BUN, MODEL BU 104-01

• K Number: K990980
• Device Name: BUN, MODEL BU 104-01
• Manufacturer: A.P. TOTAL CARE, INC.
• Date Cleared: 1999-05-25 ( 63 days)
• Product Code: CDQ
• Regulation Number: 862.1770
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Urea Nitrogen (BUN) reagent is intended for Invitro Diagnostic useein the quantitative determination of urea nitrogen in serum or plasma.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "UREA Nitrogen (BUN)". This document does not contain the specific information required to answer your questions about acceptance criteria, study details, ground truth, or expert involvement. The letter simply states that the device is substantially equivalent to a legally marketed predicate device and can, therefore, be marketed.

This type of FDA letter typically references a 510(k) submission document which would contain the study details. Without that submission, I cannot provide the requested information.

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Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.