# K012468: Modification to N/T Protein Control SL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 4, 2001 after 33 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 K002852 (2000). 1 ancestor in all.
26 later devices descend from it; 14 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002852: N/T Protein Control SL, Dade Behring, Inc. (2000) Summary page 1.

## Most influential descendants
- K061338: Dimension Vista Iga Flex Reagent Cartridge Assay (2006), 7 descendants of its own
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H (2007), 6 descendants of its own
- K062055: Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High (2006), 6 descendants of its own
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an (2007), 5 descendants of its own
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own

## Indications for use
N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, 1gG1.4, IgA, IgM, C3c, C4, Transferrin, Albumin, ay-antitrypsin, oz-macroglobulin, Haptoglobin, a.4-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, p2-microglobulin, soluble Transferrin Receptor (sTfR), Ferritin, IgE, and Total protein; and by immunoturbidimetry with the TurbiTimeSystem: I1gG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, a.4-acid glycoprotein.

Source page: https://510kreport.com/device/K012468
Methodology: https://510kreport.com/methodology