510(k) Report

510(k) · Cleared

Cleared

Elecsys T4 Calcheck 5

K112528510(k) TraditionalCleared Oct 18, 201148-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

Roche Diagnostics Corporation · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Oct 18, 2011 as substantially equivalent to K111552 (Roche Diagnostics, 2011) after a 48-day review. Its family tree reaches back 3 generations to 1992. 15 later devices descend from it.

Decided
Oct 18, 2011
Review
48 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K924862 (1992). 15 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2017: 3 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2014: 3 descendants cleared2021: 1 descendant cleared2023: 1 descendant clearedK924862 · Aia-Pack HCG Calibration Verification Test Set · Tosoh Medics, Inc. · 1992K963167 · Elecys Calcheck T 3 · Boehringer Mannheim Corp. · 1996K111552 · Elecsys T3 Calcheck 5 · Roche Diagnostics · 20111990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K111552 · Elecsys T3 Calcheck 5 · Roche Diagnostics · 2011K963167 · Elecys Calcheck T 3 · Boehringer Mannheim Corp. · 1996K924862 · Aia-Pack HCG Calibration Verification Test Set · Tosoh Medics, Inc. · 19920
  1. Root · 3 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
  2. 2 generations backK963167 Elecys Calcheck T 3Boehringer Mannheim Corp. · 1996
  3. 1 generation backK111552 Elecsys T3 Calcheck 5Roche Diagnostics · 2011
  4. This deviceK112528 Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011
  5. Descendant · cites it directly · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
  6. Descendant · cites it directly · 5 of its ownK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013
  7. Descendant · 2 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
  9. Descendant · cites it directly · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 32015: 22017: 32018: 12021: 12023: 12026: 1
2012high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 15 · See all
  • K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · cites it directly8descendants
  • K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly5descendants
  • K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 2 generations on4descendants
  • K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K924862Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc.1992—
−2K963167Elecys Calcheck T 3Boehringer Mannheim Corp.1996—
−1K111552Elecsys T3 Calcheck 5Roche Diagnostics2011—
0 (this device)K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation2011—
+1K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3…Roche Diagnostics2012—
+1K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc.2013—
+2K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D…Roche Diagnostics20172
+2K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc.2014—
+1K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201430
201520
201730
201810
202110
202310
202610
FIG. 1 — Lineage of K112528, 1992–2026Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K111552Elecsys T3 Calcheck 5
Summary page 2
…device. Characteristic Elecsys T3 CaiCheck 5 Elecsys T4 CaiCheck 5 (Predicate Device, K1 11552) (Candidate Device) Intended Use The Elecsys T3 Calcheck 5 is an The Elecsys T4 C…
Roche Diagnostics2011—

Also cleared against K111552: 2 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128
K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135
K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132
K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150

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 19 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K113546 (Roche Diagnostics, 2012) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K111552.

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. 2011, 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 Elecsys T4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Eleesys and cobas e inmmoassay analyzers.

Indications for use as stated in the FDA summary.

Also cleared against K111552

2 other devices cite the same predicate.

  • K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve…Siemens Healthcare Diagnostics, Inc. · 2015
  • K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total…Siemens Healthcare Diagnostics, Inc. · 2013

More from Roche Diagnostics Corporation

6 FDA decisions under this applicant name. See the company

  • K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 20151 recall
  • K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
  • K133862Accu-Chek Aviva Plus SystemRoche Diagnostics Corporation · 20142 recalls
  • K070172Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corporation · 2007
  • K070174Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test AccessoryRoche Diagnostics Corporation · 2007

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/K112528 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112528: Elecsys T4 Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112528

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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