MLA Electra 700

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

510(k) Number

K812124 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical Laboratory Automation Systems, Inc. →

• What is the MLA Electra 700 used for?

  The MLA Electra 700 is a reusable multipurpose system designed specifically for in vitro coagulation studies. It automates and measures clot formation time in blood plasma samples using photometric clot detection, which is essential for accurate hematology diagnostics. This device supports clinical laboratories by providing precise timing for coagulation assays, helping clinicians assess bleeding disorders, monitor anticoagulant therapy, and diagnose other hematological conditions.

• Is the MLA Electra 700 single-use or reusable?

  The MLA Electra 700 is a reusable instrument. It is not intended to be sterilized between uses, as it is designed for repeated clinical application in controlled laboratory environments. This design ensures durability and cost-effectiveness for long-term use in hematology diagnostics.

• What safety considerations should be noted when using the MLA Electra 700?

  The MLA Electra 700 must be used in environments free from electromagnetic interference, as it is not MRI-safe. This ensures accurate and reliable performance of coagulation assays. Additionally, since it is a reusable device, proper cleaning and maintenance protocols must be followed to prevent cross-contamination and ensure consistent results.

• What regulatory pathway does the MLA Electra 700 follow?

  The MLA Electra 700 is authorized under FDA 510(k) clearance (K812124) and classified under FDA regulation 864.5425 as a Class II medical device. It was determined to be substantially equivalent to a predicate device and falls under the Hematology advisory committee’s jurisdiction. This regulatory pathway ensures compliance with stringent performance standards for coagulation testing systems.

• Are there specific storage conditions mentioned for the MLA Electra 700?

  The provided documentation does not specify detailed storage conditions for the MLA Electra 700. However, as a reusable medical device, it should be stored in a clean, dry environment to prevent damage or contamination. Proper maintenance and calibration procedures should also be followed to ensure optimal performance and longevity.