510(k) Report

510(k) · Cleared

Recalled · 2006

Stratus CS Acute Care Troponin I Testpak, Model Cctni

K033487510(k) TraditionalCleared Dec 24, 200350-day reviewClass II21 CFR 862.1215Recalls 1

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 24, 2003 as substantially equivalent to K984093 (Dade Behring, Inc., 1998) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1998. 6 later devices descend from it. It has been recalled once.

Decided
Dec 24, 2003
Review
50 days
Class
Class II
Product code
MMI
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K981098 (1998). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2005: 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 · recalledK984093 · Stratus (R) CS Cardiac Troponin I (Trop) Testpak · Dade Behring, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K984093 · Stratus (R) CS Cardiac Troponin I (Trop) Testpak · Dade Behring, Inc. · 1998K981098 · Stratus CS Cardiac Troponin I Testpak · Dade Behring, Inc. · 1998 · recalled0
  1. Root · 2 generations backK981098 Stratus CS Cardiac Troponin I TestpakDade Behring, Inc. · 1998 · Recalled
  2. 1 generation backK984093 Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc. · 1998
  3. This deviceK033487 Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc. · 2003
  4. Descendant · cites it directly · 4 of its ownK100130 Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample…Mitsubishi Chemical Medience CO · 2011
  5. Descendant · 2 generations on · 2 of its ownK231974 PATHFAST®hs-cTnI-IIPhc Corporation · 2024
  6. Descendant · 3 generations on · 1 of its ownK240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025
  7. Descendant · 4 generations on · 0 of its ownK253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026
  8. Descendant · 2 generations on · 0 of its ownK130603 Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12011: 12014: 12024: 12025: 12026: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO · 2011 · cites it directly4descendants
  • K231974PATHFAST®hs-cTnI-IIPhc Corporation · 2024 · 2 generations on2descendants
  • K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 3 generations on1descendant
  • K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc. · 2026 · 4 generations on0descendants
  • K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K981098Stratus CS Cardiac Troponin I TestpakDade Behring, Inc.19981
−1K984093Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc.1998—
0 (this device)K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc.2003—
+1K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO2011—
+2K231974PATHFAST®hs-cTnI-IIPhc Corporation2024—
+3K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2025—
+4K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.2026—
+2K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201110
201410
202410
202510
202610
FIG. 1 — Lineage of K033487, 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? (2)

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
*K984093Stratus (R) CS Cardiac Troponin I (Trop) Testpak
Summary page 1
…s® CS TM Troponin I TestPak FDA Classification Name: Immunoassay Method, Troponin Subunit Predicate Device: Dade Behring Stratus® CS cTnI TestPak(K984093/K981098). Intended Use: The Stratus® CS Acute CareTM Troponin I method is an in vitro diagnostic test for the meas…
Dade Behring, Inc.1998—
*K981098Stratus CS Cardiac Troponin I Testpak
Summary page 1
…Troponin I TestPak FDA Classification Name: Immunoassay Method, Troponin Subunit Predicate Device: Dade Behring Stratus® CS cTnI TestPak(K984093/K981098). Intended Use: The Stratus® CS Acute CareTM Troponin I method is an in vitro diagnostic test for the measurement…
Dade Behring, Inc.19981

Also cleared against K984093: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO20114
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)

Recalls of this device

DateClassRecallRoot causeReason
Apr 3, 2006Not classifiedZ-0876-06OtherFoil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K100130 (Mitsubishi Chemical Medience CO, 2011) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K984093.

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 Stratus® CS Acute CareTM Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Indications for use as stated in the FDA summary.

Also cleared against K984093

1 other device cites 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

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/K033487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033487: Stratus CS Acute Care Troponin I Testpak, Model Cctni.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033487

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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