVIA Modular System<br>x = Bayer Immuno 1 System<br>n = 57<br>r = 0.996<br>Syx = 0.961 µg/dL | | | Interfering<br>Substance | Interfering Substance<br>Concentration | | Analyte<br>Concentration | | Effect | |--------------------------|----------------------------------------|---------|--------------------------|---------|--------| | | SI Units | (mg/dL) | (nmol/L) | (µg/dL) | (%) | | Hemoglobin | 10.0 g/L | 1000 | 466.4 | 16.9 | -4.8 | | Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 463.7 | 16.8 | -4.5 | | Bilirubin | 171 µmol/L | 25 | 469.2 | 17.0 | -1.9 | | Urea Nitrogen | 71.4 mmol/L | 200 | 554.8 | 20.1 | -4.4 | Interforing Subotanco Gabriel J. Muncey, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5/21/99 Date Date {3}------------------------------------------------ ## Iron Method for the Bayer ADVIA Integrated Modular System (IMS) Listed below is a comparison of the performance between the Bayer ADVIA IMS Iron method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Iron-II method). The information used in the Summary of Safety and Effectiveness was extracted from the Bayer ADVIA IMS Iron method sheet and the CHEM 1 Iron-II method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure iron (Fe) in human serum and plasma on the Bayer ADVIA IMS. Measurements of iron are used in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias. | METHOD | ADVIA IMS | CHEM 1 | |--------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Part No. | Reagents<br>B41-3735-43<br>Calibrators<br>T03-1291-62 | T01-3328-53<br>T03-1291-62 | | Analytical Range | 0 to 800 ug/dL | 0 to 1200 ug/dL | | Precision (Total) | 2.8% @ 50.7 ug/dL<br>1.1% @ 230.1 ug/dL<br>0.7% @ 438.3 ug/dL | 1.9% @ 96 ug/dL<br>1.3% @ 211 ug/dL<br>1.2% @ 383 ug/dL | | Correlation | Y=0.93X+10.8 ug/dL<br>Where<br>Y=ADVIA IMS<br>X=CHEM 1<br>N=65<br>r=0.998<br>Sy.x=9.75 ug/dL | | | Plasma/Serum Equivalence | Y=0.98X+0.46 ug/dL<br>Where<br>Y = plasma<br>X= Serum<br>N = 56<br>r = 0.99<br>Sy.x = 3.12 ug/dL | | Gabriel J. Murea, Jr. 5/21/99 {4}------------------------------------------------ Interfering Substances | Bilirubin (unconjugated) 25 mg/dL | 7.0% | effect change @ 215 ug/dL Fe | |-----------------------------------|--------|------------------------------| | Bilirubin (conjugated) 25 mg/dL | -1.0% | effect change @ 221 ug/dL Fe | | Hemoglobin (hemolysate) 500 mg/dL | 44.0% | effect change @ 217 ug/dL Fe | | Lipemia (Triglycerides) 500 mg/dL | -20.0% | effect change @ 207 ug/dL Fe | Gabriel J. Murace, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5/21/99 --- Date {5}------------------------------------------------ ## T4 Method for the Bayer ADVIA® IMS Systems · Listed below is a comparison of the performance between the Bayer ADVIA IMS T4 method and a similar device that was granted clearance of substantial equivalence (Technicon Immuno 1® method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS T4 method sheet and the Immuno 1 method sheet. ## INTENDED USE This in vitro method is intended to quantitatively measure T4 in human serum and plasma on the Bayer ADVIA IMS systems. Measurements of T4 are used to aid in the diagnosis and treatment of thyroid diseases. | METHOD | | ADVIA IMS | Immuno 1 | |--------------------|-------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | ` Part No. | Reagents | B41-3855-42<br>B41-3855-43 | T01-3260-51 | | | Calibrators | B46-4092-01 | T03-3174-01 | | Minimum Det. Conc. | | 0.25 µg/dL | 0.4 µg/dL | | Precision (Total) | | 6.0% @ 3.5µg/dL<br>5.1% @ 7.9 µg/dL<br>4.7% @14.9 µg/dL | 3.6% @ 4.7 µg/dL<br>2.6% @ 8.2 µg/dL<br>2.5% @ 15.7 µg/dL | | Correlation | SERUM | y = 1.06 x +0.11<br>where<br>y = ADVIA IMS<br>x = Immuno 1<br>n = 72<br>r = 0.994<br>Syx = 0.65 µg/dL | | | | PLASMA | y = 0.98X + 0.06<br>Where<br>y = Serum (ADVIA IMS)<br>x = Plasma (ADVIA IMS)<br>n = 24<br>r = 0.977<br>Syx = 0.36 | | {6}------------------------------------------------ | Interference<br>Substance | Interfering<br>Substance<br>Concentration | Thyroxine<br>Concentration,<br>ug/dL | Effect<br>% Change | |-----------------------------|-------------------------------------------|--------------------------------------|--------------------| | Bilirubin<br>(unconjugated) | 25 mg/dL | 15.3 | 0 | | Bilirubin<br>(conjugated) | 20 mg/dL | 15.2 | -2 | | Hemoglobin | 600 mg/dL | 15.2 | -3 | | Lipemia<br>(Triglycerides) | 1000 mg/dL | 15.0 | +3 | RgM, Jr. 5/24/95 {7}------------------------------------------------ #### Free T4 Assay for Bayer ADVIA® Integrated Modular System Listed below is a comparison of the performance between the ADVIA FREE T4 (Free Thyroxine) method, and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1 FREE T4 Assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA FREE T4 insert and the Immuno 1 FREE T4 Assay method sheet. #### INTENDED USED This in vitro method is intended to quantitatively measure the unbound FREE T4 in human serum by using the ADVA FREE T4 Assay on the Bover ADVIA® Interrated Modular System. Less than 0.05% of the Total T4 is unbound to the serum proteins and it is this Free T4 fraction that directly regulates metabolic activity. Thus Free T4 measurements are generally used in the direct or first line diagnosis of thyroid disorders. | METHOD | ADVIA FREE T4 Assay | | | Immuno 1 FREE T4 Assay<br>(predicate Device) | | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--|----------------------------------------------|-------------------|--| | Part No. | Reagents | B42-3905-41 (100 tests) | | Reagents | T01-3360-57 | | | | Reagents | B42-3905-42 (250 tests) | | Calibrators | T03-3401-07 | | | | Calibrators | B43-3936-01 | | | | | | Minimum Detectable Conc. | 0.05 ng/dL | | | 0.10 ng/dL | | | | Precision (Total CV) | 4.5% @ 0.85 ng/dL | 4.8% @ 1.46 ng/dL | | 4.9% @ 0.94 ng/dL | 3.5% @ 1.76 ng/dL | | | | 3.0% @ 3.04 ng/dL | | | 2.2% @ 4.68 ng/dL | | | | Correlation | y = 0.998 x + 0.2179<br>where<br>y = ADVIA FREE T4 Assay<br>x = Immuno 1 FREE T4 Assay<br>n = 50<br>r = 0.9928<br>S = 0.1368 ng/dL | | | | | | #### Interfering Substances | Interfering | Interfering Substance | | Analyte | | Effect | |------------------------|-----------------------|-------------|-----------------------|----------|--------| | Substance | Concentration | | Concentration, uIU/mL | | | | | SI Units - | - (mg/dL) - | I - Expected | Observed | (%) | | Hemoglobin | 10 g/L | 1000 | 1.83 | 1.76 | 3.8 | | Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 1.84 | 1.88 | 2.2 | | Bilirubin | 428 umol/L | 25 | 1.78 | 1.79 | 0.6 | | Urea Nitrogen | 71.4 mmol/L | 200 | 1.83 | 1.81 | 1.1 | Gabriel J. Muraca, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5/21/99 {8}------------------------------------------------ ## Total T3 Assay for Bayer ADVIA® Integrated Modular System Listed below is a companison of the performance between the ADVIA T3 (Trilodothyronine) method, and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 10 T3 Assay). The Summary of Safety and Effectiveness was extracted from the ADVIA T3 insert and the Immuno 1 T3 Assay method sheet. #### INTENDED USED This in vitro method is intended to quantitatively measure T3 in human serum using ADVIA T3 Assay on a Bayer ADVIA Integrated Modular System. Measurements of T3 are used in the diagnosis and treatment of thyroid disorders such as hyperthyroidism. | METHOD | ADVIA T3 Assay | | Immuno 1 T3 Assay<br>(predicate Device) | | |--------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------|--------------------------| | Part No. | Reagents<br>Reagents<br>Calibrators | B42-3916-41 (100 tests)<br>B42-3916-42 (250 tests)<br>B43-3943-01 | Reagents<br>Calibrators | T01-2942-0<br>T03-2872-0 | | Minimum Detectable Conc. | 0.13 ng/mL | 0.06 ng/mL | | | | Precision (Total CV) | 10.3% @ 0.67 ng/mL<br>4.9% @ 1.74 ng/mL<br>3.6% @ 2.89 ng/mL | 13.3% @ 0.46 ng/mL<br>6.0% @ 1.34 ng/mL<br>3.9% @ 3.43 ng/mL | | | | Correlation | y = 1.014x + 0.1368<br>where<br>y = ADVIA T3 Assay<br>x = Immuno 1 T3 Assay<br>n = 50<br>r = 0.996<br> | | | | #### Interfering Substances | Interfering<br>Substance | Interfering Substance<br>Concentration | | Analyte<br>Concentration, ng/mL | | Effect | | |--------------------------|----------------------------------------|------|---------------------------------|----------|---------|--| | | SI Units (mg/dL) | | Expected | Observed | · (%) | | | Hemoglobin | 10 g/L | 1000 | 1.85 | 1.91 | 3.7 | | | Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 1.85 | ાં તેરે | 5.5 | | | Bilirubin | 428 umol/L | 25 | I '85 | 1.90 | 3.0 | | | Urea Nitrogen | 71.4 mmol/L | 200 | I જર | 1.95 | રેંદર્ભ | | Gabriel J. Murray Jr. Syx = Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5721/99 {9}------------------------------------------------ ### Free T3 Assay for Bayer ADVIA® Integrated Modular System Listed below is a companison of the performance between the ADVIA Free T3 Assay method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1ª Free T3 Assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA Free T3 insert and the Immuno 1 " Free T3 Assay method sheet. #### INTENDED USED This in vitro method is intended to quantitatively measure Free T3, in human serven using ADVIA Free T3 Assay on a Bayer ADVIA® Integrated Modular System. Measurements of Free T3 are used in the diagnosis of thyroid or pituitary disorders. | METHOD | ADVIA Free T3 Assay | | Immuno 1 Free T3 Assay<br>(predicate Device) | | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------| | Part No. | Reagents<br>Calibrators | B42-3904-42<br>B43-3935-01 | Reagents<br>Calibrators | T01-3662-57<br>T03-3663-02 | | Minimum Detectable Conc. | | 0.4 pg/mL | | 0.3 pg/mL | | Precision (Total CV) | | 10.0% @ 2.0 pg/mL<br>5.0% @ 4.88 pg/mL<br>4.1% @ 9.35 pg/mL | | 8.5% @ 1.8 pg/mL<br>3.8% @ 5.4 pg/mL<br>2.9% @ 10.8 pg/mL | | Correlation | y = 0.97x + 0.41<br>where<br>y = ADVIA Free T3 Assay<br>x = Immuno 1 Free T3 Assay<br>n = 56<br>r = 0.998<br>Syx = 0.427 pg/mL | | | | #### Interfering Substances | Interfering<br>Substance | Interfering Substance<br>Concentration | | Analyte<br>Concentration, pg/mL | | Effect | | |--------------------------|----------------------------------------|---------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--| | | SI Units | (mg/dL) | Expected | Observed | (%) | | | Hemoglobin --- | 10 g/L | 1000 | 4.66 | રું રેણે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં છે. આ ગામનાં પ્રાથમિક | 6:4 | | | Lipids (Triglycerides) | l 1.3 mmol/L | 1000 | 4.80 | રું 30 | 9.4 | | | Bilirubin | 428 umol/L | 25 | 4.66 | 4.50 | -3.4 | | | Urea Nitrogen | 153.1mmol/L | 429 | 4.66 | 4.76 | 2.1 | | Gabriel J. Munoz, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5/2/99 {10}------------------------------------------------ ## T-Uptake Assay for Bayer ADVIA® Integrated Modular System Listed below is a comparison of the performance between the ADVIA T-Uptake method, and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 19 T-Uptake Assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA T-Uptake insert and the Immuno 1 T-Uptake Assay method sheet. #### INTENDED USED This in vitro method is intended to quantiatively measure the total amount of binding thyroid hormone on the thyroxine-binding proteins, thyroxine-binding prealbuning prealburnin, and albumin in human serum using the ADVIA T-Untake Assay on the Boyer ADVIA® Integrated Modular System. Measurements of T-Uptake are used in the diagnosis and treatment of thyroid disorders. | METHOD | ADVIA T-Uptake Assay | Immuno 1 T-Uptake Assay (predicate Device) | | | |--------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------|----------------------------| | Part No. | Reagents<br>Calibrators | B42-3915-41 (100 tests)<br>B43-3994-01 | Reagents<br>Calibrators | T01-3036-51<br>T03-3076-01 | | Minimum Detectable Conc. | N/A | | N/A | | | Precision (Total CV) | 3.2% @ 0.96<br>2.6% @ 0.89<br>2.3% @ 1.14 | | 2.8% @ 0.71<br>2.6% @ 1.03<br>2.4% @ 1.41 | | | Correlation | y = 0.96x + 0.0003<br>where<br>y = ADVIA T-UptakeAssay<br>x = Immuno 1 T-Uptake Assay<br>n = 51<br>r = 0.987 | | | | #### Interfering Substances | Interfering<br>Substance | Interfering Substance<br>Concentration | Analyte<br>Concentration, ratio | Effect | | | |--------------------------|----------------------------------------|---------------------------------|----------|----------|------| | | SI Units | (mg/dL) | Expected | Observed | (%) | | Hemoglobin | 10 g/L | 1000 | 1.13 | 1.14 | 0.88 | | Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 1.11 | 1.11 | 0.90 | | Bilirubin | 428 $\mu$ mol/L | 25 | 1.15 | 1.17 | 1.74 | | Urea Nitrogen | 71.4 mmol/L | 200 | 1.10 | 1.11 | 0.91 | Gabriel J. Munoz Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 5/21/99 {11}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Urea Nitrogen method for ADVIA® 400 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92. The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ #### 1. Intended Use This in vitro diagnostic method to measure urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma or urine on the Bayer ADVIA 400 system #### 2. Predicate Device | Product Name | | Reagent Part # Calibrator Part # | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------| | Technicon CHEM 1 " Urea | IT01-1452-53 T03-1291-62 | | | Nitrogen · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | | | #### 3. Device / Method | Product Name | Reagent Part # | Calibrator Part # | |-------------------------|----------------|-------------------| | ADVIA 400 Urea Nitrogen | B41-3745-26 | T03-1291-62 | #### Imprecision(SERUM) | ADVIA 400 | | CHEM 1 | | |------------------|----------------|------------------|----------------| | Level<br>(mg/dL) | Total<br>CV(%) | Level<br>(mg/dL) | Total<br>CV(%) | | 7.3 | 4.3 | 21 | 3 | | 17 | 2.5 | 54 | 3 | | 52 | 1.6 | 97 | 3 | #### B. Imprecision(URINE) | ADVIA 400 | | CHEM | |------------------|----------------|------------------| | Level<br>(mg/dL) | Total<br>CV(%) | Level<br>(mg/dL) | | 69 | 3.9 | 478 | | 212 | 2.1 | 648 | | 404 | 2.0 | | | CHEM 1 | | |------------------|----------------| | Level<br>(mg/dL) | Total<br>CV(%) | | 478 | 2.6 | | 648 | 2.5 | Total CV(%) 3.6 3.7 3.4 #### Correlation (Y=ADVIA 400, X=comparison system) | Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) | |---------------------|-----------------------|----|---------------------|-------------|-------|----------------------| | Serum | CHEM 1 | 50 | Y=1.03X-0.6 | 2.8 | 0.997 | 5-124 | | Plasma(y), Serum(x) | ADVIA 400 | 58 | Y=0.96X+0.6 | 1.1 | 0.975 | 6-32 | | Urine | CHEM 1 | 53 | Y=1.08X-8.9 | 22.5 | 0.997 | 70-1010 | Gabriel J. Murray Jr. 7/21/99 . {12}------------------------------------------------ ## Interfering Substances | Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Urea Nitrogen<br>Conc. (mg/dL) | Effect<br>(% change) | |--------------------------|-----------------------------------|--------------------------------|----------------------| | Bilirubin | 33 | 17.6 | -4.0 | | Hemoglobin | 500 | 36.1 | +4.4 | | Lipids (Triglycerides) | 500 | 30.5 | +23.0 | | Ascorbic Acid | 400 | 58.5 | +3.2 | | Salicylate | 500 | 66.3 | -2.4 | | Glucose | 500 | 61.9 | +9.5 | | Acetominophen | 40 | 52.9 | +4.5 | . # Analytical Range : 上 Serum/Plasma: 0 to 150 mg/dL Urine: 2 to 1030 mg/dL 1 Ядт. Jr. SYMBA {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three parallel lines forming the body and a wavy line representing the tail or base. JUL 22 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097 Re: K991817 > Trade Name: Additional IMS Assays for the Bayer ADVIA® IMS™System Regulatory Class: II Product Code: CIJ Dated: May 21, 1999 Received: May 27, 1999 Dear Mr. Muraca: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {14}------------------------------------------------ #### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html". Sincerely yours, Steven Sutman Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {15}------------------------------------------------ Page 1 of 3 510(k) Number (if known): K991817 ## Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Bayer ADVIA IMS Amylase assay is an in vitro diagnostic device intended to measure amylase activity in human serum, plasma or urine. Such measurements are used as an aid primarily in the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The Bayer ADVIA IMS Cortisol assay is an in vitro diagnostic device intended to quantitatively measure cortisol in human serum. Measurements of cortisol are used as an aid in the diagnosis and treatment of disorders of the adrenal gland. The Bayer ADVIA IMS Iron assay is an in vitro diagnostic device intended to measure iron in human serum of plasma. Measurements of iron are used as an aid in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) / Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ﮯ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) {16}------------------------------------------------ 510(k) Number (if known): ## Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Baver ADVIA IMS Thyroxine assay is an in vitro diagnostic device intended to measure thyroxine (T4), both protein bound and free, in human serum and plasma. Measurements of T4 are used as an aid in the diagnosis and treatment of thyroid diseases. The Baver ADVIA IMS Free Thyroxine (FT4) assay is an in vitro diagnostic device intended to quantitatively measure free thyroxine in human serum. Measurements of free thyroxine in conjunction with other thyroid tests and clinical indicators are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Triiodothyronine (T3) assay is an in vitro diagnostic device intended to quantitatively measure triiodothyronine (T3) in human serum. Measurements of triiodothyronine, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use L (Per 21 CFR 801.109) OR Over-The-Counter Use .. (Optional Format 1-2-96) .............................................................................................................................................................................. {17}------------------------------------------------ ### 510(k) Number (if known): ## Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Bayer ADVIA IMS Free Triiodothyronine (FT3) assay is an in vitro diagnostic device intended to quantitatively measure free triiodothyronine in human serum. Measurements of free triodothyronine, in conjunction with other first-line thyroid tests such as Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4), as well as other clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS T Uptake (TUP) assay is an in vitro diagnostic device intended to quantitatively measure the total amount of available binding sites for thyroid hormone on the thyroxine-binding proteins, globulin, pre-albumin, and albumin in human serum. Measurements of T Uptake, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Urea Nitrogen (BUN) method is an in vitro diagnostic device intended to measure urea nitrogen in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of certain renal and metabolic diseases. Alan Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 1991811 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 1-Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)