# K220163: Her-2, ER, PR IHControls

- Pathway: 510(k) (Traditional)
- Applicant: Boston Cell Standards, Inc.
- Decided: Aug 15, 2022 after 207 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: 2 generations back to P980018 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023335: QCS HER2 Immunocontrols (Product NO. C010), Qc Sciences, LLC (2003) Summary page 5.

## Indications for use
HER2/ER/PR IHControls@ -Level H are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor (PR) IHC stains. It is indicated for use with formalin-fixed paraffin-embedded (FFPE) breast tumor samples. HER2/ER/PR IHControls@ -Level H are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls@ -Level H are an additional control to the run controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device. HER2/ER/PR IHControls@ -Level M are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor (PR) IHC stains. It is indicated for use with formalin-fixed paraffm-embedded (FFPE) breast tumor samples. HER2/ER/PR IHControls@ -Level M are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls@ -Level M are an additional control to the run controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device. HER2/ER/PR IHControls@ -Level L are peptide based qualitative on-slide controls to monitor the performance of the analytic components (antigen retrieval and immunostaining) of the immunohistochemical (IHC) staining process for certain human epidermal growth factor receptor type II (HER2), estrogen receptor (ER) and progesterone receptor (PR) IHC stains. It is indicated for use with formalin-fixed paraffin-embedded (FFPE) breast tumor samples. HER2/ER/PR IHControls@ -Level L are not intended to be used for scoring HER2, ER, and PR IHC stained slides. HER2/ER/PR IHControls@ -Level L are an additional control to the run controls specified in the HER2, ER, or PR IHC device labeling and are not intended to replace the controls approved or cleared as part of an IHC device.

Source page: https://510kreport.com/device/K220163
Methodology: https://510kreport.com/methodology