(345 days)
Not Found
No
The device description and performance studies focus on a chemical oxidation method and standard analytical performance metrics, with no mention of AI or ML.
No
The device is an in vitro diagnostic tool used to measure total bilirubin, assisting in the diagnosis and treatment of conditions, but it does not directly treat or prevent a disease or condition.
Yes
The intended use explicitly states "Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis." This indicates the device provides information for diagnostic purposes.
No
The device description clearly indicates it is a reagent kit used on specific hardware systems (ADVIA Chemistry Systems) for in vitro diagnostic testing, not a software-only application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Device Description: The "Device Description" also confirms its use "for the in vitro quantitative determination of total bilirubin in human serum and plasma".
- Nature of the Test: The device performs a chemical analysis of a biological sample (serum and plasma) outside of the body ("in vitro") to diagnose or treat medical conditions.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of total billrubin in human serum and plasma on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.
Product codes
JFM
Device Description
The ADVIA Chemistry Total Bilirubin_2 is used for the in vitro quantitative determination of total bilirubin in human serum and plasma on the ADVIA® Chemistry Systems. The proposed labeling indicates the ADVIA Chemistry Total Bilirubin_2 reagents can be used on the ADVIA Chemistry Systems 1650, 1800, 2400, and 1200.
The Total Bilirubin_2 assay is based on a chemical oxidation method, utilizing vanadate r no Toxidizing agent. Total bilirubin (conjugated and unconjugated) is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both conjugated and unconjugated bilirubin are oxidized. This oxidation vanadato, both conjudical and the optical density of the yellow color, which is specific to roudon badded a accease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances, serum/plasma equivalency, and analytical range. All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Chemistry Total Bilirubin_2 assay is substantially equivalent to the ADVIA IMS Total Bilirubin assay that is currently marketed.
Imprecision (Serum) study:
- ADVIA Chemistry 1650/1800:
- Level (mg/dL) 1.0, Total CV (%) 2.0
- Level (mg/dL) 7.1, Total CV (%) 2.6
- Level (mg/dL) 15.4, Total CV (%) 3.2
- Level (mg/dL) 22.1, Total CV (%) 1.2
- Level (mg/dL) 27.5, Total CV (%) 1.1
- ADVIA Chemistry 2400:
- Level (mg/dL) 1.0, Total CV (%) 4.7
- Level (mg/dL) 7.2, Total CV (%) 2.3
- Level (mg/dL) 15.5, Total CV (%) 1.6
- Level (mg/dL) 21.8, Total CV (%) 1.0
- Level (mg/dL) 27.1, Total CV (%) 1.5
- ADVIA Chemistry 1200:
- Level (mg/dL) 1.1, Total CV (%) 3.6
- Level (mg/dL) 7.6, Total CV (%) 1.3
- Level (mg/dL) 14.7, Total CV (%) 1.4
- Level (mg/dL) 22.1, Total CV (%) 1.4
- Level (mg/dL) 27.6, Total CV (%) 1.7
- ADVIA IMS:
- Level (mg/dL) 0.8, Total CV (%) 8.2
- Level (mg/dL) 6.7, Total CV (%) 2.1
- Level (mg/dL) 16.7, Total CV (%) 2.4
Correlation (y = ADVIA Chemistry Total Bilirubin_2, x = comparison system) study:
- Specimen type, System (y): Serum, ADVIA 1650; Comparison System (x): ADVIA IMS; N: 118; Regression Equation: y = 0.925x + 0.12; Syx (mg/dL): 0.42; r: 0.998; Sample Range (mg/dL): 0.2 - 26.8
- Specimen type, System (y): Serum, ADVIA 2400; Comparison System (x): ADVIA 1650; N: 119; Regression Equation: y = 0.999x - 0.02; Syx (mg/dL): 0.19; r: 1.000; Sample Range (mg/dL): 0.3 - 24.4
- Specimen type, System (y): Serum, ADVIA 1200; Comparison System (x): ADVIA 1650; N: 119; Regression Equation: y = 1.036x - 0.05; Syx (mg/dL): 0.21; r: 1.000; Sample Range (mg/dL): 0.3 - 24.4
Interfering Substances study:
- Ascorbic acid: Conc. (mg/dL) 50; Total Bilirubin Conc. (mg/dL) ADVIA 1650/1800: 1.30, ADVIA 2400: 1.29, ADVIA 1200: 1.33; Effect (% change) ADVIA 1650/1800: -1.16, ADVIA 2400: -4.65, ADVIA 1200: 0.00
- Hemoglobin: Conc. (mg/dL) 1000; Total Bilirubin Conc. (mg/dL) ADVIA 1650/1800: 1.18, ADVIA 2400: 1.22, ADVIA 1200: 1.36; Effect (% change) ADVIA 1650/1800: 6.80, ADVIA 2400: -2.1, ADVIA 1200: 7.0
- Lipids (Triglycerides): Conc. (mg/dL) 750; Total Bilirubin Conc. (mg/dL) ADVIA 1650/1800: 1.11, ADVIA 2400: 1.11, ADVIA 1200: 1.12; Effect (% change) ADVIA 1650/1800: 8.6, ADVIA 2400: 6.8, ADVIA 1200: 7.2
Analytical Range (Serum/Plasma):
- ADVIA 1650/1800: 0.1 - 35.0 mg/dL
- ADVIA 2400: 0.1 - 35.0 mg/dL
- ADVIA 1200: 0.1 - 35.0 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
DEC 0 7 2007
| Submitter information Contact person: | Philip Liu
Manager, Regulatory Affairs & Compliance |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Siemens Medical Solutions Diagnostics
(formerly Bayer HealthCare, LLC, Diagnostics Division)
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2443
914-524-2500 (fax) |
| Date summary prepared: | November 30, 2007 |
| Device Trade or Proprietary Name: | ADVIA® Chemistry Total Bilirubin_2 |
| Device Common/Usual Name or Classification Name: | Total Bilirubin Reagent/Test System |
| Classification Number/Class: | JFM/Class II |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K063845
Predicate Devices:
| Predicate Device | |
|---|---|
| Device Name | ADVIA® IMS |
| Common name | Total Bilirubin |
| 510(k) Number | K992399 |
| Manufacturer | Bayer HealthCare LLC |
Device Description:
The ADVIA Chemistry Total Bilirubin_2 is used for the in vitro quantitative determination of total bilirubin in human serum and plasma on the ADVIA® Chemistry Systems. The proposed labeling indicates the ADVIA Chemistry Total Bilirubin_2 reagents can be used on the ADVIA Chemistry Systems 1650, 1800, 2400, and 1200.
1
The Total Bilirubin_2 assay is based on a chemical oxidation method, utilizing vanadate r no Toxidizing agent. Total bilirubin (conjugated and unconjugated) is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both conjugated and unconjugated bilirubin are oxidized. This oxidation vanadato, both conjudical and the optical density of the yellow color, which is specific to roudon badded a accease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.
Statement of Intended Use:
The ADVIA Chemistry Total Bilirubin_2 assay is for in vitro diagnostic use in the THE ADVIA Onemination of total bilirubin in human serum and plasma on the ADVIA® Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.
Comparison to the Predicate Device:
Similarities
| | ADVIA Chemistry Total
Bilirubin_2 | ADVIA IMS
(predicate device) |
|------------------|----------------------------------------------------------|----------------------------------------------------------|
| Intended Use | For the quantitative
determination of total bilirubin | For the quantitative
determination of total bilirubin |
| Specimen Type | Human serum or plasma
(lithium heparin) | Human serum or plasma
(lithium heparin) |
| Reaction Type | Colorimetric endpoint | Colorimetric endpoint |
| Calibration | Single point | Single point |
| Expected Values* | 0.2 – 1.2 mg/dL | 0.2 - 1.2 mg/dL |
- Tietz NW, Clinical Guide to Laboratory Tests. 3th ed. Philadelphia, PA: WB Saunders Company, 1995:88-91
Differences
| | ADVIA Chemistry Total
Bilirubin_2 | ADVI IMS
(predicate device) |
|-----------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Principle | Vanadate oxidation | Diazotized sulfanilic acid with
blank |
| Reagents | Two liquid reagents contained
in system specific packaging | One lyophilized reagent,
diluent, and one liquid reagent
contained in system specific
packaging |
| Standardization | AACC Reference Method | AACC Reference Method |
Siemens Medical Solutions Diagnostics (formerly Bayer HealthCare, LLC) ADVIA Chemistry Total Bilirubin 2 Premarket Notification 510(k) Attachment #1- Revised 510(k) Summary November 30, 2007
2
Performance:
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances, serum/plasma equivalency, and analytical range. The following tables summarize the precision (total), interfering substances, analytical range, and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Chemistry Total Bilirubin_2 assay is substantially equivalent to the ADVIA IMS Total Bilirubin assay that is currently marketed.
Imprecision (Serum)
| ADVIA Chemistry
1650/1800 | | ADVIA Chemistry
2400 | | ADVIA Chemistry
1200 | | ADVIA IMS | |
|------------------------------|-----------------|-------------------------|-----------------|-------------------------|-----------------|------------------|-----------------|
| Level
(mg/dL) | Total CV
(%) | Level
(mg/dL) | Total CV
(%) | Level
(mg/dL) | Total CV
(%) | Level
(mg/dL) | Total CV
(%) |
| 1.0 | 2.0 | 1.0 | 4.7 | 1.1 | 3.6 | 0.8 | 8.2 |
| 7.1 | 2.6 | 7.2 | 2.3 | 7.6 | 1.3 | 6.7 | 2.1 |
| 15.4 | 3.2 | 15.5 | 1.6 | 14.7 | 1.4 | 16.7 | 2.4 |
| 22.1 | 1.2 | 21.8 | 1.0 | 22.1 | 1.4 | -- | -- |
| 27.5 | 1.1 | 27.1 | 1.5 | 27.6 | 1.7 | -- | -- |
Correlation (y = ADVIA Chemistry Total Bilirubin_2, x = comparison system)
| Specimen type,
System (y) | Comparison
System (x) | N | Regression
Equation | Syx
(mg/dL) | r | Sample Range
(mg/dL) |
|------------------------------|--------------------------|-----|------------------------|----------------|-------|-------------------------|
| Serum, ADVIA 1650 | ADVIA IMS | 118 | $y= 0.925x + 0.12$ | 0.42 | 0.998 | 0.2 - 26.8 |
| Serum, ADVIA 2400 | ADVIA 1650 | 119 | $y= 0.999x - 0.02$ | 0.19 | 1.000 | 0.3 - 24.4 |
| Serum, ADVIA 1200 | ADVIA 1650 | 119 | $y= 1.036x - 0.05$ | 0.21 | 1.000 | 0.3 - 24.4 |
Interfering Substances
| Interfering
Substance | Interfering
Substance
Conc.
(mg/dL) | Total Bilirubin Conc. (mg/dL) | | | Effect
(% change) | | |
|--------------------------|----------------------------------------------|-------------------------------|---------------|---------------|----------------------|---------------|---------------|
| | | ADVIA
1650/1800 | ADVIA
2400 | ADVIA
1200 | ADVIA
1650/1800 | ADVIA
2400 | ADVIA
1200 |
| Ascorbic acid | 50 | 1.30 | 1.29 | 1.33 | -1.16 | -4.65 | 0.00 |
| Hemoglobin | 1000 | 1.18 | 1.22 | 1.36 | 6.80 | -2.1 | 7.0 |
| Lipids (Triglycerides) | 750 | 1.11 | 1.11 | 1.12 | 8.6 | 6.8 | 7.2 |
Siemens Medical Solutions Diagnostics (formerly Bayer HealthCare, LLC) ADVIA Chemistry Total Bilirubin_2 Premarket Notification 510(k) Attachment #1- Revised 510(k) Summary November 30, 2007
3
Analytical Range (Serum/Plasma)
| ADVIA 1650/1800 | 0.1 - 35.0 mg/dL |
|---|---|
| ADVIA 2400 | 0.1 - 35.0 mg/dL |
| ADVIA 1200 | 0.1 - 35.0 mg/dL |
Conclusions:
The ADVIA Chemistry Total Bilirubin_2 assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the Bayer ADVIA IMS Total Bilirubin method (K992399).
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 7 2007
Baver Healthcare, LLC c/o Dr. Philip Liu Manager, Regulatory Affairs and Compliance 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K063845 Trade Name: Advia Chemistry Total Bilirubin 2 Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (Total or Direct) Test System. Regulatory Class: Class II Product Code: JFM Dated: November 30, 2007 Received: December 04, 2007
Dear Dr. Liu:
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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K063845
Device Name: ADVIA CHEMISTRY TOTAL BILIRUBIN_2
Indications For Use:
For in vitro diagnostic use in the quantitative determination of total billrubin in human serum and plasma on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Postuation and Safety
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