Microsample Coagulation Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K943153 FDA 510(k)
- FDA Product Code
- GKP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5400 FDA 510(k)
- Regulation Number
- 864.5400 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Microsample Coagulation Analyzer MCA 310-C is an automated coagulation instrument designed for hematology applications. It performs coagulation testing by analyzing small blood samples to measure clotting times and platelet aggregation, supporting diagnostic assessments of bleeding disorders and coagulation disorders.
This device is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under the product code GKP. It operates as a reusable instrument, adhering to regulatory standards outlined in 21 CFR 864.5400. The analyzer is classified as a Class II medical device and is supplied with appropriate reagents for coagulation testing.
Frequently asked questions
What types of coagulation tests can the Microsample Coagulation Analyzer MCA 310-C perform, and why is this important for clinical labs?
The Microsample Coagulation Analyzer MCA 310-C is designed to measure clotting times and platelet aggregation using small blood samples. This is particularly useful for diagnosing bleeding and coagulation disorders, as it provides critical data for assessing conditions like hemophilia, von Willebrand disease, or other hemostatic abnormalities. Its ability to analyze microsamples makes it efficient for labs with limited sample volumes, such as pediatric or emergency settings.
Is the Microsample Coagulation Analyzer MCA 310-C a single-use or reusable device, and what does this mean for maintenance and cost?
The MCA 310-C is a reusable instrument, meaning it is built to withstand repeated use in clinical laboratory settings. This design reduces per-test costs compared to single-use devices, though it requires proper cleaning, maintenance, and validation per regulatory standards (e.g., 21 CFR 864.5400) to ensure accuracy and sterility between uses. Reusability also implies a longer lifespan for the device, though labs must account for maintenance and calibration expenses.
How is the Microsample Coagulation Analyzer MCA 310-C regulated, and what does its FDA 510(k) clearance under product code GKP indicate?
The MCA 310-C received FDA 510(k) clearance under product code GKP, which categorizes it as a Class II medical device for coagulation testing. This clearance indicates the device was deemed *substantially equivalent* to a legally marketed predicate device (as noted in the decision description) and meets U.S. safety and performance requirements. The Hematology (HE) advisory committee reviewed it, confirming its suitability for clinical laboratory use in diagnosing bleeding and coagulation disorders.
What clinical settings or specialties would benefit most from using the Microsample Coagulation Analyzer MCA 310-C?
The MCA 310-C is specifically designed for clinical laboratory settings, particularly those specializing in hematology. It is ideal for diagnosing coagulation disorders, bleeding abnormalities, and platelet function issues. Settings like hospital labs, reference labs, or specialized centers (e.g., hemophilia treatment centers) would benefit from its ability to analyze small blood samples efficiently, reducing turnaround time for critical diagnostic results.
Does the Microsample Coagulation Analyzer MCA 310-C come with all necessary reagents, and if so, what types are included?
Yes, the MCA 310-C is supplied with appropriate reagents for coagulation testing, though the exact types (e.g., activators for clotting assays, platelet aggregation reagents) are not specified in the data. These reagents are essential for performing tests like prothrombin time (PT), activated partial thromboplastin time (aPTT), or platelet function assays. Labs should verify compatibility with their specific diagnostic workflows and storage requirements for reagent stability.
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: Bio/data Corporation - Horsham, Pennsylvania (PA) - MedicRegister, Platelet Aggregometers and Aggregation Reagents | Bio/Data Corporation, MICROSAMPLE COAGULATION ANALYZER (K943153) — FDA 510 (k) | Innolitics, MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C by BIO/DATA CORP ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943153 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio/Data Corp.
Sources (1)
- FDA 510(k) K943153 24 fields · synced Sep 19, 2026