Cleared Traditional

K171861 - CAPILLARYS Hb A1c

K171861 is the FDA 510(k) clearance for CAPILLARYS Hb A1c by Sebia. It is a Class 2 Chemistry device (product code PDJ) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K171861 · Sebia · Chemistry device
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Feb 2018
Decision
230d
Days
Class 2
Risk

K171861 is an FDA 510(k) clearance for the CAPILLARYS 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 February 7, 2018 after a review of 230 days - an extended review cycle.

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 K171861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date February 07, 2018
Days to Decision 230 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
142d slower than avg
Panel avg: 88d · This submission: 230d
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 20
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K171861.
Dimension Hemoglobin A1c Assay
K173909 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
SEKURE HbA1c Assay
K173206 · Sekisui Diagnostics P.E.I., Inc. · Jul 2018
Afinion HbA1c Dx
K180296 · Alere Technologies AS · May 2018
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · Siemens Healthcare Diagnostics, Inc. · Dec 2017
D-10 Hemoglobin A1c Program
K161687 · Bio-Rad Laboratories, Inc. · Oct 2016
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · Bio-Rad Laboratories, Inc. · Dec 2015