Focus Diagnostics, Inc.: FDA clearances and approvals
Focus Diagnostics, Inc. has 16 FDA 510(k) clearances (first 2007, latest 2015), plus 2 De Novo decisions, across 11 product codes in 2 review panels. Median 510(k) review time: 124 days. openFDA lists 12 product recalls by a recalling firm named Focus Diagnostics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 136 |
| 2013 | 0 | — |
| 2014 | 2 | 66 |
| 2015 | 3 | 85 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 4 | 4 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 3 | 3 |
| OYP | Anti-Jcv Antibody Detection Assay | 2 | 1 |
| PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 2 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 |
| LSE | Epstein-Barr Virus, Other | 1 | 1 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | 1 |
| OOI | Real Time Nucleic Acid Amplification System | 1 | 1 |
| OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 1 | 1 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (17)
- Clinical Chemistry (1)
Most recent Focus Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | OCC | 2015-09-21 | 27 |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | OQO | 2015-08-28 | 140 |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | PGX | 2015-03-18 | 85 |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | OCC | 2014-12-05 | 102 |
| K141458 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | PGH | 2014-07-01 | 29 |
| K120986 | STRATIFY JCV DXSELECT | OYP | 2012-08-16 | 136 |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | OCC | 2012-07-13 | 154 |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | OMN | 2012-04-04 | 135 |
| K102170 | SIMPLEXA FLU A/B & RSV | OCC | 2010-11-24 | 114 |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | OOI | 2010-10-29 | 74 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130049 | De Novo | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 2014-03-21 |
| DEN120008 | De Novo | Anti-Jcv Antibody Detection Assay | 2012-01-20 |
Recalls
12 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2017-02-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Focus Diagnostics, Inc. have?
Focus Diagnostics, Inc. has 16 FDA 510(k) clearances (first 2007, latest 2015), plus 2 De Novo decisions, across 11 product codes in 2 review panels.
How long does FDA take to clear Focus Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Focus Diagnostics, Inc.'s cleared 510(k)s is 124 days.
What devices does Focus Diagnostics, Inc. make?
Its most frequent FDA product codes are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 4); MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, 3); OYP (Anti-Jcv Antibody Detection Assay, 2).
Has Focus Diagnostics, Inc. had device recalls?
openFDA lists 12 product recalls in 9 recall events by a recalling firm whose name matches Focus Diagnostics, Inc; the most recent began 2017-02-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Focus Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Focus Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.