Cleared Traditional

NeoBase 2 Non-derivatized MSMS Kit

K193103 · Perkinelmer, Inc. · Chemistry

Feb 2020

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K193103 is an FDA 510(k) clearance for the NeoBase 2 Non-derivatized MSMS Kit, a System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (Class II — Special Controls, product code NQL), submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on February 7, 2020, 91 days after receiving the submission on November 8, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1055.

Submission Details

510(k) Number	K193103 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2019
Decision Date	February 07, 2020
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NQL — System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1055
Definition	Amino Acids, Free Carnitines And Acylcarnitines Test System Is Intended For The Measurement And Evaluation Of Amino Acid, Free Carnitine And Acylcarnitine Concentrations From Newborn Whole Blood Filter Paper Samples. The Quantitative Analysis Of The Amino Acids, Free Carnitines And Acylcarnitines And Their Relationship With Each Other Is Intended To Provide Analyte Concentration Profiles That Should Aid In Identifying Elevated Levels Of These Metabolites For Screening Newborns For One Or More Of Several Metabolic Disorders.