Act Test Catridges For Coaguchek Pro System, Act Controls For Coaguchek Pro Sys…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992851 FDA 510(k)
- FDA Product Code
- JBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7140 FDA 510(k)
- Regulation Number
- 864.7140 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an Activated Whole Blood Clotting Time Test System, designed for the quantitative measurement of activated clotting time (ACT) in freshly drawn whole blood. It consists of test cartridges and control cartridges intended to operate within the CoaguChek Pro System, providing point-of-care monitoring of coagulation parameters in hematology applications.
Used in clinical settings such as operating rooms, hemodialysis units, and emergency departments, these cartridges are single-use, non-sterile devices. They require no special storage conditions beyond protection from extreme temperatures and moisture. The system has received FDA 510(k) clearance under the Hematology advisory committee, with product codes classified under JBP and regulation number 864.7140.
Frequently asked questions
What clinical environments are these ACT test cartridges primarily used in, and why are they beneficial in those settings?
These ACT test cartridges are designed for point-of-care use in high-activity clinical areas like operating rooms, hemodialysis units, and emergency departments. They enable rapid, quantitative measurement of activated clotting time (ACT) in whole blood, allowing clinicians to monitor coagulation status efficiently without relying on centralized lab testing. This is particularly useful in time-sensitive procedures where immediate feedback on blood clotting is critical, such as during cardiac surgeries or anticoagulation management.
Are the ACT test cartridges single-use or reusable, and what does that mean for workflow and cost management?
The ACT test cartridges are explicitly labeled as single-use devices, meaning each cartridge is intended for one test only. This design reduces the risk of cross-contamination and ensures consistent, accurate results per test. For workflow, this means clinicians must prepare a new cartridge for each patient sample, which may require planning for inventory and waste management. However, single-use cartridges simplify sterilization and maintenance processes, potentially lowering long-term operational costs associated with reusable equipment.
Do these cartridges require any special storage conditions, and what precautions should be taken to maintain their integrity?
The cartridges do not require specialized storage conditions beyond protecting them from extreme temperatures and moisture. This makes them convenient for clinical settings with varying environmental factors. To maintain their integrity, store them in a dry place, away from direct sunlight or heat sources, and ensure they are sealed until use. Avoid exposing them to temperatures outside the typical room temperature range to prevent potential degradation of performance.
Are there different sizes or models of these ACT test cartridges, and if so, how might that affect their compatibility with the CoaguChek Pro System?
The provided data does not specify distinct sizes or models beyond the general classification as 'ACT test cartridges' and 'ACT controls' for the CoaguChek Pro System. However, since they are designed exclusively for this system, compatibility is assumed to be consistent across all cartridges intended for the same device. Clinicians should verify compatibility with their specific CoaguChek Pro System model, but no variations in cartridge size or functionality are indicated in the available details.
How does the FDA clearance for these cartridges relate to their intended use, and what does the 'Hematology' advisory committee classification imply?
The FDA clearance under the Hematology advisory committee (review panel) indicates that these cartridges were evaluated for their safety and effectiveness in measuring activated clotting time (ACT) within the broader context of hematology applications. This classification implies that the device’s primary focus is on blood coagulation monitoring, aligning with clinical needs in areas like surgery, dialysis, and emergency care. The clearance does not define the clinical indications but confirms that the cartridges meet regulatory standards for their intended use in point-of-care ACT testing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek ..., Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek ..., K992851 FDA 510(k) - ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992851 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K992851 24 fields · synced Sep 19, 2026