Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
The Culture Plate Imaging System for Qualitative Assessment of Resistant Organisms is an automated in vitro diagnostic system that assesses the presence or absence of colony growth on solid chromogenic culture media, supporting detection of antimicrobial-resistant organisms. It is used in clinical microbiology laboratory settings to aid identification of resistant bacterial strains. Classified as FDA Class 2 under regulation 866.2190, it requires 510(k) premarket notification and falls under the Microbiology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QQY
- Device Class
- FDA class 2
- Regulation Number
- 866.2190
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | May 04, 2023 | Substantially Equivalent | Bd Kiestra B.V. |
| K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module | Oct 28, 2021 | Substantially Equivalent | Clever Culture Systems |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.