Albumin Test Rid Kit
by The Binding Site, Ltd. 510(k)
Active
510(k) K914391
Overview
The Albumin Test Rid Kit is a diagnostic in vitro device used for the qualitative detection of albumin in serum or urine samples. It employs immunochromatography to identify the presence of albumin antigens, aiding in the assessment of renal function or proteinuria screening.
This kit is supplied as a single-use, non-sterile reagent system intended for laboratory use. It is classified as a Class II device under FDA regulation 866.5040 and has been cleared via a 510(k) submission (K914391) with a decision of Substantially Equivalent. Components include antigen, antiserum, and control reagents, packaged for immunology testing environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914391 | Date10 Dec 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DCF
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5040
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Binding Site, Ltd.
Questions
What is the Albumin Test Rid Kit used for?
The Albumin Test Rid Kit is designed for the qualitative detection of albumin antigens in serum or urine samples. It helps clinicians assess renal function or screen for proteinuria by identifying the presence of albumin through immunochromatography. This is particularly useful in diagnosing conditions related to kidney health or protein leakage into urine.
How is the Albumin Test Rid Kit supplied and intended for use?
The kit is supplied as a single-use, non-sterile reagent system specifically intended for laboratory environments. It includes antigen, antiserum, and control reagents, all packaged for immunology testing. Due to its non-sterile nature, it is not suitable for direct patient use without further processing or preparation in a controlled lab setting.
Is the Albumin Test Rid Kit sterile?
No, the Albumin Test Rid Kit is explicitly labeled as non-sterile. This classification means it is not intended for direct implantation or use in sterile environments without additional sterilization or preparation. It is designed for laboratory use where sterility is managed through standard operating procedures.
What regulatory pathway was followed for this device?
The Albumin Test Rid Kit was cleared through the FDA’s 510(k) pathway, specifically under the classification of a Class II device (regulation number 866.5040). The submission was reviewed by the Immunology (IM) Advisory Committee and determined to be Substantially Equivalent (SESE) to a predicate device. The clearance number assigned is K914391.
Are there different models or sizes available for this kit?
The provided data does not specify multiple models or sizes for the Albumin Test Rid Kit. It is described as a single reagent system for qualitative albumin detection, implying a standardized format for laboratory use. For variations or custom configurations, direct inquiry with The Binding Site, Ltd. would be necessary.