Quickstart Total Bilirubin (TBIL) #5A21
by Em Diagnostic Systems, Inc. 510(k)
Active
510(k) K913307
Overview
The Quickstart Total Bilirubin (TBIL) #5A21 is a diazo colorimetry device used for measuring total bilirubin levels in blood samples. Bilirubin is a byproduct of red blood cell breakdown, and its measurement is critical in diagnosing and monitoring conditions such as jaundice, liver disease, and hemolytic anemia. This device quantifies bilirubin concentrations through a chemical reaction that produces a color change proportional to the bilirubin level, enabling accurate clinical assessment.
This device is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent, it requires no special storage conditions beyond refrigeration and protection from light. The Quickstart Total Bilirubin #5A21 is classified as a Class II medical device under FDA regulations (product code CIG, regulation number 862.1110) and has received FDA 510(k) clearance (K913307) for substantial equivalence to a predicate device. It is not intended for MRI use and must be handled according to standard laboratory protocols for in vitro diagnostics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913307 | Date11 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- Withdrawn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 Total Bilirubin (Tbil) #5A21
- 510(k) Number
- FDA Product Code
- CIG
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1110
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Em Diagnostic Systems, Inc.
Questions
What is the Abbott Quickstart Total Bilirubin #5A21 used for?
The Abbott Quickstart Total Bilirubin #5A21 is designed for measuring total bilirubin levels in blood samples using diazo colorimetry. Bilirubin is a critical biomarker for diagnosing and monitoring conditions like jaundice, liver disease, and hemolytic anemia, as it reflects red blood cell breakdown and liver function.
How is the Quickstart Total Bilirubin #5A21 supplied and stored?
This device comes as a single-use reagent, meaning each test requires a new unit. Storage is simple: keep it refrigerated and protected from light to maintain stability. No additional specialized conditions are required.
Is the Quickstart Total Bilirubin #5A21 intended for reuse?
No, the Quickstart Total Bilirubin #5A21 is explicitly designed for single-use only. Reusing it could compromise accuracy and introduce contamination risks, which is why it is supplied as a disposable reagent.
What regulatory pathway does the Quickstart Total Bilirubin #5A21 follow?
The device has received FDA 510(k) clearance (K913307) under the substantial equivalence pathway, demonstrating it is as safe and effective as a predicate device. It is classified as a Class II medical device under FDA regulations (product code CIG, regulation number 862.1110).
Can this device be used in any clinical setting?
The Quickstart Total Bilirubin #5A21 is intended exclusively for in vitro diagnostic use in clinical chemistry laboratories. It is not approved for MRI use or non-laboratory settings, and must be handled according to standard laboratory protocols for in vitro diagnostics.