The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro fliagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies.

The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.

Device Description

Not Found

AI/ML Overview

The provided text describes the performance of the Bayer ADVIA 1650 device for eight different assays, comparing it to predicate devices. The studies establish the substantial equivalence of the ADVIA 1650 assays to already cleared devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for Total CV%, Syx, or R values that the ADVIA 1650 must meet. Instead, the approach is one of demonstrating substantial equivalence to predicate devices. The reported performance metrics (Imprecision, Correlation, Interfering Substances, Analytical Range, and Expected Values) are provided for each assay, and the assumption is that these align with or are comparable to the performance of the predicate devices.

However, we can infer performance ranges based on the provided data for the ADVIA 1650 for each method. The "acceptance criteria" are implicitly met if the performance is deemed substantially equivalent to the predicate.

Method	Performance Measure	ADVIA 1650 Reported Performance
Apolipoprotein A-1	Imprecision (Total CV%)	4.5% (low level), 4.1% (high level) (Serum)
	Correlation (R)	0.986 (vs. Behring, Serum), 0.996 (Plasma vs. Serum)
	Analytical Range	15 mg/dL to Level 4 Calibrator
Apolipoprotein B	Imprecision (Total CV%)	5.7% (low level), 3.3% (high level) (Serum)
	Correlation (R)	0.993 (vs. Behring, Serum), 0.997 (Plasma vs. Serum)
	Analytical Range	15 mg/dL to Level 4 Calibrator
CO2	Imprecision (Total CV%)	6.7% (low level), 4.6% (high level) (Serum)
	Correlation (R)	0.963 (vs. DAX, Serum), 0.839 (Plasma vs. Serum)
	Analytical Range	10-40 mEq/L
CRP	Imprecision (Total CV%)	13.6% (low level), 4.6% (high level) (Serum)
	Correlation (R)	0.984 (vs. Behring, Serum)
	Analytical Range	5 mg/L to Level 5 Calibrator
IgA	Imprecision (Total CV%)	~2% (both levels) (Serum)
	Correlation (R)	0.997 (vs. Behring, Serum), 0.986 (EDTA Plasma vs. Serum), 0.975 (Heparin Plasma vs. Serum)
	Analytical Range	15 mg/dL to Level 5 Calibrator
IgG	Imprecision (Total CV%)	2.4% (low level), 1.7% (high level) (Serum)
	Correlation (R)	0.999 (vs. Behring, Serum), 0.974 (EDTA Plasma vs. Serum), 0.962 (Heparin Plasma vs. Serum)
	Analytical Range	85 mg/dL to Level 5 Calibrator
IgM	Imprecision (Total CV%)	7.4% (low level), 3.7% (high level) (Serum)
	Correlation (R)	0.98 (vs. Behring, Serum), 0.989 (EDTA Plasma vs. Serum), 0.982 (Heparin Plasma vs. Serum)
	Analytical Range	12 mg/dL to Level 5 Calibrator
Transferrin	Imprecision (Total CV%)	4.7% (low level), 3.7% (high level) (Serum)
	Correlation (R)	0.976 (vs. Behring, Serum), 0.993 (EDTA Plasma vs. Serum), 0.987 (Heparin Plasma vs. Serum)
	Analytical Range	Level 1 Calibrator to Level 5 Calibrator

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Sizes (N for Correlation sections):
- Apolipoprotein A-1: 78 (Serum: ARI), 72 (Plasma vs. Serum)
- Apolipoprotein B: 59 (Serum: Tarrytown), 71 (Plasma vs. Serum)
- CO2: 146 (Serum: Tarrytown), 79 (Plasma vs. Serum)
- CRP: 56 (Serum: Tarrytown)
- IgA: 74 (Serum: Tarrytown), 68 (EDTA Plasma vs. Serum), 69 (Heparin Plasma vs. Serum)
- IgG: 60 (Serum: Tarrytown), 72 (EDTA Plasma vs. Serum), 73 (Heparin Plasma vs. Serum)
- IgM: 74 (Serum: Tarrytown), 69 (EDTA Plasma vs. Serum), 70 (Heparin Plasma vs. Serum)
- Transferrin: 78 (Serum: Tarrytown), 71 (EDTA Plasma vs. Serum), 72 (Heparin Plasma vs. Serum)
Data Provenance: The studies were conducted at specific sites, primarily "Tarrytown" and "ARI." Based on the address provided for Bayer Corporation (Tarrytown, NY), the data provenance is likely United States. The document does not specify if the data was retrospective or prospective, but clinical correlation/imprecision studies for IVD devices are typically prospective or involve freshly collected samples for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of in vitro diagnostic device study. The "ground truth" for the test set is established by the predicate device's measurement. These are quantitative assays, and the comparison is made against existing, cleared methods, not against expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human interpretation or adjudication involved in establishing truth for quantitative chemical assays comparing a new device to a predicate.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic imaging device. It's an in vitro diagnostic chemistry system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are standalone performance evaluations of the ADVIA 1650 device. The data provided (imprecision, correlation, interference) reflects the performance of the instrument and its reagents in measuring the specified analytes without direct human-in-the-loop diagnostic decisions being evaluated. The overall clinical utility is described in the "Intended Use" and "Expected Values" sections, assuming trained laboratory personnel operate the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the correlation studies, the measurements from the predicate devices (e.g., Behring Nephelometer, Technicon DAX) served as the "comparison system" or reference for the ADVIA 1650 device. The predicate devices themselves would have established their accuracy and precision through their own clinical validation processes.

8. The sample size for the training set

The document does not explicitly state a "training set" size. For IVD devices, method validation studies typically involve method development and optimization (analogous to training) followed by performance verification (the studies reported here). The specific sample numbers used for developing the assays and optimizing parameters are not detailed in this summary. The sample sizes listed in point 2 are for the performance verification/test set studies.

9. How the ground truth for the training set was established

As with the test set, the ground truth for any internal method development (if "training set" refers to samples used during that phase) would rely on reference methods or established laboratory standards for accurate analyte quantification. The document doesn't provide details on the specific "ground truth" establishment for method development. The focus is on demonstrating equivalence to legally marketed predicate devices.

Summary

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FEB 1 5 2000

SUMMARY OF SAFETY AND EFFECTIVENESS

This section contains performance comparisons for 8 clinical methods. For each method, ADVIA 1650 was compared to a similar device (or devices) that was granted clearance of substantial equivalence. The table below lists the predicate devices and part numbers.

Method	ADVIA 1650Reagent Part #	SpecimenType	Predicate DeviceName	Predicate DeviceReagent Part #
Apolipoprotein A-1	B01-4154-01	Serum	Behring Nephelometer	OUED
Apolipoprotein B	B01-4155-01	Serum	Behring Nephelometer	OSAN
CO2	B01-4146-01	Serum	Technicon DAX	T09B-100-06
CRP	B01-4158-01	Serum	Behring Nephelometer	OQIY21
lgA	B01-4149-01	Serum	Behring Nephelometer	OSAR
IgG	B01-4150-01	Serum	Behring Nephelometer	OSAS
lgM	B01-4151-01	Serum	Behring Nephelometer	OSAT
Transferrin	B01-4152-01	Serum	Behring Nephelometer	OSAX

Gabriel J. Muraca Jr.

1/3/2000

Date

Gabriel J. Muraca, Jr. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Ave. Tarrytown, NY 10591-5097

Date

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1. APO A-1

SUMMARY OF SAFETY AND EFFECTIVENESS

Apolipoprotein A-1 Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure apolipoprotein A-1 concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	77.6	4.5
Serum	216.4	4.1

Level	Between Day CV%
145.3	5.7

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	Comparison System (X)	N	Regression Equation	Syx	R	Sample Range
Serum: ARI	BEHRING	78	$Y=0.70X-1.48$	5.49	0.986	48-273
Plasma(y), Serum(x)	ADVIA 1650	72	$Y=0.99X-0.38$	2.10	0.996	89.7-206.8

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	42.8	0.78	1.9%
Hemoglobin	525	40.3	1.77	4.2%
Lipids(Trig)	650	42.1	0.04	0.1%
Bilirubin	30	126.3	1.30	1.0%
Hemoglobin	525	124.6	0.47	0.4%
Lipids(Trig)	650	122.1	2.07	1.7%

Analytical Range

The analytical range for this method extends from 15 mg/dL to the APO A-1 concentration level in Apolipoprotein Calibrator Level 4.

Expected Values

79 mg/dL to 187 mg/dL

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2. APO B

SUMMARY OF SAFETY AND EFFECTIVENESS

Apolipoprotein B Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in virro diagnostic assay is intended to measure apolipoprotein B concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	29	5.7
Serum	110.5	3.3

Behring Nephelometer=Serum
Level	Between Day CV%
108	2.4

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	Comparison System (X)	N	Regression Equation	Syx	R	Sample Range
Serum: Tarrytown	BEHRING	59	Y=1.03X+0.53	3.66	0.993	42.1-172.8
Plasma(y), Serum(x)	ADVIA 1650	71	Y=1.00X-1.67	1.74	0.997	49.6-157.8

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	EffectConc.	%
Bilirubin	30	42.8	0.08	0.2
Hemoglobin	525	41.7	0.97	2.3
Bilirubin	30	163.6	1.61	1.0
Hemoglobin	525	159.5	4.06	2.5

Analytical Range

The analytical range for this method extends from 15 mg/dL to the APO B concentration level in Apolipoprotein Calibrator Level 4.

Expected Values

Males: 46 mg/dL to 174 mg/dL Females: 46 mg/dL to 142 mg/dL

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SUMMARY OF SAFETY AND EFFECTIVENESS

Carbon Dioxide Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure carbon dioxide concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	12.2	6.7
Serum	25.6	4.6

Level	Total CV%
13.5	6.3
23.8	5.3
27.4	4.5

Correlation (Y=ADVLA 1650, X=comparison system)

Specimen type: Site	ComparisonSystem (X)	N	RegressionEquation	Syx	R	SampleRange
Serum: Tarrytown	DAX	146	Y=0.90X-0.86	1.26	0.963	11.0-36.0
Plasma(y), Serum(x)	ADVIA 1650	79	Y=0.94X+0.08	1.98	0.839	14.2-27.0

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	17.1	0.8	5.4%
Hemoglobin	525	13.9	0.9	6.4%
Lipids(Trig)	650	14.1	0.4	2.8%
Bilirubin	30	34.0	2.8	8.5%
Hemoglobin	525	33.5	0.6	2.0%
Lipids(Trig)	650	32.9	0.0	0.0%

Analytical Range

10-40 mEq/L

Expected Values

Serum: 23 - 29 mEq/L Plasma: 22 - 28 mEq/L

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SUMMARY OF SAFETY AND EFFECTIVENESS

C-Reactive Protein Method for the Bayer ADVIA 1650 (mg/L)

Intended Use

This in vitro diagnostic assay is intended to measure C-reactive protein concentration in human serum on the ADVIA® 1650 Chemistry System. Such measurements are used in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction and malignancies.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	5	13.6
Serum	42	4.6

Behring Nephelometer=Serum
Levels	Between Day CV%
10,15,25,45,60	2.6 to 5.7

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	Comparison System (X)	N	Regression Equation	Syx (mg/L)	R	Sample Range (mg/L)
Serum: Tarrytown	BEHRING	56	Y=0.96X-3.33	2.34	0.984	5.4-67.7

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	EffectConc.	Effect%
Bilirubin	30	9.6	3.06	24.2%
Hemoglobin	525	11.3	1.37	10.8%
Lipids(Trig)	60*	12.5	0.20	1.4%
Bilirubin	30	39.1	0.58	1.5%
Hemoglobin	525	37.0	2.67	6.7%
Lipids(Trig)	650	25.6	14.0	35.4%

Levels tested above 60 mg/dL caused a high interference and no results were generated.

Analytical Range

The analytical range for this method extends from 5 mg/L to the level in CRP Calibrator Level 5.

Expected Values

Less than 10 mg/L

ADVIA 1650 Summary of Safety and Effectiveness

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SUMMARY OF SAFETY AND EFFECTIVENESS

Immunoglobulin A Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure immunoglobulin A concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%	Behring Nephelometer=Serum
Serum	150.5	2	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Between Day CV%
Serum	405.7	2	Level	an anywald be a seems of the click of the of the of the click of can and the first and the first and the first and

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Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	Comparison System (x)	N	Regression Equation	Sy.x (mg/dL)	R	Sample Range (mg/dL)
Serum: Tarrytown	BEHRING	74	$y=1.02X-1.34$	14.28	0.997	103-1110
EDTA Plasma(y), Serum(x)	ADVIA 1650	68	$y=0.92X+1.48$	13.99	0.986	85.7-517.9
Heparin Plasma(y), Serum(x)	ADVIA 1650	69	$y=0.97X+2.08$	19.42	0.975	82.9-517.9

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	131.6	17.7	15.6%
Hemoglobin	525	142.9	29.1	25.5%
Lipids(Trig)	650	367.1	253.2	222.4%
Bilirubin	30	362.5	14.5	4.2%
Hemoglobin	525	379.9	31.9	9.2%
Lipids(Trig)	650	629.8	281.8	81.0%

Analytical Range

The analytical range for this method extends from 15 mg/dL to the IgA concentration level in Specific Protein Reference Serum Calibrator Level 5.

Expected Values

40 to 350 mg/dL

ADVIA 1650 Summary of Safety and Effectiveness 11/12/99

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SUMMARY OF SAFETY AND EFFECTIVENESS

Immunoglobulin G Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure immunoglobulin G concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	926.7	2.4
Serum	2946	1.7

Level	Between Day CV%
1317	2.7

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	ComparisonSystem (x)	N	RegressionEquation	Sy.x(mg/dL)	R	SampleRange(mg/dL)
Serum: Tarrytown	BEHRING	60	$y=1.04X-32.0$	78.46	0.999	574-5392
EDTA Plasma(y), Serum(x)	ADVIA 1650	72	$y=0.97X-30.0$	51.13	0.974	527-1537
Heparin Plasma(y), Serum(x)	ADVIA 1650	73	$y=0.97X+11.4$	63.28	0.962	527-1537

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	719.5	27.7	4.0%
Hemoglobin	525	723.0	31.2	4.5%
Lipids(Trig)	650	1034.3	342.5	49.5%
Bilirubin	30	2153.9	64.2	3.1%
Hemoglobin	525	2149.6	59.9	2.9%
Lipids(Trig)	650	2553.3	463.6	22.2%

Analytical Range

The analytical range for this method extends from 85 mg/dL to the IgG concentration level in Specific Protein Reference Serum Calibrator Level 5

11/12/99

Expected Values

650 to 1600 mg/dL

ADVIA 1650 Summary of Safety and Effectiveness

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SUMMARY OF SAFETY AND EFFECTIVENESS

Immunoglobulin M Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure immunoglobulin M concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	54.8	7.4
Serum	172.8	3.7

Level	Between Day CV%
117	1.9

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	Comparison System (x)	N	Regression Equation	Sy.x (mg/dL)	R	Sample Range (mg/dL)
Serum: Tarrytown	BEHRING	74	y=0.76X+17.9	7.91	0.98	26.8-300.8
EDTA Plasma(y), Serum(x)	ADVIA 1650	69	y=0.99X-4.27	8.75	0.989	35.6-293.1
Heparin Plasma(y), Serum(x)	ADVIA 1650	70	y=0.99X-0.23	11.13	0.982	35.6-293.1

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	75.6	21.9	40.8%
Hemoglobin	525	103.0	49.3	91.8%
Lipids(Trig)	650	367.6	313.8	584.2%
Bilirubin	30	181.0	24.6	15.8%
Hemoglobin	525	210.0	53.7	34.4%
Lipids(Trig)	650	487.1	330.8	211.6%

Analytical Range

The analytical range for this method extends from 12 mg/dL to the IgM concentration level in Specific Protein Reference Serum Calibrator Level 5.

Expected Values

50 to 300 mg/dL

ADVIA 1650 Summary of Safety and Effectiveness 11/12/99

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8. Transferrin

SUMMARY OF SAFETY AND EFFECTIVENESS

Transferrin Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure transferrin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, permicious anemia, and red blood cell disorders, such as iron deficiency anemia.

Imprecision

ADVIA 1650

SpecimenType	Level	TotalCV%
Serum	193.9	4.7
Serum	473.1	3.7

Level	Between Day CV%
303	2.3

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: Site	ComparisonSystem(X)	N	RegressionEquation	Sy.x	R	SampleRange
Serum: Tarrytown	BEHRING	78	$Y=1.20X-39.2$	10.6	0.976	161-344
EDTA Plasma(y), Serum(x)	ADVIA 1650	71	$Y=0.94X-5.51$	5	0.993	196-402
Heparin Plasma(y), Serum(x)	ADVIA 1650	72	$Y=0.98X-8.45$	7.31	0.987	196-402

Interfering Substances

InterferingSubstance	InterferingSub. Conc.(mg/dL)	AnalyteConc.	Effect
Bilirubin	30	122.5	0.11	0.1%
Hemoglobin	525	124.6	1.93	1.6%
Lipids(Trig)	650	132.9	10.24	8.4%
Bilirubin	30	370.4	3.43	0.9%
Hemoglobin	525	376.0	2.16	0.6%
Lipids(Trig)	650	372.7	1.15	0.3%

Analytical Range

The analytical range for this method extends from the lowest calibration value of Specific Protein Reference Serum Level 1 to the Transferrin concentration level in Specific Protein Reference Serum Level 5.

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Transferrin (continued)

Expected Values

215 mg/dL to 365 mg/dL Males: Females: 250 mg/dL to 380 mg/dL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing health, family, and community. The figures are connected and appear to be in motion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 8 2002

Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs c/o Kenneth T, Edds, Ph.D. Manager Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591

Re: K992662

Trade/Device Name: Bayer ADVIA® 1650 Additional Assays Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: II Product Code: MSJ, CFN, DCN, JNM, KHS Dated: January 3, 2002 Received: January 5, 2002

Dear Dr. Edds:

This letter corrects our substantially equivalent letter of dated February 15, 2000, regarding the missing product codes cleared for use in the determination.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the original 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.

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Page 2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594 of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sean M. Cooper, M.S., D.U.M.

Jean M. Cooper, M.S., D.V.M. Branch Chief Chemistry and Toxicology I Branch Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 3

510(k) Number (if known):

Device Name: Bayer ADVIA® 1650 Additional Assays

Indications For Use:

(Division Sign-Off)
ision of Clinical Laboratory Devices

c) Number	K992662
-----------	---------

(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)

{13}------------------------------------------------

Page 2 of 3

510(k) Number (if known):

Device Name: Bayer ADVIA® 1650 Additional Assays

Indications For Use:

Sean Cooper

(Division Sign-Off
Division of Jime

510(k) Number K992662

(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 Format 1-2-96)

{14}------------------------------------------------

Page 3 of 3

510(k) Number (if known):

Device Name: Bayer ADVIA® 1650 Additional Assays

Indications For Use:

The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to The Bayer ADV IA 1650 Transferrin (111) assa is and plasmo on an Advia 1650 Chemistry measure Transferrin concentration in hammir so and more of malmutrition, chronic infection,
System. Such measurements are used to aid in the coll disorders, such as inon System. Such measurements are used to are in the diagneers over in the arrant deficiency anemia.

(Division Sign-Off)
Division of Clinical Laborato
510(k) Number 14992662

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------	--

Prescription Use _	OR	Over-The-Counter Use _
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.