Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes in vitro diagnostic assays for measuring specific substances in human serum using standard laboratory methods, with no mention of AI or ML.

Therapeutic

No.

The device is an in vitro diagnostic device used to measure various substances in human serum as an aid in diagnosis and treatment, but it does not directly provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the Bayer ADVIA IMS assays are "in vitro diagnostic device[s]". It further explains that the measurements obtained from these devices are "used as an aid in the diagnosis and treatment" of various medical conditions.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic device intended to measure substances in human serum, which inherently requires hardware (e.g., an analyzer, reagents) to perform the measurements. The summary describes performance studies comparing the device to predicate methods, further indicating a physical testing process.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states for each assay: "The Bayer ADVIA IMS [Assay Name] assay is an in vitro diagnostic device intended to measure..." This directly identifies the device as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.

The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.

The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA IMS IgG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism.

The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism.

The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.

The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy.

The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

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

CZW, CFQ, DBI, DDG, KTO, LEG, LEH

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human serum

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)

Comparison of performance between the Bayer ADVIA IMS methods and similar devices that were granted clearance of substantial equivalence.

C3 Method:
Correlation: y=0.92x + 9.7 where y=ADVIA IMS, x=BNA, n=101, r=0.972, Syx=12.1 mg/dL

C4 Method:
Correlation: y=0.92x - 0.3 where y=ADVIA IMS, x=BNA, n=94, r=0.989, Syx=1.9 mg/dL

IgA Method:
Correlation: y=1.00x - 1 where y=ADVIA IMS, x=BNA, n=97, r=0.994, Syx=75.6 mg/dL

IgG Method:
Correlation: y=0.97 x - 3 where y=ADVIA IMS, x=BNA, n=97, r=0.994, Syx=118 mg/dL

IgM Method:
Correlation: y=1.05x - 13.4 where y=ADVIA IMS, x=BNA, n=89, r=0.990, Syx=123.5 mg/dL

TRF Method:
Correlation: y=0.96x - 3 where y=ADVIA IMS, x=BNA, n=106, r=0.979, Syx=16.8 mg/dL

Vancomycin Method:
Correlation: y=1.02x + 0.68 where y=ADVIA IMS, x=Immuno 1, n=55, r=0.987, Syx=1.6 µg/dL

Valproic Acid Method:
Correlation: y=1.11x + 0.27 where y=ADVIA IMS, x=TDx, n=55, r=0.993, Sux=3.79 µg/mL

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.

Not Found

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

§ 866.5240 Complement components immunological test system.

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

Summary

0

C3 Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Complement C3 method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Complement C3 method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS C3 method sheet and the BNAC3 method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure C3 in human serum on the Bayer ADVIA IMS systems. Measurements of C3 are used to aid in the diagnosis and treatment of immunologic disorders.

METHOD	ADVIA IMS	BNA
Part No.	Reagents B41-3788-41
Calibrators B46-4088-60	OSAP
OSAU

2.1% @ 79.7 mg/dL 5.9% @ 72.4 mg/dL Precision (Total) 1.8% @ 154 mg/dL 2.1% @ 237 mg/dL

Correlation

y=0.92x + 9.7 where y=ADVIA IMS x=BNA n=101 r=0.972 Syx=12.1 mg/dL

Gabriel J. Munoz, Jr.
6/4/99

1

Interfering Substances
Interfering Substance	Interfering Sub
Concentration	C3
Concentration	Effect
(% Change)
Bilirubin, unconjugated	20 mg/dL	106 mg/dL	+1
Bilirubin, conjugated	20 mg/dL	113 mg/dL	+4
Hemoglobin	500 mg/dL	114 mg/dL	-2
Triglycerides	1000 mg/dL	107 mg/dL	-8

Analytical Range

:

ಿರುವ ಸಾ

| Dilution Range | Concentration Range,
mg/dL |
|-------------------|-------------------------------|
| Normal | 27 - 360 |
| Out of Range Low | 6.8 - 90 |
| Out of Range High | 135 - 1800 |

2

C4 Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Complement C4 method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Complement C4 method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS C4 method sheet and the BNAC4 method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure C4 in human serum on the Bayer ADVIA IMS systems. Measurements of C4 are used to aid in the diagnosis and treatment of immunologic disorders.

METHOD	ADVIA IMS	BNA
Part No.
Reagents	B41-3789-41	OSAO
Calibrators	B46-4088-60	OSAU
Precision (Total)	1.9% @ 19.3 mg/dL
2.0% @ 34.8 mg/dL
1.9% @ 49.3 mg/dL	2.9% @ 15.7 mg/dL
Correlation	y=0.92x - 0.3
where
y=ADVIA IMS
x=BNA
n=94
r=0.989
Syx=1.9 mg/dL

Gabriel J. Munoz, Jr.
6/4/99

3

| Interfering Substance | Interfering Sub
Concentration | C4
Concentration | Effect
(% Change) |
|-------------------------|----------------------------------|---------------------|----------------------|
| Bilirubin, unconjugated | 20 mg/dL | 19 mg/dL | 0 |
| Bilirubin, conjugated | 20 mg/dL | 21 mg/dL | 0 |
| Hemoglobin | 500 mg/dL | 20 mg/dL | 0 |

Analytical Range

| Dilution Range | Concentration Range,
mg/dL |
|-------------------|-------------------------------|
| Normal | 7.2 - 96 |
| Out of Range Low | 4.0 - 53 |
| Out of Range High | 36 - 480 |

4

IgA Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin A method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin A method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgA method sheet and the BNA IgA method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure IgA in human serum on the Bayer ADVIA IMS systems. Measurements of IgA are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

METHOD		ADVIA IMS	BNA
Part No.	Reagents	B41-3791-41	OSAR
	Calibrators	B46-4088-60	OSAU
Precision (Total)		2.3% @ 122mg/dL
1.6% @ 233mg/dL
1.4% @ 344mg/dL	3.5% @ 296mg/dL
Correlation		y=1.00x - 1
where
y=ADVIA IMS
x=BNA
n=97
r=0.994
Syx=75.6 mg/dL

Gabriel J. Munoz, Jr.

6/4/99

5

| Interfering Substance | Interfering Sub
Concentration | IgA
Concentration | Effect
(% Change) |
|-------------------------|----------------------------------|----------------------|----------------------|
| Bilirubin, unconjugated | 20 mg/dL | 180 mg/dL | +2 |
| Bilirubin, conjugated | 20 mg/dL | 200 mg/dL | -3 |
| Hemoglobin | 500 mg/dL | 191 mg/dL | +1 |
| Triglycerides | 1000 mg/dL | 184 mg/dL | -8 |

:

Analytical Range

Analytical Range
Dilution Range	Concentration Range
mg/dL
Normal	45 - 600
Out of Range Low	11.3 - 150
Out of Range High	360 - 4800

:

.

·

6

IgG Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin G method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin G method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgG method sheet and the BNA IgG method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure IgG in human serum on the Bayer ADVIA IMS systems. Measurements of IgG are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

METHOD		ADVIA IMS	BNA
Part No.	Reagents	B41-3792-41	OSAS
	Calibrators	B46-4088-60	OSAU

Precision (Total) 1.8% @ 772mg/dL 2.7% @ 1317mg/dL 1.6% @ 1416mg/dL 3.4% @ 2141mg/dL

Correlation

y=0.97 x - 3 where y=ADVIA IMS x=BNA n=97 r=0.994 Syx=118 mg/dL

Gabriel J. Murau, Jr.

6/4/99

7

| Interfering Substance | Interfering Sub
Concentration | IgG
Concentration | Effect
(% Change) |
|-------------------------|----------------------------------|----------------------|----------------------|
| Bilirubin, unconjugated | 20 mg/dL | 876 mg/dL | -3.0 |
| Bilirubin, conjugated | 20 mg/dL | 953 mg/dL | -3.0 |
| Hemoglobin | 500 mg/dL | 897 mg/dL | +7.0 |
| Triglycerides | 1000 mg/dL | 887 mg/dL | -3.0 |

:

Analytical Range

| Dilution Range | Concentration Range,
mg/dL |
|-------------------|-------------------------------|
| Normal | 225 - 3,000 |
| Out of Range Low | 56 - 750 |
| Out of Range High | 1128 - 15,000 |

8

IgM Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Immunoglobulin M method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Immunoglobulin M method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS IgM method sheet and the BNA IgM method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure IgM in human serum on the Bayer ADVIA IMS systems. Measurements of IgM are used to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

METHOD		ADVIA IMS	BNA
Part No.	Reagents	B41-3793-41	OSAT
	Calibrators	B46-4088-60	OSAU

Precision (Total)

3.6% @ 69.0mg/dL 1.9% @ 117mg/dL 2.4% @ 128mg/dL 1.5% @ 177mg/dL

Correlation

y=1.05x - 13.4 where y=ADVIA IMS x=BNA n=89 r=0.990 Syx=123.5 mg/dL

Gabriel J. Murray, Jr.
6/4/99

9

| Interfering Substance | Interfering Sub
Concentration | IgM
Concentration | Effect
(% Change) |
|-------------------------|----------------------------------|----------------------|----------------------|
| Bilirubin, unconjugated | 20 mg/dL | 77 mg/dL | +3.9 |
| Bilirubin, conjugated | 10 mg/dL | 85 mg/dL | +1.2 |
| Hemoglobin | 500 mg/dL | 86 mg/dL | 0.0 |

.

Analytical Range

·

Dilution Range	Concentration Range,
	mg/dL
Normal	30 - 400
Out of Range Low	10 - 133
Out of Range High 1	241 - 3,200
Out of Range High 2	1,203 - 16,000

:

10

TRF Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Transferrin method and a similar device that was granted clearance of substantial equivalence (Dade Behring BNA Transferrin method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS TRF method sheet and the BNATRF method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure TRF in human serum on the Bayer ADVIA IMS systems. Measurements of TRF are used to aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia and red blood disorders, such as iron deficiency anemia.

METHOD		ADVIA IMS	BNA
Part No.	Reagents	B41-3795-41	OSAX
	Calibrators	B46-4088-60	OSAU

Precision (Total) 2.2% @ 127 mg/dL 2.7% @ 303 mg/dL 1.9% @ 268 mg/dL 3.1% @ 400 mg/dL

Correlation

y=0.96x - 3 where y=ADVIA IMS x=BNA n=106 r=0.979 Syx=16.8 mg/dL

Gabriel J. Munoz, Jr.
6/4/99

11

| Interfering Substance | Interfering Sub
Concentration | TRF
Concentration | Effect
(% Change) |
|-------------------------|----------------------------------|----------------------|----------------------|
| Bilirubin, unconjugated | 20 mg/dL | 212 mg/dL | +2 |
| Bilirubin, conjugated | 20 mg/dL | 231 mg/dL | 0 |
| Hemoglobin | 500 mg/dL | 261 mg/dL | 0 |
| Triglycerides | 1000 mg/dL | 215 mg/dL | -4 |

Analytical Range

| Dilution Range | Concentration Range,
mg/dL |
|-------------------|-------------------------------|
| Normal | 54 - 720 |
| Out of Range Low | 13 - 180 |
| Out of Range High | 270 - 3,600 |

.

:

12

Vancomycin Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Vancomycin method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1 Vancomycin method) The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Vancomycin method sheet and the Immuno 1 Vancomycin method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure vancomycin in human serum on the Bayer ADVIA IMS systems. Measurements of vancomycin are used to aid in attaining optimum therapy in patients treated with the drug.

METHOD		ADVIA IMS	Immuno 1
Part No.	Reagents	B41-3767-41	T01-3705-01
	Calibrators	B46-4117-01	T03-3714-01
Analytical Range		0.4-50 µg/mL
Precision (Total)		2.8% @ 8.6 µg/mL	8.9% @ 6.7 µg/mL
		3.4% @ 21.5 µg/mL	7.5% @ 23.3 µg/mL
		3.9% @ 35.8 µg/mL	8.1% @ 32.4 µg/mL
Correlation		y=1.02x + 0.68
where
y=ADVIA IMS
x=Immuno 1
n=55
r=0.987
Svx=1.6 µg/dL

Interfering Substances

| Interfering Substance | Interfering Substance
Concentration | | Vancomycin
Concentration | | Effect
% Change |
|--------------------------|----------------------------------------|------------|-----------------------------|---------|--------------------|
| | | | (µmol/L) | (µg/mL) | |
| Bilirubin (unconjugated) | 0.43 mmol/L | 25 mg/dL | 10.6 | 15.3 | +0.3 |
| Bilirubin (conjugated) | 0.43 mmol/L | 25 mg/dL | 11.0 | 15.9 | +0.6 |
| Hemoglobin | 10 g/L | 1000 mg/dL | 11.1 | 16.1 | -7.7 |
| Lipemia (Triglycerides) | 11.4 mmol/L | 1000 mg/dL | 11.0 | 16.0 | -0.2 |

Gabriel J. Murray Jr.
6/4/99

13

Valproic Acid Method for the Bayer ADVIA IMS Systems

Listed below is a comparison of the performance between the Bayer ADVIA IMS Valproic Acid method and a similar device that was granted clearance of substantial equivalence (Abbott TDx Valproic Acid method). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA IMS Valproic Acid method sheet and the TDx Valproic Acid method sheet.

INTENDED USE

This in vitro method is intended to quantitatively measure valproic acid in human serum on the Bayer ADVIA IMS systems. Measurements of valproic acid are used to aid in attaining optimum therapy in patients treated with the drug.

METHOD		ADVIA IMS	TDx
Part No.	Reagents	B41-3766-41	9514-20
	Calibrators	B46-4118-01	9514-01
Analytical Range		0.3-150 µg/mL
Precision (Total)		3.8% @ 20.3 µg/mL	3.4% @ 37.5 µg/mL
		2.4% @ 60.2 µg/mL	3.4% @ 75 µg/mL
		2.8% @ 108.5 µg/mL	3.7% @ 125 µg/mL
Correlation		y=1.11x + 0.27
		where
		y=ADVIA IMS
		x=TDx
		n=55
		r=0.993
		Sux=3.79 µg/mL

Interfering Substances

| Interfering Substance | Interfering Substance
Concentration | Valproic acid
Concentration | | Effect
% Change |
|--------------------------|----------------------------------------|--------------------------------|---------|--------------------|
| | | (µmol/L) | (µg/mL) | |
| Bilirubin (unconjugated) | 0.43 mol/L
25 mg/dL | 573 | 82.5 | +6 |
| Bilirubin (conjugated) | 0.43 mol/L
25 mg/dL | 542 | 78.1 | +1 |
| Hemoglobin | 10 g/L
1000 mg/dL | 557 | 80.2 | +4 |
| Lipemia (Triglycerides) | 5.7 mmol/L
500 mg/dL | 561 | 80.8 | +3 |

Gabriel J. Munoz Jr.
6/4/99

14

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nov - 9 1999

Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corp. Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: K991907

Trade Name: 8 Additional Assays for the Bayer ADVIA® Integrated Modular System (IMS) Regulatory Class: II Product Code: CZW, CFQ, DBI, DDG, KTO, LEG, LEH Dated: September 3, 1999 Received: September 7, 1999

Dear Mr. Muraca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

15

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

16

Page 1 of 3

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System (IMS)

Indications For Use:

The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.

The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.

The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body's inability to resist infectious agents.

Dran Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991907

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

17

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System (IMS)

Indications For Use:

The Bayer ADVIA IMS IgG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism.

The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism.

The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.

Fein Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991907

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use - -

(Optional Format 1-2-96)

18

Page 3 of 3

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System (IMS)

Indications For Use:

The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy.

The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

Hean Coogh
(Division Sign-Off)
Division of Clinical Laboratory Devices

× 510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)