Cleared Traditional

K171537 - CAPI 3 Hb A1c (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171537 · Sebia · Chemistry device
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Sep 2017
Decision
110d
Days
Class 2
Risk

K171537 is an FDA 510(k) clearance for the CAPI 3 Hb A1c. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on September 12, 2017 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - 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 Sebia devices

Submission Details

510(k) Number K171537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date September 12, 2017
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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 Peers - PDJ Hemoglobin A1c Test System

All 25
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K171537.
Medconn 8K Glycated Hemoglobin Test System
K252749 · Shanghai Medconn Medical Technology Co., Ltd. · Jan 2026
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
K250073 · Tosoh Bioscience, Inc. · Oct 2025
Medconn Glycated Hemoglobin Test system
K242911 · Shanghai Medconn Medical Technology Co., Ltd. · Jun 2025
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999 · Shijiazhuang Hipro Biotechnology Co., Ltd. · Sep 2024
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · Tosoh Bioscience, Inc. · Aug 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256 · Siemens Healthcare Diagnostics, Inc. · Jul 2021