(96 days)
Not Found
Not Found
No
The description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.
No.
The device is an in vitro diagnostic test reagent used for quantitative determination of albumin in serum, which aids in diagnosis and treatment monitoring but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic test reagent" and that "Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia". This clearly indicates its role in diagnosis.
No
The device is described as an "in vitro diagnostic test reagent" and a "test kit," which are physical components used in a laboratory setting. It involves a chemical reaction and detection at a specific wavelength, indicating hardware (spectrophotometer or similar) is required for its use. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test reagent" and is used for the "quantitative determination of albumin in serum." It also mentions its use in the "treatment and diagnosis" of various conditions, which is a key characteristic of IVDs.
- Device Description: The description reiterates that it is an "in vitro diagnostic test reagent."
- Method: The method described involves analyzing a biological sample (serum) outside of the body ("in vitro").
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
CIX
Device Description
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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
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Intended User / Care Setting
suitably qualified laboratory personnel under appropriate laboratory conditions.
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
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAR 2 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. P. Armstrong Regulatory Affairs RANDOX LABORATORIES LTD. Biochemical Manufacturers Ardmore, Diamond Road Co. Antrim UNITED KINGDOM BT29 4QY
Re: K984494 Trade Name: Randox Albumin Regulatory Class: II Product Code: CIX Dated: January 21, 1999 Received: February 12, 1999
Dear Dr. Armstrong:
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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Page 2
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 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
| Page of | 1 of 1 |
|---|---|
| --------- | -------- |
| 510(k) Number (if known) | UNKNOWN K984494 |
|---|---|
| Device Name | ALBUMIN (BROMOCRESOL GREEN METHOD) |
Indications For Use :
The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Sean Cooper
vision Sign-Off vision of Clinical Laboratory Devices 1984494 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use i (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)