Tech-Cal(Tm)/Multiple
by R&D Systems, Inc. United States EUDAMED510(k)
510(k) K881161 Product code KSA
Overview
The Tech-Cal Multiple is a calibrator designed for red-cell and white-cell counting, classified as a Class II medical device under the FDA’s nomenclature for hematology applications. It serves as a reference standard to ensure the accuracy and precision of automated hematology analyzers by providing calibrated controls for routine quality assurance.
This device is supplied as a sterile, single-use calibrator and is intended for use in clinical laboratories and hematology settings. It is regulated under the FDA’s 510(k) clearance process and the In Vitro Diagnostic Regulation (IVDR), with multiple registration and listing numbers. Storage and handling follow standard aseptic practices for single-use diagnostic reagents, and its use is governed by the applicable FDA product code KSA.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK881161 | Date2 May 1988 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- KSA
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8185
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from R&D Systems, Inc.
Questions
What is the primary purpose of the Tech-Cal™/Multiple calibrator in a clinical lab setting?
The Tech-Cal™/Multiple is designed specifically for red-cell and white-cell counting to ensure the accuracy and precision of automated hematology analyzers. It serves as a reference standard for routine quality assurance, helping maintain reliable test results in hematology applications.
Is the Tech-Cal™/Multiple intended for single-use or repeated use in a laboratory?
The Tech-Cal™/Multiple is supplied as a sterile, single-use calibrator. This design aligns with standard aseptic practices for diagnostic reagents, ensuring consistency and minimizing contamination risks in clinical settings.
How should the Tech-Cal™/Multiple be stored, and what considerations should be taken into account?
Since it is a sterile, single-use calibrator, storage should follow standard aseptic practices for diagnostic reagents. This typically means keeping it in a clean, dry environment, protected from extreme temperatures and direct light, until use. Always refer to the manufacturer’s instructions for specific storage guidelines.
What regulatory pathways does the Tech-Cal™/Multiple follow, and how does this affect its use?
The device is cleared under the FDA’s 510(k) process (Traditional clearance, K881161) and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II medical device for hematology applications, meaning it undergoes rigorous review to ensure safety and performance before use in clinical settings.
Are there different sizes or models of the Tech-Cal™/Multiple, and if so, how do they differ?
The provided data does not specify distinct sizes or models beyond its core function as a calibrator for red-cell and white-cell counting. However, the multiple registration and listing numbers suggest variations may exist for different laboratory workflows or analyzer compatibility. For specific model details, consult the manufacturer’s documentation or technical support.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K881161
- EUDAMED