510(k) · Cleared
ClearedElecsys Precicontrol TSH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jul 22, 1996 as substantially equivalent to K961491 (Boehringer Mannheim Corp., 1996) after a 21-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 22, 1996
- Review
- 21 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915195 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915195 Enzymun-Test TSHBoehringer Mannheim Corp. · 1992
- 1 generation backK961491 Elecsys TSH AssayBoehringer Mannheim Corp. · 1996
- This deviceK962573 Elecsys Precicontrol TSHBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 0 of its ownK140534 Elecsys Precicontrol TSRoche Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK062581 Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay…Olympus America, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915195 | Enzymun-Test TSH | Boehringer Mannheim Corp. | 1992 | — |
| −1 | K961491 | Elecsys TSH Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K962573 | Elecsys Precicontrol TSH | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K140534 | Elecsys Precicontrol TS | Roche Diagnostics | 2014 | — |
| +1 | K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay System | Olympus America, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 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 JJX? 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 |
|---|---|---|---|
| * | K961491 | Elecsys TSH Assay Cleared while this submission was under review Summary page 1…Classification name: Enzyme controls (Assayed and Unassayed) The Boehringer Mannheim Elecsys® PreciControl TSH is substantially equivalent to the Elecsys® TSH CalSet (K961491). The intended use has been changed to a quality control material. Continued on next page page 24 &l Diagnostic… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140534 (Roche Diagnostics, 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K961491.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Control for Thyroid Stimulating Hormone assays.
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/K962573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962573: Elecsys Precicontrol TSH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962573
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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