FDA classifies preeclampsia risk test as Class II device

The Food and Drug Administration has officially classified a specific blood test for monitoring preeclampsia into Class II. This classification applies to the BRAHMS GmbH B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System, which measures proteins in human samples to assess the risk of developing or worsening preeclampsia during pregnancy.

Why it matters: This action matters because it creates a clear regulatory path for this type of diagnostic test. Moving from the default Class III status to Class II means future manufacturers can use a simpler approval process called 510(k) rather than undergoing the more rigorous premarket approval required for high-risk devices. It also establishes standardized special controls, such as specific labeling and practitioner training guidelines, to mitigate risks like false positives or incorrect interpretation of results.

Who it affects

• Medical device manufacturers producing in vitro diagnostic tests for pregnancy complications

---

This summary is based on a final order published by the Food and Drug Administration in the Federal Register; readers should consult the original document for full regulatory text and legal citations.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document