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Diazo Colorimetry, Bilirubin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K832870

by Pointe Scientific, Inc.

Identifiers

510(k) Number
K832870 FDA 510(k)
FDA Product Code
CIG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1110 FDA 510(k)
Regulation Number
862.1110 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diazo Colorimetry, Bilirubin is a reagent for the quantitative determination of total bilirubin in serum, classified under the nomenclature for clinical chemistry assays. It employs diazo colorimetry—a photometric method—to measure bilirubin levels by reacting with diazotized sulfanilic acid, producing a colored complex whose absorbance correlates with bilirubin concentration.

This reagent is supplied as a liquid in a single-use format, intended for in vitro diagnostic use in clinical laboratories. It requires no special storage conditions beyond refrigeration and is compatible with standard laboratory equipment. The device holds an FDA 510(k) clearance (K832870) under the product code CIG, with a classification as a Class II medical device (regulation number 862.1110). No MRI safety or reusable components are specified.

Frequently asked questions

What is the Diazo Colorimetry, Bilirubin reagent used for in a clinical setting?

The Diazo Colorimetry, Bilirubin reagent is designed for the quantitative measurement of total bilirubin levels in serum samples. It uses diazo colorimetry—a photometric technique—to react with bilirubin, forming a colored complex whose absorbance is directly proportional to the bilirubin concentration. This allows laboratories to accurately determine bilirubin levels, which is critical for diagnosing and monitoring conditions like jaundice, liver disease, or hemolytic anemia.

How is the Diazo Colorimetry, Bilirubin reagent supplied, and is it single-use?

The reagent is supplied as a liquid in a single-use format, meaning each vial or container is intended for one-time use only. This design ensures consistency and reduces the risk of contamination or cross-reactivity between samples, which is important for reliable diagnostic results.

What storage conditions are required for the Diazo Colorimetry, Bilirubin reagent?

The reagent does not require any special storage conditions beyond standard refrigeration. This makes it convenient for clinical laboratories, as it can be stored in typical laboratory refrigerators without additional equipment or precautions.

Is this device compatible with standard laboratory equipment, and does it require any special handling?

Yes, the Diazo Colorimetry, Bilirubin reagent is explicitly designed to be compatible with standard laboratory equipment. No special handling procedures are mentioned beyond typical laboratory practices for handling liquid reagents, such as avoiding contamination and following manufacturer instructions for preparation and use.

What regulatory pathway was followed for this device, and what classification does it hold?

The Diazo Colorimetry, Bilirubin reagent received FDA clearance through a traditional 510(k) pathway, classified as a Class II medical device under regulation number 862.1110. The clearance number is K832870, and it falls under the product code CIG, which is associated with clinical chemistry assays. This classification indicates it is subject to general controls and special controls relevant to its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DIAZO COLORIMETRY, BILLIRUBIN (K832870) — FDA 510(k) | Innolitics, DIAZO COLORIMETRY, BILIRUBIN (K914873) — FDA 510(k) | Innolitics, PDF K832870 - Diazo Colorimetry, Billirubin, Pointe Scientific, Inc. 13-B7576-500 Reagent for the… - FDA.report, AccessGUDID - DEVICE: Pointe Scientific, Inc. (00811727013927)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pointe Scientific, Inc.
FDA Applicant
Pointe Scientific, Inc.,

Sources (1)

  • FDA 510(k) K832870 24 fields · synced Sep 19, 2026