Cleared Traditional

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

K142595 · Ortho-Clinical Diagnostics · Chemistry

Jun 2015

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K142595 is an FDA 510(k) clearance for the VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on June 4, 2015, 262 days after receiving the submission on September 15, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K142595 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2014
Decision Date	June 04, 2015
Days to Decision	262 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.