Predicate Devices

Immuno 1 B2-Microglobulin Assay, Immuno 1 CK-MB I, Immuno 1 Myoglobin, Immuno 1 Testosterone Assay, Immuno 1 Troponin I, Immuno 1 Ferritin, Immuno 1 hCG Assay, Immuno 1 TSH Assay

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes in vitro diagnostic assays for measuring specific biomarkers and does not mention any AI or ML components.

Therapeutic

No.
The device is described as an "in vitro diagnostic device" intended to measure various substances in human samples to aid in diagnosis, not to provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the various assays (B2M, CKMB, Myoglobin, Testosterone, Troponin I, Ferritin, hCG, TSH) are "in vitro diagnostic device[s]".

SaMD (Software as a Medical Device)

No

The device is described as an "in vitro diagnostic device" intended to quantitatively measure various substances in human samples (serum, urine, plasma). This strongly implies a physical instrument or system is involved in the measurement process, not just software. The performance studies also refer to "assays" and comparisons to other "assays" on a different system ("Immuno 1 assays"), further indicating a hardware component for performing the tests.

IVD (In Vitro Diagnostic)

Yes, the provided text explicitly states that the devices are in vitro diagnostic devices (IVDs) in the "Intended Use / Indications for Use" section for each assay listed.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

This in vitro diagnostic method is intended to measure CK-MB in human serum or plasma on the Bayer ADVIA IMS system

This in vitro diagnostic method is intended to measure Myoglobin in human serum or the Bayer ADVIA IMS system

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.

This in vitro diagnostic method is intended to measure Troponin I in human serum or the Bayer ADVIA IMS system

This in vitro diagnostic method to measure Ferritin in human serum on the Bayer ADVIA IMS system.

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

JZG, JHW, DDR, JLW, JMG, DHA, CDZ, MMI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

B2-Microglobulin Assay
Correlation (Y= ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=86, Regression Equation Y=1.009X+0.055, Syx (mg/L) 0.442, R=0.996, Sample Range (mg/L) 0.72-18.9
Urine: Comparison System (X) Immuno 1, N=50, Regression Equation Y=0.923X+0.004, Syx (mg/L) 0.012, R=0.990, Sample Range (mg/L) 0.03-0.372

CK-MB method
Imprecision:
ADVIA IMS: Level (ng/mL) 2.3, Total CV(%) 5.9; Level (ng/mL) 11.6, Total CV(%) 4.1; Level (ng/mL) 42.4, Total CV(%) 4.1
Immuno 1: Level (ng/mL) 4.6, Total CV(%) 6.1; Level (ng/mL) 8.1, Total CV(%) 5.1; Level (ng/mL) 73.9, Total CV(%) 5.1
Correlation (Y=ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=75, Regression Equation Y=0.98 - 0.09, Sy.X (ng/mL) 0.79, R=0.999, Sample Range (ng/mL) 0.1 - 79.9
Plasma: Comparison System (X) Immuno 1, N=50, Regression Equation Y=0.98 - 0.25, Sy.X (ng/mL) 1.33, R=1.0, Sample Range (ng/mL) 0.2 - 73.0

Myoglobin method
Imprecision:
ADVIA IMS: Level (ng/mL) 12.7, Total CV(%) 1.6; Level (ng/mL) 64.5, Total CV(%) 2.6; Level (ng/mL) 577.6, Total CV(%) 3.1
Immuno 1: Level (ng/mL) 14.4, Total CV(%) 3.0; Level (ng/mL) 73.5, Total CV(%) 3.7; Level (ng/mL) 630.1, Total CV(%) 2.8
Correlation (Y=ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=49, Regression Equation Y=1.02X-0.80, Sample Range (ng/mL) 11 - 5885
Plasma: Comparison System (X) Immuno 1, N=61, Regression Equation Y=1.10X-4.54, Sample Range (ng/mL) 35 - 2362
Passing-Bablock correlation used

Testosterone Assay
Imprecision:
ADVIA IMS: Level (ng/mL) 0.9, Total CV (%) 7.1; Level (ng/mL) 2.7, Total CV (%) 4.2; Level (ng/mL) 7.7, Total CV (%) 3.4
Immuno 1: Level (ng/mL) 0.95, Total CV(%) 7.8; Level (ng/mL) 3.04, Total CV(%) 4.8; Level (ng/mL) 8.43, Total CV(%) 3.0
Correlation (Y= ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=77, Regression Equation Y=0.91X+0.073, Syx (ng/mL) 0.328, R=0.993, Sample Range (ng/mL) 0.04-12.2

Troponin I method
Imprecision:
ADVIA IMS: Level (ng/mL) 1.9, Total CV(%) 3.6; Level (ng/mL) 7.2, Total CV(%) 2.0; Level (ng/mL) 51.9, Total CV(%) 1.8
Immuno 1: Level (ng/mL) 2.9, Total CV(%) 3.3; Level (ng/mL) 6.9, Total CV(%) 2.3; Level (ng/mL) 47.4, Total CV(%) 2.0
Correlation (Y=ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=59, Regression Equation Y=0.96 + 0.26, Syx (ng/mL) 0.47, R=0.999, Sample Range (ng/mL) 0.1 - 70
Plasma: Comparison System (X) Immuno 1, N=52, Regression Equation Y=0.99 + 0.22, Syx (ng/mL) 0.34, R=0.999, Sample Range (ng/mL) 0.1 - 50

Ferritin method
Imprecision:
ADVIA IMS: Level (ng/mL) 51.4, Total CV(%) 3.0; Level (ng/mL) 124, Total CV(%) 3.2; Level (ng/mL) 506, Total CV(%) 3.0
Correlation (Y=ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=50, Regression Equation Y=1.01X-5.86, Sample Range (ng/mL) 1.7 - 1656
Passing-Bablock Correlation used

hCG Assay
Imprecision:
ADVIA IMS: Level (mIU/mL) 12.1, Total CV(%) 4.2; Level (mIU/mL) 23.9, Total CV(%) 4.5; Level (mIU/mL) 198.1, Total CV(%) 5.5
Immuno 1: Level (mIU/mL) 18.3, Total CV(%) 4.0; Level (mIU/mL) 55.7, Total CV(%) 3.7; Level (mIU/mL) 198.1, Total CV(%) 3.7
Correlation (Y= ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=40, Regression Equation Y=0.990X+1.96, Syx (mIU/mL) 17.5, R=1.0, Sample Range (mIU/mL) 0.1 - 1345
Plasma(y), Serum(x): Comparison System (X) ADVIA IMS, N=51, Regression Equation Y=0.956X+0.868, Syx (mIU/mL) 17.0, R=0.998, Sample Range (mIU/mL) 0.1 - 902
Urine: Comparison System (X) Immuno 1, N=87, Regression Equation Y=1.016X-2.467, Syx (mIU/mL) 12.3, R=1.0, Sample Range (mIU/mL) 0.1-1158

3rd Generation TSH Assay
Imprecision:
ADVIA IMS: Level (U/mL) 0.02, Total CV(%) 13.2; Level (U/mL) 0.52, Total CV(%) 2.9; Level (U/mL) 4.95, Total CV(%) 2.3; Level (U/mL) 31.1, Total CV(%) 2.6
Correlation (Y= ADVIA IMS, X=comparison system)
Serum: Comparison System (X) Immuno 1, N=50, Regression Equation Y=0.98X-0.357, Syx (µIU/mL) 1.48, R=0.997, Sample Range (µIU/mL) 0.06 - 76.0
Plasma(y), Serum(x): Comparison System (X) ADVIA IMS, N=46, Regression Equation Y=1.01X-0.044, Syx (µIU/mL) 0.21, R=1.0, Sample Range (µIU/mL) 0.12-63.3.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Immuno 1 B2-Microglobulin Assay, Immuno 1 CK-MB I, Immuno 1 Myoglobin, Immuno 1 Testosterone Assay, Immuno 1 Troponin I, Immuno 1 Ferritin, Immuno 1 hCG Assay, Immuno 1 TSH Assay

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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)	Total
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
Substance | Interfering Substance
Concentration
mg/dL | Analyte
Concentration
(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 anyone
SAL AT YOU L
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 |
CARTE
NO CLEASURE COLLECTION COLLECT |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A Common Col & Million Come of College of

18.70
10.00

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .

and and the collection of the commend the
Annual Comments of the count
And States of Children Company of Children Company of Children
. | Supportunities and consideration of the children
IN INCREASE E CONSULERS OF CONSULERS

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Imprecision

ADVIA IMS		Immuno 1
Level
(ng/mL)	Total
CV(%)	Level
(ng/mL)	Total
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
Substance | 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
. | 1
FREE FRI LA CHRISTON & CHINARY & CHANNEL A
A TT Y TT |
mmimo |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | ---------- | And Commend of Children Comments of Children

Antie a

Imprecision

	ADVIA IMS	Immuno 1
Level
(ng/mL)	Total
CV(%)	Level
(ng/mL)	Total
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
Substance | 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)	Total
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
System (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 |

| Interfering
Substance | Interfering Substance
Concentration
mg/dL | Analyte
Concentration
(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	06956201
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 | " ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ADVIA | lmmuno
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
MDC | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
was and and promote of the program and the comments of the comments of the many of the
Free Carder States of Canadian Comers
0.1 ng/mL | 0.1 ng/mL
of Cattle. |

Imprecision

ADVIA IMS		Immuno 1
Level
(ng/mL)	Total
CV(%)	Level
(ng/mL)	Total
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
System (X) | N | Regression Equation | Syx
ng/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 |

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Troponin I
Conc (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 noim
Company of
I |

Imprecision

ADVIA IMS
Level
(ng/mL)	Total
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
Substance | 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 and
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
Substance | Interfering Substance
Concentration
mg/dL | hCG
Concentration
(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)

| Interfering
Substance | Interfering Substance
Concentration
mg/dL | hCG
Concentration
(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 Assay
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
The property of promoted on any a

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
ADVIA IMS TSH Assay
of Real Property of Children	B42-3921-43 B43-3948-01

Imprecision

I (μ)

ADVIA IMS
Level
(U/mL)	Total
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
(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 |

| Interfering
Substance | Interfering Substance
Concentration
mg/dL | TSH
Concentration
(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:

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

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 866.5630

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS B2-Microglobulin Assay for Bayer ADVIA® Integrated Modular System (IMS)

1. Intended Use

Predicate Device 2.

3. Device / Method

Imprecision

Correlation (Y= ADVIA IMS, X=comparison system)

Minimum Detectable Concentration

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CK-MB method for ADVIA® IMS

1. Intended Use

2. Predicate Device

3. Device / Method

Minumum Detectable Conc.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .

and and the collection of the commend the Annual Comments of the count And States of Children Company of Children Company of Children . | Supportunities and consideration of the children IN INCREASE E CONSULERS OF CONSULERS

Imprecision

Correlation (Y=ADVIA IMS, X=comparison system)

Interfering Substances _______________________________________________________________________________________________________________________________________________________

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Myoglobin method for ADVIA® IMS

1. Intended Use

2. Predicate Device

3. Device / Method

Minumum Detectable Conc.

Imprecision

Correlation (Y=ADVIA IMS, X=comparison system)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Testosterone Assay for Bayer ADVIA® Integrated Modular System (IMS)

1. Intended Use

Predicate Device 2.

3. Device / Method

Imprecision

Correlation (Y= ADVIA IMS, X=comparison system)

Minimum Detectable Concentration

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Troponin I method for ADVIA® IMS

1. Intended Use

2. Predicate Device

3. Device / Method

Minumum Detectable Conc.

Imprecision

Correlation (Y=ADVIA IMS, X=comparison system)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ferritin method for ADVIA® IMS

1. Intended Use

2. Predicate Device

3. Device / Method

Minumum Detectable Conc.

Imprecision

Correlation (Y=ADVIA IMS, X=comparison system)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS hCG Assay for Bayer ADVIA® Integrated Modular System (IMS)

1. Intended Use

2. Predicate Device

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

Imprecision

Correlation (Y= ADVIA IMS, X=comparison system)

Interfering Substances (Serum)

Interfering Substances (Urine)

Analytical Range

Minimum Detectable Concentration

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 3rd Generation TSH Assay for Bayer ADVIA® Integrated Modular System (IMS)

1. Intended Use

2. Predicate Device

3. Device / Method

Imprecision

Correlation (Y= ADVIA IMS, X=comparison system)

Minimum Detectable Concentration

and and the collection of the commend the
Annual Comments of the count
And States of Children Company of Children Company of Children
. | Supportunities and consideration of the children
IN INCREASE E CONSULERS OF CONSULERS

| 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