Cleared Special

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

K200256 · Siemens Healthcare Diagnostics, Inc. · Chemistry

Jul 2021

Decision

515d

Days

Class 2

Risk

About This 510(k) Submission

K200256 is an FDA 510(k) clearance for the ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 2, 2021, 515 days after receiving the submission on February 3, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K200256 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2020
Decision Date	July 02, 2021
Days to Decision	515 days
Submission Type	Special
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.