STA R Max 3, STA Compact Max 3

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K212183 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• STA- NeoPTimal

  Class II

  CE/IVDR FDA 510(k) K211485 Active Cleared 23 Dec 2022

• Sta R Max Open recall

  Class II

  FDA 510(k) K151867 Active Cleared 7 Aug 2015

• Are the STA R Max 3 and STA Compact Max 3 systems designed for single-use or repeated use in a clinical setting?

  The STA R Max 3 and STA Compact Max 3 are reusable medical devices intended for clinical laboratories. Since they are classified as Class II devices and require maintenance and calibration, they are not single-use but are engineered for prolonged use with proper upkeep to ensure accurate coagulation testing results.

• What types of coagulation tests can these systems perform, and why is this important for hematology labs?

  The STA R Max 3 and STA Compact Max 3 systems automate key coagulation assays, including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and related tests to evaluate blood clotting parameters. This is critical for hematology labs because these tests help diagnose bleeding disorders, monitor anticoagulant therapy (e.g., warfarin), and assess clotting dysfunctions, ensuring precise patient management.

• How do I determine which registration number applies to my specific STA R Max 3 or STA Compact Max 3 unit?

  Each unit has a unique registration number listed in the provided data (e.g., `3015222335`, `3010653929`, etc.), which corresponds to its regulatory filing. To identify the correct number, check the device’s label, documentation, or contact Diagnostica Stago’s support team (e.g., Pauline Vasselon) for verification, as these numbers track compliance and maintenance history.

• Do these systems require any special storage conditions, and if so, why?

  While the data does not specify exact storage conditions, reusable medical devices like these typically require clean, controlled environments (e.g., protected from dust, extreme temperatures, or humidity) to prevent contamination or mechanical damage. Proper storage ensures longevity, calibration accuracy, and compliance with maintenance protocols for reliable coagulation testing.

• What is the regulatory pathway for these devices, and how does it affect their use in the U.S.?

  The STA R Max 3 and STA Compact Max 3 received FDA 510(k) clearance under the Traditional pathway (K212183) and comply with IVDR regulations. This means they are classified as Class II devices and have undergone premarket review to demonstrate substantial equivalence to predicate devices, ensuring their safety and effectiveness for automated coagulation testing in clinical labs.