# K021385: Atac Pak Bun Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Elan Diagnostics
- Decided: Jul 12, 2002 after 71 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HiChem BUN Reagent Kit, product no. 88806: named in the summary without a submission number

## Indications for use
The ATAC PAK BUN Reagent Kit is intended for use with the ATAC 6000 Random Access Chemistry System for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K021385
Methodology: https://510kreport.com/methodology