AutoDimer Assay Model # 1431
by Xtrana, Inc. 510(k)
Active
510(k) K012755
Overview
The AutoDimer Assay Model # 1431 is an in vitro diagnostic immunoturbidimetric assay for D-dimer detection in human plasma. It utilizes latex particles coated with monoclonal antibodies specific to fibrin D-dimer or fragment D of fibrinogen and does not react with fibrinogen. The assay is designed for use on Hitachi 911 and Hitachi 902 clinical chemistry analyzers.
This device is intended for laboratory use and is supplied as a single-use product. It is not MRI compatible and requires appropriate storage conditions. The device has received FDA 510(k) clearance with the regulation number 21 CFR § 864.7320 for Fibrinogen/Fibrin Degradation Products Assay.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012755 | Date15 Mar 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 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
Questions
What is the AutoDimer Assay Model #1431 used for?
The AutoDimer Assay Model #1431 is an in vitro diagnostic immunoturbidimetric assay designed for D-dimer detection in human plasma. It utilizes latex particles coated with monoclonal antibodies specific to fibrin D-dimer or fragment D of fibrinogen and does not react with fibrinogen.
Which analyzers is the AutoDimer Assay compatible with?
The AutoDimer Assay is specifically designed for use on Hitachi 911 and Hitachi 902 clinical chemistry analyzers. It is not compatible with MRI equipment and requires appropriate storage conditions as specified by the manufacturer.
Is the AutoDimer Assay reusable or single-use?
The AutoDimer Assay is supplied as a single-use product and should not be reused. Each assay is designed for one-time use only to ensure accurate test results and maintain sterility.
What regulatory approvals does the AutoDimer Assay have?
The AutoDimer Assay has received FDA 510(k) clearance with the regulation number 21 CFR § 864.7320 for Fibrinogen/Fibrin Degradation Products Assay. It is classified as a Class II device and was reviewed by the Hematology advisory committee.