510(k) · Cleared
ClearedQCS HER2 Immunocontrols (Product NO. C010)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qc Sciences, LLC · NJW Control Material, Her-2/Neu, Immunohistochemistry
Cleared on Jun 18, 2003 as substantially equivalent to P980018 (Agilent Technologies Singapore (International) Pte, Ltd., 1998) after a 254-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jun 18, 2003
- Review
- 254 days
- Class
- Class II
- Product code
- NJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P980018 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backP980018 Dako HerceptestAgilent Technologies Singapore (International) Pte, Ltd. · 1998 · Recalled
- This deviceK023335 QCS HER2 Immunocontrols (Product NO. C010)Qc Sciences, LLC · 2003
- Descendant · cites it directly · 0 of its ownK220163 Her-2, ER, PR IHControlsBoston Cell Standards, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220163Her-2, ER, PR IHControlsBoston Cell Standards, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980018 | Dako Herceptest | Agilent Technologies Singapore (International) Pte, Ltd. | 1998 | 1 |
| 0 (this device) | K023335 | QCS HER2 Immunocontrols (Product NO. C010) | Qc Sciences, LLC | 2003 | — |
| +1 | K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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.
Top candidate predicates for a new NJW device
- #1 K220163 Her-2, ER, PR IHControlsscore 4.1 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P980018 | Dako HerceptestSummary page 1…ical Laboratory Devices. Predicate Device: Control slides in DAKO HercepTest Kit (Product Code No. K5204, FDA PMA# P980018). DAKO HercepTest is a semi- quantitative immunohistochemical assay to determine HER2… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220163 | Her-2, ER, PR IHControls | 2022 | 0 |
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?
- Its one ancestor has a recall.
- Of its descendants, K220163 (Boston Cell Standards, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NJW devicesNJW Control Material, Her-2/Neu, Immunohistochemistry: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJW
1in 2022
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
MAUDE reports naming product code NJW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023335: QCS HER2 Immunocontrols (Product NO. C010).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023335
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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