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 (K991907).

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

CZW. It is classified under 21 CFR 866.5240 as a Class 2 device in the Immunology 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?

Dade Behring BNA Complement C3 method; Dade Behring BNA Complement C4 method; Dade Behring BNA Immunoglobulin A method; Dade Behring BNA Immunoglobulin G method; Dade Behring BNA Immunoglobulin M method; Dade Behring BNA Transferrin method; Bayer Immuno 1 Vancomycin method; Abbott TDx Valproic Acid method.

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

K991907 · Bayer Corp. · CZW · Nov 9, 1999 · Immunology

Device Facts

Record ID	K991907
Device Name	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Applicant	Bayer Corp.
Product Code	CZW · Immunology
Decision Date	Nov 9, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5240
Device Class	Class 2

Intended Use

The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA IMS IgG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism. The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism. The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia. The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy. The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

Device Story

Bayer ADVIA IMS system performs automated in vitro quantitative analysis of serum analytes (C3, C4, IgA, IgG, IgM, Transferrin, Vancomycin, Valproic Acid). System utilizes specific reagents and calibrators to process patient serum samples. Operation occurs in clinical laboratory settings by trained technicians. Device transforms sample inputs into quantitative concentration outputs; results assist clinicians in diagnosing immunologic/metabolic disorders, monitoring therapeutic drug levels, and managing patient treatment. System provides automated measurement, reducing manual processing requirements.

Clinical Evidence

Bench testing only. Performance validated via correlation studies against predicate devices (n=55 to 106 per assay). Correlation coefficients (r) ranged from 0.972 to 0.994. Precision (total CV) reported for various concentration levels, generally ranging from 1.4% to 3.9%. Interference testing conducted for bilirubin, hemoglobin, and triglycerides; effects on analyte measurement were documented.

Technological Characteristics

In vitro diagnostic assays for use on Bayer ADVIA IMS automated systems. Reagents and calibrators specific to each analyte. Quantitative measurement principle (immunoturbidimetric or similar immunoassay). System is a clinical laboratory analyzer. Connectivity and software integration are inherent to the ADVIA IMS platform.

Indications for Use

Indicated for quantitative measurement of C3, C4, IgA, IgG, IgM, Transferrin, Vancomycin, and Valproic Acid in human serum to aid in diagnosis and treatment of immunologic disorders, protein metabolism abnormalities, infectious diseases, autoimmune conditions, nutritional status, anemia, and therapeutic drug monitoring.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

Dade Behring BNA Complement C3 method
Dade Behring BNA Complement C4 method
Dade Behring BNA Immunoglobulin A method
Dade Behring BNA Immunoglobulin G method
Dade Behring BNA Immunoglobulin M method
Dade Behring BNA Transferrin method
Bayer Immuno 1 Vancomycin method
Abbott TDx Valproic Acid method

Related Devices

K993867 — BAYER ADVIA IMS SYSTEM · Bayer Corp. · Apr 10, 2000
K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Sep 15, 1999
K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) · Bayer Corp. · Nov 9, 1999
K993711 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) · Bayer Corp. · Dec 16, 1999
K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Jul 22, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ ### C3 Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Complement C3 method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Complement C3 method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS C3 method sheet and the BNAC3 method sheet. #### INTENDED USE This in vitro method is intended to quantitatively measure C3 in human serum on the Bayer ADVIA IMS systems. Measurements of C3 are used to aid in the diagnosis and treatment of immunologic disorders. | METHOD | ADVIA IMS | BNA | |----------|-------------------------------------------------|--------------| | Part No. | Reagents B41-3788-41 Calibrators B46-4088-60 | OSAP OSAU | 2.1% @ 79.7 mg/dL 5.9% @ 72.4 mg/dL Precision (Total) 1.8% @ 154 mg/dL 2.1% @ 237 mg/dL Correlation y=0.92x + 9.7 where y=ADVIA IMS x=BNA n=101 r=0.972 Syx=12.1 mg/dL Gabriel J. Munoz, Jr. 6/4/99 {1}------------------------------------------------ | Interfering Substances | | | | |-------------------------|----------------------------------|---------------------|----------------------| | Interfering Substance | Interfering Sub Concentration | C3 Concentration | Effect (% Change) | | Bilirubin, unconjugated | 20 mg/dL | 106 mg/dL | +1 | | Bilirubin, conjugated | 20 mg/dL | 113 mg/dL | +4 | | Hemoglobin | 500 mg/dL | 114 mg/dL | -2 | | Triglycerides | 1000 mg/dL | 107 mg/dL | -8 | # Analytical Range : --- : : ಿರುವ ಸಾ | Dilution Range | Concentration Range, mg/dL | |-------------------|-------------------------------| | Normal | 27 - 360 | | Out of Range Low | 6.8 - 90 | | Out of Range High | 135 - 1800 | {2}------------------------------------------------ ### C4 Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Complement C4 method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Complement C4 method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS C4 method sheet and the BNAC4 method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure C4 in human serum on the Bayer ADVIA IMS systems. Measurements of C4 are used to aid in the diagnosis and treatment of immunologic disorders. | METHOD | ADVIA IMS | BNA | |-------------------|------------------------------------------------------------------------------------|-------------------| | Part No. | | | | Reagents | B41-3789-41 | OSAO | | Calibrators | B46-4088-60 | OSAU | | Precision (Total) | 1.9% @ 19.3 mg/dL 2.0% @ 34.8 mg/dL 1.9% @ 49.3 mg/dL | 2.9% @ 15.7 mg/dL | | Correlation | y=0.92x - 0.3 where y=ADVIA IMS x=BNA n=94 r=0.989 Syx=1.9 mg/dL | | Gabriel J. Munoz, Jr. 6/4/99 {3}------------------------------------------------ | Interfering Substance | Interfering Sub Concentration | C4 Concentration | Effect (% Change) | |-------------------------|----------------------------------|---------------------|----------------------| | Bilirubin, unconjugated | 20 mg/dL | 19 mg/dL | 0 | | Bilirubin, conjugated | 20 mg/dL | 21 mg/dL | 0 | | Hemoglobin | 500 mg/dL | 20 mg/dL | 0 | # Analytical Range | Dilution Range | Concentration Range, mg/dL | |-------------------|-------------------------------| | Normal | 7.2 - 96 | | Out of Range Low | 4.0 - 53 | | Out of Range High | 36 - 480 | {4}------------------------------------------------ ### IgA Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin A method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin A method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgA method sheet and the BNA IgA method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure IgA in human serum on the Bayer ADVIA IMS systems. Measurements of IgA are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. | METHOD | | ADVIA IMS | BNA | |-------------------|-------------|-----------------------------------------------------------------------------------|-----------------| | Part No. | Reagents | B41-3791-41 | OSAR | | | Calibrators | B46-4088-60 | OSAU | | Precision (Total) | | 2.3% @ 122mg/dL 1.6% @ 233mg/dL 1.4% @ 344mg/dL | 3.5% @ 296mg/dL | | Correlation | | y=1.00x - 1 where y=ADVIA IMS x=BNA n=97 r=0.994 Syx=75.6 mg/dL | | Gabriel J. Munoz, Jr. 6/4/99 {5}------------------------------------------------ | Interfering Substance | Interfering Sub Concentration | IgA Concentration | Effect (% Change) | |-------------------------|----------------------------------|----------------------|----------------------| | Bilirubin, unconjugated | 20 mg/dL | 180 mg/dL | +2 | | Bilirubin, conjugated | 20 mg/dL | 200 mg/dL | -3 | | Hemoglobin | 500 mg/dL | 191 mg/dL | +1 | | Triglycerides | 1000 mg/dL | 184 mg/dL | -8 | : ### Analytical Range | Analytical Range | | |-------------------|------------------------------| | Dilution Range | Concentration Range mg/dL | | Normal | 45 - 600 | | Out of Range Low | 11.3 - 150 | | Out of Range High | 360 - 4800 | : . · {6}------------------------------------------------ ### IgG Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin G method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin G method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgG method sheet and the BNA IgG method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure IgG in human serum on the Bayer ADVIA IMS systems. Measurements of IgG are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. | METHOD | | ADVIA IMS | BNA | |----------|-------------|-------------|------| | Part No. | Reagents | B41-3792-41 | OSAS | | | Calibrators | B46-4088-60 | OSAU | Precision (Total) 1.8% @ 772mg/dL 2.7% @ 1317mg/dL 1.6% @ 1416mg/dL 3.4% @ 2141mg/dL Correlation y=0.97 x - 3 where y=ADVIA IMS x=BNA n=97 r=0.994 Syx=118 mg/dL Gabriel J. Murau, Jr. 6/4/99 {7}------------------------------------------------ | Interfering Substance | Interfering Sub Concentration | IgG Concentration | Effect (% Change) | |-------------------------|----------------------------------|----------------------|----------------------| | Bilirubin, unconjugated | 20 mg/dL | 876 mg/dL | -3.0 | | Bilirubin, conjugated | 20 mg/dL | 953 mg/dL | -3.0 | | Hemoglobin | 500 mg/dL | 897 mg/dL | +7.0 | | Triglycerides | 1000 mg/dL | 887 mg/dL | -3.0 | : # Analytical Range | Dilution Range | Concentration Range, mg/dL | |-------------------|-------------------------------| | Normal | 225 - 3,000 | | Out of Range Low | 56 - 750 | | Out of Range High | 1128 - 15,000 | {8}------------------------------------------------ ### IgM Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin M method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin M method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgM method sheet and the BNA IgM method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure IgM in human serum on the Bayer ADVIA IMS systems. Measurements of IgM are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. | METHOD | | ADVIA IMS | BNA | |----------|-------------|-------------|------| | Part No. | Reagents | B41-3793-41 | OSAT | | | Calibrators | B46-4088-60 | OSAU | Precision (Total) 3.6% @ 69.0mg/dL 1.9% @ 117mg/dL 2.4% @ 128mg/dL 1.5% @ 177mg/dL Correlation y=1.05x - 13.4 where y=ADVIA IMS x=BNA n=89 r=0.990 Syx=123.5 mg/dL Gabriel J. Murray, Jr. 6/4/99 {9}------------------------------------------------ | Interfering Substance | Interfering Sub Concentration | IgM Concentration | Effect (% Change) | |-------------------------|----------------------------------|----------------------|----------------------| | Bilirubin, unconjugated | 20 mg/dL | 77 mg/dL | +3.9 | | Bilirubin, conjugated | 10 mg/dL | 85 mg/dL | +1.2 | | Hemoglobin | 500 mg/dL | 86 mg/dL | 0.0 | . # Analytical Range · | Dilution Range | Concentration Range, | |---------------------|----------------------| | | mg/dL | | Normal | 30 - 400 | | Out of Range Low | 10 - 133 | | Out of Range High 1 | 241 - 3,200 | | Out of Range High 2 | 1,203 - 16,000 | : : {10}------------------------------------------------ ### TRF Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Transferrin method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Transferrin method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS TRF method sheet and the BNATRF method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure TRF in human serum on the Bayer ADVIA IMS systems. Measurements of TRF are used to aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia and red blood disorders, such as iron deficiency anemia. | METHOD | | ADVIA IMS | BNA | |----------|-------------|-------------|------| | Part No. | Reagents | B41-3795-41 | OSAX | | | Calibrators | B46-4088-60 | OSAU | Precision (Total) 2.2% @ 127 mg/dL 2.7% @ 303 mg/dL 1.9% @ 268 mg/dL 3.1% @ 400 mg/dL Correlation y=0.96x - 3 where y=ADVIA IMS x=BNA n=106 r=0.979 Syx=16.8 mg/dL Gabriel J. Munoz, Jr. 6/4/99 {11}------------------------------------------------ | Interfering Substance | Interfering Sub Concentration | TRF Concentration | Effect (% Change) | |-------------------------|----------------------------------|----------------------|----------------------| | Bilirubin, unconjugated | 20 mg/dL | 212 mg/dL | +2 | | Bilirubin, conjugated | 20 mg/dL | 231 mg/dL | 0 | | Hemoglobin | 500 mg/dL | 261 mg/dL | 0 | | Triglycerides | 1000 mg/dL | 215 mg/dL | -4 | # Analytical Range | Dilution Range | Concentration Range, mg/dL | |-------------------|-------------------------------| | Normal | 54 - 720 | | Out of Range Low | 13 - 180 | | Out of Range High | 270 - 3,600 | . : {12}------------------------------------------------ ### Vancomycin Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Vancomycin method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1 Vancomycin method) The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Vancomycin method sheet and the Immuno 1 Vancomycin method sheet. ### INTENDED USE This in vitro method is intended to quantitatively measure vancomycin in human serum on the Bayer ADVIA IMS systems. Measurements of vancomycin are used to aid in attaining optimum therapy in patients treated with the drug. | METHOD | | ADVIA IMS | Immuno 1 | |-------------------|-------------|------------------------------------------------------------------------------------------|-------------------| | Part No. | Reagents | B41-3767-41 | T01-3705-01 | | | Calibrators | B46-4117-01 | T03-3714-01 | | Analytical Range | | 0.4-50 µg/mL | | | Precision (Total) | | 2.8% @ 8.6 µg/mL | 8.9% @ 6.7 µg/mL | | | | 3.4% @ 21.5 µg/mL | 7.5% @ 23.3 µg/mL | | | | 3.9% @ 35.8 µg/mL | 8.1% @ 32.4 µg/mL | | Correlation | | y=1.02x + 0.68 where y=ADVIA IMS x=Immuno 1 n=55 r=0.987 Svx=1.6 µg/dL | | #### Interfering Substances | Interfering Substance | Interfering Substance Concentration | | Vancomycin Concentration | | Effect % Change | |--------------------------|----------------------------------------|------------|-----------------------------|---------|--------------------| | | | | (µmol/L) | (µg/mL) | | | Bilirubin (unconjugated) | 0.43 mmol/L | 25 mg/dL | 10.6 | 15.3 | +0.3 | | Bilirubin (conjugated) | 0.43 mmol/L | 25 mg/dL | 11.0 | 15.9 | +0.6 | | Hemoglobin | 10 g/L | 1000 mg/dL | 11.1 | 16.1 | -7.7 | | Lipemia (Triglycerides) | 11.4 mmol/L | 1000 mg/dL | 11.0 | 16.0 | -0.2 | Gabriel J. Murray Jr. 6/4/99 {13}------------------------------------------------ ### Valproic Acid Method for the Bayer ADVIA IMS Systems Listed below is a comparison of the performance between the Bayer ADVIA IMS Valproic Acid method and a similar device that was granted clearance of substantial equivalence (Abbott TDx Valproic Acid method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Valproic Acid method sheet and the TDx Valproic Acid method sheet. #### INTENDED USE This in vitro method is intended to quantitatively measure valproic acid in human serum on the Bayer ADVIA IMS systems. Measurements of valproic acid are used to aid in attaining optimum therapy in patients treated with the drug. | METHOD | | ADVIA IMS | TDx | |-------------------|-------------|--------------------|-------------------| | Part No. | Reagents | B41-3766-41 | 9514-20 | | | Calibrators | B46-4118-01 | 9514-01 | | Analytical Range | | 0.3-150 µg/mL | | | Precision (Total) | | 3.8% @ 20.3 µg/mL | 3.4% @ 37.5 µg/mL | | | | 2.4% @ 60.2 µg/mL | 3.4% @ 75 µg/mL | | | | 2.8% @ 108.5 µg/mL | 3.7% @ 125 µg/mL | | Correlation | | y=1.11x + 0.27 | | | | | where | | | | | y=ADVIA IMS | | | | | x=TDx | | | | | n=55 | | | | | r=0.993 | | | | | Sux=3.79 µg/mL | | #### Interfering Substances | Interfering Substance | Interfering Substance Concentration | Valproic acid Concentration | | Effect % Change | |--------------------------|----------------------------------------|--------------------------------|---------|--------------------| | | | (µmol/L) | (µg/mL) | | | Bilirubin (unconjugated) | 0.43 mol/L 25 mg/dL | 573 | 82.5 | +6 | | Bilirubin (conjugated) | 0.43 mol/L 25 mg/dL | 542 | 78.1 | +1 | | Hemoglobin | 10 g/L 1000 mg/dL | 557 | 80.2 | +4 | | Lipemia (Triglycerides) | 5.7 mmol/L 500 mg/dL | 561 | 80.8 | +3 | Gabriel J. Munoz Jr. 6/4/99 {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white. 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: K991907 Trade Name: 8 Additional Assays for the Bayer ADVIA® Integrated Modular System (IMS) Regulatory Class: II Product Code: CZW, CFQ, DBI, DDG, KTO, LEG, LEH 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 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 {15}------------------------------------------------ #### 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 {16}------------------------------------------------ Page 1 of 3 # 510(k) Number (if known): ### Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body's inability to resist infectious agents. Dran Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K991907 (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) {17}------------------------------------------------ 510(k) Number (if known): ### Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Bayer ADVIA IMS IgG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism. The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism. The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia. Fein Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K991907 (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) {18}------------------------------------------------ Page 3 of 3 510(k) Number (if known): ### Device Name: Bayer ADVIA® Integrated Modular System (IMS) Indications For Use: The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy. The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy. Hean Coogh (Division Sign-Off) Division of Clinical Laboratory Devices × 510(k) Number . (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)