Berichrom Heparin

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K925200 ↗

FDA Product Code

KFF

Device Class

Class II

Regulation

21 CFR Part 864.7525

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What clinical purpose does the Berichrom Heparin assay serve in patient care?

  The Berichrom Heparin is designed to measure heparin activity levels in plasma, enabling clinicians to monitor anticoagulant therapy. This helps ensure patients receiving heparin for blood thinning are receiving the correct dosage, reducing the risk of clotting or bleeding complications.

• Is the Berichrom Heparin kit intended for single-use or repeated use in a laboratory?

  The Berichrom Heparin is explicitly supplied as a single-use reagent kit, meaning each kit is intended for one test cycle only. This aligns with standard laboratory practices for assay reagents to maintain accuracy and prevent cross-contamination.

• How should the Berichrom Heparin kit be stored, and are there any special handling requirements?

  Storage and handling follow standard laboratory protocols for assay reagents, as no specific sterility or environmental conditions (e.g., refrigeration, temperature ranges) are mentioned in the data. Always refer to the included instructions for the manufacturer’s precise storage guidelines.

• What regulatory pathway was followed for FDA clearance of the Berichrom Heparin?

  The Berichrom Heparin received FDA 510(k) clearance (K925200) under the Traditional 510(k) review pathway, classified as substantially equivalent to a predicate device. The product code KFF (Hematology) and advisory committee HE (Hematology) confirm its regulatory classification.

• Does the Berichrom Heparin require any special laboratory setup beyond typical hematology testing?

  No special laboratory setup is implied beyond standard hematology protocols. The device is categorized under Hematology assays and does not mention MRI compatibility, sterility requirements, or additional infrastructure needs, so it integrates into routine plasma analysis workflows.