K193103 is an FDA 510(k) clearance for the NeoBase 2 Non-derivatized MSMS Kit. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1055. 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..
| 510(k) Number | K193103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |