Cleared Traditional

K181915 - PixoTest POCT System - PixoTest POCT An...

K181915 is the FDA 510(k) clearance for PixoTest POCT System - PixoTest POCT An... by Ixensor Co, Ltd.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K181915 · Ixensor Co, Ltd. · Chemistry device
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Apr 2019
Decision
269d
Days
Class 2
Risk

K181915 is an FDA 510(k) clearance for the PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ixensor Co, Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 12, 2019 after a review of 269 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ixensor Co, Ltd. devices

Submission Details

510(k) Number K181915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2018
Decision Date April 12, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 88d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Ivdd Regulatory Consultant
Feng-Yu Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 136
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K181915.
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc. · Mar 2020
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · Ixensor Co, Ltd. · Oct 2019
OneDraw A1C Test System
K183230 · Drawbridge Health, Inc. · Aug 2019
Quo-Test A1c System
K180509 · Ekf Diagnostic GmbH · Feb 2019
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
K173127 · Skyla Corporation H.S.P.B · Sep 2018
ACE Hemoglobin A1c (HbA1c) Reagent
K170623 · Alfa Wassermann Diagnostic Technologies, LLC · Feb 2018