510(k) · Cleared
ClearedBOND MMR Antibody Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Biosystems Newcastle, Ltd. · PZJ Lynch Syndrome Test System
Cleared on Feb 21, 2023 as substantially equivalent to DEN170030 (Ventana Medical Systems, 2017) after a 501-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Feb 21, 2023
- Review
- 501 days
- Class
- Class II
- Product code
- PZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170030 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170030 VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA…Ventana Medical Systems · 2017
- This deviceK213348 BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd. · 2023
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) | K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle, Ltd. | 2023 | — |
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
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 |
|---|---|---|---|
| * | DEN170030 | VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4)…Summary page 12…arison Table of the BOND MMR Antibody Panel [subject device] and the Ventana MMR IHC Panel (DEN170030) [predicate device] Leica Biosystems… | 2017 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN170030.
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?
The BOND MMR Antibody Panel is intended to be used for the qualitative identification by light microscopy of human mismatch repair (MMR) proteins MLH1, MSH2, MSH6 and PMS2 in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue sections by immunohistochemical staining. The BOND MMR Antibody Panel includes BOND Ready-to-Use Primary Antibody MLH1 (Mismatch Repair Protein) (ES05), BOND Ready-to-Use Primary Antibody MSH2 (Mismatch Repair…
Read the full statement (245 words)
The BOND MMR Antibody Panel is intended to be used for the qualitative identification by light microscopy of human mismatch repair (MMR) proteins MLH1, MSH2, MSH6 and PMS2 in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue sections by immunohistochemical staining. The BOND MMR Antibody Panel includes BOND Ready-to-Use Primary Antibody MLH1 (Mismatch Repair Protein) (ES05), BOND Ready-to-Use Primary Antibody MSH2 (Mismatch Repair Protein) (79H11), BOND Ready-to-Use Primary Antibody MSH6 (Mismatch Repair Protein) (EP49) and BOND Ready-to-Use Primary Antibody PMS2 (Mismatch Repair Protein) (EP51). The BOND MMR Antibody Panel is intended for use on the BOND-III or BOND-MAX fully automated systems with BOND Polymer Refine Detection.
The BOND MMR Antibody Panel is indicated for the detection of MMR protein deficiency as an aid in the identification of potential hereditary nonpolyposis colorectal cancer (HNPCC)/Lynch Syndrome in patients diagnosed with CRC. Patients with “MMR Loss” results should receive additional diagnostic testing consistent with clinical practice guidelines for diagnosis of Lynch syndrome. The BOND MMR Antibody Panel is not intended for use in indications other than CRC. This test should not be used for diagnosis of CRC.
The clinical interpretation of any staining or its absence when using the BOND MMR Antibody Panel should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
The clinical performance of this device to guide treatment of MMR deficient patients has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213348: BOND MMR Antibody Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213348
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