510(k) · Cleared
ClearedIdylla MSI Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocartis NV · PZJ Lynch Syndrome Test System
Cleared on Feb 27, 2023 as substantially equivalent to K200129 (Promega Corporation, 2021) after a 678-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Feb 27, 2023
- Review
- 678 days
- Class
- Class II
- Product code
- PZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170030 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PZJ? 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 PZJ device
- #1 K213348 BOND MMR Antibody Panelscore 4.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K200129 | OncoMate MSI Dx Analysis System Cleared while this submission was under review Summary page 5…NV Proposed Predicate Device OncoMate™ MSI Dx Analysis System K200129 2. Device Description The Biocartis Idylla™ System covers the entire process from sample to result with fully integrated sample… | 2021 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PZJ devicesPZJ Lynch Syndrome Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PZJ
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PZJ
Too few PZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PZJ
No recall names PZJ since 2007.
Adverse event reports per year · PZJ
1in 2019
MAUDE reports naming product code PZJ, 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use. For use on the Biocartis Idylla™ System only. The Idylla™ MSI Test, for use on the Idylla™ System, uses formalin-fixed, paraffin-embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla™ MSI Test reports results as either…
Read the full statement (186 words)
For in vitro diagnostic use.
For use on the Biocartis Idylla™ System only.
The Idylla™ MSI Test, for use on the Idylla™ System, uses formalin-fixed, paraffin-embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla™ MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.
Idylla™ MSI Test is indicated for use by healthcare professionals for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors, indicative of mismatch repair deficiency, as an aid in the identification of potential Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.
The results from the Idylla™ MSI Test should be interpreted by healthcare professionals in conjunction with other clinical findings, family history, and other laboratory data. The Idylla™ MSI Test should not be used for diagnosis of CRC.
The clinical performance of this device to guide treatment decision for MSI high patients has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211181: Idylla MSI Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211181
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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