510(k) · Cleared
ClearedCVM, Unconjugated Estriol (UE3) Calibration Verification Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 21, 2011 as substantially equivalent to K102904 (Siemens Healthcare Diagnostics, 2010) after a 254-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Sep 21, 2011
- Review
- 254 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950469 (1995). 14 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 3 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 2 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 1 generation backK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
- This deviceK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
- Descendant · cites it directly · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK141444 Immulite 2000; Cortisol Calibration Verification Material, Folic…Siemens Healthcare Diagnostics, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly13descendants
- K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on7descendants
- K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
- K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on2descendants
- K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −3 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −2 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −1 | K102904 | Enhanced Estradiol (EE2) Master Curve Material | Siemens Healthcare Diagnostics | 2010 | — |
| 0 (this device) | K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification Material | Siemens Healthcare Diagnostics | 2011 | — |
| +1 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +2 | K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +3 | K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 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 |
|---|---|---|---|
| * | K102904 | Enhanced Estradiol (EE2) Master Curve MaterialSummary page 1…l is for in vitro diagnostic use in the verification of calibration and reportable Range in the ADVIA Centaur®@ Enhanced Estradiol (eE2) assay cleared under 51l0k number K102904. G. Device Description: IMMULITE unconjugated Estriol assays are traceable to an internal standard and manufactured using quali… | 2010 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification… | 2013 | 13 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133128 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K102904.
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. 2011, this device’s year, is highlighted.
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?
For in vitro diagnostic use as a control for calibration verification of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE/IMMULITE 1000, 2000 systems.
The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.16, 2.70 and 11.2 ng/ml, and 0.00, 0.19, 2.90 and 12.00 for IMULITE 2000 systems. The matrix is estriol in processed horse serum.
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/K110061 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110061
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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