FDA product code MKQ: Processor, Cervical Cytology Slide, Automated
MKQ is the FDA product code for processor, cervical cytology slide, automated. It is a Class III device, reviewed by the Pathology panel. Devices under MKQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 29 recalls for MKQ devices.
Definition
It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Classification
| Field | Value |
|---|---|
| Device name | Processor, Cervical Cytology Slide, Automated |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MKQ devices
29 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-12.
Frequently asked questions
What is FDA product code MKQ?
MKQ is the FDA product code for processor, cervical cytology slide, automated. It is a Class III device, reviewed by the Pathology panel.
What device class is MKQ?
Class III. Typical premarket route: PMA.
Have MKQ devices been recalled?
Yes: 29 product recalls across 6 recall events; the most recent began 2016-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MKQ
- Run a recall and safety report across every MKQ manufacturer
- Watch product code MKQ 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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