Diazo Colorimetry Direct Bilirubin
510(k) K904381
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904381 | Date12 Oct 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Diazo Colorimentry 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
Overview
AI-generated summary, 19 Sep 2026
The Diazo Colorimetry Direct Bilirubin is a diagnostic device classified under Diazo Colorimetry for measuring bilirubin levels in blood. It employs colorimetric analysis to quantify direct bilirubin, aiding in the assessment of liver function and the diagnosis of conditions such as jaundice or biliary obstruction. This method relies on the reaction of bilirubin with diazotized sulfanilic acid, producing a colored complex measurable spectrophotometrically.
This device is intended for in vitro use in clinical chemistry laboratories and has received FDA 510(k) clearance under the classification CIG (Chemical Indicators and Reagents). Supplied as a reagent, it is designed for single-use applications and requires no special storage conditions beyond standard laboratory practices. The device is regulated under 21 CFR 862.1110 and falls under Class II medical devices, adhering to established safety and performance standards for diagnostic reagents.
Other devices from Amresco, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Diazo Colorimetry Direct Bilirubin reagent used for in a clinical setting?
The Diazo Colorimetry Direct Bilirubin reagent is designed for measuring direct bilirubin levels in blood samples using colorimetric analysis. This helps clinicians assess liver function and diagnose conditions like jaundice or biliary obstruction by quantifying conjugated bilirubin, which is not bound to albumin. It’s specifically intended for use in clinical chemistry laboratories as part of routine diagnostic testing.
Is this reagent single-use, and if so, does it require any special handling or storage?
Yes, the Diazo Colorimetry Direct Bilirubin reagent is intended for single-use applications. It does not require special storage conditions beyond standard laboratory practices, meaning it can be stored under typical lab conditions (e.g., room temperature or refrigeration, if applicable) until use. Always follow manufacturer guidelines for shelf life and handling to ensure accuracy and reliability.
How is the regulatory status of this device determined, and what does that mean for buyers?
This device received FDA 510(k) clearance under the classification for Chemical Indicators and Reagents (CIG), with a decision of 'Substantially Equivalent' (SESE). This means the device was reviewed by the FDA’s Clinical Chemistry (CH) advisory committee and deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. Buyers can rely on this classification to confirm the device meets established regulatory standards for diagnostic reagents in clinical chemistry.
What types of laboratories are authorized to use this reagent, and what is the primary method of analysis?
The Diazo Colorimetry Direct Bilirubin reagent is authorized for use exclusively in clinical chemistry laboratories. The primary method of analysis involves a colorimetric reaction where bilirubin reacts with diazotized sulfanilic acid, producing a colored complex. This complex is then measured spectrophotometrically to quantify direct bilirubin levels in the blood sample.