# K012470: Modification to N Protein Standard SL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 28, 2001 after 57 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002804 (2000). 1 ancestor in all.
28 later devices descend from it; 16 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002804: N Protein Standard 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
- K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control (2006), 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

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0190-2018: Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Pr

## Indications for use
Establishment of reference curves for the determination of IgG, 1gG14, IgA, IgM, IgE, C3c, C4, Transferrin, Albumin, a4-antitrypsin, az-macroglobulin, Haptoglobin, o4-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, soluble Transferrin Receptor (sTfR), Ferritin, Bz-microglobulin, and Total protein by immunonephelometry with BN™ Systems.

Source page: https://510kreport.com/device/K012470
Methodology: https://510kreport.com/methodology