(68 days)
The quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use.
Not Found
This is a 510(k) clearance letter for an in vitro diagnostic device (Bilirubin-SL (Total) Assay), which means the FDA has determined it is substantially equivalent to a predicate device. For such devices, detailed studies proving device performance against specific acceptance criteria, including sample sizes, expert qualifications, and ground truth methodologies, are typically found in the 510(k) submission itself, not directly in the clearance letter or the Indications for Use statement provided here.
The provided document does not contain the information requested in points 1-9 regarding the acceptance criteria and the study proving the device meets those criteria. Such details are usually part of the applicant's 510(k) submission, specifically within the performance data sections.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.
The document only provides:
- Trade/Device Name: Bilirubin-SL (Total) Assay
- Regulation Number: 21 CFR 862.1110
- Regulation Name: Bilirubin (total or direct) test system
- Regulatory Class: Class II
- Product Code: CIG
- Indications for Use: The quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use.
To obtain the detailed study information, one would need to access the full 510(k) submission (K023330) which is typically available through the FDA's public access policies, but not contained within this particular letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Rockville MD 20850
Ms. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown PE Canada C1E 2A6 ·
Re: K023330
Trade/Device Name: Bilirubin-SL (Total) Assay Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: October 3, 2002 Received: October 4, 2002
Dear Ms. Olscamp:
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).
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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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Diagnostic Chemicals Limited i10(K) Notification
Bilirubin-SL (Total) Assay Cat. No. 284-10/30
INDICATIONS FOR USE
K023330 510(k) Number (if known): Not Known
Bilirubin-SL (Total) Assay Device Name:
Indications for Use:
Bilirubin is a bile pigment normally found in serum as a result of red cell destruction. It is a product of hemoglobin breakdown by the reticuloendothelial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted.
The elevation of total serum bilirubin may occur due to hemolytic processes, liver disease, or a disorder of the biliary tract.
he quantitative determination of Bilirubin (Total) in serum. For IN VITRO diagnostic use. Г
(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
teoin Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
§ 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.