510(k) · Cleared
Recalled · Class II · 2021Dimension Vista MMB Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JHY Colorimetric Method, Cpk Or Isoenzymes
Cleared on Sep 18, 2015 as substantially equivalent to K970343 (Dade Chemistry Systems, Inc., 1997) and 1 other predicate after a 263-day review. Its family tree reaches back 3 generations to 1992. It has been recalled 5 times.
- Decided
- Sep 18, 2015
- Review
- 263 days
- Class
- Class II
- Product code
- JHY
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922273 (1992). 14 ancestors in all, the oldest K860021 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK922273 Array (R) 360Beckman Instruments, Inc. · 1992
- 2 generations backK990551 Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
- 1 generation backK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
- This deviceK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922273 | Array (R) 360 | Beckman Instruments, Inc. | 1992 | — |
| −2 | K990551 | Igg Flex Reagent Cartridge | Dade Behring, Inc. | 1999 | — |
| −1 | K051087 | Dimension Vista Integrated System | Dade Behring, Inc. | 2005 | 32 |
| 0 (this device) | K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 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 JHY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K970343 | MMB MethodSummary page 4…o JJE Panels: o Chemistry 3. Identification of the Predicate Devices: Dimension Vista® MMB (Mass creatine kinase MB isoenzyme) - K970343 Dimension Vista® 1500 Integrated System - K051087 Siemens Healthcare Diagnostics ® Dimension Vis… | 1997 |
| * | K051087 | Dimension Vista Integrated SystemSummary page 4…Identification of the Predicate Devices: Dimension Vista® MMB (Mass creatine kinase MB isoenzyme) - K970343 Dimension Vista® 1500 Integrated System - K051087 Siemens Healthcare Diagnostics ® Dimension Vista MMB Assay on ® the Dimension Vista 1500 S… | 2005 |
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 |
|---|---|---|---|---|
| Oct 15, 2021 | Class II | Z-0330-2022 | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Oct 15, 2021 | Class II | Z-0331-2022 | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Dec 12, 2018 | Class II | Z-1015-2019 | Under Investigation by firm | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination. |
| Oct 16, 2018 | Class II | Z-0617-2019 | Under Investigation by firm | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample… |
| Jan 2, 2018 | Class II | Z-1672-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 5 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K970343.
How does its category compare?
All JHY devicesJHY Colorimetric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JHY
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · JHY
Too few JHY 510(k)s in any year since 2007 to give a median.
Recalls per year · JHY
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHY
3in 2023
MAUDE reports naming product code JHY, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143720: Dimension Vista MMB Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143720
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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