FDA product code · Pathology
Cancer-Related Germline Gene Mutation Detection System
2 FDA decisions since 2014. No recall names this code.
The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PJG at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PJG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PJG
Too few PJG 510(k)s in any year since 2007 to give a median.
Recalls per year · PJG
No recall names PJG since 2007.
Adverse event reports per year · PJG
1in 2022
MAUDE reports naming product code PJG, 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 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 5 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 5 | — | 0 | 0 |
| 2019 | 3 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 5 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in PJG? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report