ThinPrep Processor 2000/3000 System
PMA P950039
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP950039 | Date20 May 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Thinprep(R) Processor, Model Tp 2000
- Generic name
- Processor, cervical cytology slide, automated
- PMA number
- FDA product code
- MKQ
- Device class
- Class III
- Advisory committee
- Pathology
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The ThinPrep Processor 2000/3000 System is an automated processor for cervical cytology slides, designed to prepare liquid-based cytology specimens from collected cells. It generates uniform, single-layer cell preparations from ThinPrep PreservCyt collection vials, improving diagnostic accuracy by reducing obscuring elements such as blood and inflammatory cells.
This system is intended for use in pathology laboratories and requires sterile single-use reagents and disposable components. The Processor 2000/3000 is classified as a Class III device under FDA regulations and holds a Premarket Approval (PMA P950039) with subsequent supplements. It operates with multiple model variants (2000/3000) and is supplied with proprietary ThinPrep collection vials and processing cartridges, adhering to strict sterility and quality control standards.
Other devices from Hologic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the ThinPrep Processor 2000/3000 System in a pathology lab?
The ThinPrep Processor 2000/3000 System automates the preparation of cervical cytology slides by creating uniform, single-layer cell samples from ThinPrep PreservCyt collection vials. This process reduces interference from blood or inflammatory cells, which can obscure diagnostic details, thereby improving the accuracy of cervical cancer screening.
Are the reagents and components used with the ThinPrep Processor 2000/3000 System single-use or reusable?
The system requires **sterile single-use reagents and disposable components**, including proprietary ThinPrep collection vials and processing cartridges. This design ensures consistency, sterility, and compliance with laboratory best practices for cytology specimen processing.
What model variants of the ThinPrep Processor are available, and how do they differ?
The system is available in two model variants: the **ThinPrep Processor 2000** and the **ThinPrep Processor 3000**. While the exact functional differences between them are not specified in the data, both share the same core purpose—automating liquid-based cytology slide preparation—and are designed for use with ThinPrep PreservCyt vials and disposable cartridges.
How is the ThinPrep Processor 2000/3000 System regulated, and what does that mean for laboratories?
The device holds a **Premarket Approval (PMA P950039)** from the FDA, classifying it as a **Class III medical device**. This means it undergoes rigorous review to ensure safety and effectiveness for its intended use in pathology labs. Laboratories must adhere to the manufacturer’s instructions and regulatory guidelines to maintain compliance.
What type of collection vials and cartridges are compatible with the ThinPrep Processor 2000/3000 System?
The system is designed to work exclusively with **proprietary ThinPrep collection vials** and **processing cartridges** supplied by Hologic. These components are engineered to meet the system’s sterility and quality standards, ensuring reliable performance for liquid-based cytology specimen preparation.