# K991705: N Protein Standard UY

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 15, 1999 after 57 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K904254: NA Alpha 1 Microglobulin Kit, Behring Diagnostics, Inc. (1991). Our OCR of the scanned summary read K904254, FDA’s number for NA Alpha 1 Microglobulin Kit (Behring Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Protein Standard Urine Concentrate”. Kept off the family tree. Summary page 1.

## Indications for use
N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of a.-microglobulin in urine using the Behring Nephelometer Systems.

Source page: https://510kreport.com/device/K991705
Methodology: https://510kreport.com/methodology