# K991181: Modification of N Protein Standard SL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 1, 1999 after 55 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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
Longest line of descent: 1 generation back to K964062 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964062: N Protein Strandard SL, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
Establishment of reference curves for the determination of IgG, 1gG1., IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, az-macroglobulin, Haptoglobin, a4-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, lg/L-chain lambda & kappa, pB2-microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.

Source page: https://510kreport.com/device/K991181
Methodology: https://510kreport.com/methodology