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Sysmex POCH-100I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032677

by Sysmex America, Inc.

Identifiers

510(k) Number
K032677 FDA 510(k)
FDA Product Code
GKL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5200 FDA 510(k)
Regulation Number
864.5200 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sysmex Poch-100i is an automated cell counter designed for hematology applications. It performs automated differential and complete blood counts, including measurements of red blood cells, white blood cells, platelets, and hemoglobin levels, providing rapid and precise hematological analysis.

This device is intended for use in clinical laboratories processing up to 30 samples per day. Supplied as a reusable instrument, it requires proper maintenance and calibration as outlined in its instructions for use. The Poch-100i is classified under FDA 510(k) clearance (K032677) and adheres to regulatory standards for automated hematology analyzers, ensuring compliance with medical device regulations.

Frequently asked questions

What types of blood tests can the Sysmex Poch-100i perform, and is it suitable for high-volume clinical labs?

The Sysmex Poch-100i is an automated cell counter designed to perform complete blood counts (CBC) and differential white blood cell counts, including measurements of red blood cells, white blood cells, platelets, and hemoglobin levels. It is specifically intended for clinical laboratories processing up to 30 samples per day, making it suitable for smaller or low-to-moderate volume settings rather than high-throughput environments.

Is the Sysmex Poch-100i a single-use or reusable device, and what maintenance is required?

The Sysmex Poch-100i is a reusable instrument, meaning it is not disposable after each use. Like all reusable medical devices, it requires regular maintenance, calibration, and cleaning as outlined in its instructions for use to ensure accurate and reliable performance over time.

How is the regulatory status of this device determined, and what does that mean for users?

The Sysmex Poch-100i holds FDA 510(k) clearance (K032677), meaning it has been deemed substantially equivalent to a legally marketed predicate device under the Traditional 510(k) review pathway. This classification ensures it meets regulatory standards for automated hematology analyzers, but users should confirm compliance with local laboratory protocols and maintenance requirements to ensure continued accuracy.

What are the key specifications or models associated with this device, and how might they impact selection?

The Sysmex Poch-100i is listed under OpenFDA product codes (e.g., GKL) and registration numbers, which categorize it as an automated cell counter for hematology. While the data does not specify exact model variations, the device is designed for low-to-moderate throughput labs (up to 30 samples/day). Buyers should verify compatibility with their workflow and consult the manufacturer’s documentation for technical details.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: pocH-100i™ Hematology Analyzers | Sysmex America, SYSMEX POCH-100I INSTRUCTIONS FOR USE MANUAL Pdf Download, PDF Automated Hematology Analyzer pocH-100iTM - sysmex.com, PDF Automated Haematology Analyser pocH-100i - Sysmex

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sysmex America, Inc.

Sources (1)

  • FDA 510(k) K032677 24 fields · synced Sep 19, 2026