# K991182: Modification of N/T Protein Control SL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 19, 1999 after 42 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K964065 (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)
- K964065: N/T Protein Control SL, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
N/T Protein Controls SL/L, M, and H are for use ag accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, 1gG, ., IgA, IgM, C3c, C4, Transferrin, Albumin, o-antitrypsin, az-macroglobulin, Haptoglobin, a4-acid glycoprotein, Prealbumin, Cerulopiasmin, RbP, Ig/L-chain lambda & kappa, B.-microglebulin, Soluble transferrin receptar (sTfR), Ferritin, IgE; and, by immunoturbidmetry with the TurbiTimeSystem: 1gG, IgGy, IgA, igM, C3c¢, C4, Transferrin, Albumin, Haptoglobin, as-acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

Source page: https://510kreport.com/device/K991182
Methodology: https://510kreport.com/methodology