(63 days)
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No
The provided text describes a device for quantitative determination of direct bilirubin, a standard laboratory test. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is for the quantitative determination of direct bilirubin, which is used in diagnosis and treatment monitoring, but it does not directly provide therapy or treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's measurement is "used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage," which directly implies a diagnostic purpose.
No
The 510(k) summary describes a device for the quantitative determination of direct bilirubin in serum or plasma, which implies a laboratory or point-of-care testing device that would involve hardware for sample analysis. The lack of a device description prevents confirmation, but the intended use strongly suggests a physical device, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of direct bilirubin in serum or plasma." This involves testing biological samples (serum or plasma) outside of the body (in vitro).
- Clinical Significance: The intended use also explains that the measurement of bilirubin is used in the "diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders." This clearly indicates a medical purpose related to diagnosing or monitoring health conditions.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bilirubin is an organic compound formed during the normal catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
Product codes
CIG
Device Description
Direct Bilirubin Reagent
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
AUG 2 7 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. P.O. Box 2219 Longview, WA 98632
Re: K011972 Trade/Device Name: Direct Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulatory Class: II Product Code: CIG Dated: June 12, 2001 Received: June 25, 2001
Dear Dr. Legaz:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 nouncation. The I Dri imamig of succion 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 1 If you desire specific advice for your actives), please contact the Office of Compliance at additionally 807.10 for in vito allegitestions on the promotion and advertising of your device, (301) 594-4566. Additionally, Ice quice 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 Information on your responsionates and er Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Somber 11ttp://www.fda.gov/cdrb/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
2
Indication for Use
Trade Name of the Device: Direct Bilirubin Reagent
510(k) Number:
Classification Name; Number:
Bilirubin (total or direct) Test System; 21 CFR §862.1110
Indications for Use
whis Jor Use A onfraom tool by seem or plasma. Bilirubin is an organic compound formed during the qualifical voly in berain of pred blood cells and its measurement is used in the normal and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
prescription use
Kesia Alexander for Juan Cuper
510(k) Number