Stratus Primidone Fluorometric Enzyme

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K904683 ↗

FDA product code

LFT

Device class

Class II

Regulation

21 CFR Part 862.3680

Advisory committee

Clinical Toxicology

FDA decision

SESE Substantially Equivalent

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• What clinical specialty is the Stratus Primidone Fluorometric Enzyme designed for, and how does that influence its use in a lab setting?

  The Stratus Primidone Fluorometric Enzyme is specifically designed for clinical toxicology, a specialty focused on identifying and managing poisonings or drug overdoses. This means it is intended for use in labs that test patient samples to detect the presence of primidone—a barbiturate—often in cases of suspected poisoning or drug exposure. Clinicians and toxicologists rely on this device to assist in rapid and accurate identification of primidone levels, helping guide treatment decisions in emergency or critical care settings.

• Is the Stratus Primidone Fluorometric Enzyme a single-use device, or can it be reused after testing multiple samples?

  The provided data does not explicitly state whether the Stratus Primidone Fluorometric Enzyme is single-use or reusable. However, fluorometric immunoassay devices of this type are typically designed for single-use per test to ensure accuracy, sterility, and reliability. Reusing such devices could introduce contamination or measurement errors, which is critical in toxicology testing where precision is essential. Always follow the manufacturer’s instructions for proper disposal or reuse protocols, if applicable.

• How was the FDA clearance for this device determined, and what does the ‘substantially equivalent’ classification mean in this context?

  The Stratus Primidone Fluorometric Enzyme received FDA 510(k) clearance through a traditional review process, meaning the manufacturer demonstrated that it is substantially equivalent (SESE) to a legally marketed device already on the market. This classification indicates that the new device has the same intended use, technological characteristics, and performance as the predicate device, ensuring it meets regulatory standards for safety and effectiveness in detecting primidone via fluorometric immunoassay. The clearance was granted on November 28, 1990.

• What type of samples is this device intended to analyze, and where would it typically be used in a healthcare facility?

  The Stratus Primidone Fluorometric Enzyme is intended for clinical toxicology testing, meaning it analyzes patient samples—such as serum, plasma, or whole blood—to detect the presence of primidone, a medication used to treat epilepsy. It would typically be used in hospital laboratories, emergency departments, or specialized toxicology labs where rapid drug screening is critical for diagnosing overdoses or monitoring therapeutic drug levels. The device’s immunoassay technology allows for quick and sensitive detection, supporting timely clinical decisions.