BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
Device Facts
| Record ID | K992136 |
|---|---|
| Device Name | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) |
| Applicant | Bayer Corp. |
| Product Code | CIT · Clinical Chemistry |
| Decision Date | Nov 9, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1100 |
| Device Class | Class 2 |
Indications for Use
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy. The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes. The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
Device Story
ADVIA IMS system performs automated in-vitro diagnostic assays for AST, CK, Creatinine, and Phenobarbital; utilizes patient serum, plasma, or urine samples; processes samples via reagent-based chemical reactions; provides quantitative concentration or activity measurements; used in clinical laboratory settings by trained technicians; results assist physicians in diagnosing liver/heart conditions, renal function, muscle disorders, and therapeutic drug monitoring; enables timely clinical intervention and patient management.
Clinical Evidence
Bench testing only. Performance validated via precision studies (total CV% reported for various concentration levels), analytical range verification, and correlation studies against predicate devices (n=52 to 119; r=0.98 to 0.999). Interference testing conducted for hemolysis, bilirubin, lipemia, and specific drugs (ascorbic acid, acetaminophen, salicylic acid) to determine % change in analyte measurement.
Technological Characteristics
In-vitro diagnostic reagent assays for automated chemistry analyzers. Sensing principle: chemical/enzymatic reaction-based quantification. Connectivity: integrated modular system. Software: embedded firmware for automated analysis and result calculation.
Indications for Use
Indicated for patients requiring diagnostic testing for liver/heart disease (AST), myocardial infarction/muscle disease (CK), renal disease/dialysis monitoring (Creatinine), or phenobarbital therapeutic monitoring/overdose assessment (Phenobarbital). Applicable to human serum, plasma, or urine samples.
Regulatory Classification
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Bayer CHEM 1 AST method
- Bayer CHEM 1 CK method
- Bayer Chem 1 Creatinine method
- Technicon RA-1000 method
Submission Summary (Full Text)
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K992136
## Aspartate Aminotransferase (AST) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Aspartate Ammotransferase (AST) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM® 1 AST method). The information was extracted from the Bayer ADVIA IMS AST method and Bayer CHEM 1 AST method sheet.
#### INTENDED USE
The Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay is an in-vitro diagnostic device intended to measure AST in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain liver diseases and heart diseases.
| AST METHOD: | ADVIA IMS | CHEM 1 |
|---------------------------------------------|--------------------------------------------------------------------------------------------|---------------|
| Part Number: | Reagents B41-3722-23 | T01-1631-53 |
| Analytical Range: | 0 to 1000 U/L | 0 to 1030 U/L |
| Precision (Total): | mean (U/L) | % CV |
| | 30 | 4.2 |
| | 63 | 2.4 |
| | 153 | 1.6 |
| | mean (U/L) | % CV |
| | 31 | 4.1 |
| | 231 | 2.1 |
| | 369 | 3.6 |
| Regression Equation: (serum) | $y = 0.99x - 2.8$ | |
| where: | y = ADVIA IMS<br>x = Chem 1<br>n = 66<br>r = 0.998<br>Sy.x = 16.9<br>range = 16 to 910 U/L | |
| Regression Equation: (plasma qualification) | $y = 0.975x + 0.7$ | |
| where: | y = plasma<br>x = serum<br>n = 53<br>r = 0.997<br>Sy.x = 0.77<br>range = 14 to 69 U/L | |
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| | Interfering Substance<br>Concentration | AST<br>(U/L) | Effect<br>% Change |
|--------------------------|----------------------------------------|--------------|--------------------|
| Hemolysis (Hemoglobin) | 500 mg/dL | 90 | 59 |
| Bilirubin (conjugated) | 20 mg/dL | 89 | -3 |
| Bilirubin (unconjugated) | 25 mg/dL | 88 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 96 | 3 |
Gabriel J. Murray Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Date 6/22/99
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## Creatine Kinase (CK) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Creatine Kinase (CK) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM 1® CK method). The information was extracted from the Bayer ADVIA IMS CK method and Bayer CHEM 1 CK method sheet.
### INTENDED USE
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in-vitro diagnostic device intended to measure CK in human serum or plasma. Such measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases.
| CK METHOD: | ADVIA IMS | | CHEM 1 | |
|------------------------------------------------|----------------------|-----------------|---------------|------|
| Part Number: | Reagents B41-3729-23 | | T01-1491-53 | |
| Analytical Range: | 0 to 2200 U/L | | 0 to 2200 U/L | |
| Precision (Total): | mean<br>(U/L) | % CV | mean<br>(U/L) | % CV |
| | 97 | 1.9 | 142 | 2.0 |
| | 231 | 1.3 | 407 | 2.9 |
| | 562 | 1.3 | 457 | 2.3 |
| Regression Equation:<br>(serum) | y = 0.99x + 2.7 | | | |
| where: | y | = ADVIA IMS | | |
| | x | = Chem 1 | | |
| | n | = 67 | | |
| | r | = 0.999 | | |
| | Sy.x | = 18.2 | | |
| | range | = 4 to 1873 U/L | | |
| Regression Equation:<br>(plasma qualification) | y = 1.01x - 0.3 | | | |
| where: | y | = plasma | | |
| | x | = serum | | |
| | n | = 60 | | |
| | r | = 0.999 | | |
| | Sy.x | = 2.8 | | |
| | range | = 37 to 472 U/L | | |
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| | Interfering Substance<br>Concentration | CK<br>(U/L) | Effect<br>% Change |
|--------------------------|----------------------------------------|-------------|--------------------|
| Hemoglobin | 500 mg/dL | 113 | 28 |
| Bilirubin (conjugated) | 20 mg/dL | 112 | -2 |
| Bilirubin (unconjugated) | 25 mg/dL | 109 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 114 | -4 |
Gabriel A. Munoz Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/22/99
Date
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## Creatinine Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA Creatinine method and a similar device that was granted clearance of substantial equivalence (Bayer Chem 1® Creatinine method). The information was extracted from the Bayer ADVIA IMS Creatinine method sheet.
### INTENDED USE
The Bayer ADVIA IMS Creatinine assay is an in-vitro diagnostic device intended to measure Creatinine in human serum, plasma, or urine. Such measurements are used in the diagnosis, monitoring and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
### SERUM
| CREATININE<br>METHOD: | ADVIA IMS | CHEM 1 | | |
|-----------------------|-------------------------------------------------|----------------------------|------|-----|
| Part Number: | Reagents B41-3730-46<br>Calibrators T03-1291-62 | T01-1456-53<br>T03-1291-62 | | |
| Analytical Range: | 0 to 30 mg/dL | 0.3 to 29 mg/dL | | |
| Imprecision (Total): | Mean<br>(mg/dL) | % CV | | |
| Level 1 | 1.10 | 2.96 | 1.3 | 5.6 |
| Level 2 | 2.82 | 2.99 | 9.0 | 2.3 |
| Level 3 | 5.67 | 1.70 | 15.1 | 2.6 |
| Correlation to existing system | |
|---------------------------------------|-----------------------------------|
| Regression Equation: y = 0.96x + 0.38 | |
| where: | y = ADVIA IMS |
| | x = Chem 1 |
| | n = 108 (54 samples in duplicate) |
| | r = 0.999 |
| | Sy.x = .31 |
| | range = 0.4 to 28.9 mg/dL |
Gabriel J. Munoz Jr.
6/22/99
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| Plasma Qualification | |
|------------------------------------|-----------------------------------|
| Regression Equation: y=0.96X +0.05 | |
| where: | y = plasma |
| | x = serum |
| | n = 119 (60 samples in duplicate) |
| | r = 0.98 |
| | Sy.x = 0.03 |
| | range = .69 to 1.55 mg/dL |
| | Interfering Substance<br>Concentration | Creatinine<br>Concentration | Effect<br>% Change |
|--------------------------|----------------------------------------|-----------------------------|--------------------|
| Hemoglobin | 1000 mg/dL | 2.98 mg/dL | +7 |
| Bilirubin (conjugated) | 18.8 mg/dL | 2.94 mg/dL | -8 |
| Bilirubin (unconjugated) | 25 mg/dL | 3.02 mg/dL | -5 |
| Lipemia (Triglycerides) | 1000 mg/dL | 3.08 mg/dL | -2 |
# URINE
| CREATININE<br>METHOD: | ADVIA IMS | CHEM 1 |
|-----------------------|-------------------------------------------------|--------------------------------------------------------------------|
| Part Number: | Reagents B41-3730-46<br>Calibrators T03-1291-62 | T01-1456-53<br>T03-1291-62 |
| Analytical Range: | 0 to 300 mg/dL | 2.4 to 232 mg/dL<br>(0.3 mg/dL to 29.0mg/dL for undiluted samples) |
| Imprecision (Total): | Mean<br>(mg/dL) | mean<br>(mg/dL) |
| | % CV | % CV |
| Level 1 | 63.80<br>2.89 | 31<br>3.5 |
| Level 2 | 111.30<br>2.33 | 51<br>3.3 |
| Level 3 | 155.0<br>2.13 | 119<br>4.1 |
Gabriel J. Munoz, Jr.
6/22/99
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| Correlation to existing system | |
|-----------------------------------------|---------------------------------|
| Regression Equation: $y = 1.01x - 0.06$ | |
| where: | |
| y | = ADVIA IMS |
| x | = Chem 1 |
| n | = 102 (51 samples in duplicate) |
| r | = 0.998 |
| Sy.x | = 4.01 |
| range | = 7 to 352 mg/dL |
| | Interfering Substance<br>Concentration | Creatinine<br>Concentration | Effect<br>% Change |
|----------------|----------------------------------------|-----------------------------|--------------------|
| Ascorbic Acid | 220 mg/dL | 60.36 mg/dL | <1% |
| Acetaminophen | 60 mg/dL | 52.97 mg/dL | <1% |
| Salicylic Acid | 550 mg/dL | 56.02 mg/dL | <1% |
Gabriel J. Muraco Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/22/99
Date
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#### Phenobarbital Method for the Bayer ADVIA® IMS Systems
Listed below is a comparison of the performance between the Bayer ADVIA IMS Phenobarbital method and a similar device that was granted clearance of substantial equivalence (Technicon RA-1000 method), The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Phenobarbital method sheet and the RA-1000 method sheet.
#### INTENDED USE
This in vitro method is intended to quantitatively measure phenobarbital in human serum on the Bayer ADVIA IMS systems. Measurements of phenobarbital are used to aid in the diagnosis and treatment of phenobarbital overdose, patient compliance and to monitor serum levels of phenobarbital to ensure appropriate therapy.
| METHOD | | ADVIA IMS | RA-1000 |
|-------------------|-------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| | | Part No. | Part No. |
| | Reagents | B41-3760-41 | T01-2952-01 |
| | Calibrators | B46-4091-01 | T03-2953-01 |
| Minimum Det. | | Conc. 0.49 µg/mL | 0.9 µg/mL |
| Precision (Total) | | | |
| | | 4.8% @ 14.7 µg/mL<br>5.1% @ 24.9 µg/mL<br>3.4% @ 40.3 µg/mL | 3.0% @ 9.0 µg/mL<br>2.6% @ 23.0 µg/mL<br>2.7% @ 44.0 µg/mL |
| Correlation | | $y = 0.98x + 0.80$<br>where y = ADVIA IMS, x = RA-1000<br>n = 52<br>r = 0.992<br>Syx = 1.23 µg/mL | |
#### Interferences
| Interfering Substance | Interfering Substance<br>Concentration | Phenobarbital<br>Concentration, μg/mL | Effect,<br>% Change |
|--------------------------|----------------------------------------|---------------------------------------|---------------------|
| Bilirubin (unconjugated) | 25 mg/dL | 15.5 | +2 |
| Bilirubin (conjugated) | 20 mg/dL | 15.9 | -2 |
| Hemoglobin | 600 mg/dL | 19.7 | -5 |
| Lipemia (Triglycerides) | 1000 mg/dL | 19.6 | -3 |
Gabriel J. Munacy, Jr.
6/27/66
6/22/99
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines above and below, resembling a bird in flight or water waves. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corp. Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K992136
> Trade Name: 4 Additional Assays for the Bayer ADVIA® Integrated Modular System (IMS) Regulatory Class: II Product Code: CIT, CGX, DLZ, JLB Dated: September 3, 1999 Received: September 7, 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 OS 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
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#### 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 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
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Attachment 6
Page Page of
510(k) Number (if known): K992136
Device Name: Bayer ADVIA® Integrated Modular System (IMS)
Indications For Use:
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital 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)
(Division Sign-Off)
sion of Clinical Laboratory Devices
her A992136
