510(k) · Cleared
ClearedAbbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 17, 2001 as substantially equivalent to K990610 (Bio-Rad, 1999) after a 34-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jul 17, 2001
- Review
- 34 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990610 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990610 Abbott Tumor Marker-MCC (Lyophilized), Model 6E21-10Bio-Rad · 1999
- This deviceK011853 Abbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10Bio-Rad · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990610 | Abbott Tumor Marker-MCC (Lyophilized), Model 6E21-10 | Bio-Rad | 1999 | — |
| 0 (this device) | K011853 | Abbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10 | Bio-Rad | 2001 | — |
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 JJY? 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
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 |
|---|---|---|---|
| * | K990610 | Abbott Tumor Marker-MCC (Lyophilized), Model 6E21-10Summary page 1…Number: CFR 862.1660 Device to Which Substantial Equivalence is Claimed Abbott Tumor Marker — MCC (Lyophilized) Bio-Rad Laboratories Irvine, California Docket Number: K990610 Descri-ption of Device Abbott Tumor Marker — MCC (Lyophilized) is prepared from human serum with added constituents of human or… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Abbott Tumor Marker — MCC (Lyophilized) is intended for use as an assayed quality control serum to moniotr the precision of laboratory testing procedures for the analytes listed in the insert.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011853: Abbott Tumormarker-MCC (Lyophilized), Levels 1 and 2, 2ML NO. 6E21-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011853
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026