PATHFAST NtproBNP and D-Dimer Tests
510(k) K072189
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072189 | Date5 Feb 2008 | StatusActive |
Recalls
-
- Terminated Z-3186-2018
A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NBC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1117
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The PATHFAST NtproBNP and D-Dimer Tests are in vitro diagnostic assays designed to quantify N-terminal pro-B-type natriuretic peptide (NtproBNP) and D-dimer concentrations in whole blood and plasma samples. These tests are used in clinical chemistry settings to aid in the evaluation of cardiac and thrombotic biomarkers, providing rapid results to support diagnostic decision-making. The assays are intended for use with the PATHFAST automated chemiluminescent immunoassay system.
The PATHFAST NtproBNP and D-Dimer Tests are supplied as part of a single-use, ready-to-use immunoassay kit intended for in vitro diagnostic use only. They are designed for use in clinical laboratory settings and are not intended for home use. The tests are regulated under FDA Class II device classification with product code NBC and were authorized through the 510(k) premarket notification pathway under number K072189. Storage conditions and shelf life details are specified by the manufacturer and should be followed according to the product labeling.
Other devices from Mitsubishi Kagaku Iatron
Questions
AI-generated answers, 25 Sep 2026
What are the PATHFAST NtproBNP and D-Dimer Tests used for?
These tests are in vitro diagnostic assays designed to quantify N-terminal pro-B-type natriuretic peptide (NtproBNP) and D-dimer concentrations in whole blood and plasma samples. They aid in evaluating cardiac and thrombotic biomarkers to support diagnostic decision-making in clinical chemistry settings.
How are the PATHFAST tests supplied and used?
The tests are supplied as part of a single-use, ready-to-use immunoassay kit intended for in vitro diagnostic use only. They are designed for use in clinical laboratory settings with the PATHFAST automated chemiluminescent immunoassay system and are not intended for home use.
Are the PATHFAST tests single-use or reusable?
The PATHFAST NtproBNP and D-Dimer Tests are supplied as single-use, ready-to-use immunoassay kits. Each kit is intended for one-time use per test to ensure accuracy and prevent cross-contamination between samples.
What is the regulatory classification of these tests?
The PATHFAST NtproBNP and D-Dimer Tests are regulated under FDA Class II device classification with product code NBC. They were authorized through the 510(k) premarket notification pathway under number K072189, indicating they are substantially equivalent to existing legally marketed devices.
Where should the PATHFAST tests be stored?
Storage conditions and shelf life details are specified by the manufacturer and should be followed according to the product labeling. Users must refer to the manufacturer's instructions for proper storage requirements to maintain test integrity and performance.