510(k) Report

510(k) · Cleared

Cleared

Her-2, ER, PR IHControls

K220163510(k) TraditionalCleared Aug 15, 2022207-day reviewClass II21 CFR 864.1860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Cell Standards, Inc. · NJW Control Material, Her-2/Neu, Immunohistochemistry

Cleared on Aug 15, 2022 as substantially equivalent to K023335 (Qc Sciences, LLC, 2003) after a 207-day review. Its family tree reaches back 2 generations to 1998.

Decided
Aug 15, 2022
Review
207 days
Class
Class II
Product code
NJW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to P980018 (1998). No later device cites it as a predicate yet.

P980018 · Dako Herceptest · Agilent Technologies Singapore (International) Pte, Ltd. · 1998 · recalledK023335 · QCS HER2 Immunocontrols (Product NO. C010) · Qc Sciences, LLC · 2003199520002005201020152020
K023335 · QCS HER2 Immunocontrols (Product NO. C010) · Qc Sciences, LLC · 2003P980018 · Dako Herceptest · Agilent Technologies Singapore (International) Pte, Ltd. · 1998 · recalled0
  1. Root · 2 generations backP980018 Dako HerceptestAgilent Technologies Singapore (International) Pte, Ltd. · 1998 · Recalled
  2. 1 generation backK023335 QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC · 2003
  3. This deviceK220163 Her-2, ER, PR IHControlsBoston Cell Standards, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2P980018Dako HerceptestAgilent Technologies Singapore (International) Pte, Ltd.19981
−1K023335QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC2003—
0 (this device)K220163Her-2, ER, PR IHControlsBoston Cell Standards, Inc.2022—
FIG. 1 — Lineage of K220163, 1998–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NJW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K023335QCS HER2 Immunocontrols (Product NO. C010)
Summary page 5
…, peptide-based controls for HER2, ER, and PR, Immunohistochemistry Regulation number: 864.1860 Product Code: NJW Class: 2 5.3 Predicate Device QCS HER2 Immunocontrols (K023335) Boston Cell Standards HER2/ER/PR IHControls® 1…
Qc Sciences, LLC2003—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 19.2 years on median.
  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All NJW devices

NJW Control Material, Her-2/Neu, Immunohistochemistry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · NJW

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NJW

Too few NJW 510(k)s in any year since 2007 to give a median.

Recalls per year · NJW

No recall names NJW since 2007.

Adverse event reports per year · NJW

1in 2021

2016: 12021: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code NJW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—01
20221—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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…

Read the full statement (351 words)

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.

Indications for use as stated in the FDA summary.

Recent decisions in NJW

The NJW category page

  • K023335QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC · 2003

https://510kreport.com/device/K220163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220163: Her-2, ER, PR IHControls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220163

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026