Hematology Quality Control Mixtures
510(k) K810756
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810756 | Date30 Jun 1981 | 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- Withdrawn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
- Hemotology Quality Control Mixtures
- 510(k) Number
- FDA Product Code
- JPK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hematology Quality Control Mixtures are liquid reference standards designed for use in hematology testing. These mixtures are classified as mixtures under FDA product code JPK and serve as controls to verify the accuracy, precision, and reliability of manual, semiautomated, and automated hematology analyzers. They are specifically formulated to replicate known hematological parameters, enabling laboratories to monitor instrument performance and ensure consistent diagnostic results.
These mixtures are supplied as sterile, single-use liquid controls intended for in vitro diagnostic use in clinical hematology laboratories. They are regulated under 21 CFR 864.8625 and cleared by the FDA through a 510(k) submission (K810756) as substantially equivalent to predicate devices. Each lot is individually packaged and must be stored according to manufacturer instructions to maintain stability and sterility. The mixtures are not intended for MRI use and are classified as Class II devices under the FDA’s regulatory framework.
Other devices from Scientific Standards, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Hematology Quality Control Mixtures used for?
These mixtures are designed as liquid reference standards to validate the performance of manual, semiautomated, and automated hematology analyzers. By replicating known hematological parameters, they help laboratories ensure the accuracy, precision, and reliability of their diagnostic results, maintaining consistent test outcomes for patient care.
How are the Hematology Quality Control Mixtures supplied and packaged?
Each lot of the Hematology Quality Control Mixtures is individually packaged as a sterile, single-use liquid control. This packaging ensures sterility and stability while preventing cross-contamination between uses, making them ideal for routine quality assurance in clinical hematology laboratories.
Are these mixtures intended for reuse or single-use?
The Hematology Quality Control Mixtures are explicitly formulated for single-use only. This design minimizes the risk of contamination and degradation over time, ensuring consistent and reliable performance for each test run.
What storage instructions should be followed to maintain their stability?
To preserve sterility and stability, these mixtures must be stored according to the manufacturer’s instructions. Typically, this involves keeping them refrigerated (between 2°C and 8°C) and protected from light until use. Avoid freezing or exposing them to extreme temperatures, as this could compromise their integrity.
Are these mixtures regulated for any specific use beyond hematology testing?
No, these mixtures are not intended for MRI use or any other diagnostic modality outside of in vitro hematology testing. They are classified under 21 CFR 864.8625 and are specifically designed to support the performance verification of hematology analyzers in clinical laboratories.