510(k) Report

510(k) · Cleared

Cleared

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

K162895510(k) TraditionalCleared Jan 18, 201793-day reviewClass II21 CFR 862.1215

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics · MMI Immunoassay Method, Troponin Subunit

Cleared on Jan 18, 2017 as substantially equivalent to K051752 (Roche Diagnostics, 2005) and 3 other predicates after a 93-day review. Its family tree reaches back 7 generations to 1993. 8 later devices descend from it.

Decided
Jan 18, 2017
Review
93 days
Class
Class II
Product code
MMI
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K931172 (1993). 25 ancestors in all. 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2005: 3 other ancestors1996: 1 other ancestor2010: 2 other ancestors2004: 2 other ancestors2002: 3 other ancestors2001: 1 other ancestor1998: 1 other ancestor2003: 2 other ancestors2000: 2 other ancestors2018: 2 descendants cleared2021: 1 descendant cleared2019: 3 descendants cleared2022: 1 descendant cleared2023: 1 descendant clearedK931172 · Imx (R) Stat CK-MB · Abbott Laboratories · 1993×2: 2 generations cleared close together, K961501 (1996), K962575 (1996) K983492 · Boehringer Mannheim Elecsys Presicontrol Cardiac · Boehringer Mannheim Corp. · 1998K032089 · Roche Diagnostics Elecsys Precicontrol Cardiac · Roche Diagnostics Corp. · 2003K072437 · Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset · Roche Diagnostics · 2008K082699 · Elecsys Troponin I and Troponin I Stat Test Systems · Roche Diagnostics · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 6 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K082699 · Elecsys Troponin I and Troponin I Stat Test Systems · Roche Diagnostics · 2009 · recalledK072437 · Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset · Roche Diagnostics · 2008K032089 · Roche Diagnostics Elecsys Precicontrol Cardiac · Roche Diagnostics Corp. · 2003K983492 · Boehringer Mannheim Elecsys Presicontrol Cardiac · Boehringer Mannheim Corp. · 1998K962575 · Elecsys Precicontrol Cardiac · Boehringer Mannheim Corp. · 1996K961501 · Elecsys CK-MB · Boehringer Mannheim Corp. · 1996K931172 · Imx (R) Stat CK-MB · Abbott Laboratories · 1993−50
  1. Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
  2. 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
  3. 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
  4. 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
  5. 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
  6. 2 generations backK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
  7. 1 generation backK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled
  8. This deviceK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
  9. Descendant · cites it directly · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
  10. Descendant · 2 generations on · 1 of its ownK202525 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022
  11. Descendant · 3 generations on · 0 of its ownK230994 Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023
  12. Descendant · cites it directly · 0 of its ownK201441 Elecsys Troponin T Gen 5Roche Diagnostics · 2021
  13. Descendant · cites it directly · 0 of its ownK190675 Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc. · 2019 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018: 22019: 32021: 12022: 12023: 1
2018high 3 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · cites it directly2descendants
  • K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2022 · 2 generations on1descendant
  • K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2023 · 3 generations on0descendants
  • K201441Elecsys Troponin T Gen 5Roche Diagnostics · 2021 · cites it directly0descendants
  • K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K931172Imx (R) Stat CK-MBAbbott Laboratories1993—
−6K961501Elecsys CK-MBBoehringer Mannheim Corp.1996—
−5K962575Elecsys Precicontrol CardiacBoehringer Mannheim Corp.1996—
−4K983492Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp.1998—
−3K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp.2003—
−2K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics2008—
−1K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics20094
0 (this device)K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet…Roche Diagnostics2017—
+1K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2019—
+2K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2022—
+3K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2023—
+1K201441Elecsys Troponin T Gen 5Roche Diagnostics2021—
+1K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200020
200110
200230
200320
200420
200530
201020
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201930
202110
202210
202310
FIG. 1 — Lineage of K162895, 1993–2023Source: 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 MMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MMI device

  1. #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K051752Roche Elecsys Troponin T Stat (Short Turnaround Time)
Summary page 8
…ly marketed in the United States. (1) Elecsys Troponin T Gen 5 STAT Immunoassay is equivalent to Elecsys Troponin T, 4th generation STAT Immunoassay, Roche Diagnostics (K051752). (2) Elecsys Troponin T Gen 5 STAT CalSet is equivalent to the Elecsys Troponin T CalSet (K961500). (3) Elecsys PreciControl T…
Roche Diagnostics20051
*K961500Elecsys Troponin T
Summary page 8
…ecsys Troponin T, 4th generation STAT Immunoassay, Roche Diagnostics (K051752). (2) Elecsys Troponin T Gen 5 STAT CalSet is equivalent to the Elecsys Troponin T CalSet (K961500). (3) Elecsys PreciControl Troponin is equivalent to the Elecsys PreciControl Troponin T (K082699). (4) Elecsys Troponin T Gen…
Boehringer Mannheim Corp.1996—
*K082699Elecsys Troponin I and Troponin I Stat Test Systems
Summary page 8
…in T Gen 5 STAT CalSet is equivalent to the Elecsys Troponin T CalSet (K961500). (3) Elecsys PreciControl Troponin is equivalent to the Elecsys PreciControl Troponin T (K082699). (4) Elecsys Troponin T Gen 5 CalCheck 5 is equivalent to the Elecsys CA 15-3 Il CalCheck 5 (K122242). e Immunoassay for the i…
Roche Diagnostics20094
*K122242Elecsys CA 15-3 II Calcheck 5
Summary page 8
…rol Troponin is equivalent to the Elecsys PreciControl Troponin T (K082699). (4) Elecsys Troponin T Gen 5 CalCheck 5 is equivalent to the Elecsys CA 15-3 Il CalCheck 5 (K122242). e Immunoassay for the in vitro quantitative determination of cardiac troponin T (¢TnT) in lithium heparin plasma. The immunoas…
Roche Diagnostics2012—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192
K201441Elecsys Troponin T Gen 5Roche Diagnostics20210
K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.20190
K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.20190
K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180
K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180

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 24 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • 6 of the 25 ancestors have a recall of any class.
  • Of its descendants, K191595 (Abbott Laboratories Diagnostics Division, 2019) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MMI devices

MMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MMI

4in 2025

2007: 32008: 12009: 12010: 22011: 12013: 22017: 12018: 42019: 32021: 12022: 12023: 32024: 22025: 42026 (partial year): 1
2007high 4 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMI

266in 2025

2007: 190 days median2018: 344 days median2019: 88 days median2023: 270 days median2025: 266 days median
2007high 344 (2018) · low 88 (2019)2026

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

Recalls per year · MMI

1in 2024

2007: 62008: 22009: 32010: 52011: 12012: 62014: 12015: 12019: 12020: 12021: 12024: 1
2007high 6 (2007) · low 0 (2013)2026

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

Adverse event reports per year · MMI

805in 2025

2007: 3522008: 8372009: 1,0102010: 1,3352011: 2,4062012: 1,8412013: 1,3942014: 1,1502015: 8312016: 4872017: 6182018: 4872019: 5212020: 3872021: 3562022: 5072023: 7482024: 9212025: 805
2007high 2,406 (2011) · low 352 (2007)2025

MAUDE reports naming product code MMI, 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
200731906352
20081—2837
20091—31,010
20102—51,335
20111—12,406
20120—61,841
20132—01,394
20140—11,150
20150—1831
20160—0487
20171—0618
201843440487
20193881521
20200—1387
20211—1356
20221—0507
202332700748
20242—1921
202542660805
20261—0—

What is it indicated for?

Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers. CalSet Troponin T Gen 5 STAT is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. PreciControl Troponin is…

Read the full statement (155 words)

Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas system analyzers.

CalSet Troponin T Gen 5 STAT is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers.

PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers.

PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers.

The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers.

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

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Recent decisions in MMI

The MMI category page

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  • K243483Access hsTnIBeckman Coulter, Inc. · 2025
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https://510kreport.com/device/K162895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 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/K162895

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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