510(k) · Cleared
ClearedIron Standard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIT Calibrator, Secondary
Cleared on Aug 22, 2005 as substantially equivalent to K033873 (Roche Diagnostics Corp., 2004) after a 28-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 22, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900779 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK900779 Enzymun Test (R) LHBoehringer Mannheim Corp. · 1990
- 3 generations backK964694 Elecsys LH AssayBoehringer Mannheim Corp. · 1997
- 2 generations backK031299 Elecsys LH Calset IIRoche Diagnostics Corp. · 2003
- 1 generation backK033873 Elecsys C-Peptide CalsetRoche Diagnostics Corp. · 2004
- This deviceK052002 Iron StandardRoche Diagnostics Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900779 | Enzymun Test (R) LH | Boehringer Mannheim Corp. | 1990 | — |
| −3 | K964694 | Elecsys LH Assay | Boehringer Mannheim Corp. | 1997 | — |
| −2 | K031299 | Elecsys LH Calset II | Roche Diagnostics Corp. | 2003 | — |
| −1 | K033873 | Elecsys C-Peptide Calset | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K052002 | Iron Standard | Roche Diagnostics Corp. | 2005 | — |
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 JIT? 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 |
|---|---|---|---|
| * | K033873 | Elecsys C-Peptide CalsetSummary page 1…: Calibrator, Secondary, Class 11 Predicate The Iron Standard is substantially equivalent to the currently marketed device Eleesys®9 C-Peptide Calset (K033873). Device The Iron Standard is a single-level product consisting of a gravimetrically description prepared aqueou… | 2004 |
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 15 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K033873.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052002: Iron Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052002
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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