FPR Phenobarbital Kit

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

510(k) Number

K894525 ↗

FDA Product Code

LGQ

Device Class

Class II

Regulation

21 CFR Part 862.3660

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Colony Laboratories, Inc. →

• What is the FPR Phenobarbital Kit used for in a clinical setting?

  The FPR Phenobarbital Kit is designed for qualitative detection of phenobarbital in biological specimens, such as blood or urine. It is specifically intended for use in clinical toxicology laboratories to help identify the presence of phenobarbital, a barbiturate, as part of drug screening or poisoning assessments.

• Is this kit single-use, or can it be reused across multiple tests?

  The FPR Phenobarbital Kit is explicitly labeled as a single-use diagnostic tool. This means each kit is intended for one test cycle only, and reuse is not recommended or supported by the manufacturer.

• What type of technology does this kit use to detect phenobarbital?

  This kit employs fluorescence polarization immunoassay (FPIA) technology, which measures changes in fluorescence polarization to determine whether phenobarbital is present in the tested specimen. This method is sensitive to the molecular interactions between phenobarbital and the assay’s antibodies.

• Are there any special storage requirements for the FPR Phenobarbital Kit?

  The kit does not require specialized storage conditions beyond those outlined in the manufacturer’s instructions. Standard laboratory storage practices (e.g., protecting from extreme temperatures and light) should suffice, but always refer to the included documentation for precise guidance.

• How was the FDA clearance for this device determined, and what does that mean for its use?

  The kit received FDA 510(k) clearance under the Traditional pathway, with a substantially equivalent (SESE) decision, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms the device meets FDA safety and performance standards for in vitro diagnostic use in clinical toxicology, but it does not imply any clinical indication—only that it is suitable for detecting phenobarbital in regulated settings.