(65 days)
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No
The description details a chemical assay based on a colorimetric reaction and absorbance measurement, with no mention of AI or ML.
No
Explanation: The device is an in vitro diagnostic assay used for the quantitative determination of direct bilirubin, which aids in diagnosis and treatment monitoring, but does not directly deliver therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the "Measurement of direct bilirubin...is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders." This clearly indicates its role in diagnosis.
No
The device description clearly states it is an "in vitro diagnostic assay" which involves chemical reactions and measurement of absorbance, indicating it is a physical kit or reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of direct bilirubin in human serum and plasma. This indicates that it is used to test samples taken from the human body.
- Device Description: The "Device Description" section further clarifies that it is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum and plasma. The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living organism.
- Purpose: The assay is used in the diagnosis and treatment of various medical conditions (liver, hemolytic hematological, and metabolic disorders). This is a key characteristic of IVDs, which are used to provide information for diagnostic purposes.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct 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, JIT
Device Description
Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum and plasma. Direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is proportional to the direct bilirubin concentration.
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
Comparative performance studies were conducted using the AEROSET System and ARCHITECT c8000 System. The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer. On the AEROSET System, the correlation coefficient = 0.995, slope = 1.08, and the Y-intercept = 0.21 mg/dL. On the ARCHITECT c8000 System, the correlation coefficient = 0.996, slope = 1.08, and the Y-intercept = 0.21 mg/dL. Precision studies were conducted using the Direct Bilirubin assay. Within-run, between-run, and between-day studies were performed using four levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 3.6 to 4.1%, Level 2 ranged from 0.9 to 2.6%, Level 3 ranged from 1.0 to 2.7%, and Level 4 ranged from 0.7 to 2.6 %. On the ARCHITECT c8000 System, the total %CV for Level 1 ranged from 3.0 to 3.6%, Level 2 ranged from 0.9 to 1.2%, Level 3 ranged from 1.3 to 1.5%, and Level 4 ranged from 0.8 to 1.1 %. The Direct Bilirubin assay range is 0.1 to 16.9 mg/dL. The limit of quantitation (sensitivity) of the Direct Bilirubin assay is 0.04 mg/dL on the AEROSET System and 0.04 mg/dL on the ARCHITECT c8000 System. These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer.
Key Metrics
Correlation coefficient = 0.995 (AEROSET), 0.996 (ARCHITECT c8000); Slope = 1.08; Y-intercept = 0.21 mg/dL; Total %CV for Level 1 ranged from 3.6 to 4.1% (AEROSET) and 3.0 to 3.6% (ARCHITECT c8000); Total %CV for Level 2 ranged from 0.9 to 2.6% (AEROSET) and 0.9 to 1.2% (ARCHITECT c8000); Total %CV for Level 3 ranged from 1.0 to 2.7% (AEROSET) and 1.3 to 1.5% (ARCHITECT c8000); Total %CV for Level 4 ranged from 0.7 to 2.6 % (AEROSET) and 0.8 to 1.1 % (ARCHITECT c8000); Assay range is 0.1 to 16.9 mg/dL; Limit of quantitation (sensitivity) is 0.04 mg/dL.
Predicate Device(s)
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Reference Device(s)
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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.
0
6 2002 SEP
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, TX 75038
Contact Person Michele Smith-Waheed Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-7466 Fax (972) 753-3367
| Date of Preparation of this Summary: | June 28, 2002 |
|---|---|
| Device Trade or Proprietary Name: | Direct Bilirubin |
| Device Common/Usual Name or Classification Name: | Direct Bilirubin |
| Classification Number/Class: | CIG, 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: KO 22180
Test Description:
Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum and plasma. Direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is proportional to the direct bilirubin concentration.
Section II Page 1
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1
Substantial Equivalence:
The Direct Bilirubin assay is substantially equivalent to the Roche Direct Bilirubin assay on the Hitachi® 717 Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro colorimetric assays.
- Both assays can be used for the quantitative determination of direct bilirubin. .
- Both assays yield similar clinical results. .
- Both assays are based on the reaction of bilirubin with a diazonium salt in the . presence of acid.
Differences:
- . Human serum and plasma are suitable specimens for the Direct Bilirubin assay and only human serum is a suitable specimen for Roche Direct Bilirubin assay.
- . There is a difference between the assay ranges.
- . There is a difference in the use of calibrators.
Intended Use:
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma.
Section II Page 2
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Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System and ARCHITECT® c8000™ System. The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer. On the AEROSET System, the correlation coefficient = 0.995, slope = 1.08, and the Y-intercept = 0.21 mg/dL. On the ARCHITECT c8000 System, the correlation coefficient = 0.996, slope = 1.08, and the Y-intercept = 0.21 mg/dL. Precision studies were conducted using the Direct Bilirubin assay. Within-run, between-run, and between-day studies were performed using four levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 3.6 to 4.1%, Level 2 ranged from 0.9 to 2.6%, Level 3 ranged from 1.0 to 2.7%, and Level 4 ranged from 0.7 to 2.6 %. On the ARCHITECT c8000 System, the total %CV for Level 1 ranged from 3.0 to 3.6%, Level 2 ranged from 0.9 to 1.2%, Level 3 ranged from 1.3 to 1.5%, and Level 4 ranged from 0.8 to 1.1 %. The Direct Bilirubin assay range is 0.1 to 16.9 mg/dL. The limit of quantitation (sensitivity) of the Direct Bilirubin assay is 0.04 mg/dL on the AEROSET System and 0.04 mg/dL on the ARCHITECT c8000 System. These data demonstrate that the performance of the Direct Bilirubin assay is substantially equivalent to the performance of the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer.
Conclusion:
The Direct Bilirubin assay is substantially equivalent to the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Section II Page 3
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, represented by three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2002
Ms. Michele Smith-Waheed Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, TX 75038
Re: K022180
Trade/Device Name: Direct bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total and direct) Test System Regulatory Class: Class II Product Code: CIG, JIT Dated: June 28, 2002 Received: July 3, 2002
Dear Ms. Smith-Waheed:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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
5
510(k) Number (if known): KO22-180
Direct Bilirubin Device Name: . . .
Indications For Use:
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct 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.
(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)
Veronica P. O'Brien for Di Juan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022180
Direct Bilirubin 510(k) 6/28/2002 Bil D 5 RI doc