510(k) · Cleared
ClearedN Protein Standard SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Oct 5, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Oct 5, 2000
- Review
- 27 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK002804 N Protein Standard SLDade Behring, Inc. · 2000
- Descendant · cites it directly · 28 of its ownK012470 Modification to N Protein Standard SLDade Behring, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 7 of its ownK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK061990 Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3…Dade Behring, Inc. · 2006
- Descendant · 3 generations on · 6 of its ownK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K012470Modification to N Protein Standard SLDade Behring, Inc. · 2001 · cites it directly28descendants
- K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006 · 2 generations on7descendants
- K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc. · 2007 · 2 generations on6descendants
- K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc. · 2006 · 2 generations on6descendants
- K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc. · 2006 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002804 | N Protein Standard SL | Dade Behring, Inc. | 2000 | — |
| +1 | K012470 | Modification to N Protein Standard SL | Dade Behring, Inc. | 2001 | 1 |
| +2 | K061338 | Dimension Vista Iga Flex Reagent Cartridge Assay | Dade Behring, Inc. | 2006 | — |
| +2 | K063663 | Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and… | Dade Behring, Inc. | 2007 | — |
| +2 | K061990 | Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator… | Dade Behring, Inc. | 2006 | — |
| +3 | K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High | Dade Behring, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012470 | Modification to N Protein Standard SL | 2001 | 28 |
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?
- Of its descendants, K012470 (Dade Behring, Inc., 2001) has gone furthest, with 28 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K002804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002804: N Protein Standard SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002804
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026