Who is the manufacturer of ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

Bayer Corp. filed the 510(k) submission for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K992399).

What is the FDA product code for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

CIX. It is classified under 21 CFR 862.1035 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

Technicon CHEM 1 Albumin (T01-1458-53); Technicon CHEM 1 T.Bilirubin (T01-1522-53); Technicon CHEM 1 Carbon Dioxide (Enzymatic); Bayer Immuno 1 Digoxin (T01-2875-51); Bayer Technicon Chem 1 HDL cholesterol; Technicon CHEM 1 Inorganic Phosphorus (T01-1609-53).

Who can help prepare an FDA 510(k) submission like ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

K992399 · Bayer Corp. · CIX · Sep 15, 1999 · Clinical Chemistry

Device Facts

Record ID	K992399
Device Name	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Applicant	Bayer Corp.
Product Code	CIX · Clinical Chemistry
Decision Date	Sep 15, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1035
Device Class	Class 2

Intended Use

The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney. The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders. The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy. The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance. The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.

Device Story

ADVIA IMS is an automated in vitro diagnostic system for clinical chemistry analysis; processes human serum, plasma, or urine samples; utilizes reagent-based assays and Ion Selective Electrode (ISE) technology to measure specific analytes; provides quantitative results to clinicians; used in clinical laboratory settings; results assist in diagnosis, monitoring, and treatment of various metabolic, renal, hepatic, and electrolyte disorders; system automates sample handling and measurement to improve diagnostic efficiency and patient management.

Clinical Evidence

Bench testing only. Performance validated via precision studies (Total CVs typically 1-7%) and method correlation studies against predicate systems (N=48-107 per analyte, r=0.957-0.999). Interference testing conducted for common substances (bilirubin, hemoglobin, lipids).

Technological Characteristics

Automated clinical chemistry analyzer; utilizes colorimetric/enzymatic reagent assays and Ion Selective Electrode (ISE) potentiometric sensing; serum/plasma/urine matrices; standalone system; standard laboratory reagents and calibrators.

Indications for Use

Indicated for patients requiring diagnostic testing of serum, plasma, or urine for albumin, total bilirubin, CO2, digoxin, HDL cholesterol, inorganic phosphorus, sodium, potassium, and chloride to manage liver, kidney, metabolic, hematological, lipid, and electrolyte disorders.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

Technicon CHEM 1 Albumin (T01-1458-53)
Technicon CHEM 1 T.Bilirubin (T01-1522-53)
Technicon CHEM 1 Carbon Dioxide (Enzymatic)
Bayer Immuno 1 Digoxin (T01-2875-51)
Bayer Technicon Chem 1 HDL cholesterol
Technicon CHEM 1 Inorganic Phosphorus (T01-1609-53)

Related Devices

K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Jul 22, 1999
K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) · Bayer Corp. · Nov 9, 1999
K993867 — BAYER ADVIA IMS SYSTEM · Bayer Corp. · Apr 10, 2000
K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) · Beckman Coulter, Inc. · Dec 18, 2001
K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR · Carolina Liquid Chemistries Corp. · May 16, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Albumin method for ADVIA® IMS 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: K992396 # 1. Intended Use This in vitro diagnostic method is intended to measure albumin in human serum or plasma on the Baver ADVIA IMS system. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidneys. # 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |---------------------------|----------------|-------------------| | Technicon CHEM 1 Albumin | T01-1458-53 | T03-1291-62 | # 3. Device / Method | Product Name | Reagent Part # | Calibrator Part # | |------------------|----------------|-------------------| | ADVIA IM Albumin | B41-3717-26 | T03-1291-62 | # A. Imprecision(SERUM) | ADVIA IMS | | |--------------|-------------| | Level (g/dL) | Total CV(%) | | 2.1 | 1.9 | | 3.4 | 1.6 | | 4.9 | 1.5 | #### Correlation (Y=ADVLA IMS. X=comparison system) 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | Specimen type | Comparison System (X) | N | Regression Equation | Syx (g/dL) | r | Sample Range (g/dL) | |---------------------|-----------------------|----|---------------------|------------|-------|---------------------| | Serum | CHEM 1+ | 53 | Y=1.01X+0.55 | 0.13 | 0.990 | 1.4 - 5.3 | | Plasma(y), Serum(x) | ADVIA IMS | 59 | Y=0.96X+0.12 | 0.06 | 0.978 | 3.9 - 5.2 | # Interfering Substances | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Albumin Conc. (g/dL) | Effect (% change) | |--------------------------|-----------------------------------|-------------------------|----------------------| | U. Bilirubin | 25 | 4.2 | -4.8 | | Hemoglobin | 1000 | 3.5 | +5.7 | | Lipids (Triglycerides) | 1000 | 3.5 | -2.9 | **Analytical Range** Scrum/Plasma: 1 10 6 g/dL 7/16/99 Gabriel J. Murray, Jr. Manager Reg Affairs. {1}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS T.Bilirubin method for ADVIA® IMS 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 method is intended to quantitatively measure total bilirubin in human serum and plasma on the Bayer ADVIA IMS systems. Measurements of total bilirubin are used in the diagnosis and treatment of liver, bemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders. #### 2. Predicate Device | Product Name | would be and the country of the country of the country of the country of the country of the country of the country of the country of the country of the country of the country Reagent Part # Calibrator Part # for and and the program and and the many of the many of the many of the many of the many of the may be the may be the may be the may be the may be the may be the may be the b | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technicon CHEM 1 T.Bilirubin T01-1522-53 T03-1291-62 | | # 3. Device / Method | Product Name | | Reagent Part # Calibrator Part # | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | www.rangestion.com/production/compress/from the managements of the comments of the comments of the comments of the comments of the comments of the comments of the comments of ADVIA IMS T.Bilirubin | B41-3723-46 T03-1291-62 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | #### Imprecision(SERUM) | ADVIA IMS | CHEM 1 | | | |------------------|----------------|------------------|----------------| | Level (mg/dL) | Total CV(%) | Level (mg/dL) | Total CV(%) | | 1.1 | 7.0 | 1.1 | 9.1 | | 4.5 | 5.1 | 5.0 | 4.8 | | 17.0 | 2.4 | 20.0 | 2.6 | #### Correlation (Y=ADVIA IMS, X=comparison system) | Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | r | Sample Range (mg/dL) | |---------------------|--------------------------|----|---------------------|----------------|-------|-------------------------| | Serum | CHEM 1+ | 58 | Y=1.08X-0.11 | 0.26 | 0.998 | 0.2 - 26.1 | | Plasma(y), Serum(x) | ADVIA IMS | 57 | Y=1.01X-0.01 | 0.02 | 0.994 | 0.16 - 0.92 | #### Interfering Substances | Interfering Substance | Interfering Sub. Conc. (mg/dL) | T.Bilirubin Conc. (mg/dL) | Effect (% change) | |--------------------------|-----------------------------------|------------------------------|----------------------| | Hemoglobin | 500 | 6.9 | +1 | | Lipids (Triglycerides) | 500 | 6.7 | -34 | Gabriel J. Murray Jr. Manager Reg. Affairs #### Analytical Range Serum/Plasma: 0 to 45 mg/dL {2}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS # CO2 Method for the Bayer ADVIA Integrated Modular System (IMS) Listed below is a comparison of the performance between the Bayer ADVIA IMS CO2 method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Carbon Dioxide, Enzymatic). The information used in the Summary of Safety and Effectiveness was extracted from the Bayer ADVIA IMS CO2 method sheet and the CHEM 1 CO2 (Enzymztic) method sheet. ## INTENDED USE This in-vitro diagnostic method is intended to measure carbon dioxide (CO2) in human serum. Measurement of CO, is used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. | METHOD | | ADVIA IMS | CHEM 1 | |-------------------|-----------------------------|----------------------------------------------------------------------------|-------------------------------------------------------| | Part No. | Reagents | B41-3726-43 | T01-3253-53 | | | Calibrators/ CO2 diluent | T03-1291-62/ T23-1291-52 | T01-1291-62/ T23-1291-52 | | Analytical Range | | 10 to 40 mEq/L | 10 to 40 mEq/L | | Precision (Total) | | 5.3% @ 11.98 mEq/L 4.3% @ 19.10 mEq/L 3.0% @ 28.39 mEq/L | 4.5% @ 14 mEq/L 3.8% @ 22 mEq/L 3.3% @ 28 mEq/L | | Correlation | | Y=0.99X+0.41 mEq/L Where Y=ADVIA IMS X=CHEM 1 N=106 (53 pairs) | 7/16/99 Gabriel J. Mno | r=0.993 Sy.x=0.999 mEq/L # Interfering Substances Bilirubin (unconjugated) 25 mg/dL Bilirubin (conjugated) 25 mg/dL Hemoglobin (hemolysate) 500 mg/dL Lipemia (Triglycerides) 500 mg/dL -2.0% effect change @ 27.84 mEq/L CO2 -37% effect change @ 28.83 mEq/L CO2 -10.0% effect change @ 28.67 mEq/L CO2 {3}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Digoxin Method for ADVIA IMS 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: (leave blank) #### 1. Intended Use This in vitro method is intended to quantitatively measure digoxin in human serum on the Bayer ADVIA IMS systems. Measurements of digoxin are used to aid in attaining optimum therapy in patients treated with the drug. #### Predicate Device 2. | Product Name | Reagent Part # | Calibrator Part # | |------------------------|----------------|-------------------| | Bayer Immuno 1 Digoxin | T01-2875-51 | T01-2864-01 | #### Device / Method 3. | Name | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | ---------------------------------------------------------------------- AMC T unxoxobili the call a the collection of the consideration of the are of | A 40 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1 | 11 | # A. Imprecision | ADVIA IMS | | Immuno 1 | | |------------------|-----------------|------------------|-----------------| | Level (ng/mL) | Total CV (%) | Level (ng/mL) | Total CV (%) | | 0.82 | 6.8 | 0.7 | 8.2 | | 1.80 | -5.1 | 2.2 | 4.2 | | 3.81 | 4.8 | 3.4 | 3.6 | # B. Correlation (Y=ADVIA IMS, X=Comparison system) | Specimen type | Comparison System (X) | N | Regression Equation | Syx (ng/mL) | R | Sample Range (ng/mL) | |---------------|-----------------------|----|---------------------|-------------|------|----------------------| | Serum | Immuno 1 | 63 | $Y=0.93X - 0.11$ | 0.17 | 0.98 | 0.15-3.90 | 7/14/99 Gabriel J. Murray Jr. - Manager Reg. Affairs {4}------------------------------------------------ | C. Interfering Substances | | | | |-----------------------------|-----------------------------------|--------------------------|----------------------| | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Digoxin Conc. (ng/mL) | Effect (% change) | | Bilirubin | 25 | 2 | 3.9 | | Bilirubin (unconjugated) | 25 | 2 | -3.9 | | Hemoglobin | 500 | 2 | -0.3 | | Lipids (Triglycerides) | 500 | 2 | -11.7 | 1. 2011 . .......... . . . . . . . . . . . . . . . . . . . . . : · · Analytical Range: 0.1-5.0 ng/mL Minimum Detectable Concentration: 0.1 ng/mL Date 7/16/99 Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. M. Gabriel J. Muraca, Jr. Manager Regulatory Affairs 914-524-3494 (fax 914-524-2500) {5}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS # HDL cholesterol Method for the ADVIA IMS Systems Listed below is a comparison of the performance of the Bayer ADVIA HDL cholesterol method and a similar device that was granted clearance of substantial equivalence (Bayer Technicon Chem 1 HDL cholesterol method). The information was extracted from the Baver ADVIA IMS HDL cholesterol method sheet. # INTENDED USE The Bayer ADVIA IMS HDL cholesterol assay is an in-vitro diagnostic device intended to measure HDL cholesterol in human serum and plasma. Such measurements are used in the diagnosis, monitoring and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This diagnostic method is not intended for use on any other diagnostic system. # SERUM | HDL CHOLESTEROL METHOD: | ADVIA IMS | CHEM 1 | |----------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Part Number: | Cholesterol Reagent B41-3727-46 HDL precipitating reagent B21-3733-01 Calibrators T03-1291-62 | cholesterol reagent T01-2869-01 HDL Precipitating reagent T01-1897-56 Calibrators T03-1291-62 | | Analytical Range: | 0 to 250 mg/dL | 10 to 100 mg/dL | | Precision (Total): | Mean (mg/dL) | % CV | | Level 1 | 18 | 3.2 | | Level 2 | 42 | 2.6 | | Level 3 | 121 | 2.8 | | | mean (mg/dL) | % CV | | | 20 | 8.5 | | | 46 | 6.7 | | | 58 | 4.8 | | Correlation to existing system | | |----------------------------------------|-----------------------------------| | Regression Equation: y = 0.997x + 1.95 | | | where: | y = ADVIA IMS | | | x = Chem 1 | | | n = 107 (54 samples in duplicate) | | | r = 0.987 | | | Sy.x = 3.58 | | | range = 19 to 123 mg/dL | 7/16/94 Gabriel J. Muraca Jr. - Muraca By. Affairs. {6}------------------------------------------------ | Plasma Qualification | | | |-------------------------------------|-------|--------------------------------| | Regression Equation: y=0.995X +0.12 | | | | where: | y | = plasma | | | x | = serum | | | n | = 90 (47 samples in duplicate) | | | r | = 0.996 | | | Sy.x | = 1.3 | | | range | = 18 to 71 mg/dL | Interference | | Interfering Substance Concentration | HDL cholesterol Concentration | Effect % Change | |--------------------------|----------------------------------------|-------------------------------------|--------------------| | Hemoglobin | 250 mg/dL | 47.2 mg/dL | -19 | | Bilirubin (conjugated) | 6.25 mg/dL | 45.2 mg/dL | -27 | | Bilirubin (unconjugated) | 25 mg/dL | 43.1 mg/dL | -2 | | Lipemia (Triglycerides) | 1000 mg/dL | 44.3 mg/dL | +1 | Gabriel J. Munaco Jr. Andrews and . Gabriel J. Muraca, Jr. Manager Regulatory Affairs. .................................................................................................................................................. Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 7/6/99 Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : 上一篇: 上一篇: {7}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Inorganic Phosphorus method for ADVIA® IMS 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 is intended to measure Inorganic Phosphorus in luman serum, plasma or urine on the Bayer ADVIA IMS system. . Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. # 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |-------------------------------------------|----------------|-------------------| | Technicon CHEM 1® Inorganic Phosphorus | T01-1609-53 | T03-1291-62 | # 3. Device / Method | Product Name | Reagent Part # | Calibrator Part # | |-----------------------------------|----------------|-------------------| | ADVIA IMS Inorganic Phosphorus | B41-3734-46 | T03-1291-62 | ## A. Imprecision(SERUM) | ADVIA IMS | | | |------------------|-------------|---------| | Level (mg/dL) | Total CV(%) | L (m | | 2.5 | 1.7 | | | 5.0 | 2.1 | | | 8.8 | 2.7 | | | CHEM 1 | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 3.1 | 3.4 | | 6.6 | 2.7 | | 7.7 | 2.8 | #### B. Imprecision(URINE) | ADVIA IMS | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 24.8 | 1.9 | | 69.8 | 2.2 | | 96.3 | 1.9 | | CHEM 1 | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 37 | 2.6 | | 55 | 2.7 | #### Correlation (Y=ADVIA IMS, X=comparison system) | Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | r | Sample Range (mg/dL) | |---------------------|-----------------------|----|---------------------|-------------|-------|----------------------| | Serum | CHEM 1+ | 50 | Y = 0.94X + 0.15 | 0.15 | 0.997 | 1.3 - 10.0 mg/dL | | Plasma(y), Serum(x) | ADVIA IMS | 58 | Y=0.96X-0.17 | 0.12 | 0.977 | 1.9-4.4 mg/dL | | Urine | CHEM 1 | 48 | Y = 1.01X + 0.15 | 1.17 | 0.999 | 4.5 - 99.9 mg/dL | Gabriel J. Menaca Jr. - Manager Reg. Affairs. 7/16/99 {8}------------------------------------------------ # Interfering Substances | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Inorganic Phosphorus Conc. (mg/dL) | Effect (% change) | |--------------------------|-----------------------------------|------------------------------------------|----------------------| | Bilirubin | 20 | 3.7 | +2.2 | | Hemoglobin | 500 | 3.6 | +19.4 | | Lipids (Triglycerides) | 500 | 3.8 | +21.6 | | Acetaminophen | 50 | 8.0 | -3.8 | | Ascorbic Acid | 200 | 18.4 | +1.3 | | Salicylate | 500 | 18.4 | +5.0 | : . : Analytical Range Serum/Plasma: Urine: 0 to 15 mg/dL 0 to 100 ing/dL : : : . : 上一篇: Gabriel J. Munoz Jr. 7/16/99 . 1 : : : {9}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS #### Sodium,Potassium,and Chloride ISE methods for ADVIA® IMS I. 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 Sodium (Na), Potassium (K) and Chloride (CI) in human serum, plasma on the Bayer ADVIA IMS system ## 2. Device / Method | Product Name | Reagent Part # | Calibrator Part # | |------------------------------------------|----------------|--------------------------------------| | ADVIA IMS Sodium, Potassium, Chloride | B48-4054-54 | T21-4055-01 (Hi) T21-4056-01 (Lo) | # Imprecision | ANALYTE | Level (mmol/L) | Total CV(%) | |-----------|----------------|-------------| | Sodium | 113 | 1.0 | | | 139 | 1.0 | | Potassium | 3.4 | 1.3 | | | 5.9 | 1.2 | | Chloride | 93 | 1.2 | | | 113 | 1.2 | # Correlation (Y=ADVIA IMS, X=comparison system) | ANALYTE (Serum) | Comparison System (X) | N | Regression Equation | Syx (mmol/L) | R | Sample Range (mmol/L) | |-----------------|-----------------------|----|--------------------------------------|--------------|-------|-----------------------| | Sodium | IL Flame | 53 | $0.94 x Flame + 7.08 mmol/L$ | 1.68 | 0.957 | 120.0-147.1 | | Potassium | IL Flame | 54 | $1.03 x Flame - 0.15 mmol/L$ | 0.17 | 0.990 | 2.55-8.72 | | Chloride | Chloridometer | 51 | $0.84 x Chloridometer + 16.0 mmol/L$ | 1.1 | 0.986 | 83.6-115.5 | #### Plasma/Serum Comparison | | Sodium | Potassium | Chloride | |-------------------|--------|-----------|----------| | Mean Serum Level | 137.2 | 3.97 | 105.2 | | Mean Plasma Level | 137.2 | 3.76 | 105.2 | | Mean Difference | 0.0 | 0.21 | 0.0 | | % Difference | 0.0 | 5.6 | 0.0 | Gabriel J. Muraca Jr. G. J. Muraca Jr. Manager RA Bayer Corporation 7/6/99 --- Date {10}------------------------------------------------ # ADVIA IMS ISE Na, K and Cl Report #### Interfering Substances Sodium: No significant effect on serum has been demonstrated from bromide, ammonium and iodide. Potassium: Since the concentration of potassium inside erythrocytes is much greater than that in extracellular fluid, hemolysis should be avoided, and the serum/plasma should be separated from the cells as soon as possible after collection. Chloride: Sodium Salicylate at a level of 2.2 mmol/L (30 mg/dL) will elevate the chloride result by less than 2.0 mmol/L. The presence of bromide or iodide salts will falsely elevate chloride results. Analytical Range Serum or Plasma: Sodium 40 to 205 mmol/L Potassium 1.5 to 15 mmol/L 50 to 200 mmol/L Chloride Gabriel J. Munoz, Jr. 7/16/99 {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 1 5 1999 Mr. Gabriel J. Muraca, Jr. Manager. Regulatory Affairs Baver Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097 K992399 Re: > Trade Name: 9 Additional IMS Assays for the Bayer ADVIA® IMS™ System Regulatory Class: II Product Code: CIX, CIG, CHS, KXT, CHH, CEO JGS, CEM, CGZ Dated: July 16, 1999 Received: July 19, 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. {12}------------------------------------------------ # 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/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Putman 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 {13}------------------------------------------------ # 510(k) Number (if known): # Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney. The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders. The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) | |------------------------------------------|----|--------------------------------------------------| |------------------------------------------|----|--------------------------------------------------| | | <div> <img alt="signature" src="signature.png" width="200"/> <div>(Division Sign-Off)</div> <div>Division of Clinical L</div> <div>510(k) Number K992399</div> </div> | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| {14}------------------------------------------------ Page 2 of 2 # 510(k) Number (if known): # Device Name: Bayer ADVIA® Integrated Modular System IMS Indications For Use: The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance. The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)