FDA product code QFO: Zika Virus Serological Reagents
QFO is the FDA product code for zika virus serological reagents. It is a Class II device, regulated under 21 CFR 866.3935 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QFO, from 3 different applicants. The average 510(k) review took 72 days (median 89). 1 De Novo request was granted under it.
Definition
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Zika Virus Serological Reagents |
| Device class | Class II |
| Regulation | 21 CFR 866.3935 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QFO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 61 |
| 2020 | 1 | 93 |
Compare with all 510(k) review times · Search every QFO clearance
Top QFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chembio Diagnostic Systems | 1 | 2020-06-03 |
| DiaSorin, Inc. | 1 | 2019-10-28 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2019-07-17 |
Most recent QFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200506 | Chembio Diagnostic Systems | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | 2020-06-03 | 93 |
| K192046 | DiaSorin, Inc. | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | 2019-10-28 | 89 |
| K191578 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | 2019-07-17 | 33 |
Recalls for QFO devices
openFDA lists no recalls for product code QFO.
Frequently asked questions
What is FDA product code QFO?
QFO is the FDA product code for zika virus serological reagents. It is a Class II device, regulated under 21 CFR 866.3935 and reviewed by the Microbiology panel.
What device class is QFO?
Class II, regulation 21 CFR 866.3935. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFO?
Across 3 cleared submissions the average was 72 days from receipt to decision (median 89).
Which companies have the most QFO clearances?
Chembio Diagnostic Systems (1); DiaSorin, Inc. (1); Siemens Healthcare Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFO
- Run a recall and safety report across every QFO manufacturer
- Watch product code QFO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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