Personal Genome Diagnostics: FDA filings under this applicant name
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Personal Genome Diagnostics” (first 2020, latest 2020), plus 1 PMA and 1 De Novo decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 267 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 267 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Personal Genome Diagnostics took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 267 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 1 | 0 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 1 | 1 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 1 | 0 |
Review panels
- Pathology (3)
Most recent Personal Genome Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192063 | PGDx elio tissue complete | PZM | 2020-04-24 | 267 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250036 | PMA | PGDx elio tissue complete CDx | 2026-07-30 |
| DEN230046 | De Novo | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 2024-08-01 |
Recalls
openFDA lists no recalls under a recalling firm named Personal Genome Diagnostics.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Personal Genome Diagnostics, Inc. (2)
- Personal Genome Diagnostics (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Personal Products Co. (45 510(k)s)
- Personal Products Company, Div. of Mcneil-Ppc, Inc. (4 510(k)s)
- Personal Sound Technologies, Inc. (2 510(k)s)
- Personal Computers For Medicine, Inc. (1 510(k)s)
- Personal Emergency Response System (1 510(k)s)
- Personal Health Institute International (1 510(k)s)
- Personal Professional Products, Inc. (1 510(k)s)
- Personal Health & Hygiene, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Personal Genome Diagnostics?
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Personal Genome Diagnostics” (first 2020, latest 2020), plus 1 PMA and 1 De Novo decisions, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Personal Genome Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Personal Genome Diagnostics is 267 days.
Which FDA product codes appear under Personal Genome Diagnostics?
The most frequent FDA product codes under this applicant name are PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 1); PZM (Next Generation Sequencing Based Tumor Profiling Test, 1); SBY (High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids, 1).
Next steps
- See all 1 Personal Genome Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code PQP, Personal Genome Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.