(211 days)
Bayer Chem 1 ALP(AMP) method, Technicon CHEM 1 Calcium method, Bayer Technicon Chem 1 Glucose method, Immuno 1 Ferritin assay, Bayer Immuno 19 hCG Assay, Bayer Immuno 19 TSH Assay
Bayer Chem 1 ALP(AMP) method, Technicon CHEM 1 Calcium method, Bayer Technicon Chem 1 Glucose method, Immuno 1 Ferritin assay, Bayer Immuno 19 hCG Assay, Bayer Immuno 19 TSH Assay
No
The document describes standard in-vitro diagnostic assays and performance metrics, with no mention of AI or ML technologies.
No.
The device is described as an "in-vitro diagnostic device intended to measure ALP in human serum or plasma" and other substances like calcium, glucose, ferritin, hCG, and TSH, with measurements used in the "diagnosis, monitoring and treatment of a variety of diseases". It explicitly states it is a diagnostic method and its components are assays for measurement, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device" and similar phrasing for other assays listed, all of which are used in the "diagnosis" of various diseases.
No
The device is described as an in-vitro diagnostic device intended to measure various analytes in human serum or plasma using the Bayer ADVIA IMS system. This indicates a hardware component (the ADVIA IMS system) is integral to the device's function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states for each assay (ALP, Calcium, Glucose, Ferritin, hCG, TSH) that the Bayer ADVIA IMS assay is an "in-vitro diagnostic device" intended to measure specific analytes in human serum or plasma.
This clear and repeated declaration confirms its classification as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
This in vitro method is intended to quantitatively measure calcium in human serum and plasma on the Bayer ADVIA IMS. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
This in vitro method is intended to quantitatively measure ferritin, an iron storage protein, in human serum using Bayer Immuno 1 ferritin reagents on a Bayer ADVIA Modular System. Measurements of ferritin are used in the diagnosis and treatment of iron deficiency or iron overload disease states.
This in viro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum using ADVIA hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy.
This in viro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum using ADVIA 3d Generation TSH Assay on a Bayer ADVIA® Integrated Modular System. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 µIU/mL, as defined by the American Thyroid Association.
Product codes (comma separated list FDA assigned to the subject device)
CJO, CFR, CIC, CJO, DHA, JLW, JMG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human serum or plasma
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of performance between the Bayer ADVIA Alkaline Phosphatase (AMP) method and a similar device that was granted clearance of substantial equivalence (Bayer Chem 1 ALP(AMP) method).
Analytical Range for ALP(AMP) method: 0 to 2800 U/L. Precision: 3.6% CV at 74 U/L, 2.9% CV at 160 U/L, 2.1% CV at 420 U/L. Regression Equation (serum): y = 0.96x + 2.0 (n=74, r=0.999, Sy.x=11.2, range=36 to 1599 U/L). Regression Equation (plasma qualification): y = 1.06x - 0.9 (n=59, r=0.999, Sy.x=0.93, range=33 to 111 U/L).
Comparison of performance between the Bayer ADVIA IMS Calcium method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Calcium method).
Analytical Range for ADVIA IMS: 0 to 14.0 mg/dL. Precision (Total): 1.1% @ 8.4 mg/dL, 2.2% @ 10.4 mg/dL, 0.9% @ 13.6 mg/dL. Correlation: y=0.96-0.8 mg/dL (y=ADVIA IMS, x=CHEM 1, n=48, r=0.996, Sy.x=0.01 mg/dL). Plasma/Serum Equivalence: 8.4 mg/dL (Difference 0.00), Within-run CV 0.75% for plasma, 0.73% for serum.
Comparison of performance between the Bayer ADVIA IMS Glucose method and a similar device that was granted clearance of substantial equivalence (Bayer Technicon Chem 1 Glucose method).
Analytical Range for ADVIA IMS: 0 to 800 mg/dL. Precision (Total): 3.66% CV at 48 mg/dL, 3.03% CV at 97 mg/dL, 1.80% CV at 293 mg/dL. Regression Equation (serum): y = 1.03x + 0.71 (y = ADVIA IMS, x = Chem 1, n = 58, r = 0.993, Sy.x = 11.4, range = 51 to 534 mg/dL). Regression Equation (plasma qualification): y = 0.97x + 4.12 (y = plasma, x = serum, n = 60, r = 0.943, Sy.x = 4.1, range = 58 to 174 mg/dL).
Comparison of performance between the ADVIA Ferritin method and a similar device that was granted clearance of substantial equivalence (Immuno 1 Ferritin assay).
Minimum Detectable Conc. for ADVIA Ferritin: 0.06 ng/mL. Precision (Total CV%): 4.1% at 28 ng/mL, 4.8% at 108 ng/mL, 5.0% at 245 ng/mL. Correlation: y = 1.040 x - 6.132 (y = Bayer ADVIA Modular System, x = Bayer Immuno 1 System, n = 50, r = 0.993, Syx = 57.50 ng/mL).
Comparison of performance between the ADVIA hCG method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 19 hCG Assay).
Minimum Detectable Conc. for ADVIA hCG Assay: 0.1 mIU/mL. Precision (Total CV): 4.2% @ 12.1 mIU/mL, 4.5% @ 23.9 mIU/mL, 5.5% @ 198.1 mIU/mL. Correlation: y = 0.99x + 1.96 (y = ADVIA hCG Assay, x = Immuno 1 hCG Assay, n = 40, r = 1.0, Syx = 17.5 mIU/mL).
Comparison of performance between the ADVIA 3d Generation TSH method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 19 TSH Assay).
Minimum Detectable Conc. for ADVIA TSH Assay: 0.005 µIU/mL. Precision (Total CV): 13.2% @ 0.02 µIU/mL, 2.9% @ 0.52 µIU/mL, 2.3% @ 4.95 µIU/mL, 2.6% @ 31.10 µIU/mL. Correlation: y = 0.98x - 0.357 (y = ADVIA TSH Assay, x = Immuno 1 TSH Assay, n = 50, r = 0.997, Syx = 1.48 µIU/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.
Bayer Chem 1 ALP(AMP) method, Technicon CHEM 1 Calcium method, Bayer Technicon Chem 1 Glucose method, Immuno 1 Ferritin assay, Bayer Immuno 19 hCG Assay, Bayer Immuno 19 TSH Assay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
Alkaline Phosphatase (AMP) Method for the ADVIA IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA Alkaline Phosphatase (AMP) method and a similar device that was granted clearance of substantial equivalence (Bayer Chem 1 ALP(AMP) method). The information was extracted from the Bayer ADVIA ALP(AMP) method and Bayer Chem 1 method sheet.
INTENDED USE
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
| ALP(AMP) METHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3718-23 | T01-1459-53 | ||
| Analytical Range: | 0 to 2800 U/L | 0 to 2250 U/L | ||
| Precision (Total): | mean (U/L) | % CV | mean (U/L) | % CV |
| 74 | 3.6 | 65 | 3.8 | |
| 160 | 2.9 | 263 | 3.3 | |
| 420 | 2.1 | 547 | 3.2 | |
| Regression Equation: (serum) | $y = 0.96x + 2.0$ | |||
| where: | y = ADVIA IMS | |||
| x = Chem 1 | ||||
| n = 74 | ||||
| r = 0.999 | ||||
| Sy.x = 11.2 | ||||
| range = 36 to 1599 U/L | ||||
| Regression Equation: (plasma qualification) | $y = 1.06x - 0.9$ | |||
| where: | y = plasma | |||
| x = serum | ||||
| n = 59 | ||||
| r = 0.999 | ||||
| Sy.x = 0.93 | ||||
| range = 33 to 111 U/L |
1
Interference
| | Interfering Substance
Concentration | ALP(AMP) | Effect
% Change |
|--------------------------|----------------------------------------|----------|--------------------|
| Hemoglobin | 500 mg/dL | 97 U/L | 9 |
| Bilirubin (conjugated) | 20 mg/dL | 100 U/L | 8 |
| Bilirubin (unconjugated) | 25 mg/dL | 107 U/L | 1 |
| Lipemia (Triglycerides) | 1000 mg/dL | 110 U/L | 3 |
Gabriel J. Muracy Jr.
Gabriel J. Muraco, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/30/98
Date
Date
00168
2
Calcium Method for the Bayer ADVIA Integrated Modular System (IMS)
Listed below is a comparison of the performance between the Bayer ADVIA IMS Calcium method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Calcium method). The information used in the Summary of Safety and Effectiveness was extracted from the Bayer ADVIA IMS Calcium method sheet and the CHEM 1 Calcium method sheet.
INTENDED USE
This in vitro method is intended to quantitatively measure calcium in human serum and plasma on the Bayer ADVIA IMS. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
| METHOD | ADVIA IMS | CHEM 1 | |
|---|---|---|---|
| Part No. | Reagents | ||
| Calibrators | B41-3725-25 | ||
| T03-1291-62 | T01-1614-01 | ||
| T03-1291-62 | |||
| Analytical Range | 0 to 14.0 mg/dL | 1 to 15 mg/dL | |
| Precision (Total) | 1.1% @ 8.4 mg/dL | ||
| 2.2% @ 10.4 mg/dL | |||
| 0.9% @ 13.6 mg/dL | 2.3% @ 8.4 mg/dL | ||
| 2.5% @10.6 mg/dL | |||
| 2.2% @ 13.4 mg/dL | |||
| Correlation | y=0.96-0.8 mg/dL | ||
| where | |||
| y=ADVIA IMS | |||
| x=CHEM 1 | |||
| n=48 | |||
| r=0.996 | |||
| Sy.x=0.01 mg/dL |
| Plasma/Serum Equivalence | Plasma | Serum | Difference |
|---|---|---|---|
| 8.4 mg/dL | 8.4 mg/dL | 0.00 | |
| Within-run CV | 0.75% | 0.73% | 0.02% |
3
Interfering Substances
| Bilirubin (unconjugated) 25 mg/dL | 1.1% effect change @ 9.0 mg/dL Ca |
|---|---|
| Hemoglobin 1000 mg/dL | 3.0% effect change @ 8.9 mg/dL Ca |
| Triglycerides 500 mg/dL | 3.0% effect change @ 9.1 mg/dL Ca |
Gabriel J. Muraca Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/30/98
__
Date
Date
000170
ﻪ ﻣﺴ
4
Glucose Method for the ADVIA IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Glucose method and a similar device that was granted clearance of substantial equivalence (Bayer Technicon Chem 1 Glucose method). The information was extracted from the Bayer ADVIA IMS Glucose method sheet.
INTENDED USE
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
| GLUCOSE METHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3732-26 | T01-1460-53 | ||
| Calibrators T03-1291-62 | T03-1291-62 | |||
| Analytical Range: | 0 to 800 mg/dL | 0 to 675 mg/dL | ||
| Precision (Total): | mean | |||
| (mg/dL) | % CV | mean | ||
| (mg/dL) | % CV | |||
| 48 | 3.66 | 87 | 2.7 | |
| 97 | 3.03 | 262 | 2.9 | |
| 293 | 1.80 | 305 | 2.3 | |
| 562 | 1.3 | |||
| Regression Equation: | ||||
| (serum) | y = $1.03x + 0.71$ | |||
| where: | y | = ADVIA IMS | ||
| x | = Chem 1 | |||
| n | = 58 | |||
| r | = 0.993 | |||
| Sy.x | = 11.4 | |||
| range | = 51 to 534 mg/dL | |||
| Regression Equation: | ||||
| (plasma qualification) | y = $0.97x + 4.12$ | |||
| where: | y | = plasma | ||
| x | = serum | |||
| n | = 60 | |||
| r | = 0.943 | |||
| Sy.x | = 4.1 |
range = 58 to 174 mg/dL
5
Interference
| | Interfering Substance
Concentration | Glucose
Concentration | Effect
% Change |
|--------------------------|----------------------------------------|--------------------------|--------------------|
| Hemoglobin | 1000 mg/dL | 297 mg/dL | 0.5 |
| Bilirubin (conjugated) | 25 mg/dL | 288 mg/dL | 0.5 |
| Bilirubin (unconjugated) | 25 mg/dL | 271 mg/dL | 1.3 |
| Lipemia (Triglycerides) | 500 mg/dL | 274 mg/dL | 9.5 |
Gabriel J. Munoz, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/30/98
Date
00172
6
Ferritin Method for Bayer ADVIA™ MODULAR SYSTEM
Listed below is a comparison of the performance between the ADVIA Ferritin method and a similar device that was granted clearance of substantial equivalence (Immuno 1 Ferritin assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA ferritin method sheet and the Immuno 1 ferritin method sheet.
INTENDED USED
This in vitro method is intended to quantitatively measure ferritin, an iron storage protein, in human serum using Bayer Immuno 1 ferritin reagents on a Bayer ADVIA Modular System. Measurements of ferritin are used in the diagnosis and treatment of iron deficiency or iron overload disease states.
| METHOD | Immuno 1 Ferritin
(predicate device) | | ADVIA Ferritin | |
|--------------------------|-----------------------------------------|----------------------------------------|----------------|--------------------------------------|
| Part No. | Reagents | T01-2863-51
Calibrators T03-3251-01 | Reagents | B42-3902-2
Calibrators B43-3933-0 |
| Minimum Detectable Conc. | 0.3 ng/mL | | 0.06 ng/mL | |
| Precision (Total CV%) | 21 ng/mL | 7.1% | 28 ng/mL | 4.1% |
| | 148 ng/mL | 5.0% | 108 ng/mL | 4.8% |
| | 344 ng/mL | 5.0% | 245 ng/mL | 5.0% |
Correlation
y = 1.040 x - 6.132
| where | |
|---|---|
| y = | Bayer ADVIA Modular System |
| x = | Bayer Immuno 1 System |
| n = | 50 |
| r = | 0.993 |
| Syx = | 57.50 ng/mL |
7
Interference
| | Interfering Substance
Concentration | Ferritin
concentration | Ferritin (Neat
concentration) | Effect
% Change |
|-------------------------|----------------------------------------|---------------------------|----------------------------------|--------------------|
| Hemoglobin | 1000 mg/dL | 179.8 ng/mL | 178.3 ng/mL | 0.8 |
| Bilirubin | 27.5 mg/dL | 34.74 ng/mL | 36.01ng/mL | 3.5 |
| Urea Nitrogen | 200 mg/dL | 175.1 ng/mL | 182.0 ng/ml | 3.8 |
| Lipemia (Triglycerides) | 1110 mg/dL | 212.6 ng/mL | 222.6 ng/ml | 4.5 |
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/30/98
Date
Date
8
hCG Assay for Bayer ADVIA® Integrated Modular System
Listed below is a comparison of the performance between the ADVIA hCG method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 19 hCG Assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA hCG insert and the Immuno 1° hCG Assay method sheet.
INTENDED USED
This in viro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum using ADVIA hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy.
| METHOD | ADVIA hCG Assay | Immuno 1 hCG Assay
(predicate Device) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Part No. | Reagents B42-3907-43
Calibrators B43-3941-01 | Reagents T01-2966-5
Calibrators T03-3148-0 |
| Minimum Detectable Conc. | 0.1 mIU/mL | 0.5 mIU/mL |
| Precision (Total CV) | 4.2% @ 12.1 mIU/mL
4.5% @ 23.9 mIU/mL
5.5% @ 198.1 mIU/mL | 4.0% @ 18.3 mIU/mL
3.7% @ 55.7 mIU/mL
3.7% @ 198.1 mIU/mL |
| Correlation | y = 0.99x + 1.96
where
y = ADVIA hCG Assay
x = Immuno 1 hCG Assay
n = 40
r = 1.0
Syx = 17.5 mIU/mL | |
Interfering Substances
| Interfering
Substance | Interfering Substance
Concentration | | Analyte
Concentration, mIU/mL | | Effect |
|--------------------------|----------------------------------------|---------|----------------------------------|----------|--------|
| | SI Units | (mg/dL) | Expected | Observed | (%) |
| Hemoglobin | 1.0 g/L | 1000 | 17.2 | 16.8 | -2.3 |
| Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 17.2 | 15.7 | -8.7 |
| Bilirubin | 428 $\mu$ mol/L | 25 | 16.5 | 15.5 | -6.1 |
| Urea Nitrogen | 71.4 mmol/L | 200 | 17.2 | 15.9 | -7.6 |
9
Gabriel J. Menaca Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/30/98
Date
10
3rd Generation TSH Assay for Bayer ADVIA® Integrated Modular System
Listed below is a comparison of the performance between the ADVIA 3d Generation TSH method and a similar device that was granted clearnice of substantial equivalence (Bayer Immuno 19 TSH Assay). The information used in the Summary of Safety and Effectiveness was extracted from the ADVIA 3ª Generation TSH insert and the Immuno 1 TSH Assay method sheet.
INTENDED USED
This in viro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum using ADVIA 3d Generation TSH Assay on a Bayer ADVIA® Integrated Modular System. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 µIU/mL, as defined by the American Thyroid Association.
| METHOD | ADVIA TSH Assay | | Immuno 1 TSH Assay
(predicate Device) | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------|
| Part No. | Reagents | B42-3921-43
Calibrators B43-3948-01 | Reagents | T01-2942-51
Calibrators T03-3568-01 |
| Minimum Detectable Conc. | 0.005 µIU/mL | | 0.03 µIU/mL | |
| Precision (Total CV) | | 13.2% @ 0.02 µIU/mL
2.9% @ 0.52 µIU/mL
2.3% @ 4.95 µIU/mL
2.6% @ 31.10 µIU/mL | | 6.3% @ 1.3 µIU/mL
2.0% @ 9.0 µIU/mL
1.8% @ 22.5 µIU/mL |
| Correlation | y = 0.98x - 0.357
where
y = ADVIA TSH Assay
x = Immuno 1 TSH Assay
n = 50
r = 0.997
Syx = 1.48 µIU/mL | | | |
Interfering Substances
| Interfering | Interfering Substance | Analyte | Effect | ||
|---|---|---|---|---|---|
| Substance | Concentration | Concentration, ulU/mL | |||
| SI Units | (mg/dL) | Expected | Observed | (%) | |
| Hemoglobin | 1.0 g/L | 1000 | 3.32 | 3.38 | 1.8 |
| Lipids (Triglycerides) | 11.3 mmol/L | 1000 | 3.49 | 3.45 | -0.9 |
| Bilirubin | 428 umol/L | ટર્ડ | 3.25 | 3.30 | ાં રે |
| Urea Nitrogen | 71.4 mmol/L | 200 | 3.30 | 3.31 | -1.5 |
11
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs
Bayer Corporation 511 Benedict Avenue
Tarrytown, New York 10591-5097
6/30/98
Date
Date
12
JAN 2 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gabriel J. Muraca, Jr. Manager Regulatory Affairs BAYER CORPORATION Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097
K982328 Re: Trade Name: Bayer ADVIA® IMS™ System Regulatory Class: II Product Code: CJO, CFR, CIC, CJO, DHA, JLW, JMG Dated: November 12, 1998 Received: November 19, 1998
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
13
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 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
14
510(k) Number (if known):___
Device Name: Bayer ADVIA™ Integrated Module System (IMS™)
Indications For Use:
ALKALINE PHOSPHATASE (ALP)
Intended Use:
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
CALCIUM (CA)
Intended Use:
The Bayer ADVIA IMS Calcium assay is an in vitro diagnostic device intended to measure calcium in human serum or plasma. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. This diagnostic method is not intended for use on any other diagnostic system.
GLUCOSE (GLU)
Intended Use:
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
(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)
000252
Page 1 of 2
15
510(k) Number (if known): A4893238
Device Name: Bayer ADVIA™ Integrated Module System (IMS™)
Indications For Use:
FERRITIN (FERR)
Intended Use:
The Bayer ADVIA IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system.
HUMAN CHORIONIC GONDADOTROPIN (hCG)
Intended Use:
The Bayer ADVIA IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (8) in human chorionic gonadotropin (hcG) in human serum. Measurements of human chorionic gonadotropin are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system.
THYROID STIMULATING HORMONE (TSH)
Intended Use:
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The Bayer ADVIA IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH)in human serum. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient variation (CV) at 0.01 to 0.02 mIUL or uiU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.
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000253 Optional Format 1-2-96)