510(k) Report

510(k) · Cleared

Recalled · 2008

Dimension Ctni Flex Reagent Cartridge

K010313510(k) TraditionalCleared Apr 20, 200177-day reviewClass II21 CFR 862.1215Recalls 2

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 Apr 20, 2001 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.

Decided
Apr 20, 2001
Review
77 days
Class
Class II
Product code
MMI
Recalls
2
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2008: 2 descendants cleared200020052010201520202025
  1. This deviceK010313 Dimension Ctni Flex Reagent CartridgeDade Behring, Inc. · 2001
  2. Descendant · cites it directly · 2 of its ownK053577 Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and…Dade Behring, Inc. · 2006
  3. Descendant · cites it directly · 1 of its ownK063756 Dimension Vista Ctni Flex Reagent CartridgeDade Behring, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK081683 Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics · 2008 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK081643 Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with…Siemens Healthcare Diagnostics · 2008 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K053577Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentDade Behring, Inc. · 2006 · cites it directly2descendants
  • K063756Dimension Vista Ctni Flex Reagent CartridgeDade Behring, Inc. · 2007 · cites it directly1descendant
  • K081683Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
  • K081643Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692Siemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010313Dimension Ctni Flex Reagent CartridgeDade Behring, Inc.2001—
+1K053577Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample…Dade Behring, Inc.2006—
+1K063756Dimension Vista Ctni Flex Reagent CartridgeDade Behring, Inc.20071
+2K081683Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics20083
+2K081643Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models…Siemens Healthcare Diagnostics20084

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200820
FIG. 1 — Lineage of K010313, 2001–2008Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K053577Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentDade Behring, Inc.20062
K063756Dimension Vista Ctni Flex Reagent CartridgeDade Behring, Inc.20071

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 8, 2008Not classifiedZ-1731-2009Process controlpossibility of falsely elevated results
Mar 2, 2007Not classifiedZ-0858-2010Material/Component ContaminationTests exhibit falsely elevated results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053577 (Dade Behring, Inc., 2006) 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.

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—

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/K010313 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010313: Dimension Ctni Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010313

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026