510(k) Report

510(k) · Cleared

Cleared

Enhanced Estradiol (EE2) Master Curve Material

K102904510(k) AbbreviatedCleared Nov 23, 201053-day reviewClass I21 CFR 862.1660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Nov 23, 2010 as substantially equivalent to K062501 (Maine Standards Co., 2006) after a 53-day review. Its family tree reaches back 3 generations to 1995. 18 later devices descend from it.

Decided
Nov 23, 2010
Review
53 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K950469 (1995). 18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2013: 2 descendants cleared2014: 9 descendants cleared2015: 5 descendants clearedK950469 · Document Serum Multianalyte Calibration Verification Test Set · Casco Standards · 1995K992034 · Document Thyroid Cal*Ver · Casco-Nerl Diagnostics Corporation (Maine) · 1999K062501 · Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 · Maine Standards Co. · 20061995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants K062501 · Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 · Maine Standards Co. · 2006K992034 · Document Thyroid Cal*Ver · Casco-Nerl Diagnostics Corporation (Maine) · 1999K950469 · Document Serum Multianalyte Calibration Verification Test Set · Casco Standards · 19950
  1. Root · 3 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
  2. 2 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
  3. 1 generation backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
  4. This deviceK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
  5. Descendant · cites it directly · 14 of its ownK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
  6. Descendant · 2 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
  7. Descendant · 3 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
  8. Descendant · cites it directly · 5 of its ownK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013
  9. Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011: 22013: 22014: 92015: 5
2011high 9 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 18 · See all
  • K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011 · cites it directly14descendants
  • K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on13descendants
  • K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on7descendants
  • K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly5descendants
  • K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K950469Document Serum Multianalyte Calibration Verification Test SetCasco Standards1995—
−2K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine)1999—
−1K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co.2006—
0 (this device)K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics2010—
+1K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics2011—
+2K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…Siemens Healthcare Diagnostics, Inc.2013—
+3K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…Siemens Healthcare Diagnostics, Inc.2014—
+1K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc.2013—
+2K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201320
201490
201550
FIG. 1 — Lineage of K102904, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901
Summary page 1
…VALIDATE Thyraid Calibration Verification Test Set ICommon name VALIDATE THY Calibration Verification Test Set 510(k) Number K062501 Manufacturer Maine Standards Company Siemens Healthcare Diagnostics, Inc AD VIA Centaur eE2 Master Curve Mat…
Maine Standards Co.2006—

Also cleared against K062501: 4 other devices →

What descends from it? (18)

See all 18

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics201114
K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135
K103683Immulite/Immulite 1000 Progesterone Calibration Verification (CVM)Siemens Healthcare Diagnostics20111

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 4 companies; a new generation was cleared every 4.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K110061 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 14 descendants of its own.
  • 4 other devices also cite its predicate K062501.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.

Indications for use as stated in the FDA summary.

Also cleared against K062501

4 other devices cite the same predicate.

  • K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. · 20117 recalls
  • K092993Advia Centaur Cyclosporine Master Curve MaterialSiemens Healthcare Diagnostics · 2009
  • K091123Advia Centaur Dheas Master Curve MaterialsSiemens Healthcare Diagnostics · 2009
  • K083891Validate Thyroid Calibration Verification Test Set, Model 901Maine Standards Co. · 2009

More from Siemens Healthcare Diagnostics

344 FDA decisions under this applicant name. See the company

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  • P090024/S013Atellica IM Hepatitis B e Antigen (HBeAg)Siemens Healthcare Diagnostics · 2025
  • P990055/S029ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA)Siemens Healthcare Diagnostics · 2025
  • P950021/S030ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA)Siemens Healthcare Diagnostics · 2025
  • P000021/S047Dimension TPSA Flex reagent cartridgeSiemens Healthcare Diagnostics · 2025

Recent decisions in JJX

The JJX category page

  • K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K102904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102904: Enhanced Estradiol (EE2) Master Curve Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102904

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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