(132 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. It describes a quantitative measurement of a chemical in a biological sample, which is typically performed using standard laboratory techniques.
No.
The device is intended for in vitro diagnostic measurement of Total Bilirubin, which is used in the diagnosis and management of diseases, rather than directly treating them.
Yes
The device is used for the quantitative measurement of Total Bilirubin, which is explicitly stated to be "used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin." This indicates its role in identifying or characterizing a disease or condition.
No
The 510(k) summary describes an in vitro diagnostic device for measuring Total Bilirubin in serum and plasma, which inherently involves laboratory equipment and reagents, not just software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma." The term "IN VITRO" is a key indicator of an IVD, meaning it's used to test samples taken from the body (like serum and plasma) outside of the body.
- Purpose: The purpose of the measurement is for "diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin." This aligns with the typical use of IVDs in diagnosing and monitoring medical conditions.
The other sections being "Not Found" or "Not Applicable" do not negate the fact that the intended use clearly defines it as an in vitro diagnostic test.
N/A
Intended Use / Indications 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.
Product codes
CIG
Device Description
Total Bilirubin L3K, Model 295-10 and 295-30
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.
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).
1
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
2
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