Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221
by Sigma Diagnostics, Inc. 510(k)
Active
510(k) K013545
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013545 | Date15 Nov 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7320
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 is a lyophilized human plasma-based control designed for coagulation testing. It falls under the category of fibrinogen and fibrin split products, antigen, antiserum, and control, specifically used to monitor the performance of automated D-dimer assays in hematology laboratories. This product provides a standardized reference for quality assurance in patient plasma testing, ensuring accurate diagnostic results.
This control is supplied as a lyophilized powder requiring reconstitution with water before use. After reconstitution, it remains stable for up to three days when stored at 2–8°C or 24 hours at 18–26°C. Intended for laboratory use, it is not sterile or single-use but is regulated under FDA 510(k) clearance (K013545) as a Class II device under regulation number 864.7320. The product is distributed for quality control purposes in hematology settings and adheres to the specified storage and handling conditions to maintain integrity.
Other devices from Sigma Diagnostics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 used for?
This product is a lyophilized human plasma-based control specifically designed for monitoring the performance of automated D-dimer assays in hematology laboratories. It serves as a standardized reference to verify the accuracy and reliability of patient plasma testing, helping ensure consistent and dependable diagnostic results in clinical settings.
How is the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 supplied and prepared for use?
The control is supplied as a lyophilized powder. Before use, it must be reconstituted with water according to the provided instructions. This preparation step is essential to activate the control for quality assurance testing in automated D-dimer assays.
What are the storage conditions and stability requirements for the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 after reconstitution?
After reconstitution, the control remains stable for up to three days when stored at 2–8°C (refrigerated). If immediate use is not possible, it can also be stored at 18–26°C (room temperature) for up to 24 hours. Proper storage conditions are critical to maintaining the integrity and accuracy of the control for quality assurance purposes.
Is the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 sterile or intended for single-use?
No, the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 is not sterile and is not intended for single-use. It is designed for laboratory quality control purposes and can be used multiple times within its specified stability period, provided it is stored correctly.
What regulatory pathway does the Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221 follow?
This product is regulated under the FDA 510(k) clearance pathway and is classified as a Class II device under regulation number 864.7320. The clearance number assigned is K013545, indicating it has been deemed substantially equivalent to a predicate device through a traditional review process by the FDA’s Hematology (HE) advisory committee.