FDA product code QQY: Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
QQY is the FDA product code for culture plate imaging system for qualitative assessment of resistant organisms. It is a Class II device, regulated under 21 CFR 866.2190 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QQY, 1 in the last five years, from 2 different applicants. The average 510(k) review took 578 days (median 578).
Definition
Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.
Classification
| Field | Value |
|---|---|
| Device name | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms |
| Device class | Class II |
| Regulation | 21 CFR 866.2190 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QQY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 576 |
| 2023 | 1 | 580 |
Compare with all 510(k) review times · Search every QQY clearance
Top QQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Kiestra B.V. | 1 | 2023-05-04 |
| Clever Culture Systems | 1 | 2021-10-28 |
Most recent QQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213280 | Bd Kiestra B.V. | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | 2023-05-04 | 580 |
| K200839 | Clever Culture Systems | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module | 2021-10-28 | 576 |
Recalls for QQY devices
openFDA lists no recalls for product code QQY.
Frequently asked questions
What is FDA product code QQY?
QQY is the FDA product code for culture plate imaging system for qualitative assessment of resistant organisms. It is a Class II device, regulated under 21 CFR 866.2190 and reviewed by the Microbiology panel.
What device class is QQY?
Class II, regulation 21 CFR 866.2190. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQY?
Across 2 cleared submissions the average was 578 days from receipt to decision (median 578).
Which companies have the most QQY clearances?
Bd Kiestra B.V. (1); Clever Culture Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQY
- Run a recall and safety report across every QQY manufacturer
- Watch product code QQY 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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