# K023335: QCS HER2 Immunocontrols (Product NO. C010)

- Pathway: 510(k) (Traditional)
- Applicant: Qc Sciences, LLC
- Decided: Jun 18, 2003 after 254 days
- Product code: NJW (Control Material, Her-2/Neu, Immunohistochemistry)
- Device class: 2
- Regulation: 21 CFR 864.1860
- 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 P980018 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980018: Dako Herceptest, Agilent Technologies Singapore (International) Pte, Ltd. (1998) Summary page 1.

## Most influential descendants
- K220163: Her-2, ER, PR IHControls (2022), 0 descendants of its own

## Indications for use
For in VifroDiagnostic Use: QCS f i E R 2 ImmunoCotifrols,are intended for a laboratory to control semi-quantitat~e immunohistochemistry using different HER2/neu antibodies. Each QCS HER2 c o n t d slide contains four control sections prepared from breast cancer cell lines that represent di rfercnt levels of Her-2/neu protein expression. The cells are formalin-fixed and paraffin-embedded. ‘I‘tiesc controls ensure that performance of immunohistochemical staining is consistent i n onc laboratory over time and also aids in correlation with the results of other laboratories.

Source page: https://510kreport.com/device/K023335
Methodology: https://510kreport.com/methodology