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PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

by iXensor Co., Ltd. 2 variants

510(k) K181915

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181915↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK181915 Date12 Apr 2019ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LCP
FDA applicant
Ixensor Co, Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PixoTest POCT System is a Point-of-Care Testing (POCT) Assay Device for measuring glycosylated hemoglobin (HbA1c) levels. It is designed to provide rapid, accurate, and convenient HbA1c testing outside traditional laboratory settings, supporting diabetes management and monitoring.

This system consists of a PixoTest POCT Analyzer paired with PixoTest A1c Test Kits, intended for single-use in clinical or home healthcare environments. It has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, adhering to regulatory standards for hematology applications. The device operates as a Class II medical device under FDA classification 864.7470.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical setting is the PixoTest POCT System intended for, and how does it differ from traditional lab testing for HbA1c?

    The PixoTest POCT System is designed for clinical or home healthcare environments, enabling rapid HbA1c testing outside traditional laboratory settings. Unlike lab-based testing, which requires specialized equipment and trained personnel, this system provides convenient, point-of-care results—ideal for diabetes management in outpatient clinics, primary care offices, or even patient self-monitoring at home. Its portability and single-use test kits make it practical for frequent monitoring without the need for centralized lab infrastructure.

  • Is the PixoTest A1c Test Kit reusable, or is it intended for single-use only? How does this affect workflow?

    The PixoTest A1c Test Kit is intended for single-use only, as explicitly stated in the device description. This design ensures accuracy, sterility, and reduces the risk of cross-contamination between patients. Clinically, this means each test requires a new kit, which simplifies workflow by eliminating the need for cleaning or reprocessing between uses—though it does require careful inventory management to maintain availability for repeated testing.

  • What regulatory pathways has the PixoTest POCT System undergone, and how does this impact its use in different markets?

    The system has undergone FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, confirming compliance with U.S. and European regulatory standards for hematology applications. The FDA classification as a Class II device (864.7470) indicates it meets stringent performance and safety requirements for diagnostic use. Clinically, this means it can be legally marketed and used in both the U.S. and EU markets under these regulatory frameworks, though local compliance (e.g., labeling, training) may still apply.

  • Are there multiple sizes or models of the PixoTest POCT Analyzer, or is it a single-unit device?

    The provided data does not specify multiple sizes or models of the PixoTest POCT Analyzer itself, only that it is paired with single-use PixoTest A1c Test Kits. However, the OpenFDA registration numbers suggest multiple kit variants (e.g., different lot codes or configurations), which may imply slight variations in test kit compatibility or features. For precise sizing or model distinctions, consulting the manufacturer’s technical documentation or support would be advisable to ensure compatibility with your workflow.