Cleared Traditional

CAPILLARYS Hb A1c

K171861 · Sebia · Chemistry

Feb 2018

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K171861 is an FDA 510(k) clearance for the CAPILLARYS Hb A1c, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on February 7, 2018, 230 days after receiving the submission on June 22, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K171861 FDA.gov
FDA Decision	Cleared 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

Device Classification

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