# K991157: N Latex STFR Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 2, 1999 after 117 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926221 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa), R&D Systems, Inc. (1997) Summary page 1.

## Indications for use
The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNIl), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Source page: https://510kreport.com/device/K991157
Methodology: https://510kreport.com/methodology