510(k) · Cleared
ClearedBiocentrex Cardiac Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocentrex · MYT Biosensor, Immunoassay, Cpk Or Isoenzymes
Cleared on Jan 12, 2004 as substantially equivalent to K021814 (Beckman Coulter, Inc., 2002) and 2 other predicates after a 104-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 12, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- MYT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010429 (2001). 4 ancestors in all, the oldest K951634 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK010429 Accutni and Accutni Calibrators on the Access Immunoassay System #…Beckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK021814 Accutni and Accutni Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2002 · Recalled
- This deviceK033155 Biocentrex Cardiac PanelBiocentrex · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345 | Beckman Coulter, Inc. | 2001 | 3 |
| −1 | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2002 | 3 |
| 0 (this device) | K033155 | Biocentrex Cardiac Panel | Biocentrex | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 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 MYT? 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? (3)
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 |
|---|---|---|---|
| * | K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345Summary page 1…Cardiac panel performed on the Bio(enie Analyzer Predicate Device: Access® AccuTnI' for Use on the Access® Iminunoassay Analyzer 510(k) Number. K021814 Access® CK-MB for Use on the Access® Immunoassay Analyzer 510(k) Number. K000716 Access® Myoglobin for Use on the Access® Immun… | 2002 |
| * | K000716 | Access CK-MB on the Access Immunoassay AnalyzerSummary page 1…e Device: Access® AccuTnI' for Use on the Access® Iminunoassay Analyzer 510(k) Number. K021814 Access® CK-MB for Use on the Access® Immunoassay Analyzer 510(k) Number. K000716 Access® Myoglobin for Use on the Access® Immunoassay Analyzer 510(k) Number: K951634 Device Description: BioCentrex Cardiac Pa… | 2000 |
| * | K951634 | Access Myoglobin ReagentsSummary page 1…. K021814 Access® CK-MB for Use on the Access® Immunoassay Analyzer 510(k) Number. K000716 Access® Myoglobin for Use on the Access® Immunoassay Analyzer 510(k) Number: K951634 Device Description: BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (cT… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K021814.
How does its category compare?
All MYT devicesMYT Biosensor, Immunoassay, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYT
FDA has decided no MYT device since 2007.
Median 510(k) review, days · MYT
Too few MYT 510(k)s in any year since 2007 to give a median.
Recalls per year · MYT
No recall names MYT since 2007.
Adverse event reports per year · MYT
1in 2015
MAUDE reports naming product code MYT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033155 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033155: Biocentrex Cardiac Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033155
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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