The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.

The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes.

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

The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv.

The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy.

The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy.

The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.

Device Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting studies for each of the devices mentioned in the provided 510(k) summaries. It's important to note that these documents are primarily for demonstrating substantial equivalence to a predicate device, which often means showing comparable performance rather than setting strict, pre-defined "acceptance criteria" against an absolute standard. The "reported device performance" is essentially the data presented to demonstrate this equivalence.

For all devices, the data provenance is assumed to be retrospective as these are 510(k) summaries, typically presented after studies have been completed. The country of origin for the data is not explicitly stated but can be inferred as the "Bayer Corporation, Business Group Diagnostics Tarrytown, NY" is the submitter.

General Caveats for all devices:

Sample Size for Training Set: The documents do not provide information on the sample size or ground truth establishment for any training sets. This is typical for 510(k) summaries of in vitro diagnostic assays, which often focus on analytical performance rather than machine learning algorithm development.
Number of Experts & Qualifications / Adjudication Method / MRMC Comparative Effectiveness Study / Standalone Performance: These concepts are not applicable to the analytical performance testing of in vitro diagnostic assays described in these summaries. These are typically relevant for image-based diagnostic AI/ML devices where reader interpretation is a key component. The "ground truth" for these assays is the reference method's result, or values from a highly characterized reference material.

1. Direct Bilirubin method for ADVIA® 400 (K993867)

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA 400)
Imprecision (CV%)		Level 0.7 mg/dL: 9.0% CV
Level 0.7-1.0 mg/dL	Similar to predicate (e.g., < 10% CV)	Level 5.5 mg/dL: 3.4% CV
Level 5.0-5.5 mg/dL	Similar to predicate (e.g., < 4% CV)	Level 11.8 mg/dL: 3.3% CV
Level 8.3-11.8 mg/dL	Similar to predicate (e.g., < 4% CV)
Correlation (vs. CHEM 1)
Regression Equation (Y=ADVIA 400, X=CHEM 1)	Slope close to 1, Intercept close to 0	Y=0.98X-0.10
Syx (mg/dL)	Low (indicating good fit)	0.19
r (correlation coefficient)	Close to 1 (e.g., > 0.95)	0.994
Sample Range	Appropriate for clinical use	0.0 - 10.6 mg/dL
Matrix Comparison (Plasma vs. Serum)
Regression Equation (Y=Plasma, X=Serum)	Slope close to 1, Intercept close to 0	Y=0.89X+0.06
Syx (mg/dL)	Low	0.03
r (correlation coefficient)	Close to 1	0.852
Sample Range	Appropriate for clinical use	0.09 - 0.42 mg/dL
Interference	Minimal clinical impact	Hemoglobin (500 mg/dL): -17% effect @ 0.9 mg/dL D. Bilirubin Lipids (Triglycerides 500 mg/dL): -69% effect @ 1.8 mg/dL D. Bilirubin
Analytical Range	Clinically relevant	0 to 14 mg/dL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated, typically involves replicate measurements of controls or pooled samples.
- Correlation (Serum vs. CHEM 1): N=59
- Correlation (Plasma vs. Serum): N=59
- Interfering Substances: Not explicitly stated, typically involves a few samples spiked with interferents.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

Imprecision: Measured value from the ADVIA 400 system itself, demonstrating repeatability.
Correlation: The comparison system (Technicon CHEM 1) is used as the reference/ground truth for the test.
Interfering Substances: The true concentration of D. Bilirubin in the sample prior to adding the interferent.
Analytical Range: Established by demonstrating linearity and acceptable recovery across the stated range, with reference materials or spiked samples.

2. HbA1c Method for ADVIA IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Minimum Detectable Concentration (MDC)	Lower than or comparable to predicate	0.61%
Imprecision (CV%)		Level 5.71%: 5.4% CV
Level 4.6-5.71%	Similar to predicate (e.g., < 6% CV)	Level 8.36%: 4.7% CV
Level 8.36-8.4%	Similar to predicate (e.g., < 5% CV)	Level 11.17%: 4.6% CV
Level 11.17-11.2%	Similar to predicate (e.g., < 5% CV)
Correlation (vs. RA-1000)
Regression Equation (Y=ADVIA IMS, X=RA-1000)	Slope close to 1, Intercept close to 0	Y=1.00X + 0.62
Syx (%)	Low (indicating good fit)	0.33
R (correlation coefficient)	Close to 1 (e.g., > 0.95)	0.991
Sample Range	Appropriate for clinical use	5.09 - 17.21 %
Interference	Minimal clinical impact	Bilirubin (unconjugated 25 mg/dL): -1% effect Bilirubin (conjugated 20 mg/dL): -2% effect Urea (500 mg/dL): +4% effect Lipids (Triglycerides 1000 mg/dL): -4% effect
Analytical Range	Clinically relevant	0.61 to 17.2%

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- MDC: Not explicitly stated, typically involves multiple measurements of low-concentration samples.
- Imprecision (CV%): Not explicitly stated, usually multiple replicates across different runs/days.
- Correlation (Serum vs. RA-1000): N=57
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Bayer RA-1000 HbAlc) is used as the reference/ground truth.
Interfering Substances: The true concentration of HbA1c in the sample prior to adding the interferent.
Analytical Range: Established using materials with known HbA1c concentrations.

3. Gentamicin Method for ADVIA® IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Minimum Detectable Concentration (MDC)	Lower than or comparable to predicate	0.06 µg/mL
Imprecision (CV%)		Level 1.79 µg/mL: 7.2% CV
Level 1.79-3.20 µg/mL	Similar to predicate (e.g., < 8% CV)	Level ~4.5 µg/mL: 4.6% CV
Level ~4.5-7.00 µg/mL	Similar to predicate (e.g., < 5% CV)	Level 9.14 µg/mL: 4.9% CV
Level 9.14-9.50 µg/mL	Similar to predicate (e.g., < 5% CV)
Correlation (vs. Immuno 1)
Regression Equation (Y=ADVIA IMS, X=Immuno 1)	Slope close to 1, Intercept close to 0	Y=1.09X - 0.29
Syx (µg/mL)	Low (indicating good fit)	0.51
R (correlation coefficient)	Close to 1 (e.g., > 0.95)	0.989
Sample Range	Appropriate for clinical use	0.5 - 11.5 µg/mL
Interference	Minimal clinical impact	Bilirubin (unconjugated 25 mg/dL): +3% effect Bilirubin (conjugated 20 mg/dL): +3% effect Hemoglobin (600 mg/dL): -4% effect Lipids (Triglycerides 1000 mg/dL): +4% effect
Analytical Range	Clinically relevant	0.06 to 16.0 µg/mL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=54
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Bayer Immuno 1 Gentamicin) is used as the reference/ground truth.
Interfering Substances: The true concentration of Gentamicin in the sample prior to adding the interferent.
Analytical Range: Established using materials with known Gentamicin concentrations.

4. Magnesium method for ADVIA® IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Imprecision (Serum CV%)		Level 1.76 mg/dL: 2.4% CV
Level 1.6-1.76 mg/dL	Similar to predicate (e.g., < 4.1% CV)	Level 2.32 mg/dL: 1.7% CV
Level 2.32-2.8 mg/dL	Similar to predicate (e.g., < 2.5% CV)	Level 5.29 mg/dL: 1.8% CV
Level 3.6-5.29 mg/dL	Similar to predicate (e.g., < 2.3% CV)
Imprecision (Urine CV%)		Level 1.00 mg/dL: 8.6% CV
Level 1.00-1.1 mg/dL	Similar to predicate (e.g., < 12.6% CV)	Level 6.50 mg/dL: 3.7% CV
Level 6.50-6.5 mg/dL	Similar to predicate (e.g., < 2.9% CV)	Level 14.24 mg/dL: 2.1% CV
Level 14.24-14.2 mg/dL	Similar to predicate (e.g., < 1.4% CV)
Correlation (Serum vs. CHEM 1)
Regression Equation (Y=ADVIA IMS, X=CHEM 1)	Slope close to 1, Intercept close to 0	Y=0.97X+0.06
Syx (mg/dL)	Low	0.16
R (correlation coefficient)	Close to 1	0.998
Sample Range	Appropriate for clinical use	0.2 - 8.05 mg/dL
Correlation (Urine vs. CHEM 1)
Regression Equation (Y=ADVIA IMS, X=CHEM 1)	Slope close to 1, Intercept close to 0	Y=1.02X-0.24
Syx (mg/dL)	Low	0.34
R (correlation coefficient)	Close to 1	0.998
Sample Range	Appropriate for clinical use	1.4 - 25.0 mg/dL
Plasma vs. Serum Comparison	Minimal difference	Difference: 0% Sample Range: 1.63 - 2.3 mg/dL
Interference	Minimal clinical impact	Serum: Bilirubin (unconj. 25 mg/dL): -1%; Bilirubin (conj. 25 mg/dL): 0%; Hemoglobin (1000 mg/dL): +8%; Lipids (Trig. 500 mg/dL): -1%; Calcium (20 mg/dL): -3% Urine: Ascorbate (200 mg/dL): +2%; Salicylate (500 mg/dL): +2%; Acetaminophen (50 mg/dL): -7%
Analytical Range	Clinically relevant	Serum/Plasma: 0 to 8.0 mg/dL Urine: 0 to 25 mg/dL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. CHEM 1): N=44
- Correlation (Urine vs. CHEM 1): N=48
- Plasma vs. Serum Comparison: N=60
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Technicon CHEM 1) is used as the reference/ground truth.
Plasma vs. Serum Comparison: Paired samples analyzed on the ADVIA IMS.
Interfering Substances: The true concentration of Magnesium in the sample prior to adding the interferent.
Analytical Range: Established using materials with known Magnesium concentrations.

5. Theophylline Method for ADVIA® IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Minimum Detectable Concentration (MDC)	Lower than or comparable to predicate	0.47 µg/mL
Imprecision (CV%)	Similar to predicate	Level 9.37 µg/mL: 3.4% CV
		Level 19.59 µg/mL: 3.0% CV
		Level 29.17 µg/mL: 4.1% CV
Correlation (vs. RA-1000)
Regression Equation (Y=ADVIA IMS, X=RA-1000)	Slope close to 1, Intercept close to 0	Y=0.98X - 0.13
Syx (µg/mL)	Low (indicating good fit)	1.37
R (correlation coefficient)	Close to 1 (e.g., > 0.95)	0.991
Sample Range	Appropriate for clinical use	4.1 - 39.6 µg/mL
Interference	Minimal clinical impact	Bilirubin (unconjugated 25 mg/dL): +6% effect Bilirubin (conjugated 15 mg/dL): +7% effect Hemoglobin (600 mg/dL): -4% effect Lipids (Triglycerides 1000 mg/dL): -6% effect
Analytical Range	Clinically relevant	0.47 to 40 µg/mL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. RA-1000): N=51
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Bayer RA-1000 Theophylline) is used as the reference/ground truth.
Interfering Substances: The true concentration of Theophylline in the sample prior to adding the interferent.
Analytical Range: Established using materials with known Theophylline concentrations.

6. Tobramycin Method for ADVIA® IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Minimum Detectable Concentration (MDC)	Lower than or comparable to predicate	0.34 µg/mL
Imprecision (CV%)		Level 1.92 µg/mL: 4.3% CV
Level 1.15-1.92 µg/mL	Similar to predicate (e.g., < 4.3% CV)	Level 3.71 µg/mL: 2.9% CV
Level 3.71-4.42 µg/mL	Similar to predicate (e.g., < 2.9% CV)	Level 7.86 µg/mL: 3.3% CV
Level 7.86-8.29 µg/mL	Similar to predicate (e.g., < 3.3% CV)
Correlation (vs. Immuno 1)
Regression Equation (Y=ADVIA IMS, X=Immuno 1)	Slope close to 1, Intercept close to 0	Y=0.99X - 0.05
Syx (µg/mL)	Low (indicating good fit)	0.22
R (correlation coefficient)	Close to 1 (e.g., > 0.95)	0.997
Sample Range	Appropriate for clinical use	0.3 - 11.5 µg/mL
Interference	Minimal clinical impact	Bilirubin (unconjugated 25 mg/dL): +6% effect Bilirubin (conjugated 20 mg/dL): +3% effect Hemoglobin (600 mg/dL): 0% effect Lipids (Triglycerides 1000 mg/dL): -1% effect
Analytical Range	Clinically relevant	0.34 to 16.0 µg/mL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=69
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Bayer Immuno 1 Tobramycin) is used as the reference/ground truth.
Interfering Substances: The true concentration of Tobramycin in the sample prior to adding the interferent.
Analytical Range: Established using materials with known Tobramycin concentrations.

7. Uric Acid method for ADVIA® IMS

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

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Imprecision (Serum CV%)		Level 3.68 mg/dL: 3.6% CV
Level 3.68-3.8 mg/dL	Similar to predicate (e.g., < 6.3% CV)	Level 6.84 mg/dL: 3.2% CV
Level 6.84-9.3 mg/dL	Similar to predicate (e.g., < 3.6% CV)	Level 11.50 mg/dL: 1.7% CV
Level 11.50-16.3 mg/dL	Similar to predicate (e.g., < 3.3% CV)
Imprecision (Urine CV%)		Level 20.5 mg/dL: 7.2% CV
Level 20.5 mg/dL	Applicable only to ADVIA IMS	Level 32.4 mg/dL: 4.0% CV
Level 26.4-32.4 mg/dL	Similar to predicate (e.g., < 8.2% CV)	Level 45.2 mg/dL: 5.6% CV
Level 35.4-45.2 mg/dL	Similar to predicate (e.g., < 7.2% CV)
Correlation (Serum vs. CHEM 1)
Regression Equation (Y=ADVIA IMS, X=CHEM 1)	Slope close to 1, Intercept close to 0	Y=0.96X + 0.14
Syx (mg/dL)	Low	0.98
r (correlation coefficient)	Close to 1	0.973
Sample Range	Appropriate for clinical use	1.5 - 19.7 mg/dL
Matrix Comparison (Plasma vs. Serum)
Regression Equation (Y=Plasma, X=Serum)	Slope close to 1, Intercept close to 0	Y=1.01X + 0.06
Syx (mg/dL)	Low	0.16
r (correlation coefficient)	Close to 1	0.989
Sample Range	Appropriate for clinical use	2.9 - 8.0 mg/dL
Correlation (Urine vs. CHEM 1)
Regression Equation (Y=ADVIA IMS, X=CHEM 1)	Slope close to 1, Intercept close to 0	Y=1.11X - 3.1
Syx (mg/dL)	Low	4.0
r (correlation coefficient)	Close to 1	0.992
Sample Range	Appropriate for clinical use	1.0 - 123.0 mg/dL
Interference (Serum)	Minimal clinical impact	Bilirubin (20 mg/dL): -7.9% effect Hemoglobin (500 mg/dL): +15.8% effect Lipids (Triglycerides 500 mg/dL): +36.7% effect
Interference (Urine)	Minimal clinical impact	Acetaminophen (500 mg/dL): +1.1% effect Ascorbic Acid (200 mg/dL): +10.9% effect Salicylate (500 mg/dL): -2.7% effect
Analytical Range	Clinically relevant	Serum/Plasma: 0 to 23 mg/dL Urine: 0 to 200 mg/dL

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. CHEM 1): N=60
- Matrix Comparison (Plasma vs. Serum): N=60
- Correlation (Urine vs. CHEM 1): N=51
- Interfering Substances: Not explicitly stated.
Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).

7. The type of ground truth used

Imprecision: Measured value from the ADVIA IMS system itself.
Correlation: The comparison system (Technicon CHEM 1 Uric Acid) is used as the reference/ground truth.
Matrix Comparison: Paired samples analyzed on the ADVIA IMS.
Interfering Substances: The true concentration of Uric Acid in the sample prior to adding the interferent.
Analytical Range: Established using materials with known Uric Acid concentrations.

Summary

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APR 1 0 2000

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS D. Bilirubin method for ADVIA® 400

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: K993867

1. Intended Use

This in virro diagnostic method is intended to measure D. Bilirubin (a product formed during the normal and abnormal destruction of red blood cells) in human serum or plasma on the Bayer ADVIA 400 system

2. Predicate Device

Product Name	The first for the first and the count of the count of the commend to be and the comments of the comments of the comments of the comments of the comments of the comments of th	and and and and of the strength and the country of the submitteen and the submitteen Reagent Part # Calibrator Part #
Technicon CHEM 100 D. Bilirubin T01-1522-53 T03-1291-62		Canadination of programments and consisted in below and

3. Device / Method

Product Name		Reagent Part # Calibrator Part #The for the contract of the commended to the comments of the contract and the many of the many of
ADVIA 400 D. Bilirubin	B41-3723-46 T03-1291-62

A. Imprecision(SERUM)

ADVIA 400		CHEM 1
Level(mg/dL)	TotalCV(%)	Level(mg/dL)	TotalCV(%)
0.7	9.0	0.2	n/a
5.5	3.4	5.0	3.9
11.8	3.3	8.3	3.2

Correlation (Y=ADVIA 400, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	r	Sample Range (mg/dL)
Serum	CHEM 1	59	Y=0.98X-0.10	0.19	0.994	0.0 - 10.6
Plasma(y), Serum(x)	ADVIA 400	59	Y=0.89X+0.06	0.03	0.852	0.09 - 0.42

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	D. BilirubinConc. (mg/dL)	Effect(% change)
Hemoglobin	500	0.9	-17
Lipids (Triglycerides)	500	1.8	-69

Analytical Range

Serum/Plasma: 0 to 14 mg/dL

Gabriel J. Musara Jr.
10/4/22

11/4/92

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS HbA1c 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: ___________________(leave blank)

1. Intended Use

This in vitro method is intended to quantitatively measure %HbA1c in human blood on the Bayer ADVIA IMS systems. Measurements of %HbAlc are used to aid in the diagnosis and for monitoring the long term care of persons with diabetes.

2. Predicate Device

adminProduct Name		Reagent Part # Calibrator Part #
And and the first and the program and the comments of the comments of the first ofBayer RA-1000 HbAlcMarket Comments of Children Market Market Comments of Comments of Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com	T01-3639-01	Property of the Property of Children Comments of Concerner Comments of Children Comments of ChildrenT03-3644-01

3. Device / Method

produktion for the final may and many comprehensive and many management in a many may maging home management of the may and the film of the film of the may and the film of thProduct NameA Property of Concession Complete of Children Complete of Children Compress of Children Comments of Children Comments of Children Comments of Children Comments of Children Co	Reagent BAN	Calibrator BANthe with a frequently of the required in the may may may may high comment of the comments of the comments of the
ADVIA IMS HbAlcAnd Children Children Comment Comment Comments of Concellent Comments of Children Comments of Children	00395488	08248751

Minimum Detectable Concentration

Method	and and the controlled on the consisted on the consistent of the commended to controllaboration of the comments of the commended on the commended on the commended to commendeADVIA IMS	RA-1000
and and any and of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many ofMDC	for from the first of the first from the many and the many and the may be the0.61%her and the figure the state of the mail of the mail of the mail of the mail and seems and the mail and the mail be mail be mail be mail be mail be mail be mail be mail be ma	- Show and the result of the submit is and the mail be the local be the like the block17.2%

A. Imprecision

	ADVIA IMS	Bayer RA-1000
Level	Total	Level	Total
%	CV (%)	(%)	CV(%)
5.71	5.4	4.6	3.4
8.36	4.7	8.4	2.6
11.17	4.6	11.2	2.5

Specimen type	ComparisonSystem (X)	N	RegressionEquation	Syx%	R	SampleRange(%)
Serum	RA-1000	57	$Y=1.00 X + 0.62$	0.33	0.991	5.09 - 17.21

Gabriel J. Munoz, Jr.

11/5/99

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InterferingSubstance	Interfering Sub.Conc. (mg/dL)	HbA1c Conc.(%)	Effect(% change)
Bilirubin(unconjugated)	25	5.21	-1
Bilirubin(conjugated)	20	5.19	-2
Urea	500	7.86	+4
Lipids(Triglycerides)	1000	5.26	-4

D. Analytical Range 0.61 to 17.2%

Date 1/15/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY.

Gabriel J. Muscaz Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Gentamicin 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 method is intended to quantitatively measure gentamicin in human serum on the Bayer ADVIA® IMS systems. Measurements of gentamicin are used to aid in the diagnosis and treatment of gentamicin overdose and in monitoring serum levels of gentamicin to ensure appropriate therapy.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Bayer Immuno 1Gentamicin	T01-3154-51	T03-2864-01

3. Device / Method

Product Name	Reagent BAN	Calibrator BAN
ADVIA IMS Gentamicin 'and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the first	02543484	05442131

Minimum Detectable Concentration

Method	ADVIA IMS	Immuno 1
MDC	0.06 ug/mL	0.11ug/mL

Imprecision

ADVIA IMS		Bayer Immuno I
Level	Total	Level	Total
ug/mL	CV (%)	ug/mL	CV(%)
1.79	7.2	3.20	4.6
ર્સ્વે એ જિલ્લામાં આવેલું એ તાલુકામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે કરવામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વ	4.6	7.00	2.6
9.14	4.9	9.50	2.9

Specimen type	ComparisonSystem (X)	N	RegressionEquation	Syxµg/mL	R	SampleRangeµg/mL
Serum	Immuno 1	54	$Y=1.09X - 0.29$	0.51	0.989	0.5 - 11.5

Gabriel J. Muraca Jr.
11/5/99

{4}------------------------------------------------

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	GentamicinConcentrationμg/mL	Effect(% change)
Bilirubin(unconjugated)	25	4.23	+3
Bilirubin(conjugated)	20	4.34	+3
Hemoglobin	600	4.37	-4
Lipids(Triglycerides)	1000	4.05	+4

Analytical Range

0.06 to 16.0 µg/mL

Date 11/5/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY.

Gabriel J. Muraca, Jr.

Manager Regulatory Affairs

{5}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Magnesium 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 method is intended to quantitatively measure magnesium in human serum, plasma and urine on the Bayer ADVIA IMS. Measurements of serum magnesium are used in the diagnosis and treatment of hypomagnesiumia and monitoring of patients receiving prolonged magnesium-free intravenous therapy. Measurements of urine magnesium are used to aid in the management of patients with renal dysfunction.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1	T01-3269-53	T03-1291-62

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
Bayer ADVIA IMS	BAN 02115121	T03-1291-62

A. Imprecision (Serum)

Level (mg/dL)	Total CV(%)
1.76	2.4%
2.32	1.7%
5.29	1.8%

CHEM 1
Level(mg/dL)	TotalCV(%)
1.6	4.1%
2.8	2.5%
3.6	2.3%

B. Imprecision (Urine)

ADVIA IMS
Level(mg/dL)	TotalCV(%)
1.00	8.6%
6.50	3.7%
14.24	2.1%

CHEM 1
Level(mg/dL)	TotalCV(%)
1.1	12.6%
6.5	2.9%
14.2	1.4%

Gabriel J. Murray, Jr.
11/5/99

{6}------------------------------------------------

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

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	R	Sample Range (mg/dL)
Serum	CHEM I	44	Y=0.97X+0.06	0.16	0.998	0.2 - 8.05
Urine	CHEM I	48	1.02X-0.24	0.34	0.998	1.4 - 25.0

Plasma (Y) vs. Serum (X) Comparison

	Plasma	Serum	N	Difference	Sample Range
	mg/dL	mg/dL	60	(%)	mg/dL
concentration	1.97	1.97		0	1.63 - 2.3
Within-run CV	8.92	9.73

Interfering Substances

Source	InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Magnesium Conc(mg/dL)	Effect(% change)
Serum	Bilirubin (unconjugated)	25	2.23	-1
Serum	Bilirubin (conjugated)	25	1.98	0
Serum	Hemoglobin	1000	2.21	+8
Serum	Lipids (Triglycerides)	500	2.12	-1
Serum	Calcium	20	2.08	-3
Urine	Ascorbate	200	5.92	+2
Urine	Salicylate	500	5.67	+2
Urine	Acetaminophen	50	6.02	-7

Analytical Range

Serum/Plasma: 0 to 8.0 mg/dL Urine: 0 to 25 mg/dL

Gabriel J. Munoz, Jr.

11/5/99

Date

Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains a series of small, dark, indistinct shapes arranged in a diagonal line from the upper left to the lower right. The shapes appear to be isolated against a bright, uniform background, making them stand out despite their small size. Due to the lack of detail, it is difficult to determine the exact nature or purpose of these shapes.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Theophylline 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: _______________________________________________(leave blank)

1. Intended Use

This in vitro method is intended to quantitatively measure theophylline in human serum on the Bayer ADVIA® IMS systems. Measurements of theophylline are used to aid in the diagnosis and treatment of theophylline overdose and asthama in children and adults.

2. Predicate Device

Product Name		. Phone of the contributed the result of the result of the may of the contributed to the comments of the may of the comments of the may of the comments of the may of the commReagent Part # Calibrator Part #
Bayer RA-1000	T01-1695-01	and the country of the count of the count of the county of the county of the county of the county of the county of the county of the county of the county of the county of theT03-1692-01
Theophylline------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3. Device / Method

Product Nameof the completed by the program and the promotive of the comments of the comments of the comments of	Reagent BAN	Calibrator BAN
ADVIA IMS Theophylline	03246211and the many of the control of the contribution of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comment	08491893------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Minimum Detectable Concentration

www.comments.com/short/colors/colors/controllers/Method	age of the contract of the program and the province the complex of the may be any the complex of the manufactures of the manufactures of the manufacturerADVIA IMS	Immuno
Householder from the would many from and the confinited the finition of the find of the find of the find of the first of the first of the first for the find of the find of thMDCManagement of American Collection of Children Comments of Street Charge of States of States of States of States of States of States of States of States of States of States of	of the many of the many of the many of the many of the many of the many of the more of the many of0.47 ug/mLCompany of the program and the manager of the comments of the comments of the comments of the comments of the count	1 0.4 Oug/mL

A. Imprecision

ADVIA IMS
Levelμg/mL	TotalCV (%)
9.37	3.4
19.59	3.0
29.17	4.1

Specimen type	Comparison System (X)	N	Regression Equation	Syxµg/mL	R	Sample Rangeµg/mL
Serum	RA-1000	51	$Y=0.98 X - 0.13$	1.37	0.991	4.1 - 39.6

Gabriel J. Mware, Jr.
11/5/99

{8}------------------------------------------------

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	TheophyllineConcentrationμg/mL	Effect(% change)
Bilirubin(unconjugated)	25	8.65	+6
Bilirubin(conjugated)	15	9.00	+7
Hemoglobin	600	9.03	-4
Lipids(Triglycerides)	1000	9.01	-6

Analytical Range 0.47 to 40 µg/mL

Date 11/07/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY.

Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.

Manager Regulatory Affairs

{9}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Tobramycin 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: _______________________________________________________________________________________________________________________________________________ (leave blank)

1. Intended Use

This in vitro method is intended to quantitatively measure tobramycin in human serum on the Bayer ADVIA® IMS systems. Measurements of tobram circums are used to aid in the diagnosis and treatment of tobramycin overdose and in monitoring serum levels of tobramycin to ensure appropriate therapy.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Bayer Immuno ITobramycin	T01-3157-51	T03-2864-01

3. Device / Method

Product Name	Reagent BAN	Calibrator BAN
ADVIA IMS Tobramycin 'Property of the proportion of the program and one of the first of the first of the first of the first of	04946969	05442131

Minimum Detectable Concentration

Method	ADVIA IMS	Immuno 1
MDC	0.34 $ $\mu$ $ g/mL	0.08 $ $\mu$ $ g/mL

A. Imprecision

ਜ

ADVIA IMS			Bayer Immuno
Level	Total	Level	Total
g/mL	CV (%)	μg/mL	CV(%)
1.92	4.3	1.15	4.0
3.71	2.9	4.42	2.4
7.86	3.3	8.29	2.2

Specimen type	Comparison System (X)	N	Regression Equation	Syx μg/mL	R	Sample Range μg/mL
Serum	Immuno 1	69	$Y = 0.99X - 0.05$	0.22	0.997	0.3-11.5

Gabriel J. Munoz, Jr.
11/5/99

{10}------------------------------------------------

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	TobramycinConcentrationµg/mL	Effect(% change)
Bilirubin(unconjugated)	25	2.36	+6
Bilirubin(conjugated)	20	2.46	+3
Hemoglobin	600	2.44	0
Lipids(Triglycerides)	1000	2.42	-1

Analytical Range 0.34 to 16.0 µg/mL

Date 11/5/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY.

Gabriel J. Murray, Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs

{11}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid 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 varo diagnostic method is intended to measure Uric Acid in human serum, plasma or urine on the Bayer ADVIA IMS system

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1° Uric Acid	T01-1655-53	T03-1291-62

3. Device / Method

Product Name		Reagent Part # Calibrator Part #
ADVIA IMS Uric Acid	05132620was and the commend of the commend of the been and the been	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------T03-1291-62

ﻧﮯ Imprecision(SERUM)

ADVIA IMS		CHEM 1
Level(mg/dL)	TotalCV(%)	Level(mg/dL)	TotalCV(%)
3.68	3.6	3.8	6.3
6.84	3.2	9.3	3.1
11.50	1.7	16.3	3.3

B. Imprecision(URINE)

ADVIA IMS	CHEM 1
Level(mg/dL)	TotalCV(%)	Level(mg/dL)	TotalCV(%)
20.5	7.2	N/A	N/A
32.4	4.0	26.4	8.2
45.2	5.6	35.4	7.2

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	r	Sample Range (mg/dL)
Serum	CHEM 1	60	$Y = 0.96X + 0.14$	0.98	0.973	1.5 - 19.7 mg/dL
Plasma(v), Serum(x)	ADVIA IMS	60	$Y = 1.01X + 0.06$	0.16	0.989	2.9-8.0 mg/dL
Urine	CHEM 1	51	$Y = 1.11X - 3.1$	4.0	0.992	1.0 - 123.0 mg/dL

Gabriel J. Munaco, Jr.
11/5/99

{12}------------------------------------------------

Interfering Substances(In Serum)

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Uric Acid Conc.(mg/dL)	Effect(% change)
Bilirubin	20	3.8	-7.9
Hemoglobin	500	3.8	+15.8
Lipids (Triglycerides)	500	3.8	+36.7

Interfering Substances(In Urine)

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Uric Acid Conc.(mg/dL)	Effect(% change)
Acetaminophen	500	18.4	+1.1
Ascorbic Acid	200	18.4	+10.9
Salicylate	500	18.4	-2.7

Analytical Range

Serum/Plasına Urine:

0 10 23 ing/dL 0 to 200 mg/dL

Gabriel J. Munoz, Jr.

///5799

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.

Public Health Service

APR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K993867 Trade Name: Bayer ADVIA® IMS System Regulatory Class: II Product Code: CIG, JGJ, KLS, KNK, LCD, LCP, LDO Dated: February 21, 2000 Received: February 29, 2000

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 (OS) 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.

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

Page 2

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" (21CFR 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 Butman

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

{15}------------------------------------------------

Page 1 of 3

K493867 510(k) Number (if known):

Device Name: Direct Bilirubin (DBIL)

Indications For Use:

Device Name: Hemoglobin A1c (HbA1c)

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K493867

(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 Formal 1-2-96

{16}------------------------------------------------

Page 2 of 3

510(k) Number (if known):

Device Name: Gentamicin

Indications For Use:

Device Name: Magnesium (MG)

Indications For Usc:

Device Name: Theophylline (THEO)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
Sean Cooge		Optional Formal 1-2-96
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K993862

{17}------------------------------------------------

510(k) Number (if known):

Device Name: Tobramycin (TOBRA)

Indications For Use:

Device Name: Uric Acid (UA)

Indications For Use:

in Cooper

on of Clinical L 510(k) Number

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

Concuplence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 2 (Per 21 CFR 801.109)

Over-The-Counter Use

Optional Formal 1-2-96

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.