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 djagnostic 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 Description

Not Found

AI/ML Overview

The provided text describes several distinct in vitro diagnostic assays for the Bayer ADVIA® Integrated Modular System (IMS). Since each assay details its own performance criteria and study results, I will describe the acceptance criteria and study for one of the assays, the B2-Microglobulin (B2M) Assay, as an example.

B2-Microglobulin (B2M) Assay for Bayer ADVIA® Integrated Modular System (IMS)

The Bayer ADVIA® IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure β2-Microglobulin in human serum and urine. It aids in the management of patients with renal dysfunction and rheumatoid arthritis.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the comparison to a predicate device (Immuno 1 B2-Microglobulin Assay) and are demonstrated through various analytical performance studies. The key performance metrics evaluated are Imprecision, Correlation, Analytical Range, Minimum Detectable Concentration (MDC), and Interference.

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Industry Standard)	Reported Device Performance (ADVIA IMS B2M Assay)
Imprecision (Total CV%)	Comparable to or better than predicate; generally < 10% for clinical assays, often lower for highly sensitive assays.	1.03 mg/L: 2.5%4.01 mg/L: 3.2%
Correlation (vs. Predicate)	High correlation (e.g., R > 0.95, slope near 1, intercept near 0).	Serum (N=86): Y = 1.009X + 0.055, Syx = 0.442 mg/L, R = 0.996 (vs. Immuno 1)Urine (N=50): Y = 0.923X + 0.004, Syx = 0.012 mg/L, R = 0.990 (vs. Immuno 1)
Analytical Range	Clinically relevant range of measurement.	Serum: 0.001 – 20 mg/LUrine: 0.001 – 10 mg/L
Minimum Detectable Concentration (MDC)	Low enough for clinical utility.	ADVIA IMS: 0.001 mg/LImmuno 1 (Predicate): 0.01 mg/L
Interference (% change)	Generally, interference effects should be within a clinically acceptable limit (e.g., ±10% or ±15%).	Hemoglobin (1000 mg/dL): -6.18%Lipids (Triglycerides, 1000 mg/dL): 4.68%Bilirubin (25 mg/dL): 4.92%Creatinine (2.5 mg/dL): -3.68%Urea (200 mg/dL): 4.35%Albumin (6500 mg/dL): 8.90%Immunoglobulin (6000 mg/dL): 4.56%

2. Sample Size Used for the Test Set and Data Provenance

The test sets for the correlation studies were:

Serum: N = 86 samples
Urine: N = 50 samples

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given the context of laboratory analytical validation, these are typically prospective studies performed on collected human samples in a controlled laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For this type of in vitro diagnostic device (quantitative assay), the "ground truth" for the test set is established by the measurement results from a legally marketed predicate device (Immuno 1 B2-Microglobulin Assay) or by established reference methods. While laboratory personnel with specific qualifications would perform these measurements, the concept of "experts" to establish ground truth in the sense of medical image interpretation (e.g., radiologists) is not applicable here. The accuracy of the predicate device itself serves as the benchmark.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for qualitative or subjective assessments where multiple human readers disagree. For quantitative assays like this, the ground truth is established by the numerical result from the reference or predicate method. Therefore, no adjudication method in the traditional sense was used for the test set. Direct numerical comparison and statistical analysis (regression) are applied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers make subjective assessments that an AI might assist. This device is a fully automated quantitative assay, not involving human interpretation in the same way.

6. Standalone Performance Study

Yes, a standalone performance study was done for the ADVIA IMS B2-Microglobulin assay. The reported data for Imprecision, Analytical Range, Minimum Detectable Concentration, and Interference refer to the performance of the ADVIA IMS assay itself, independent of operator influence other than proper sample preparation and instrument operation. The correlation studies also demonstrate the standalone performance of the new device by comparing its output to the predicate device's output.

7. Type of Ground Truth Used

The ground truth used for performance evaluation, particularly for the correlation studies, was the results obtained from the predicate device, the Immuno 1 B2-Microglobulin Assay. This is a common approach for demonstrating substantial equivalence for new IVD assays. Other ground truths are inherent in the analytical methodologies used for imprecision, MDC, and interference studies which rely on known concentrations or spiked samples.

8. Sample Size for the Training Set

This document describes a cleared in vitro diagnostic assay, which is typically a chemical or immunoassay method, not a machine learning or AI-based device that requires a "training set" in the computational sense. Therefore, the concept of a "training set" sample size as it applies to AI/ML models is not applicable to this device. The development of such assays involves reagent formulation, optimization, and characterization, but not "training" on data in the way an algorithm is trained.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a "training set" does not apply to this type of traditional in vitro diagnostic assay. Therefore, there is no ground truth established for a training set. The development process involves chemical and biological engineering, not data-driven model training.

Summary

{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(mg/L)	TotalCV(%)
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

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	AnalyteConcentration(mg/L)	Effect(% 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(mg/L)	Immuno 1(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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Children and consisted consisted and consisted on anyoneSAL AT YOU Lbecame 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	CARTENO CLEASURE COLLECTION COLLECT
A Common Col & Million Come of College of1. 18.7010.00------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and and the collection of the commend theAnnual Comments of the countAnd States of Children Company of Children Company of Children.	Supportunities and consideration of the childrenIN INCREASE E CONSULERS OF CONSULERS----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Imprecision

ADVIA IMS		Immuno 1
Level(ng/mL)	TotalCV(%)	Level(ng/mL)	TotalCV(%)
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 _______________________________________________________________________________________________________________________________________________________

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Myoglobin Conc(ng/mL)	Effect(% 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.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1.	1FREE FRI LA CHRISTON & CHINARY & CHANNEL AA TT Y TT	mmimo
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000	----------	And Commend of Children Comments of ChildrenAntie a------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Imprecision

	ADVIA IMS	Immuno 1
Level(ng/mL)	TotalCV(%)	Level(ng/mL)	TotalCV(%)
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

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Myoglobin Conc(ng/mL)	Effect(% 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(ng/mL)	TotalCV (%)
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	ComparisonSystem (X)	N	Regression Equation	Syx(ng/mL)	R	Sample Range(ng/mL)
Serum	Immuno 1	77	Y=0.91X+0.073	0.328	0.993	0.04-12.2

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	AnalyteConcentration(ng/mL)	Effect(% 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(ng/mL)	Immuno 1(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	06956201and 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	" ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------ADVIA	lmmunoA C A Commenssion Commens of Concession Company of Canadian Company Company of Children
and of the property of the property of the property ofMDC	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------was and and promote of the program and the comments of the comments of the many of theFree Carder States of Canadian Comers0.1 ng/mL	0.1 ng/mLof Cattle.

Imprecision

ADVIA IMS		Immuno 1
Level(ng/mL)	TotalCV(%)	Level(ng/mL)	TotalCV(%)
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	ComparisonSystem (X)	N	Regression Equation	Syxng/mL	R	Sample Range(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

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Troponin IConc (ng/mL)	Effect(% 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	----------------------------------------------------------------------------------------------------------------------ATVI	Immuno
MDC	ng/m	1 noimCompany ofI

Imprecision

ADVIA IMS
Level(ng/mL)	TotalCV(%)
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

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Ferritin Conc(ng/mL)	Effect(% 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.Product Name		Carles Concession Company Company Company Company Company Company Company Company Company Company Comments of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reagent Part # Calibrator Part #
program believe and the program of the Research of Articles and Articles and Articles andADVIA 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)

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	hCGConcentration(mIU/mL)	Effect(% 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)

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	hCGConcentration(mIU/mL)	Effect(% 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(mIU/mL)	Immuno 1(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 AssayConcession 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 LThe property of promoted on any aProduct 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 firstADVIA IMS TSH Assayof Real Property of Children	B42-3921-43 B43-3948-01

Imprecision

I (μ)

ADVIA IMS
Level(U/mL)	TotalCV(%)
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(µIU/mL)	R	Sample Range(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

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	TSHConcentration(µIU/mL)	Effect(% 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(µIU/mL)	Immuno 1(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

{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:

Device Name: Creatine Kinase - MB Isoenzyme (CKMB)

Indications For Use:

Division C: Divisinr

510(k) x 9937 11

Device Name: Myoglobin (MYO)

Indications For Use:

(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)

Over-The-Counter Use

Optional Formal 1-2-96

{19}------------------------------------------------

510(k) Number (if known): K935711

Device Name: Testosterone

Indications For Use:

Device Name: Troponin I (TNI)

Indications For Use:

Device Name: Ferritin (FERR)

Indications For Use:

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)

Over-The-Counter Use

Optional Formal 1-2-96

{20}------------------------------------------------

510(k) Number (if known):

Device Name: Human Chorionic Gonadotropin (hCG)

Indications For Use:

Device Name: Thyroid Stimulating Hormone (TSH)

Indications For Use:

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)

Over-The-Counter Use

Optional Formal 1-2-96

Regulation Number and Section

§ 866.5630

Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
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.