510(k) Report

510(k) · Cleared

Cleared

Elecsys Calcheck Prolactin

K970147510(k) TraditionalCleared Feb 10, 199726-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

Boehringer Mannheim Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Feb 10, 1997 as substantially equivalent to K924863 (Tosoh Medics, Inc., 1992) after a 26-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided
Feb 10, 1997
Review
26 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K924863 (1992). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant clearedK924863 · Aia-Pack FSH Calibration Verification Test Set · Tosoh Medics, Inc. · 19921990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 1 descendant K924863 · Aia-Pack FSH Calibration Verification Test Set · Tosoh Medics, Inc. · 19920
  1. Root · 1 generation backK924863 Aia-Pack FSH Calibration Verification Test SetTosoh Medics, Inc. · 1992
  2. This deviceK970147 Elecsys Calcheck ProlactinBoehringer Mannheim Corp. · 1997
  3. Descendant · cites it directly · 5 of its ownK053059 Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics · 2005
  4. Descendant · 2 generations on · 4 of its ownK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
  5. Descendant · 3 generations on · 1 of its ownK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK223867 Ids Acth IIImmunodiagnostic Systems Limited · 2023
  7. Descendant · 4 generations on · 0 of its ownK143296 AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12011: 12013: 12014: 12023: 1
2005high 1 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics · 2005 · cites it directly5descendants
  • K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006 · 2 generations on4descendants
  • K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc. · 2011 · 3 generations on1descendant
  • K223867Ids Acth IIImmunodiagnostic Systems Limited · 2023 · 3 generations on0descendants
  • K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924863Aia-Pack FSH Calibration Verification Test SetTosoh Medics, Inc.1992—
0 (this device)K970147Elecsys Calcheck ProlactinBoehringer Mannheim Corp.1997—
+1K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics2005—
+2K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.2006—
+3K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.20112
+3K223867Ids Acth IIImmunodiagnostic Systems Limited2023—
+4K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201110
201310
201410
202310
FIG. 1 — Lineage of K970147, 1992–2023Source: 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 JJY? 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
*K924863Aia-Pack FSH Calibration Verification Test Set
Summary page 1
…ayed) The Boehringer Mannheim Elecsys CalCheck Prolactin is substantially equivalent tq the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) The Boehringer Mannheim Elecsys CalCheck Prolactin is manufactured using human serum albumin and human Prolactin. The analyte i…
Tosoh Medics, Inc.1992—

Also cleared against K924863: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics20055

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?

  • Its one ancestor has no recall.
  • Of its descendants, K053059 (Roche Diagnostics, 2005) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K924863.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

What is it indicated for?

The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K924863

4 other devices cite the same predicate.

  • K970984The Elecsys Calcheck ProgesteroneBoehringer Mannheim Corp. · 1997
  • K970146Elecsys Calcheck TestosteroneBoehringer Mannheim Corp. · 1997
  • K964830Elecsys Calcheck LHBoehringer Mannheim Corp. · 1996
  • K964829Elecsys Calcheck FSHBoehringer Mannheim Corp. · 1996

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in JJY

The JJY category page

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  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K970147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970147: Elecsys Calcheck Prolactin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970147

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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