Alcyon Direct Bilirubin Modification
by Abbott Laboratories 510(k)
Active
510(k) K991175
Overview
The Alcyon Direct Bilirubin Modification is a diazo colorimetry device designed for measuring direct bilirubin levels in plasma or serum. Bilirubin is an organic pigment produced during the breakdown of red blood cells, and its quantification aids in diagnosing and monitoring liver disorders, hemolytic conditions, and metabolic abnormalities.
This modification is intended for use in clinical chemistry laboratories and has received FDA 510(k) clearance under the product code CIG, classified as a Class II device under special controls. Supplied as a reusable or single-use system (as specified in the original Alcyon platform), it requires adherence to standard laboratory protocols for sample preparation and measurement. The device is not MRI-compatible and must be stored according to manufacturer instructions to maintain accuracy and sterility.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991175 | Date28 May 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to Alcyon Direct Bilirubin
- 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 Abbott Laboratories
Questions
What is the primary purpose of the Alcyon Direct Bilirubin Modification, and where is it intended for use?
The Alcyon Direct Bilirubin Modification is designed specifically for measuring direct bilirubin levels in plasma or serum using diazo colorimetry. This measurement helps diagnose and monitor liver disorders, hemolytic conditions, and metabolic abnormalities. It is intended exclusively for use in clinical chemistry laboratories, where standard protocols for sample preparation and measurement are followed.
Is the Alcyon Direct Bilirubin Modification system reusable or single-use, and how does this affect its use in a lab?
The Alcyon Direct Bilirubin Modification can be supplied as either reusable or single-use, depending on the configuration of the original Alcyon platform it integrates with. This flexibility allows laboratories to choose based on their workflow, infection control policies, and resource constraints. Reusable components would require proper cleaning and maintenance per manufacturer guidelines, while single-use systems ensure sterility and reduce cross-contamination risks.
What storage requirements must be followed to ensure the device maintains accuracy and sterility?
The device must be stored strictly according to the manufacturer’s instructions to preserve its accuracy and sterility. While the data does not specify exact storage conditions (e.g., temperature, humidity), typical diazo colorimetry reagents and systems require protection from light, moisture, and extreme temperatures. Laboratories should follow Abbott Laboratories’ guidelines to avoid degradation of performance or contamination.
Can this device be used in conjunction with MRI equipment, and if not, what limitations does this impose?
No, the Alcyon Direct Bilirubin Modification is not MRI-compatible. This means it cannot be used in environments where MRI scans are performed, nor should it be stored near MRI machines, as exposure to magnetic fields could potentially affect its functionality or safety. Laboratories must ensure the device is kept in non-MRI areas to avoid interference.
What regulatory pathway was followed for FDA clearance of this modification, and what does that mean for its use in clinical settings?
The modification received FDA 510(k) clearance under the product code CIG, classified as a Class II device under special controls. This pathway demonstrates that Abbott Laboratories has shown the device is substantially equivalent to a legally marketed predicate device, meaning it meets established safety and performance standards for clinical chemistry applications. Clinicians and laboratories can rely on this clearance as evidence of regulatory review, though they should always follow the manufacturer’s instructions for proper use and maintenance.