# K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 29, 2006 after 177 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992858 (1999). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992858: Abbott Axsym Homocysteine, Abbott Laboratories (1999) Summary page 1.

## Most influential descendants
- K063206: Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High (2006), 1 descendant of its own
- K110874: Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator (2012), 0 descendants of its own
- K083463: Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M (2009), 0 descendants of its own
- K062105: Diazyme Creatinine Liquid Reagents Assay (2007), 0 descendants of its own

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0191-2018: 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
- Jan 11, 2017 · Class II · Z-1227-2017: The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stabilit

## Indications for use
N Latex HCY: In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BNW II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. N Protein Standard SL: Esthblishment of reference curves for the determination of IgG, IgG1 ,, IgA, IgM, IgE, C3c, C4, transferrin, albumin, ct1-antitrypsin, cX2-macroglobulin, haptoglobin, a,-acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, soluble transferrin receptor, ferritin, 32-microglobulin, total protein and homocysteine by immunonephelometry with BNTM Systems. N/T Protein Control SULL, M and H: 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 TM Systems: IgG, IgG1 ,, IgA, IgM, C3c, C4, transferrin, albumin, al-antitrypsin, ca2 -macroglobulin, haptoglobin, a1 -acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, 152-microglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.

Source page: https://510kreport.com/device/K052788
Methodology: https://510kreport.com/methodology