510(k) Report

510(k) · Cleared

Cleared

Stratus (R) CS Cardiac Troponin I (Trop) Testpak

K984093510(k) TraditionalCleared Dec 14, 199828-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

Dade Behring, Inc. · MMI Immunoassay Method, Troponin Subunit

Cleared on Dec 14, 1998 as substantially equivalent to K981098 (Dade Behring, Inc., 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998. 7 later devices descend from it.

Decided
Dec 14, 1998
Review
28 days
Class
Class II
Product code
MMI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K981098 (1998). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK981098 · Stratus CS Cardiac Troponin I Testpak · Dade Behring, Inc. · 1998 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K981098 · Stratus CS Cardiac Troponin I Testpak · Dade Behring, Inc. · 1998 · recalled0+5
  1. Root · 1 generation backK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998 · Recalled
  2. This deviceK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
  3. Descendant · cites it directly · 6 of its ownK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
  5. Descendant · 3 generations on · 2 of its ownK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
  6. Descendant · 4 generations on · 1 of its ownK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
  7. Descendant · 5 generations on · 0 of its ownK253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12011: 12014: 12024: 12025: 12026: 1
2003high 1 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003 · cites it directly6descendants
  • K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO · 2011 · 2 generations on4descendants
  • K231974PATHFAST®hs-cTnI-IIPhc Corporation · 2024 · 3 generations on2descendants
  • K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 4 generations on1descendant
  • K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K981098Stratus CS Cardiac Troponin I TestpakDade Behring, Inc.19981
0 (this device)K984093Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc.1998—
+1K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc.20031
+2K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO2011—
+3K231974PATHFAST®hs-cTnI-IIPhc Corporation2024—
+4K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2025—
+5K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201110
201410
202410
202510
202610
FIG. 1 — Lineage of K984093, 1998–2026Source: 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 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? (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
*K981098Stratus CS Cardiac Troponin I Testpak
Summary page 1
…Stratus® CS Cardiac Troponin | (TROP) TestPak Classification Name: Immunoassay Method, Troponin Subunit Predicate Device: Stratus® CS Cardiac Troponin | (TROP) TestPak (K981098) Device Description: The TROP TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper em…
Dade Behring, Inc.19981

Also cleared against K981098: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc.20036
K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…Dade Behring, Inc.20050

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 a recall.
  • Of its descendants, K033487 (Dade Behring, Inc., 2003) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K981098.

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.

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?

The TROP TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

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 K981098

2 other devices cite the same predicate.

  • K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak.Dade Behring, Inc. · 200511 recalls
  • K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 20031 recall

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in MMI

The MMI category page

  • K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
  • K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc. · 2025
  • K243483Access hsTnIBeckman Coulter, Inc. · 2025
  • K242870Access hsTnIBeckman Coulter, Inc. · 2025
  • K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025

https://510kreport.com/device/K984093 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984093: Stratus (R) CS Cardiac Troponin I (Trop) Testpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984093

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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