Sysmex CC-800
by Sysmex/Toa Medical Electronics, Inc. 510(k)
Active
510(k) K821575
Overview
The Sysmex CC-800 is an automated cell counter designed for hematology applications. It performs automated differential and total white blood cell counts, red blood cell counts, and platelet counts, providing quantitative and qualitative analysis of blood cell parameters.
This device is intended for use in clinical laboratories and is classified as a Class II medical device under 21 CFR 864.5200. It is supplied as a reusable instrument and requires proper maintenance and calibration. The Sysmex CC-800 holds an FDA 510(k) clearance (K821575) and is regulated under the product code GKL, with a decision of Substantially Equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821575 | Date2 Jul 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GKL
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5200
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of blood cell counts does the Sysmex CC-800 perform, and how does it differ from manual counting methods?
The Sysmex CC-800 automates total and differential white blood cell counts, red blood cell counts, and platelet counts, providing both quantitative and qualitative analysis. Unlike manual counting—which relies on visual inspection under a microscope—this device uses automated technology to deliver faster, more consistent results with reduced human error. It’s designed specifically for clinical laboratories to streamline hematology workflows.
Is the Sysmex CC-800 a single-use or reusable instrument, and what maintenance is required?
The Sysmex CC-800 is a reusable instrument, not intended for single-use. It requires proper maintenance and calibration to ensure accurate performance over time. Regular upkeep, as outlined in the manufacturer’s instructions, is essential to sustain its functionality and reliability in clinical settings.
What regulatory pathway was followed for FDA clearance of the Sysmex CC-800, and what does this mean for its use in the U.S.?
The Sysmex CC-800 received FDA 510(k) clearance (K821575) under the Traditional 510(k) review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same performance standards as an existing approved device and is classified as a Class II medical device under 21 CFR 864.5200. It is legally marketable in the U.S. for its intended clinical laboratory use.
How is the Sysmex CC-800 classified in terms of medical specialty, and what does this imply for its clinical application?
The device is categorized under Hematology as its primary medical specialty, as indicated in regulatory records. This classification implies it is specifically designed for use in clinical laboratories to analyze blood cell parameters, supporting diagnostics related to blood disorders, infections, or other hematological conditions. Its automated functions align with standard hematology workflows.