# K982786: Traccell 2000 Slide Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Accumed Intl., Inc.
- Decided: Oct 16, 1998 after 67 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) TracCell™ 2000 Slide Mapping System: named in the summary without a submission number

## Indications for use
The new TracCell™ 2000 Slide Mapping System is intended as a computer-aided Slide Mapping System integrated to an automated optical microscope workstation (AccuMed International's AcCell™ Workstation). The TracCell™ 2000 Slide Mapping System is used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. In addition to the present intended use as cleared by FDA, the new TracCell™ 2000 Slide Mapping System can be used for the purposes of mapping Cytyc ThinPrep® specimens. The mapping of the slide into presented and excluded fields of view is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. 1. All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view. 2. All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening. The mapping of a Cytyc Thin Prep™ specimen is carried out in precisely the same manner as the predicate TracCell 2000 Slide Mapping System. The mapping of the slide in presented and excluded fields-of-view, is performed by segmenting the light absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. These techniques are identical to the predicate TracCell 2000™.

Source page: https://510kreport.com/device/K982786
Methodology: https://510kreport.com/methodology