Ames Dca 2000 Hemoglobin Alc Controls
by Heraeus Kulzer, Inc. 510(k)
Active
510(k) K940971
Overview
The Ames DCA 2000 Hemoglobin A1c Controls are designed as quality control materials for glycosylated hemoglobin assays. These controls are used to monitor and validate the performance of hemoglobin A1c testing systems, ensuring accurate and reliable measurement of diabetic management markers in clinical hematology laboratories.
Supplied as single-use controls, these products are intended for use with the DCA 2000 analyzer system. They are classified as Class II devices under FDA regulations (21 CFR 864.7470) and were granted FDA 510(k) clearance (K940971) in 1994. The controls are not sterile and must be stored under recommended conditions to maintain integrity until use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940971 | Date19 Jul 1994 | 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- Withdrawn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
- LCP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7470
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Heraeus Kulzer, Inc.
Questions
Are these controls compatible with any other hemoglobin A1c testing systems besides the DCA 2000 analyzer?
No, these controls are specifically designed for use with the DCA 2000 analyzer system only. They are not intended for compatibility with other hemoglobin A1c testing systems, as their formulation and specifications are tailored to validate and monitor the performance of that particular analyzer.
How should I store the Ames DCA 2000 Hemoglobin A1c Controls to ensure they remain effective until use?
The controls must be stored under recommended conditions to maintain their integrity. While the exact storage instructions are not detailed in the provided data, typical quality control materials like these are generally stored at room temperature, protected from light and extreme temperatures, and kept in a dry environment until use. Always refer to the manufacturer’s packaging or accompanying documentation for precise storage guidelines.
Are the Ames DCA 2000 Hemoglobin A1c Controls sterile, and can they be reused?
These controls are explicitly labeled as not sterile, so they should not be used in procedures requiring sterile conditions. Additionally, they are designed as single-use materials, meaning each control should only be used once for accurate and reliable testing. Reuse is not recommended or supported by the manufacturer.
What is the regulatory pathway for this device, and how was its equivalence determined?
The Ames DCA 2000 Hemoglobin A1c Controls were granted FDA 510(k) clearance (K940971) under the Traditional 510(k) review pathway. Their equivalence was determined through a substantially equivalent (SESE) decision by the FDA’s Hematology (HE) Advisory Committee, meaning they were found to have the same intended use, technological characteristics, and performance as a legally marketed predicate device. The classification is Class II under 21 CFR 864.7470.