Submission Details
| 510(k) Number | K173568 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2017 |
| Decision Date | September 04, 2018 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
NeoBase 2 Non-derivatized MSMS Kit
Sep 2018
Decision
288d
Days
Class 2
Risk
About This 510(k) Submission
K173568 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 Wallac Oy, Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on September 4, 2018, 288 days after receiving the submission on November 20, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1055.
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. |
Manufacturer
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