ChemWell Model 2900
by Awareness Technology, Inc. 510(k)
Active
510(k) K010877
Overview
The ChemWell Model 2900 is a Bromcresol Green Dye-Binding, Albumin analyzer designed for automated immunoassay and chemiluminescent detection. It performs quantitative measurements of albumin and other analytes using dye-binding and immunoassay techniques, supporting clinical chemistry applications.
This system is intended for laboratory use and operates as a reusable, automated analyzer capable of processing multiple assay types, including clinical, veterinary, environmental, food, and water analysis. Supplied as a Class II device under FDA 510(k) clearance (K010877), it requires proper calibration, maintenance, and adherence to regulatory standards for clinical chemistry testing. Storage and handling follow standard laboratory protocols for automated immunoassay equipment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010877 | Date23 May 2001 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- CIX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1035
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
The ChemWell 2 Automated ELISA/Chemiluminescent analyzer offers a two plate solution for running a variety of applications. The ability to mix a wide range of ELISA/CLIA assays on two microwell plates, provide a level of flexibility that makes the ChemWell 2 an excellent choice for your next laboratory analyzer purchase.
Other devices from Awareness Technology, Inc.
Questions
What types of analytes can the ChemWell Model 2900 measure, and how does it perform these measurements?
The ChemWell Model 2900 is designed for quantitative measurements of albumin and other analytes using Bromcresol Green dye-binding and immunoassay techniques, along with chemiluminescent detection. It supports clinical chemistry applications, including veterinary, environmental, food, and water analysis, making it versatile for laboratories requiring automated immunoassay capabilities.
Is the ChemWell Model 2900 a single-use or reusable device, and what maintenance does it require?
The ChemWell Model 2900 is a reusable automated analyzer, meaning it is built for repeated use in laboratory settings. Like all automated immunoassay systems, it requires proper calibration, regular maintenance, and adherence to regulatory standards to ensure accurate and reliable performance. Standard laboratory protocols for storage and handling apply.
What regulatory pathway was followed for FDA clearance of the ChemWell Model 2900, and what does this mean for users?
The ChemWell Model 2900 was cleared via an FDA 510(k) submission (K010877) under an Abbreviated 510(k) pathway, determined to be substantially equivalent to a predicate device. This means it was reviewed by the Clinical Chemistry (CH) Advisory Committee and classified as a Class II device, ensuring compliance with FDA standards for clinical chemistry testing while allowing streamlined market access for users.
Does the ChemWell Model 2900 come with specific storage requirements, and how should it be handled in a laboratory?
While the provided data does not specify exact storage conditions, as a reusable automated analyzer, the ChemWell Model 2900 should be stored and handled according to standard laboratory protocols for automated immunoassay equipment. This typically includes protection from extreme temperatures, humidity, and contamination, along with proper cleaning and maintenance procedures to preserve functionality and accuracy.