Blood Urea Nitrogen (BUN) Reagent

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K771312 ↗

FDA Product Code

CDW

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is the Blood Urea Nitrogen (BUN) Reagent used for?

  The Blood Urea Nitrogen (BUN) Reagent is designed to measure urea nitrogen levels in serum or plasma samples. Urea nitrogen is a byproduct of protein metabolism, and its concentration in blood provides critical insights into renal function and metabolic health. Elevated BUN levels often indicate impaired kidney function, while lower levels may suggest malnutrition or liver dysfunction. This reagent helps clinicians assess kidney performance and diagnose conditions affecting protein metabolism.

• How is the BUN Reagent supplied and intended for use?

  The BUN Reagent is supplied as a single-use diagnostic reagent for in vitro clinical chemistry testing. It is intended for use in both automated and manual laboratory systems, allowing flexibility depending on the lab’s workflow and equipment. Since it is single-use, each vial is meant for one test to ensure accuracy and prevent cross-contamination, adhering to standard laboratory sterility and handling protocols.

• Is the BUN Reagent sterile, and how should it be stored?

  The BUN Reagent is classified as a diagnostic reagent and follows standard sterility protocols for in vitro use, meaning it is intended to be handled in a controlled laboratory environment. While the exact sterility assurance level isn’t specified beyond typical reagent handling, it should be stored in a clean, dry place protected from direct light and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage conditions, as improper storage could affect reagent stability and test accuracy.

• What regulatory clearance does the BUN Reagent hold, and what does that mean for users?

  The BUN Reagent holds FDA 510(k) clearance under the reference number K771312, classified as a Class II device under traditional review. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. For users, this clearance ensures the reagent has undergone rigorous evaluation by the FDA for clinical chemistry applications, particularly for measuring urea nitrogen in serum or plasma.

• Can the BUN Reagent be used interchangeably with other diacetyl-monoxime-based urea nitrogen tests?

  While the BUN Reagent is a diacetyl-monoxime-based urea nitrogen test, interchangeability with other similar reagents depends on several factors, including calibration curves, laboratory equipment compatibility, and manufacturer specifications. Each reagent may have slight variations in sensitivity, precision, or reaction conditions. Clinicians should validate any new reagent against existing methods in their lab to ensure consistent and accurate results before routine use, as differences could impact diagnostic reliability.