ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
Device Facts
| Record ID | K993711 |
|---|---|
| Device Name | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) |
| Applicant | Bayer Corp. |
| Product Code | JZG · Immunology |
| Decision Date | Dec 16, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5630 |
| Device Class | Class 2 |
Intended Use
The Bayer Advia IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure ß2-Microglobulin in human serum and urine. When used in conjunction with clinical data and other diagnostic procedures, measurements of B2-Microglobulin aid in the management of patients with renal dysfunction and rheumatoid arthritis. The Bayer Advia IMS Creatine Kinase (CKMB) assay is an in vitro diagnostic device intended to quantitatively measure the MB isoenzyme in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of CK-MB aid in the diagnosis of acute myocardial infarction (AMI). The Bayer Advia IMS Myoglobin assay is an in vitro diagnostic device intended to quantitatively measure the myoglobin in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of myoglobin aid in the diagnosis of acute myocardial infarction (AMI). The Bayer Advia IMS Testosterone assay is an in vitro diagnostic device intended to quantitatively measure total testosterone in human serum. Measurements of testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. This diagnostic method is not intended for use on any other diagnostic system. The Bayer Advia IMS Troponin I assay is an in vitro diagnostic device intended to quantitatively measure the cardiac Troponin I in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI). The Bayer Advia IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system. The Bayer Advia IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (B) human chorionic gonadotropin (hCG) in human serum, plasma, and urine. Measurements of human chorionic gonadotropin are used in the detection of pregnancy. The Bayer Advia IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum, plasma. This assay allows the determination of TSH with 3rd generation sensitivity of less than 20% total coefficient of variation (CV) at 0.01 to 0.02 mIU/L or uIU/mL, as defined by the American Thyroid Association. Measurements of thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders.
Device Story
The Bayer ADVIA IMS is an integrated modular system for in vitro diagnostic testing. It processes human serum, plasma, or urine samples to quantitatively measure specific analytes: B2-Microglobulin, CK-MB, Myoglobin, Testosterone, Troponin I, Ferritin, hCG, and TSH. The system utilizes specific reagent and calibrator kits for each assay. Operation occurs in clinical laboratory settings, managed by trained laboratory personnel. The system automates the analytical process, providing quantitative results that clinicians use alongside patient history and other diagnostic procedures to manage renal dysfunction, rheumatoid arthritis, AMI, hormonal disorders, iron metabolism, and pregnancy. The device benefits patients by providing rapid, accurate diagnostic data to guide clinical decision-making and treatment pathways.
Clinical Evidence
Bench testing only. Performance validated through imprecision studies (Total CV% reported for all assays), correlation studies against Immuno 1 predicate systems (N=40-87 per assay, R=0.990-1.0), and interference testing (evaluating effects of hemoglobin, lipids, bilirubin, etc.). Analytical ranges and minimum detectable concentrations (MDC) were established for each analyte. No clinical prospective or retrospective studies were required for this 510(k) submission.
Technological Characteristics
In vitro diagnostic assays for the ADVIA IMS system. Reagents and calibrators are specific to each analyte. Sensing principle involves automated immunoassay analysis. System is a modular, networked laboratory instrument. Software manages assay execution and data processing. No specific materials of construction or sterilization methods provided; standard laboratory reagent handling applies.
Indications for Use
Indicated for patients requiring quantitative measurement of B2-Microglobulin (renal dysfunction, rheumatoid arthritis), CK-MB (AMI diagnosis), Myoglobin (AMI diagnosis), Testosterone (hormonal sexual disorders), Troponin I (AMI diagnosis), Ferritin (iron metabolism disorders), hCG (pregnancy detection), and TSH (thyroid/pituitary disorders). Specimens include human serum, plasma, and/or urine.
Regulatory Classification
Identification
A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney 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 § 866.9.
Predicate Devices
- Immuno 1 B2-Microglobulin Assay (T01-3669-51)
- Immuno 1 CK-MB I (T01-3587-51)
- Immuno 1 Myoglobin (T01-3653-51)
- Immuno 1 Testosterone Assay (T01-3694-51)
- Immuno 1 Troponin I (T01-3887-51)
- Immuno 1 Ferritin (T01-2863-51)
- Immuno 1 hCG Assay (T01-2966-51)
- Immuno 1 TSH Assay (T01-2942-51)
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
- K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) · Bayer Corp. · Jan 29, 1999
- K993867 — BAYER ADVIA IMS SYSTEM · Bayer Corp. · Apr 10, 2000
- K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Jul 22, 1999
Submission Summary (Full Text)
{0}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS B2-Microglobulin Assay for Bayer ADVIA® Integrated Modular System (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: 19937 11
## 1. Intended Use
The Bayer ADVIA® IMS (32-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure ß2-Microglobulin in human serum and urine. When used in conjunction with clinical data and other diagnostic procedures, measurements of B2-Microglobulin aid in the management of patients with renal dysfunction and rheumatoid arthritis.
#### Predicate Device 2.
| 1 1 1 2 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------|--|--|
| Product Name | | Calibrator Part # | | |
| Immuno 1 B2-Microglobulin Assay | T01-3669-51 | IT03-3670-01 | | |
#### 3. Device / Method
| Product Name | Reagent Part # | Calibrator Part # |
|----------------------------------|----------------|-------------------|
| ADVIA IMS β2-Microglobulin Assay | B42-3892-21 | B43-3924-01 |
#### Imprecision
| ADVIA IMS | |
|-----------------|----------------|
| Level<br>(mg/L) | Total<br>CV(%) |
| 1.03 | 2.5 |
| 4.01 | 3.2 |
### Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/L) | R | Sample Range (mg/L) |
|---------------|-----------------------|----|---------------------|------------|-------|---------------------|
| Serum | Immuno 1 | 86 | $Y=1.009X+0.055$ | 0.442 | 0.996 | 0.72-18.9 |
| Urine | Immuno 1 | 50 | $Y=0.923X+0.004$ | 0.012 | 0.990 | 0.03-0.372 |
| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | Analyte<br>Concentration<br>(mg/L) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|------------------------------------|----------------------|
| Hemoglobin | 1000 | 0.86 | -6.18 |
| Lipids (Triglycerides) | 1000 | 0.37 | 4.68 |
| Bilirubin | 25 | 0.44 | 4.92 |
| Creatinine | 2.5 | 0.74 | -3.68 |
| Urea | 200 | 0.73 | 4.35 |
| Albumin | 6500 | 1.36 | 8.90 |
| Immunoglobulin | 6000 | 0.39 | 4.56 |
Gabriel J. Murray Jr.
10/21/99-RA
{1}------------------------------------------------
Analytical Range Serum: 0.001 – 20 mg/L
Urine: 0.001 – 10 mg/L
# Minimum Detectable Concentration
| ADVIA IMS<br>(mg/L) | Immuno 1<br>(mg/L) |
|---------------------|--------------------|
| 0.001 | 0.01 |
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/21/99
**Date**
{2}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CK-MB 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: 19937 11
### 1. Intended Use
This in vitro diagnostic method is intended to measure CK-MB in human serum or plasma on the Bayer ADVIA IMS system
### 2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|------------------|----------------|-------------------|
| Immuno 1 CK-MB I | T01-3587-51 | T03-3586-01 |
### 3. Device / Method
| Product Name | Reagent Part # | BAN | Calibrator Part # | BAN |
|-------------------|----------------|----------|-------------------|----------|
| ADVIA IMS CK-MB I | B42-3898-22 | 05509473 | B43-3930-01 | 02852592 |
### Minumum Detectable Conc.
| CALL COLLECTION AN COLLECT CLANDE COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONTRACTOR COLLECTION CONTRACT<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Children and consisted consisted and consisted on anyone<br>SAL AT YOU L<br>became of the other of contractions of consistences and consistences and consistences and consistences and consisted to the consisted to the consisted to the consisted to the | <br>CARTE<br>NO CLEASURE COLLECTION COLLECT |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A Common Col & Million Come of College of<br>1. 18.70<br>10.00<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and and the collection of the commend the<br>Annual Comments of the count<br>And States of Children Company of Children Company of Children<br>. | Supportunities and consideration of the children<br>IN INCREASE E CONSULERS OF CONSULERS<br>----------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
### Imprecision
| ADVIA IMS | | Immuno 1 | |
|------------------|----------------|------------------|----------------|
| Level<br>(ng/mL) | Total<br>CV(%) | Level<br>(ng/mL) | Total<br>CV(%) |
| 2.3 | 5.9 | 4.6 | 6.1 |
| 11.6 | 4.1 | 8.1 | 5.1 |
| 42.4 | 4.1 | 73.9 | 5.1 |
### Correlation (Y=ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Sy.X (ng/mL) | R | Sample Range (ng/mL) |
|---------------|-----------------------|----|---------------------|--------------|-------|----------------------|
| Serum | Immuno 1 | 75 | Y=0.98 - 0.09 | 0.79 | 0.999 | 0.1 - 79.9 |
| Plasma | Immuno 1 | 50 | Y=0.98 - 0.25 | 1.33 | 1.0 | 0.2 - 73.0 |
### Interfering Substances _______________________________________________________________________________________________________________________________________________________
| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Myoglobin Conc<br>(ng/mL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|---------------------------|----------------------|
| Bilirubin | 25 | 41.1 | 1.9 |
| Hemoglobin | 1000 | 39.9 | 5.8 |
| Urea Nitrogen | 200 | 39.9 | 10.0 |
| Lipids (Triglycerides) | 1000 | 44.0 | 0.0 |
Gabriel J. Murara Jr.
10/21/99-R1
{3}------------------------------------------------
Serum/Plasma:
0.05 to 300 ng/mL
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/21/99
---
Date
{4}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Myoglobin 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: ¥49.37/ /
### 1. Intended Use
This in vitro diagnostic method is intended to measure Myoglobin in human serum or the Bayer ADVIA IMS system
### 2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|--------------------|----------------|-------------------|
| Immuno 1 Myoglobin | T01-3653-51 | T03-3654-01 |
### 3. Device / Method
| Product Name | Reagent Part # | BAN | Calibrator Part # | BAN |
|---------------------|----------------|----------|-------------------|----------|
| ADVIA IMS Myoglobin | B42-3909-21 | 03514070 | B43-3938-01 | 06268712 |
#### Minumum Detectable Conc.
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>. | 1<br>FREE FRI LA CHRISTON & CHINARY & CHANNEL A<br>A TT Y TT | <br>mmimo |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | ---------- | And Commend of Children Comments of Children<br>Antie a<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
### Imprecision
| | ADVIA IMS | Immuno 1 | |
|------------------|----------------|------------------|----------------|
| Level<br>(ng/mL) | Total<br>CV(%) | Level<br>(ng/mL) | Total<br>CV(%) |
| 12.7 | 1.6 | 14.4 | 3.0 |
| 64.5 | 2.6 | 73.5 | 3.7 |
| 577.6 | 3.1 | 630.1 | 2.8 |
#### Correlation (Y=ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Sample Range (ng/mL) |
|---------------|-----------------------|----|---------------------|----------------------|
| Serum | Immuno 1 | 49 | $Y=1.02X-0.80$ | 11 - 5885 |
| Plasma | Immuno 1 | 61 | $Y=1.10X-4.54$ | 35 - 2362 |
Passing-Bablock correlation used
| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Myoglobin Conc<br>(ng/mL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|---------------------------|----------------------|
| Bilirubin | 25 | 534.6 | 6.6 |
| Hemoglobin | 1000 | 577.6 | -1.6 |
| Creatinine | 2.5 | 540.7 | 5.7 |
| Urea Nitrogen | 200 | 536.8 | 7.0 |
| Lipids (Triglycerides) | 1000 | 452.8 | 1.5 |
Gabriel J. Munoz, Jr.
10/7/99-RA.
{5}------------------------------------------------
Analytical Range Serum/Plasma:
0.22 to 3000 ng/mL
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
Bayer Corporation
511 Benedict Avenue
Tarrytown, New York 10591-5097
10/27/99
---
Date
{6}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Testosterone Assay for Bayer ADVIA® Integrated Modular System (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: K9937 //
## 1. Intended Use
This in vitro method is intended to quantitatively measure Testosterone, in human serum using ADVIA IMS Testosterone Assay on a Bayer ADVIA® Integrated Modular System. The measurement of serum testosterone in men is useful in the assessment of infertility, impotence and sexual development in young adults. The clinical symptoms of excess testosterone in female including hirsutism, virilization, amenorthea, infertility and obesity.
#### Predicate Device 2.
| Product Name | Reagent Part # | Calibrator Part # |
|-----------------------------|----------------|-------------------|
| Immuno 1 Testosterone Assay | T01-3694-51 | T03-3695-01 |
### 3. Device / Method
| Product Name | Reagent Part # | Calibrator Part # |
|------------------------------|----------------|-------------------|
| ADVIA IMS Testosterone Assay | B42-3917-21 | B43-3945-01 |
### Imprecision
| ADVIA IMS | |
|------------------|-----------------|
| Level<br>(ng/mL) | Total<br>CV (%) |
| 0.9 | 7.1 |
| 2.7 | 4.2 |
| 7.7 | 3.4 |
| Immuno 1 | |
|---------------|-------------|
| Level (ng/mL) | Total CV(%) |
| 0.95 | 7.8 |
| 3.04 | 4.8 |
| 8.43 | 3.0 |
### Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx<br>(ng/mL) | R | Sample Range<br>(ng/mL) |
|---------------|--------------------------|----|---------------------|----------------|-------|-------------------------|
| Serum | Immuno 1 | 77 | Y=0.91X+0.073 | 0.328 | 0.993 | 0.04-12.2 |
| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | Analyte<br>Concentration<br>(ng/mL) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|-------------------------------------|----------------------|
| Human IgG | 6000 | 2.2 | 6.7 |
| Hemoglobin | 1000 | 3.1 | -8.2 |
| Lipids (Triglycerides) | 1000 | 2.2 | -1.8 |
| Bilirubin | 25 | 2.2 | -3.9 |
| Urea | 429 | 2.3 | -1.3 |
Gabriel J. Mman Jr.
01/22/2001
{7}------------------------------------------------
0.05 - 20 ng/mL
### Minimum Detectable Concentration
| ADVIA IMS<br>(ng/mL) | Immuno 1<br>(ng/mL) |
|----------------------|---------------------|
| 0.05 | 0.05 |
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation
511 Benedict Avenue Tarrytown, New York 10591-5097
10/22/99
---
Date
{8}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Troponin I 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: 1999 1
### 1. Intended Use
This in vitro diagnostic method is intended to measure Troponin I in human serum or the Bayer ADVIA IMS system
### 2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|---------------------|----------------|-------------------|
| Immuno 1 Troponin I | T01-3887-51 | T03-3888-01 |
### 3. Device / Method
| Product Name | Reagent Part # | BAN | Calibrator Part # | BAN |
|--------------------|----------------|----------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADVIA IMS Troponin | B42-3920-22 | 06120626 | B43-3947-01 | 06956201<br>and and the property of the program and the first of the county of the county of the county of the county of the county of the county of the first of the first of the first o |
### Minumum Detectable Conc.
| Method | " ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>ADVIA | lmmuno<br>A C A Commenssion Commens of Concession Company of Canadian Company Company of Children |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| and of the property of the property of the property of<br>MDC | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>was and and promote of the program and the comments of the comments of the many of the<br>Free Carder States of Canadian Comers<br>0.1 ng/mL | 0.1 ng/mL<br>of Cattle. |
### Imprecision
| ADVIA IMS | | Immuno 1 | |
|------------------|----------------|------------------|----------------|
| Level<br>(ng/mL) | Total<br>CV(%) | Level<br>(ng/mL) | Total<br>CV(%) |
| 1.9 | 3.6 | 2.9 | 3.3 |
| 7.2 | 2.0 | 6.9 | 2.3 |
| 51.9 | 1.8 | 47.4 | 2.0 |
### Correlation (Y=ADVIA IMS, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx<br>ng/mL | R | Sample Range<br>(ng/mL) |
|---------------|--------------------------|----|---------------------|--------------|-------|-------------------------|
| Serum | Immuno 1 | 59 | $Y=0.96 + 0.26$ | 0.47 | 0.999 | 0.1 - 70 |
| Plasma | Immuno 1 | 52 | $Y=0.99 + 0.22$ | 0.34 | 0.999 | 0.1 - 50 |
| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Troponin I<br>Conc (ng/mL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|----------------------------|----------------------|
| Bilirubin | 25 | 6.08 | -0.3 |
| Hemoglobin | 1000 | 7.14 | -4.5 |
| Urea Nitrogen | 200 | 6.2 | -1.6 |
| Lipids (Triglycerides) | 1000 | 6.15 | 0.5 |
Gabriel J. Muraca Jr.
10/22/89-RA
{9}------------------------------------------------
Serum/Plasma:
0.1 to 200 ng/mL
Gabriel J. Muraca Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation
511 Benedict Avenue Tarrytown, New York 10591-5097
10/22/99
__
Date
{10}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ferritin 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 to measure Ferritin in human serum on the Bayer ADVIA IMS system.
### 2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|-------------------|----------------|-------------------|
| Immuno 1 Ferritin | T01-2863-51 | T03-4311-01 |
### 3. Device / Method
| Product Name | Reagent Part # | BAN | Calibrator Part # | BAN |
|--------------------|----------------|----------|-------------------|----------|
| ADVIA IMS Ferritin | B42-3902-22 | 05782072 | B43-3933-01 | 02467486 |
#### Minumum Detectable Conc.
| Method | ----------------------------------------------------------------------------------------------------------------------<br>ATVI | Immuno |
|--------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| MDC | ng/m | 1 noim<br>Company of<br>I |
### Imprecision
| ADVIA IMS | |
|------------------|----------------|
| Level<br>(ng/mL) | Total<br>CV(%) |
| 51.4 | 3.0 |
| 124 | 3.2 |
| 506 | 3.0 |
### Correlation (Y=ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Sample Range (ng/mL) |
|---------------|-----------------------|----|---------------------|----------------------|
| Serum | Immuno 1 | 50 | Y=1.01X-5.86 | 1.7 - 1656 |
Passing-Bablock Correlation used
| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Ferritin Conc<br>(ng/mL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|--------------------------|----------------------|
| Bilirubin | 30.5 | 156.1 | -1.7 |
| Hemoglobin | 1000 | 169.9 | -2.0 |
| Urea Nitrogen | 200 | 152.6 | 2.0 |
| Lipids (Triglycerides) | 1000 | 146.8 | -7.4 |
Gabriel J. Murray Jr.
10/26/99
{11}------------------------------------------------
Serum/Plasma: 0.1 to 2500 ng/mL
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue
Tarrytown, New York 10591-5097
10/26/99
**Date**
{12}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS hCG Assay for Bayer ADVIA® Integrated Modular System (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: | K993711 |
|--------------------------------|---------|
|--------------------------------|---------|
### 1. Intended Use
This in vitro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum, urine, and plasma (lithium heparin) using ADVIA IMS hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy.
### 2. Predicate Device
| Product Name | Reagent Part # | Calibrator Part # |
|--------------------|----------------|-------------------|
| Immuno 1 hCG Assay | T01-2966-51 | T03-3148-01 |
## 3. Device / Method
| and of the programment of the provinced and A.S.A.<br>Product Name | | Carles Concession Company Company Company Company Company Company Company Company Company Company Comments of Children<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> Reagent Part # Calibrator Part # |
|------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| program believe and the program of the Research of Articles and Articles and Articles and<br>ADVIA IMS hCG Assay | B42-3907-43 B43-3941-01 | of the property of the program of the program of the management of the many of the many of the many of the many of the may be of the may be any of the many of the many of the |
#### Imprecision
| ADVIA IMS | | Immuno 1 | |
|----------------|-------------|----------------|-------------|
| Level (mIU/mL) | Total CV(%) | Level (mIU/mL) | Total CV(%) |
| 12.1 | 4.2 | 18.3 | 4.0 |
| 23.9 | 4.5 | 55.7 | 3.7 |
| 198.1 | 5.5 | 198.1 | 3.7 |
#### Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mIU/mL) | R | Sample Range (mIU/mL) |
|---------------------|-----------------------|----|---------------------|--------------|-------|-----------------------|
| Serum | Immuno 1 | 40 | $Y=0.990X+1.96$ | 17.5 | 1.0 | 0.1 - 1345 |
| Plasma(y), Serum(x) | ADVIA IMS | 51 | $Y=0.956X+0.868$ | 17.0 | 0.998 | 0.1 - 902 |
| Urine | Immuno 1 | 87 | $Y=1.016X-2.467$ | 12.3 | 1.0 | 0.1-1158 |
#### Interfering Substances (Serum)
| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | hCG<br>Concentration<br>(mIU/mL) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|----------------------------------|----------------------|
| Hemoglobin | 1000 | 17.2 | -2.3 |
| Lipids (Triglycerides) | 1000 | 17.2 | -8.7 |
| Bilirubin | 25 | 16.5 | -6.1 |
| Urea Nitrogen | 200 | 17.2 | -7.6 |
Gabriel J. Munoz Jr.
10/26/99
{13}------------------------------------------------
### Interfering Substances (Urine)
| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | hCG<br>Concentration<br>(mIU/mL) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|----------------------------------|----------------------|
| Hemoglobin | 10 | 16.7 | 7.2 |
| Creatinine | 500 | 17.1 | 0.0 |
| Bilirubin | 200 | 18.2 | 0.0 |
| Urea Nitrogen | 1000 | 18.5 | 0.0 |
| Uric Acid | 150 | 18.8 | - 4.3 |
| Vitamin C | 500 | 16.9 | 5.9 |
### Analytical Range
0.1 - 1000 mIU/mL
### Minimum Detectable Concentration
| ADVIA IMS<br>(mIU/mL) | Immuno 1<br>(mIU/mL) |
|-----------------------|----------------------|
| 0.1 | 0.5 |
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/26/99
---
Date
**Date**
{14}------------------------------------------------
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 3rd Generation TSH Assay for Bayer ADVIA® Integrated Modular System (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: 19937)
### 1. Intended Use
This in vitro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum and plasma (lithium heparin) using ADVIA IMS 3rd Generation TSH Assay on a Bayer ADVIAC Integrated Modular System. Measurements of TSH are used in the diagnosis of thyroid or pinuitary disorders. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 to 0.02 µIU/mL, as defined by the American Thyroid Association.
### 2. Predicate Device
| Product Name | | Reagent Part # Calibrator Part # |
|-----------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| Immuno 1 TSH Assay<br>Concession Compressional Concession | T01-2942-51 T03-3568-01 | would and a many a commend of the commend of the argument the first and the first the first the first the first |
### 3. Device / Method
| STATE A LEASE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE L<br>The property of promoted on any a<br>Product Name | | Reagent Part # Calibrator Part # |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------------|
| and the program and the many of the county of the county of the county of the first of the first of the first of the first of the first of the first of the first of the first<br>ADVIA IMS TSH Assay<br>of Real Property of Children | B42-3921-43 B43-3948-01 | |
#### Imprecision
I (μ)
| ADVIA IMS | |
|-----------------|----------------|
| Level<br>(U/mL) | Total<br>CV(%) |
| 0.02 | 13.2 |
| 0.52 | 2.9 |
| 4.95 | 2.3 |
| 31.1 | 2.6 |
### Correlation (Y= ADVIA IMS, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx<br>(µIU/mL) | R | Sample Range<br>(µIU/mL) |
|---------------------|-----------------------|----|---------------------|-----------------|-------|--------------------------|
| Serum | Immuno 1 | 50 | Y=0.98X-0.357 | 1.48 | 0.997 | 0.06 - 76.0 |
| Plasma(y), Serum(x) | ADVIA IMS | 46 | Y=1.01X-0.044 | 0.21 | 1.0 | 0.12-63.3 |
| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | TSH<br>Concentration<br>(µIU/mL) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|----------------------------------|----------------------|
| Hemoglobin | 1000 | 3.32 | 1.8 |
| Lipids (Triglycerides) | 1000 | 3.49 | -1.15 |
| Bilirubin | 25 | 3.25 | 1.5 |
| Urea Nitrogen | 1000 | 3.30 | 0.3 |
Gabriel J. Munsen, Jr.
10/26/99
{15}------------------------------------------------
0.005-- 100 µIU/mL
# Minimum Detectable Concentration
| ADVIA IMS<br>(µIU/mL) | Immuno 1<br>(µIU/mL) |
|-----------------------|----------------------|
| 0.005 | 0.03 |
Gabriel J. Murray Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/26/99
---
Date
Date
{16}------------------------------------------------
Image /page/16/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1999
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K993711
Trade Name: Additional IMS Assays for the Bayer Advia IMSTM System Regulatory Class: II Product Code: JZG, JHW, DDR, JLW, JMG, DHA Regulatory Class: I Product Code: CDZ, MMI Dated: October 27, 1999 Received: November 3, 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.
{17}------------------------------------------------
### 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
{18}------------------------------------------------
Page 1 of 3
510(k) Number (if known): K993711
Device Name: B2-Microglobulin (B2M)
Indications For Use:
The Bayer Advia IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure ß2-Microglobulin in human serum and urine. When used in conjunction with clinical data and other diagnostic procedures, measurements of B2-Microglobulin aid in the management of patients with renal dysfunction and rheumatoid arthritis.
Device Name: Creatine Kinase - MB Isoenzyme (CKMB)
Indications For Use:
The Bayer Advia IMS Creatine Kinase (CKMB) assay is an in vitro diagnostic device intended to quantitatively measure the MB isoenzyme in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of CK-MB aid in the diagnosis of acute myocardial infarction (AMI).
> Division C: Divisinr
510(k) x 9937 11
Device Name: Myoglobin (MYO)
Indications For Use:
The Bayer Advia IMS Myoglobin assay is an in vitro diagnostic device intended to quantitatively measure the myoglobin in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of myoglobin aid in the diagnosis of acute myocardial infarction (AMI).
(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 Formal 1-2-96
{19}------------------------------------------------
510(k) Number (if known): K935711
Device Name: Testosterone
Indications For Use:
The Bayer Advia IMS Testosterone assay is an in vitro diagnostic device intended to quantitatively measure total testosterone in human serum. Measurements of testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. This diagnostic method is not intended for use on any other diagnostic system.
Device Name: Troponin I (TNI)
Indications For Use:
The Bayer Advia IMS Troponin I assay is an in vitro diagnostic device intended to quantitatively measure the cardiac Troponin I in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI).
Device Name: Ferritin (FERR)
Indications For Use:
The Bayer Advia IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This djagnostic method is not intended for use on any other diagnostic system.
Sean Cooper
Division Sign-Off
sion Sign-Off)
sion of Clinical Laboratory Devices
No.: 499274
(PLEASE DO NOT WRITE BE HIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Formal 1-2-96
{20}------------------------------------------------
# 510(k) Number (if known):
# Device Name: Human Chorionic Gonadotropin (hCG)
Indications For Use:
The Bayer Advia IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (B) human chorionic gonadotropin (hCG) in human serum, plasma, and urine. Measurements of human chorionic gonadotropin are used in the detection of pregnancy.
## Device Name: Thyroid Stimulating Hormone (TSH)
Indications For Use:
The Bayer Advia IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum, plasma. This assay allows the determination of TSH with 3rd generation sensitivity of less than 20% total coefficient of variation (CV) at 0.01 to 0.02 mIU/L or uIU/mL, as defined by the American Thyroid Association. Measurements of thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders.
Jean Cooper
vision Sign-Off)
of Clinical Laboratory Devices
mber K993711
# (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 Formal 1-2-96
