510(k) Report

510(k) · Cleared

Cleared

Elecsys CA 15-3 II Calcheck 5

K122242510(k) TraditionalCleared Dec 5, 2012131-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 · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 5, 2012 as substantially equivalent to K101365 (Roche Diagnostics Corp., 2010) after a 131-day review. Its family tree reaches back 6 generations to 2000. 10 later devices descend from it.

Decided
Dec 5, 2012
Review
131 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K001015 (2000). 7 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2017: 1 descendant cleared2014: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2019: 3 descendants cleared2022: 1 descendant cleared2023: 1 descendant clearedReference device: K001468 · Elecsys CA 15-3 Test System · Roche Diagnostics Corp. · 2000K001015 · Elecsys Thyroglobulin Calcheck · Roche Diagnostics Corp. · 2000K020883 · Elecsys Probnp Calcheck · Roche Diagnostics Corp. · 2002K031698 · Elecys SHBG Calcheck · Roche Diagnostics Corp. · 2003K040157 · Elecsys C-Peptide Calcheck · Roche Diagnostics Corp. · 2004K051185 · Elecsys CA 19-9 Calcheck · Roche Diagnostics Corp. · 2005K101365 · Elecsys CA 19-9 Calcheck 5 · Roche Diagnostics Corp. · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K101365 · Elecsys CA 19-9 Calcheck 5 · Roche Diagnostics Corp. · 2010K051185 · Elecsys CA 19-9 Calcheck · Roche Diagnostics Corp. · 2005K040157 · Elecsys C-Peptide Calcheck · Roche Diagnostics Corp. · 2004K031698 · Elecys SHBG Calcheck · Roche Diagnostics Corp. · 2003K020883 · Elecsys Probnp Calcheck · Roche Diagnostics Corp. · 2002K001015 · Elecsys Thyroglobulin Calcheck · Roche Diagnostics Corp. · 2000−50
  1. Root · 6 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
  2. 5 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
  3. 4 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
  4. 3 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
  5. 2 generations backK051185 Elecsys CA 19-9 CalcheckRoche Diagnostics Corp. · 2005
  6. 1 generation backK101365 Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp. · 2010
  7. This deviceK122242 Elecsys CA 15-3 II Calcheck 5Roche Diagnostics · 2012
  8. Descendant · cites it directly · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
  9. Descendant · 2 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
  10. Descendant · 3 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
  11. Descendant · 4 generations on · 0 of its ownK230994 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023
  12. Descendant · 2 generations on · 0 of its ownK201441 Elecsys Troponin T Gen 5Roche Diagnostics · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014: 12017: 12018: 22019: 32021: 12022: 12023: 1
2014high 3 (2019) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all
  • K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · cites it directly8descendants
  • K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 2 generations on2descendants
  • K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 3 generations on1descendant
  • K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023 · 4 generations on0descendants
  • K201441Elecsys Troponin T Gen 5Roche Diagnostics · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K001015Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp.2000—
−5K020883Elecsys Probnp CalcheckRoche Diagnostics Corp.2002—
−4K031698Elecys SHBG CalcheckRoche Diagnostics Corp.2003—
−3K040157Elecsys C-Peptide CalcheckRoche Diagnostics Corp.2004—
−2K051185Elecsys CA 19-9 CalcheckRoche Diagnostics Corp.2005—
−1K101365Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp.2010—
0 (this device)K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics2012—
+1K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet…Roche Diagnostics2017—
+2K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2019—
+3K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2022—
+4K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2023—
+2K201441Elecsys Troponin T Gen 5Roche Diagnostics2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
201820
201930
202110
202210
202310
FIG. 1 — Lineage of K122242, 2000–2023Source: 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
*K101365Elecsys CA 19-9 Calcheck 5
Summary page 1
…roducts in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CA 19-9 CalCheck 5 (K1 01365). Device The Elecsys CA 15-3 11 CalCheck 5 is a lyophilized product consisting of CA Description 15-3 in equine…
Roche Diagnostics Corp.2010—
†K001468Elecsys CA 15-3 Test SystemRoche Diagnostics Corp.2000—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178
K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140

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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K162895 (Roche Diagnostics, 2017) has gone furthest, with 8 descendants of its own.

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. 2012, 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 CA 15-3 11 CaiCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Eleesys CA 15-3 11 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.

Indications for use as stated in the FDA summary.

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The JJX category page

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https://510kreport.com/device/K122242 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122242: Elecsys CA 15-3 II Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122242

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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