Cleared Traditional

CAPI 3 Hb A1c

K171537 · Sebia · Chemistry

Sep 2017

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K171537 is an FDA 510(k) clearance for the CAPI 3 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 September 12, 2017, 110 days after receiving the submission on May 25, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K171537 FDA.gov
FDA Decision	Cleared 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

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.