510(k) · Cleared

Cleared

OncoMate MSI Dx Analysis System

K200129510(k) TraditionalCleared Jul 26, 2021552-day reviewClass II21 CFR 864.1866

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Promega Corporation · PZJ Lynch Syndrome Test System

Cleared on Jul 26, 2021 as substantially equivalent to DEN170030 (Ventana Medical Systems, 2017) after a 552-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.

Decided: Jul 26, 2021
Review: 552 days
Class: Class II
Product code: PZJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN170030 (2017). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN170030 VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA…Ventana Medical Systems · 2017
This deviceK200129 OncoMate MSI Dx Analysis SystemPromega Corporation · 2021
Descendant · cites it directly · 0 of its ownK211181 Idylla MSI TestBiocartis NV · 2023

Most influential descendants

Showing 1 of 1 · See all

K211181Idylla MSI TestBiocartis NV · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN170030	VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2…	Ventana Medical Systems	2017	—
0 (this device)	K200129	OncoMate MSI Dx Analysis System	Promega Corporation	2021	—
+1	K211181	Idylla MSI Test	Biocartis NV	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K200129, 2017–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211181 Idylla MSI Testscore 5.2 · 2 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	DEN170030	VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4)… Summary page 11 …6 SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Table 3: Substantial Equivalence Comparison Device & K200129 DEN170030 Predicate Device(s): Device Trade Promega OncoMateTM MSI Dx Ventana MMR IHC panel Name Analysis Sy…	Ventana Medical Systems	2017	—

Also cleared against DEN170030: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K211181	Idylla MSI Test	Biocartis NV	2023	0

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?

Its one ancestor has no recall.
Of its descendants, K211181 (Biocartis NV, 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN170030.

How does its category compare?

All PZJ devices

PZJ Lynch Syndrome Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · PZJ

2in 2023

2007high 2 (2023) · low 0 (2007)2026

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

2007high 1 (2019) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	1
2020	0	—	0
2021	1	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The OncoMate™ MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed, paraffin-embedded (FFPE) colorectal tissue sections. The OncoMate™ MSI Dx Analysis System is for use with the Applied Biosystems® 3500Dx Genetic Analyzer and OncoMate™ MSI…

Read the full statement (158 words)

The OncoMate™ MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to

detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using

matched tumor and normal DNA obtained from formalin fixed, paraffin-embedded (FFPE) colorectal tissue sections. The

OncoMate™ MSI Dx Analysis System is for use with the Applied Biosystems® 3500Dx Genetic Analyzer and

OncoMate™ MSI Dx Interpretive Software.

The OncoMate™ MSI Dx Analysis System is indicated in patients diagnosed with colorectal cancer (CRC) to detect

microsatellite instability (MSI) as an aid in the identification of probable Lynch syndrome to help identify patients that

would benefit from additional genetic testing to diagnose Lynch syndrome.

Results from the OncoMate™ MSI Dx Analysis System should be interpreted by healthcare professionals in conjunction

with other clinical findings, family history, and other laboratory data.

The clinical performance of this device to guide treatment decision for MSI high patients has not been established.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K200129 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200129: OncoMate MSI Dx Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200129

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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