(132 days)
For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.
Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.
Not Found
This is a 510(k) clearance letter for a device called "Total Bilirubin L3K, Model 295-10 and 295-30," which is an in vitro diagnostic (IVD) test system. The document states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on:
- Device Name: Total Bilirubin L3K, Model 295-10 and 295-30
- Regulation Number/Name: 21 CFR Sec. 862.1110, Bilirubin (total or direct) test system
- Regulatory Class: Class II
- Product Code: CIG
- Submission Date: December 5, 2008 (Received December 8, 2008)
- Clearance Date: December 16, 2008
- Manufacturer: Genzyme Diagnostics P.E.I. Inc.
- Intended Use: For the in vitro quantitative measurement of Total Bilirubin in serum and plasma, used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases, and disorders involving the metabolism of bilirubin.
To answer your specific questions, I would need access to the actual 510(k) submission document (K082210) itself, which would detail the performance data, acceptance criteria, and study methodologies used to demonstrate substantial equivalence. This clearance letter is merely the FDA's decision based on that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
DEC 1 6 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Genzyme Diagnostics P.E.I. Inc c/o Ms. Penny J White 70 Watts Avenue Charlottetown, Prince Edward Island C1E 2B9, Canada
K082210 Trade/Device Name: Total Bilirubin L3K, Model 295-10 and 295-30 Regulation Number: 21CFR Sec.- 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: December. 5, 2008 Received: December 8, 2008
Dear Ms White:
Re:
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 (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.
Sean 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
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Indication for Use
510(k) Number (if known):
Device Name: Total Bilirubin L3K® Assay (295 Series)
Indication For Use:
For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.
Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Sean Cooper
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082210
§ 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.