(61 days)
None
None
No
The summary describes a standard in vitro diagnostic test for albumin and contains no mention of AI, ML, or related concepts.
No.
The device is an in vitro diagnostic device used to measure albumin concentration, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Albumin measurements are used in the diagnosis and treatment of numerous diseases".
No
The 510(k) summary describes an "in vitro device intended to measure albumin concentration quantitatively in serum or plasma." This description strongly suggests a physical device that interacts with biological samples, not a software-only device. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "An albumin test system is an in vitro device..." This directly identifies the device as an in vitro device.
- "...intended to measure albumin concentration quantitatively in serum or plasma." This describes the device's function, which is to analyze biological samples (serum or plasma) outside of the body.
- "Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys." This indicates the clinical purpose of the measurements, which is for diagnostic and treatment decisions.
These points align perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of disease.
N/A
Intended Use / Indications for Use
An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
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 (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.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 7 2002
Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. P.O. Box 2219 Longview, WA 98632
Re: K021636 Trade/Device Name: Albumin Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CJW Dated: May 10, 2002 Received: May 17, 2002
Dear Dr. Legaz:
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. Ilisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours.
Steven Putman
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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Indication for Use
Trade Name of the Device:
Albumin Reagent
510(k) Number: K021636
Classification Name; Number: Albumin Test System; 21 CFR §862.1035
Indications for Use
An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Lan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K021636