Who is the manufacturer of BAYER ADVIA IMS SYSTEM?

Bayer Corp. filed the 510(k) submission for BAYER ADVIA IMS SYSTEM (K993867).

What is the FDA product code for BAYER ADVIA IMS SYSTEM?

CIG. It is classified under 21 CFR 862.1110 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for BAYER ADVIA IMS SYSTEM?

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

What are the predicate devices for BAYER ADVIA IMS SYSTEM?

Technicon CHEM 1 D. Bilirubin (T01-1522-53); Bayer RA-1000 HbA1c; Bayer Immuno 1 Gentamicin (T01-3154-51); Technicon CHEM 1 Magnesium (T01-3269-53); Bayer RA-1000 Theophylline (T01-1695-01); Bayer Immuno 1 Tobramycin (T01-3157-51); Technicon CHEM 1 Uric Acid (T01-1655-53).

Who can help prepare an FDA 510(k) submission like 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.

BAYER ADVIA IMS SYSTEM

K993867 · Bayer Corp. · CIG · Apr 10, 2000 · Clinical Chemistry

Device Facts

Record ID	K993867
Device Name	BAYER ADVIA IMS SYSTEM
Applicant	Bayer Corp.
Product Code	CIG · Clinical Chemistry
Decision Date	Apr 10, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1110
Device Class	Class 2

Intended Use

The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated 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 Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes. The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy. The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv. The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy. The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy. The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.

Device Story

ADVIA IMS system performs automated in vitro diagnostic assays on human serum, plasma, or blood samples. System measures specific analytes (Direct Bilirubin, HbA1c, Gentamicin, Magnesium, Theophylline, Tobramycin, Uric Acid) to aid clinical diagnosis and therapeutic monitoring. Operation involves reagent-sample mixing and photometric/chemical analysis. Results are provided to clinicians for patient management, including monitoring drug toxicity, metabolic status, and chronic disease (diabetes). Used in clinical laboratory settings by trained personnel. Output facilitates clinical decision-making regarding dosage adjustments, disease diagnosis, and treatment efficacy.

Clinical Evidence

Bench testing only. Performance validated via precision studies (Total CVs typically <10%) and method comparison studies against predicate devices (N=44-69 per analyte). Correlation coefficients (r) ranged from 0.852 to 0.998. Analytical ranges established for each analyte. Interference testing conducted for common substances (bilirubin, hemoglobin, lipids, etc.) with reported % change in results.

Technological Characteristics

Automated clinical chemistry analyzer. Photometric/chemical detection principle. Analyte-specific reagents and calibrators. Serum, plasma, blood, or urine samples. Standalone system. Software-controlled processing. No specific material standards or connectivity protocols (e.g., DICOM/HL7) detailed.

Indications for Use

Indicated for patients requiring quantitative measurement of Direct Bilirubin (liver/metabolic disorders), HbA1c (diabetes monitoring), Gentamicin (therapeutic drug monitoring/overdose), Magnesium (hypo/hypermagnesemia), Theophylline (asthma/overdose), Tobramycin (therapeutic drug monitoring/overdose), and Uric Acid (renal/metabolic disorders).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

Technicon CHEM 1 D. Bilirubin (T01-1522-53)
Bayer RA-1000 HbA1c
Bayer Immuno 1 Gentamicin (T01-3154-51)
Technicon CHEM 1 Magnesium (T01-3269-53)
Bayer RA-1000 Theophylline (T01-1695-01)
Bayer Immuno 1 Tobramycin (T01-3157-51)
Technicon CHEM 1 Uric Acid (T01-1655-53)

Related Devices

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
K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Nov 9, 1999
K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Jul 22, 1999
K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) · Bayer Corp. · Jan 29, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ # APR 1 0 2000 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS D. Bilirubin 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: K993867 ### 1. Intended Use This in virro diagnostic method is intended to measure D. Bilirubin (a product formed during the normal and abnormal destruction of red blood cells) in human serum or plasma on the Bayer ADVIA 400 system ### 2. Predicate Device | Product Name | The first for the first and the count of the count of the commend to be and the comments of the comments of the comments of the comments of the comments of the comments of th | and and and and of the strength and the country of the submitteen and the submitteen Reagent Part # Calibrator Part # | | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--| | Technicon CHEM 100 D. Bilirubin T01-1522-53 T03-1291-62 | | Canadination of programments and consisted in below and | | ### 3. Device / Method | Product Name | | Reagent Part # Calibrator Part # The for the contract of the commended to the comments of the contract and the many of the many of | |------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | ADVIA 400 D. Bilirubin | B41-3723-46 T03-1291-62 | | ### A. Imprecision(SERUM) | ADVIA 400 | | CHEM 1 | | |------------------|----------------|------------------|----------------| | Level (mg/dL) | Total CV(%) | Level (mg/dL) | Total CV(%) | | 0.7 | 9.0 | 0.2 | n/a | | 5.5 | 3.4 | 5.0 | 3.9 | | 11.8 | 3.3 | 8.3 | 3.2 | #### 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 | 59 | Y=0.98X-0.10 | 0.19 | 0.994 | 0.0 - 10.6 | | Plasma(y), Serum(x) | ADVIA 400 | 59 | Y=0.89X+0.06 | 0.03 | 0.852 | 0.09 - 0.42 | #### Interfering Substances | Interfering Substance | Interfering Sub. Conc. (mg/dL) | D. Bilirubin Conc. (mg/dL) | Effect (% change) | |--------------------------|-----------------------------------|-------------------------------|----------------------| | Hemoglobin | 500 | 0.9 | -17 | | Lipids (Triglycerides) | 500 | 1.8 | -69 | ### Analytical Range Serum/Plasma: 0 to 14 mg/dL Gabriel J. Musara Jr. 10/4/22 11/4/92 {1}------------------------------------------------ ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS HbA1c 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 %HbA1c in human blood on the Bayer ADVIA IMS systems. Measurements of %HbAlc are used to aid in the diagnosis and for monitoring the long term care of persons with diabetes. #### 2. Predicate Device | admin Product Name | | Reagent Part # Calibrator Part # | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------------| | And and the first and the program and the comments of the comments of the first of Bayer RA-1000 HbAlc Market Comments of Children Market Market Comments of Comments of Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com | T01-3639-01 | Property of the Property of Children Comments of Concerner Comments of Children Comments of Children T03-3644-01 | #### 3. Device / Method | produktion for the final may and many comprehensive and many management in a many may maging home management of the may and the film of the film of the may and the film of th Product Name A Property of Concession Complete of Children Complete of Children Compress of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | Reagent BAN | Calibrator BAN the with a frequently of the required in the may may may may high comment of the comments of the comments of the | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------| | ADVIA IMS HbAlc And Children Children Comment Comment Comments of Concellent Comments of Children Comments of Children | 00395488 | 08248751 | ### Minimum Detectable Concentration | Method | and and the controlled on the consisted on the consistent of the commended to controllaboration of the comments of the commended on the commended on the commended to commende ADVIA IMS | RA-1000 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | and and any and of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of MDC | for from the first of the first from the many and the many and the may be the 0.61% her and the figure the state of the mail of the mail of the mail of the mail and seems and the mail and the mail be mail be mail be mail be mail be mail be mail be mail be ma | - Show and the result of the submit is and the mail be the local be the like the block 17.2% | ### A. Imprecision | | ADVIA IMS | Bayer RA-1000 | | |-------|-----------|---------------|-------| | Level | Total | Level | Total | | % | CV (%) | (%) | CV(%) | | 5.71 | 5.4 | 4.6 | 3.4 | | 8.36 | 4.7 | 8.4 | 2.6 | | 11.17 | 4.6 | 11.2 | 2.5 | | Specimen type | Comparison System (X) | N | Regression Equation | Syx % | R | Sample Range (%) | |---------------|--------------------------|----|------------------------|----------|-------|------------------------| | Serum | RA-1000 | 57 | $Y=1.00 X + 0.62$ | 0.33 | 0.991 | 5.09 - 17.21 | Gabriel J. Munoz, Jr. 11/5/99 {2}------------------------------------------------ | Interfering Substance | Interfering Sub. Conc. (mg/dL) | HbA1c Conc. (%) | Effect (% change) | |-----------------------------|-----------------------------------|--------------------|----------------------| | Bilirubin (unconjugated) | 25 | 5.21 | -1 | | Bilirubin (conjugated) | 20 | 5.19 | -2 | | Urea | 500 | 7.86 | +4 | | Lipids (Triglycerides) | 1000 | 5.26 | -4 | #### D. Analytical Range 0.61 to 17.2% Date 1/15/99 Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. Muscaz Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs {3}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Gentamicin 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 gentamicin in human serum on the Bayer ADVIA® IMS systems. Measurements of gentamicin are used to aid in the diagnosis and treatment of gentamicin overdose and in monitoring serum levels of gentamicin to ensure appropriate therapy. #### 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |------------------------------|----------------|-------------------| | Bayer Immuno 1 Gentamicin | T01-3154-51 | T03-2864-01 | #### 3. Device / Method | Product Name | Reagent BAN | Calibrator BAN | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------|--|--| | ADVIA IMS Gentamicin ' and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the first | 02543484 | 05442131 | | | ## Minimum Detectable Concentration | Method | ADVIA IMS | Immuno 1 | |--------|------------|-----------| | MDC | 0.06 ug/mL | 0.11ug/mL | ### Imprecision | ADVIA IMS | | Bayer Immuno I | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------|-------|--| | Level | Total | Level | Total | | | ug/mL | CV (%) | ug/mL | CV(%) | | | 1.79 | 7.2 | 3.20 | 4.6 | | | ર્સ્વે એ જિલ્લામાં આવેલું એ તાલુકામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે કરવામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વ | 4.6 | 7.00 | 2.6 | | | 9.14 | 4.9 | 9.50 | 2.9 | | | Specimen type | Comparison System (X) | N | Regression Equation | Syx µg/mL | R | Sample Range µg/mL | |---------------|--------------------------|----|------------------------|--------------|-------|--------------------------| | Serum | Immuno 1 | 54 | $Y=1.09X - 0.29$ | 0.51 | 0.989 | 0.5 - 11.5 | Gabriel J. Muraca Jr. 11/5/99 {4}------------------------------------------------ | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Gentamicin Concentration μg/mL | Effect (% change) | |-----------------------------|-----------------------------------|--------------------------------------|----------------------| | Bilirubin (unconjugated) | 25 | 4.23 | +3 | | Bilirubin (conjugated) | 20 | 4.34 | +3 | | Hemoglobin | 600 | 4.37 | -4 | | Lipids (Triglycerides) | 1000 | 4.05 | +4 | Analytical Range 0.06 to 16.0 µg/mL Date 11/5/99 Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. Muraca, Jr. Manager Regulatory Affairs {5}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Magnesium 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 magnesium in human serum, plasma and urine on the Bayer ADVIA IMS. Measurements of serum magnesium are used in the diagnosis and treatment of hypomagnesiumia and monitoring of patients receiving prolonged magnesium-free intravenous therapy. Measurements of urine magnesium are used to aid in the management of patients with renal dysfunction. #### 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |------------------|----------------|-------------------| | Technicon CHEM 1 | T01-3269-53 | T03-1291-62 | #### 3. Device / Method | Product Name | Reagent Part # | Calibrator Part # | |-----------------|----------------|-------------------| | Bayer ADVIA IMS | BAN 02115121 | T03-1291-62 | ### A. Imprecision (Serum) | Level (mg/dL) | Total CV(%) | |---------------|-------------| | 1.76 | 2.4% | | 2.32 | 1.7% | | 5.29 | 1.8% | | CHEM 1 | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 1.6 | 4.1% | | 2.8 | 2.5% | | 3.6 | 2.3% | ### B. Imprecision (Urine) | ADVIA IMS | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 1.00 | 8.6% | | 6.50 | 3.7% | | 14.24 | 2.1% | | CHEM 1 | | |------------------|----------------| | Level (mg/dL) | Total CV(%) | | 1.1 | 12.6% | | 6.5 | 2.9% | | 14.2 | 1.4% | Gabriel J. Murray, Jr. 11/5/99 {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 I | 44 | Y=0.97X+0.06 | 0.16 | 0.998 | 0.2 - 8.05 | | Urine | CHEM I | 48 | 1.02X-0.24 | 0.34 | 0.998 | 1.4 - 25.0 | #### Plasma (Y) vs. Serum (X) Comparison | | Plasma | Serum | N | Difference | Sample Range | |---------------|--------|-------|----|------------|--------------| | | mg/dL | mg/dL | 60 | (%) | mg/dL | | concentration | 1.97 | 1.97 | | 0 | 1.63 - 2.3 | | Within-run CV | 8.92 | 9.73 | | | | #### Interfering Substances | Source | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Magnesium Conc (mg/dL) | Effect (% change) | |--------|--------------------------|-----------------------------------|---------------------------|----------------------| | Serum | Bilirubin (unconjugated) | 25 | 2.23 | -1 | | Serum | Bilirubin (conjugated) | 25 | 1.98 | 0 | | Serum | Hemoglobin | 1000 | 2.21 | +8 | | Serum | Lipids (Triglycerides) | 500 | 2.12 | -1 | | Serum | Calcium | 20 | 2.08 | -3 | | Urine | Ascorbate | 200 | 5.92 | +2 | | Urine | Salicylate | 500 | 5.67 | +2 | | Urine | Acetaminophen | 50 | 6.02 | -7 | #### Analytical Range Serum/Plasma: 0 to 8.0 mg/dL Urine: 0 to 25 mg/dL Gabriel J. Munoz, Jr. 11/5/99 --- Date Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains a series of small, dark, indistinct shapes arranged in a diagonal line from the upper left to the lower right. The shapes appear to be isolated against a bright, uniform background, making them stand out despite their small size. Due to the lack of detail, it is difficult to determine the exact nature or purpose of these shapes. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Theophylline 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 theophylline in human serum on the Bayer ADVIA® IMS systems. Measurements of theophylline are used to aid in the diagnosis and treatment of theophylline overdose and asthama in children and adults. #### 2. Predicate Device | Product Name | | . Phone of the contributed the result of the result of the may of the contributed to the comments of the may of the comments of the may of the comments of the may of the comm Reagent Part # Calibrator Part # | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bayer RA-1000 | T01-1695-01 | and the country of the count of the count of the county of the county of the county of the county of the county of the county of the county of the county of the county of the T03-1692-01 | | Theophylline ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | #### 3. Device / Method | Product Name of the completed by the program and the promotive of the comments of the comments of the comments of | Reagent BAN | Calibrator BAN | |----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ADVIA IMS Theophylline | 03246211 and the many of the control of the contribution of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comment | 08491893 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ## Minimum Detectable Concentration | www.comments.com/short/colors/colors/controllers/ Method | age of the contract of the program and the province the complex of the may be any the complex of the manufactures of the manufactures of the manufacturer ADVIA IMS | Immuno | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Householder from the would many from and the confinited the finition of the find of the find of the find of the first of the first of the first for the find of the find of th MDC Management of American Collection of Children Comments of Street Charge of States of States of States of States of States of States of States of States of States of States of | of the many of the many of the many of the many of the many of the many of the more of the many of 0.47 ug/mL Company of the program and the manager of the comments of the comments of the comments of the comments of the count | 1 0.4 Oug/mL | ### A. Imprecision | ADVIA IMS | | |----------------|-----------------| | Level μg/mL | Total CV (%) | | 9.37 | 3.4 | | 19.59 | 3.0 | | 29.17 | 4.1 | | Specimen type | Comparison System (X) | N | Regression Equation | Syx µg/mL | R | Sample Range µg/mL | |---------------|-----------------------|----|---------------------|--------------|-------|-----------------------| | Serum | RA-1000 | 51 | $Y=0.98 X - 0.13$ | 1.37 | 0.991 | 4.1 - 39.6 | Gabriel J. Mware, Jr. 11/5/99 {8}------------------------------------------------ | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Theophylline Concentration μg/mL | Effect (% change) | |-----------------------------|-----------------------------------|----------------------------------------|----------------------| | Bilirubin (unconjugated) | 25 | 8.65 | +6 | | Bilirubin (conjugated) | 15 | 9.00 | +7 | | Hemoglobin | 600 | 9.03 | -4 | | Lipids (Triglycerides) | 1000 | 9.01 | -6 | Analytical Range 0.47 to 40 µg/mL Date 11/07/99 Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. Muraca, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs {9}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Tobramycin 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 tobramycin in human serum on the Bayer ADVIA® IMS systems. Measurements of tobram circums are used to aid in the diagnosis and treatment of tobramycin overdose and in monitoring serum levels of tobramycin to ensure appropriate therapy. #### 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |------------------------------|----------------|-------------------| | Bayer Immuno I Tobramycin | T01-3157-51 | T03-2864-01 | #### 3. Device / Method | Product Name | Reagent BAN | Calibrator BAN | |------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------| | ADVIA IMS Tobramycin ' Property of the proportion of the program and one of the first of the first of the first of the first of | 04946969 | 05442131 | ## Minimum Detectable Concentration | Method | ADVIA IMS | Immuno 1 | |--------|----------------------------|----------------------------| | MDC | 0.34 $ $\mu$ $ g/mL | 0.08 $ $\mu$ $ g/mL | ## A. Imprecision I ਜ | ADVIA IMS | | | Bayer Immuno | |-----------|--------|-------|--------------| | Level | Total | Level | Total | | g/mL | CV (%) | μg/mL | CV(%) | | 1.92 | 4.3 | 1.15 | 4.0 | | 3.71 | 2.9 | 4.42 | 2.4 | | 7.86 | 3.3 | 8.29 | 2.2 | | Specimen type | Comparison System (X) | N | Regression Equation | Syx μg/mL | R | Sample Range μg/mL | |---------------|-----------------------|----|---------------------|-----------|-------|--------------------| | Serum | Immuno 1 | 69 | $Y = 0.99X - 0.05$ | 0.22 | 0.997 | 0.3-11.5 | Gabriel J. Munoz, Jr. 11/5/99 {10}------------------------------------------------ | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Tobramycin Concentration µg/mL | Effect (% change) | |-----------------------------|-----------------------------------|--------------------------------------|----------------------| | Bilirubin (unconjugated) | 25 | 2.36 | +6 | | Bilirubin (conjugated) | 20 | 2.46 | +3 | | Hemoglobin | 600 | 2.44 | 0 | | Lipids (Triglycerides) | 1000 | 2.42 | -1 | Analytical Range 0.34 to 16.0 µg/mL Date 11/5/99 Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. Murray, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs {11}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid 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 varo diagnostic method is intended to measure Uric Acid in human serum, plasma or urine on the Bayer ADVIA IMS system ## 2. Predicate Device | Product Name | Reagent Part # | Calibrator Part # | |-----------------------------|----------------|-------------------| | Technicon CHEM 1° Uric Acid | T01-1655-53 | T03-1291-62 | ## 3. Device / Method | Product Name | | Reagent Part # Calibrator Part # | |---------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ADVIA IMS Uric Acid | 05132620 was and the commend of the commend of the been and the been | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ T03-1291-62 | #### ﻧﮯ Imprecision(SERUM) | ADVIA IMS | | CHEM 1 | | |------------------|----------------|------------------|----------------| | Level (mg/dL) | Total CV(%) | Level (mg/dL) | Total CV(%) | | 3.68 | 3.6 | 3.8 | 6.3 | | 6.84 | 3.2 | 9.3 | 3.1 | | 11.50 | 1.7 | 16.3 | 3.3 | #### B. Imprecision(URINE) | ADVIA IMS | CHEM 1 | | | |------------------|----------------|------------------|----------------| | Level (mg/dL) | Total CV(%) | Level (mg/dL) | Total CV(%) | | 20.5 | 7.2 | N/A | N/A | | 32.4 | 4.0 | 26.4 | 8.2 | | 45.2 | 5.6 | 35.4 | 7.2 | | Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | r | Sample Range (mg/dL) | |---------------------|-----------------------|----|---------------------|-------------|-------|----------------------| | Serum | CHEM 1 | 60 | $Y = 0.96X + 0.14$ | 0.98 | 0.973 | 1.5 - 19.7 mg/dL | | Plasma(v), Serum(x) | ADVIA IMS | 60 | $Y = 1.01X + 0.06$ | 0.16 | 0.989 | 2.9-8.0 mg/dL | | Urine | CHEM 1 | 51 | $Y = 1.11X - 3.1$ | 4.0 | 0.992 | 1.0 - 123.0 mg/dL | Gabriel J. Munaco, Jr. 11/5/99 {12}------------------------------------------------ ### Interfering Substances(In Serum) | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Uric Acid Conc. (mg/dL) | Effect (% change) | |--------------------------|-----------------------------------|----------------------------|----------------------| | Bilirubin | 20 | 3.8 | -7.9 | | Hemoglobin | 500 | 3.8 | +15.8 | | Lipids (Triglycerides) | 500 | 3.8 | +36.7 | ## Interfering Substances(In Urine) | Interfering Substance | Interfering Sub. Conc. (mg/dL) | Uric Acid Conc. (mg/dL) | Effect (% change) | |--------------------------|-----------------------------------|----------------------------|----------------------| | Acetaminophen | 500 | 18.4 | +1.1 | | Ascorbic Acid | 200 | 18.4 | +10.9 | | Salicylate | 500 | 18.4 | -2.7 | ### Analytical Range Serum/Plasına Urine: 0 10 23 ing/dL 0 to 200 mg/dL Gabriel J. Munoz, Jr. ///5799 {13}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/13/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it. Public Health Service ## APR 1 0 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Business Group Diagnostic 511 Benedict Avenue Tarrytown, New York 10591-5097 Re: K993867 Trade Name: Bayer ADVIA® IMS System Regulatory Class: II Product Code: CIG, JGJ, KLS, KNK, LCD, LCP, LDO Dated: February 21, 2000 Received: February 29, 2000 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 (OS) 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 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" (21CFR 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 Butman 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 K493867 510(k) Number (if known): Device Name: Direct Bilirubin (DBIL) Indications For Use: The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated 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. Device Name: Hemoglobin A1c (HbA1c) Indications For Use: The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes. e (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K493867 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Optional Formal 1-2-96 {16}------------------------------------------------ Page 2 of 3 510(k) Number (if known): Device Name: Gentamicin Indications For Use: The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy. Device Name: Magnesium (MG) Indications For Usc: The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv. Device Name: Theophylline (THEO) Indications For Use: The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline 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 ______ | | <div align="center">Sean Cooge</div> | | Optional Formal 1-2-96 | | <div align="center">(Division Sign-Off)</div> | | | | <div align="center">Division of Clinical Laboratory Devices</div> | | | | 510(k) Number: K993862 | | | {17}------------------------------------------------ 510(k) Number (if known): Device Name: Tobramycin (TOBRA) Indications For Use: The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy. Device Name: Uric Acid (UA) Indications For Use: The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs. in Cooper on of Clinical L 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concuplence of CDRH, Office of Device Evaluation (ODE) Prescription Use 2 (Per 21 CFR 801.109) OR Over-The-Counter Use Optional Formal 1-2-96