510(k) Report

510(k) · Cleared

Cleared

Elecsys Insulin Calcheck 5

K101075510(k) TraditionalCleared Jun 11, 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

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

Cleared on Jun 11, 2010 as substantially equivalent to K092168 (Roche Diagnostics, 2009) after a 53-day review. Its family tree reaches back 2 generations to 2001. 16 later devices descend from it.

Decided
Jun 11, 2010
Review
53 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K010237 (2001). 16 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 9 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared2015: 5 descendants clearedK010237 · Elecsys HCG+B Calcheck · Roche Diagnostics Corp. · 2001K092168 · Elecsys HCG+B Calcheck 5 · Roche Diagnostics · 2009200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants K092168 · Elecsys HCG+B Calcheck 5 · Roche Diagnostics · 2009K010237 · Elecsys HCG+B Calcheck · Roche Diagnostics Corp. · 20010
  1. Root · 2 generations backK010237 Elecsys HCG+B CalcheckRoche Diagnostics Corp. · 2001
  2. 1 generation backK092168 Elecsys HCG+B Calcheck 5Roche Diagnostics · 2009
  3. This deviceK101075 Elecsys Insulin Calcheck 5Roche Diagnostics Corp. · 2010
  4. Descendant · cites it directly · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
  5. Descendant · 2 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
  6. Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
  7. Descendant · 2 generations on · 2 of its ownK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014
  8. Descendant · cites it directly · 1 of its ownK142864 ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2013: 12014: 92015: 52016: 1
2013high 9 (2014) · low 0 (2017)2026

Most influential descendants

Showing 5 of 16 · 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
  • K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010237Elecsys HCG+B CalcheckRoche Diagnostics Corp.2001—
−1K092168Elecsys HCG+B Calcheck 5Roche Diagnostics2009—
0 (this device)K101075Elecsys Insulin Calcheck 5Roche Diagnostics Corp.2010—
+1K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…Siemens Healthcare Diagnostics, Inc.2013—
+2K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…Siemens Healthcare Diagnostics, Inc.2014—
+2K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc.2014—
+2K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc.2014—
+1K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201490
201550
201610
FIG. 1 — Lineage of K101075, 2001–2016Source: 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
*K092168Elecsys HCG+B Calcheck 5
Summary page 1
…products device in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys HCG+p CaiCheck 5 (K092 168). Device The Eiecsys Insulin CalCheck 5 is a lyophilized product consisting of Description recombinant human ins…
Roche Diagnostics2009—

Also cleared against K092168: 5 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc.201313
K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Siemens Healthcare Diagnostics, Inc.20141

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 9 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K133128 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 13 descendants of its own.
  • 5 other devices also cite its predicate K092168.

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 Elecsys Insulin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Insulin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Indications for use as stated in the FDA summary.

Also cleared against K092168

5 other devices cite the same predicate.

  • K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master…Siemens Healthcare Diagnostics, Inc. · 2014
  • K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D…Siemens Healthcare Diagnostics, Inc. · 2013
  • K094031Elecsys Folate Iii Calcheck 5Roche Diagnostics · 2010
  • K100594Elecsys Troponin I Calcheck 5Roche Diagnostics · 2010
  • K093700Elecsys HCG Stat Calcheck 5Roche Diagnostics Corp. · 2010

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 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/K101075 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101075: Elecsys Insulin 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/K101075

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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