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No
The device description and performance studies focus on a standard clinical chemistry assay based on a chemical reaction and absorbance measurement, with no mention of AI/ML techniques.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of total bilirubin, which aids in diagnosis and treatment monitoring, not for providing therapy directly.
Yes
The "Intended Use / Indications for Use" section states that the measurement of bilirubin "is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a chemical reaction involving oxidation and absorbance measurement, indicating it is a physical assay kit or system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is "used for the quantitation of total bilirubin in human serum or plasma" and that this measurement is "used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders". This clearly indicates the device is intended for use in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The description further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma."
- Predicate Device: The mention of a predicate device (K962919 Total Bilirubin on the Johnson & Johnson® Vitros™ System) which is also an IVD, reinforces the classification of this device as an IVD.
The core function of the device is to analyze a biological sample (serum or plasma) in a laboratory setting to provide quantitative data used in the diagnosis and treatment of medical conditions. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Product codes
CIG, JIX
Device Description
Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin is oxidized to biliverdin. The resulting decrease in absorbance at 444 nm is directly proportional to the concentration of total bilirubin.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Comparative performance studies were conducted using the AEROSET™ System. The Total Bilirubin assay method comparison yielded acceptable correlation with the Total Bilirubin on the Johnson & Johnson Vitros System. The correlation coefficient = 0.994, slope = 1.055, and Y-intercept = 0.009 mg/dL. Precision studies were conducted using the Total Bilirubin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 5.6% and Level 2/Panel 102 is 4.3%. The Total Bilirubin assay is linear up to 23.38 mg/dL. The limit of quantitation (sensitivity) for the Total Bilirubin assay is 0.13 mg/dL. These data demonstrate that the performance of the Total Bilirubin assay is substantially equivalent to the performance of the Total Bilirubin on the Johnson & Johnson Vitros System.
Key Metrics
correlation coefficient = 0.994, slope = 1.055, Y-intercept = 0.009 mg/dL, total %CV for Level 1/Panel 101 is 5.6%, total %CV for Level 2/Panel 102 is 4.3%, linear up to 23.38 mg/dL, limit of quantitation (sensitivity) is 0.13 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Affairs Specialist (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | September 4, 1998 |
|---|---|
| Device Trade or Proprietary Name: | TBil |
| Device Common/Usual Name or Classification Name: | Total Bilirubin |
| Classification Number/Class: | Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: KG83133
Test Description:
Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin is oxidized to biliverdin. The resulting decrease in absorbance at 444 nm is directly proportional to the concentration of total bilirubin.
Substantial Equivalence:
The Total Bilirubin assay is substantially equivalent to the following device: Total Bilirubin (K962919) on the Johnson & Johnson® Vitros™ System.
Total Bilirubin 510(k) September 4, 1998 TBil_5_V1.lwp
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Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of total bilirubin. .
- . Both assays yield similar clinical results.
- . Both assays are based on the oxidation of bilirubin to biliverdin
Differences:
- There is a difference between the assay range. .
Intended Use:
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Total Bilirubin assay method comparison yielded acceptable correlation with the Total Bilirubin on the Johnson & Johnson Vitros System. The correlation coefficient = 0.994, slope = 1.055, and Y-intercept = 0.009 mg/dL. Precision studies were conducted using the Total Bilirubin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 5.6% and Level 2/Panel 102 is 4.3%. The Total Bilirubin assay is linear up to 23.38 mg/dL. The limit of quantitation (sensitivity) for the Total Bilirubin assay is 0.13 mg/dL. These data demonstrate that the performance of the Total Bilirubin assay is substantially equivalent to the performance of the Total Bilirubin on the Johnson & Johnson Vitros System.
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Conclusion:
The Total Bilirubin assay is substantially equivalent to the Total Bilirubin on the Johnson & Johnson Vitros System as demonstrated by results obtained in the studies.
Total Bilirubin 510(k)
September 4, 1998 TBil_5_V1.lwp
Section II Page 3
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 6 1998
Linda Morris Senior Requlatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038
Re : K983133 Total Bilirubin Regulatory Class: II Product Code: CIG, JIX September 4, 1998 Dated: Received: September 8, 1998
Dear Ms. Morris:
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 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.
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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/dsmamain.html".
Sincerely yours,
Steven Litman
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
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510(k) Number (if known): H983133
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
(Division Sign-Off)
Division of Clinical Laboratory Devises
510(k) Number. h 983933
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Total Bilirubin 510(k) September 4, 1998 TBil 5 VI.Jwn