Quickstart Albumin BCP (ALBP)#5A16
by Em Diagnostic Systems, Inc. 510(k)
Active
510(k) K913025
Overview
The Quickstart Albumin BCP (ALBP)#5A16 is an in vitro diagnostic reagent designed for the quantitative determination of albumin in serum or plasma using the bromcresol purple dye-binding method. It falls under the category of bromcresol purple dye-binding reagents, a type of clinical chemistry assay used to measure protein levels in patient samples.
This single-use reagent is supplied as a ready-to-use liquid for immediate clinical application in point-of-care or laboratory settings. It requires no additional preparation beyond standard handling procedures and is intended for use with compatible automated or semi-automated clinical chemistry analyzers. The device is classified under FDA regulation 862.1035 and holds a 510(k) clearance (K913025) for clinical chemistry applications, ensuring compliance with U.S. regulatory standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913025 | Date9 Oct 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- Withdrawn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
- Full name
- Abbott Quickstart Albumin Bcp (Albp)#5A16
- 510(k) Number
- FDA Product Code
- CJW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1035
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Em Diagnostic Systems, Inc.
Questions
What is the Quickstart Albumin BCP (ALBP)#5A16 used for?
This reagent is designed for the quantitative determination of albumin levels in serum or plasma samples. It employs the bromcresol purple dye-binding method, a standard clinical chemistry assay to measure protein concentrations accurately. This is particularly useful in diagnosing and monitoring conditions related to protein metabolism, such as liver disease, malnutrition, or kidney disorders.
How is the Quickstart Albumin BCP (ALBP)#5A16 supplied and prepared for use?
The Quickstart Albumin BCP (ALBP)#5A16 is supplied as a ready-to-use liquid reagent, eliminating the need for additional preparation beyond standard handling procedures. It is intended for immediate clinical application in both point-of-care and laboratory settings. Simply ensure compatibility with automated or semi-automated clinical chemistry analyzers before use.
Is the Quickstart Albumin BCP (ALBP)#5A16 single-use or reusable?
This reagent is explicitly designed for single-use only. Each unit is intended to be used once per patient sample to maintain accuracy, reliability, and sterility. Reusing the reagent could compromise test results and introduce contamination risks.
What types of analyzers are compatible with this reagent?
The Quickstart Albumin BCP (ALBP)#5A16 is compatible with automated or semi-automated clinical chemistry analyzers. Compatibility is ensured through its formulation as a ready-to-use liquid, which aligns with standard operating protocols for these systems. Always verify compatibility with your specific analyzer model before use.
What regulatory clearance does the Quickstart Albumin BCP (ALBP)#5A16 hold?
This reagent holds a 510(k) clearance (K913025) from the FDA under the classification of clinical chemistry assays. It is classified under FDA regulation 862.1035 and is deemed substantially equivalent to a predicate device, ensuring compliance with U.S. regulatory standards for clinical chemistry applications.