K093916 is an FDA 510(k) clearance for the NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U. 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. (Indianapolis, US). The FDA issued a Cleared decision on August 23, 2010, 244 days after receiving the submission on December 22, 2009.
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 | K093916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2009 |
| Decision Date | August 23, 2010 |
| Days to Decision | 244 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. |