510(k) Report

510(k) · Cleared

Cleared

Modification to Roche Elecsys Folate II Calcheck II

K043320510(k) SpecialCleared Dec 17, 200415-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 Dec 17, 2004 as substantially equivalent to K974384 (Boehringer Mannheim Corp., 1997) after a 15-day review. Its family tree reaches back 3 generations to 1992. 8 later devices descend from it.

Decided
Dec 17, 2004
Review
15 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K924862 (1992). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2024: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant clearedK924862 · Aia-Pack HCG Calibration Verification Test Set · Tosoh Medics, Inc. · 1992K963147 · Elecsys Calcheck TSH · Boehringer Mannheim Corp. · 1996K974384 · Elecsys Calcheck Folate · Boehringer Mannheim Corp. · 19971990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K974384 · Elecsys Calcheck Folate · Boehringer Mannheim Corp. · 1997K963147 · Elecsys Calcheck TSH · 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 backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
  3. 1 generation backK974384 Elecsys Calcheck FolateBoehringer Mannheim Corp. · 1997
  4. This deviceK043320 Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp. · 2004
  5. Descendant · cites it directly · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
  6. Descendant · 2 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
  7. Descendant · 3 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
  8. Descendant · 2 generations on · 1 of its ownK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011
  9. Descendant · 4 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12011: 22013: 12014: 12018: 12024: 12026: 1
2009high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · cites it directly7descendants
  • K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 2 generations on3descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 3 generations on2descendants
  • K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011 · 2 generations on1descendant
  • K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K924862Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc.1992—
−2K963147Elecsys Calcheck TSHBoehringer Mannheim Corp.1996—
−1K974384Elecsys Calcheck FolateBoehringer Mannheim Corp.1997—
0 (this device)K043320Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp.2004—
+1K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche…Roche Diagnostics Corp.2009—
+2K111506Elecsys Precicontrol Varia 3Roche Diagnostics20111
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—
+2K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics2011—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201120
201310
201410
201810
202410
202610
FIG. 1 — Lineage of K043320, 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
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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
*K974384Elecsys Calcheck Folate
Summary page 1
…E170 immunoassay analyzers. Predicate We claim substantial equivalence to the currently marketed Elecsys Folate Device CalCheck. (K974384). Device The table below illustrates the similarities between the Elecsys Folate Comparison CalCheck (K974384…
Boehringer Mannheim Corp.1997—

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097

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 3 companies; a new generation was cleared every 3.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K082340 (Roche Diagnostics Corp., 2009) has gone furthest, with 7 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.

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?

For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Indications for use as stated in the FDA summary.

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/K043320 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043320: Modification to Roche Elecsys Folate II Calcheck II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043320

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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