510(k) · Cleared
Recalled · Class II · 2018Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MMI Immunoassay Method, Troponin Subunit
Cleared on Jul 3, 2008 as substantially equivalent to K063756 (Dade Behring, Inc., 2007) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 2001. It has been recalled 4 times.
- Decided
- Jul 3, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010313 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK010313 Dimension Ctni Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
- 1 generation backK053577 Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and…Dade Behring, Inc. · 2006
- This deviceK081643 Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with…Siemens Healthcare Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010313 | Dimension Ctni Flex Reagent Cartridge | Dade Behring, Inc. | 2001 | 2 |
| −1 | K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample… | Dade Behring, Inc. | 2006 | — |
| 0 (this device) | K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models… | Siemens Healthcare Diagnostics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
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 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063756 | Dimension Vista Ctni Flex Reagent CartridgeSummary page 1…CTNI Sample Diluent No FDA classification 3. Identification of the Predicate Device Dimension Vista® CTNI Flex® reagent cartridge, K063756 Dimension Vista® CTNI Sample Diluent, K053577 4. Device Description The Dimension® TNI Flex® reagent cartrid… | 2007 |
| * | K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentSummary page 1…lassification 3. Identification of the Predicate Device Dimension Vista® CTNI Flex® reagent cartridge, K063756 Dimension Vista® CTNI Sample Diluent, K053577 4. Device Description The Dimension® TNI Flex® reagent cartridge is an in vitro diagnostic device that consi… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2018 | Class II | Z-2436-2018 | Under Investigation by firm | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced… |
| Mar 21, 2017 | Class II | Z-2606-2017 | Under Investigation by firm | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units… |
| Aug 31, 2011 | Not classified | Z-0069-2012 | Process control | Firm has confirmed customer complaints for low recovery of QC and patient samples. |
| Apr 12, 2010 | Not classified | Z-0460-2011 | Other | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXLTM integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The CTNI Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL TM integrated chemistry system with LOCI® module.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081643 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081643: Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081643
Report an extraction error
Are you the manufacturer?
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