(138 days)
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No
The summary describes standard in vitro diagnostic assays measuring chemical concentrations and enzyme activity, with performance evaluated through analytical range, precision, and correlation to predicate devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
This device is an in vitro diagnostic device used to measure various substances in human samples (serum, plasma, urine) to aid in the diagnosis and treatment of diseases, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device" for all listed assays, and that the measurements are "used in the diagnosis and treatment" of various conditions.
No
The device is described as an "in vitro diagnostic device" and the performance studies compare it to other methods for measuring analytes in human serum, plasma, or urine. This strongly suggests a physical instrument or kit is involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states for each assay: "The Bayer ADVIA IMS [Assay Name] assay is an in vitro diagnostic device intended to measure..." This directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
CIT, CGX, DLZ, JLB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 IMS methods (AST, CK, Creatinine, Phenobarbital) and predicate devices. Key performance indicators presented include analytical range, precision (total), regression equation (correlation to existing systems), and interference studies.
AST Method:
Analytical Range: 0 to 1000 U/L
Precision (Total):
mean (U/L): 30, %CV: 4.2
mean (U/L): 63, %CV: 2.4
mean (U/L): 153, %CV: 1.6
Interfering Substances: Hemolysis (Hemoglobin) at 500 mg/dL, AST 90 U/L, Effect 59% Change; Bilirubin (conjugated) at 20 mg/dL, AST 89 U/L, Effect -3% Change; Bilirubin (unconjugated) at 25 mg/dL, AST 88 U/L, Effect 0% Change; Lipemia (Triglycerides) at 500 mg/dL, AST 96 U/L, Effect 3% Change.
CK Method:
Analytical Range: 0 to 2200 U/L
Precision (Total):
mean (U/L): 97, %CV: 1.9
mean (U/L): 231, %CV: 1.3
mean (U/L): 562, %CV: 1.3
Interfering Substances: Hemoglobin at 500 mg/dL, CK 113 U/L, Effect 28% Change; Bilirubin (conjugated) at 20 mg/dL, CK 112 U/L, Effect -2% Change; Bilirubin (unconjugated) at 25 mg/dL, CK 109 U/L, Effect 0% Change; Lipemia (Triglycerides) at 500 mg/dL, CK 114 U/L, Effect -4% Change.
Creatinine Method (Serum):
Analytical Range: 0 to 30 mg/dL
Imprecision (Total):
Level 1: Mean 1.10 mg/dL, %CV 2.96
Level 2: Mean 2.82 mg/dL, %CV 2.99
Level 3: Mean 5.67 mg/dL, %CV 1.70
Interfering Substances: Hemoglobin at 1000 mg/dL, Creatinine 2.98 mg/dL, Effect +7% Change; Bilirubin (conjugated) at 18.8 mg/dL, Creatinine 2.94 mg/dL, Effect -8% Change; Bilirubin (unconjugated) at 25 mg/dL, Creatinine 3.02 mg/dL, Effect -5% Change; Lipemia (Triglycerides) at 1000 mg/dL, Creatinine 3.08 mg/dL, Effect -2% Change.
Creatinine Method (Urine):
Analytical Range: 0 to 300 mg/dL
Imprecision (Total):
Level 1: Mean 63.80 mg/dL, %CV 2.89
Level 2: Mean 111.30 mg/dL, %CV 2.33
Level 3: Mean 155.0 mg/dL, %CV 2.13
Interfering Substances: Ascorbic Acid at 220 mg/dL, Creatinine 60.36 mg/dL, Effect
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Aspartate Aminotransferase (AST) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Aspartate Ammotransferase (AST) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM® 1 AST method). The information was extracted from the Bayer ADVIA IMS AST method and Bayer CHEM 1 AST method sheet.
INTENDED USE
The Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay is an in-vitro diagnostic device intended to measure AST in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain liver diseases and heart diseases.
| AST METHOD: | ADVIA IMS | CHEM 1 |
|---|---|---|
| Part Number: | Reagents B41-3722-23 | T01-1631-53 |
| Analytical Range: | 0 to 1000 U/L | 0 to 1030 U/L |
| Precision (Total): | mean (U/L) | % CV |
| 30 | 4.2 | |
| 63 | 2.4 | |
| 153 | 1.6 | |
| mean (U/L) | % CV | |
| 31 | 4.1 | |
| 231 | 2.1 | |
| 369 | 3.6 | |
| Regression Equation: (serum) | $y = 0.99x - 2.8$ | |
| where: | y = ADVIA IMS | |
| x = Chem 1 | ||
| n = 66 | ||
| r = 0.998 | ||
| Sy.x = 16.9 | ||
| range = 16 to 910 U/L | ||
| Regression Equation: (plasma qualification) | $y = 0.975x + 0.7$ | |
| where: | y = plasma | |
| x = serum | ||
| n = 53 | ||
| r = 0.997 | ||
| Sy.x = 0.77 | ||
| range = 14 to 69 U/L |
1
| | Interfering Substance
Concentration | AST
(U/L) | Effect
% Change |
|--------------------------|----------------------------------------|--------------|--------------------|
| Hemolysis (Hemoglobin) | 500 mg/dL | 90 | 59 |
| Bilirubin (conjugated) | 20 mg/dL | 89 | -3 |
| Bilirubin (unconjugated) | 25 mg/dL | 88 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 96 | 3 |
Gabriel J. Murray Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Date 6/22/99
2
Creatine Kinase (CK) Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA IMS Creatine Kinase (CK) method and a similar device that was granted clearance of substantial equivalence (Bayer CHEM 1® CK method). The information was extracted from the Bayer ADVIA IMS CK method and Bayer CHEM 1 CK method sheet.
INTENDED USE
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in-vitro diagnostic device intended to measure CK in human serum or plasma. Such measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases.
| CK METHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3729-23 | T01-1491-53 | ||
| Analytical Range: | 0 to 2200 U/L | 0 to 2200 U/L | ||
| Precision (Total): | mean | |||
| (U/L) | % CV | mean | ||
| (U/L) | % CV | |||
| 97 | 1.9 | 142 | 2.0 | |
| 231 | 1.3 | 407 | 2.9 | |
| 562 | 1.3 | 457 | 2.3 | |
| Regression Equation: | ||||
| (serum) | y = 0.99x + 2.7 | |||
| where: | y | = ADVIA IMS | ||
| x | = Chem 1 | |||
| n | = 67 | |||
| r | = 0.999 | |||
| Sy.x | = 18.2 | |||
| range | = 4 to 1873 U/L | |||
| Regression Equation: | ||||
| (plasma qualification) | y = 1.01x - 0.3 | |||
| where: | y | = plasma | ||
| x | = serum | |||
| n | = 60 | |||
| r | = 0.999 | |||
| Sy.x | = 2.8 | |||
| range | = 37 to 472 U/L |
3
| | Interfering Substance
Concentration | CK
(U/L) | Effect
% Change |
|--------------------------|----------------------------------------|-------------|--------------------|
| Hemoglobin | 500 mg/dL | 113 | 28 |
| Bilirubin (conjugated) | 20 mg/dL | 112 | -2 |
| Bilirubin (unconjugated) | 25 mg/dL | 109 | 0 |
| Lipemia (Triglycerides) | 500 mg/dL | 114 | -4 |
Gabriel A. Munoz Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/22/99
Date
4
Creatinine Method for the ADVIA™ IMS Systems
Listed below is a comparison of the performance of the Bayer ADVIA Creatinine method and a similar device that was granted clearance of substantial equivalence (Bayer Chem 1® Creatinine method). The information was extracted from the Bayer ADVIA IMS Creatinine method sheet.
INTENDED USE
The Bayer ADVIA IMS Creatinine assay is an in-vitro diagnostic device intended to measure Creatinine in human serum, plasma, or urine. Such measurements are used in the diagnosis, monitoring and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
SERUM
| CREATININE
| METHOD: | ADVIA IMS | CHEM 1 | ||
|---|---|---|---|---|
| Part Number: | Reagents B41-3730-46 | |||
| Calibrators T03-1291-62 | T01-1456-53 | |||
| T03-1291-62 | ||||
| Analytical Range: | 0 to 30 mg/dL | 0.3 to 29 mg/dL | ||
| Imprecision (Total): | Mean | |||
| (mg/dL) | % CV | |||
| Level 1 | 1.10 | 2.96 | 1.3 | 5.6 |
| Level 2 | 2.82 | 2.99 | 9.0 | 2.3 |
| Level 3 | 5.67 | 1.70 | 15.1 | 2.6 |
| Correlation to existing system | |
|---|---|
| Regression Equation: y = 0.96x + 0.38 | |
| where: | y = ADVIA IMS |
| x = Chem 1 | |
| n = 108 (54 samples in duplicate) | |
| r = 0.999 | |
| Sy.x = .31 | |
| range = 0.4 to 28.9 mg/dL |
Gabriel J. Munoz Jr.
6/22/99
5
| Plasma Qualification | |
|---|---|
| Regression Equation: y=0.96X +0.05 | |
| where: | y = plasma |
| x = serum | |
| n = 119 (60 samples in duplicate) | |
| r = 0.98 | |
| Sy.x = 0.03 | |
| range = .69 to 1.55 mg/dL |
| | Interfering Substance
Concentration | Creatinine
Concentration | Effect
% Change |
|--------------------------|----------------------------------------|-----------------------------|--------------------|
| Hemoglobin | 1000 mg/dL | 2.98 mg/dL | +7 |
| Bilirubin (conjugated) | 18.8 mg/dL | 2.94 mg/dL | -8 |
| Bilirubin (unconjugated) | 25 mg/dL | 3.02 mg/dL | -5 |
| Lipemia (Triglycerides) | 1000 mg/dL | 3.08 mg/dL | -2 |
URINE
| CREATININE
| METHOD: | ADVIA IMS | CHEM 1 |
|---|---|---|
| Part Number: | Reagents B41-3730-46 | |
| Calibrators T03-1291-62 | T01-1456-53 | |
| T03-1291-62 | ||
| Analytical Range: | 0 to 300 mg/dL | 2.4 to 232 mg/dL |
| (0.3 mg/dL to 29.0mg/dL for undiluted samples) | ||
| Imprecision (Total): | Mean | |
| (mg/dL) | mean | |
| (mg/dL) | ||
| % CV | % CV | |
| Level 1 | 63.80 | |
| 2.89 | 31 | |
| 3.5 | ||
| Level 2 | 111.30 | |
| 2.33 | 51 | |
| 3.3 | ||
| Level 3 | 155.0 | |
| 2.13 | 119 | |
| 4.1 |
Gabriel J. Munoz, Jr.
6/22/99
6
| Correlation to existing system | |
|---|---|
| Regression Equation: $y = 1.01x - 0.06$ | |
| where: | |
| y | = ADVIA IMS |
| x | = Chem 1 |
| n | = 102 (51 samples in duplicate) |
| r | = 0.998 |
| Sy.x | = 4.01 |
| range | = 7 to 352 mg/dL |
| | Interfering Substance
Concentration | Creatinine
Concentration | Effect
% Change |
|----------------|----------------------------------------|-----------------------------|--------------------|
| Ascorbic Acid | 220 mg/dL | 60.36 mg/dL | Trade Name: 4 Additional Assays for the Bayer ADVIA® Integrated Modular System (IMS) Regulatory Class: II Product Code: CIT, CGX, DLZ, JLB Dated: September 3, 1999 Received: September 7, 1999
Dear Mr. Muraca:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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
9
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 Sutman
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
10
Attachment 6
Page Page of
510(k) Number (if known): K992136
Device Name: Bayer ADVIA® Integrated Modular System (IMS)
Indications For Use:
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Sugh measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne's dystrophy.
The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes.
The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.
(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)
(Division Sign-Off)
sion of Clinical Laboratory Devices
her A992136