← Product Code [JOY](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY) · K964689

# TRACCELL 2000 SLIDE MAPPING SYSTEM (K964689)

_Accumed Intl., Inc. · JOY · Aug 18, 1997 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K964689

## Device Facts

- **Applicant:** Accumed Intl., Inc.
- **Product Code:** [JOY](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY.md)
- **Decision Date:** Aug 18, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5260
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas 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.

## Device Story

TracCell™ 2000 is a computer-aided optical microscope system for cervical cytology. Input: Papanicolaou or Pap-like stained cervical cytology slides. Operation: System performs automated image processing to segment light-absorbing objects (cells/clusters) from background material; maps slide into 'presented' and 'excluded' areas. Output: Visual presentation of specific slide regions to a cytotechnologist or cytopathologist. Context: Used in clinical laboratory settings; operated by trained laboratory personnel. Benefit: Improves efficiency of diagnostic interpretation by directing the clinician's attention to relevant areas of the slide.

## Clinical Evidence

No clinical data provided in the document. Bench testing only.

## Technological Characteristics

Computer-aided optical microscope system. Utilizes standard image processing techniques for segmentation of light-absorbing objects from background. System is designed for integration into clinical laboratory workflows for cervical cytology slide review.

## Regulatory Identification

An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

AUG 18 1997

Mr. John R. Miers
Director of Regulatory Affairs
ACCUMED INTERNATIONAL, INC.
900 N. Franklin, Suite 401
Chicago, Illinois 60610

Re: K964689/S2
Trade Name: AccuMed International's TracCell™ 2000 Slide Mapping System
Regulatory Class: II
Product Code: JOY
Dated: May 30, 1997
Received: June 2, 1997

Dear Mr. Miers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven I. Gutman

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K964689

Device Name:

TracCell™ 2000 Slide Mapper System

## Indications For Use:

TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

![img-0.jpeg](img-0.jpeg)

Prescription Use ☑ (Per 21 CFR 301.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K964689](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOY/K964689)

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