(62 days)
Not Found
Not Found
No
The summary describes a reagent for laboratory testing and contains no mention of AI or ML.
No
The device is described as an in vitro diagnostic (IVD) reagent used for quantitative determination of bilirubin in serum or plasma. IVD devices are designed for diagnostic purposes, not for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents are for "Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma." This indicates that the device (reagents) is used to diagnose conditions by measuring bilirubin levels.
No
The device is described as reagents for in vitro diagnostic use, which are chemical substances, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma."
This statement directly identifies the intended use as "Invitro Diagnostic use," which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.
Product codes
CIG
Device Description
Not Found
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 2 1999
A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 Bridgeport, Connecticut 06606
Re: K991866 Trade Name: Bilirubin, Total and Direct Regulatory Class: II Product Code: CIG Dated: May 27, 1999 Received: June 1, 1999
Dear Mr. Leon:
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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 vours.
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
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Page 1 of 1
510 (k) NUMBER (IF KNOWN): K 99/8VA م
DEVICE NAME: BILIRUBIN
(Total and Direct)
IDICATIONS FOR USE:
The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (OED)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter-Use (Optional Format 1-2-96)