510(k) · Cleared
ClearedTraccell 2000 Slide Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accumed Intl., Inc. · JOY Device, Automated Cell-Locating
Cleared on Oct 16, 1998 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 16, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- JOY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOY device
- #1 K243144 X100/X100HT with Full Field Peripheral Blood…score 11.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | TracCell™ 2000 Slide Mapping System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JOY devicesJOY Device, Automated Cell-Locating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOY
136in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOY
1in 2025
MAUDE reports naming product code JOY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 136 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (271 words)
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™.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982786: Traccell 2000 Slide Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982786
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026