(63 days)
Not Found
None
No
The summary describes a reagent for quantitative determination of albumin, which is a chemical assay and does not involve AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is described as an "Invitro diagnostic in the quantitative determination of albumin in serum use or plasme," indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme."
No
The 510(k) summary describes a reagent for in vitro diagnostic use, which is a chemical substance, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme."
This statement clearly identifies the device's purpose as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum u se or plasme.
Product codes
CJW
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
Not Found
Key Metrics
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
Image /page/0/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - Visa. The logo features a stylized image of an eagle with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - VISA" is arranged in a circular pattern around the eagle image.
MAY 25 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
A.P. Total Care, Inc. Luis P. Leon c/o Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, CT
K990978 Re: Trade Name: Albumin BCG Regulatory Class: II Product Code: CJW March 18, 1999 Dated: March 23, 1999 Received:
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 yitro 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
ਹ lof Page_
510(k) Number (if known):_K990978
ALBUMIN BCG Device Name:_
Indications For Use:
THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum u se or plasme.
Tan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices K990978 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 (Per 21 CFR 801.109)
C
OR
Over-The-Counter Use_
(Optional Format 1-2-96)