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
| Device Type ID | 636 |
| Device Name | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Regulation Description | Newborn Screening Test System For Amino Acids, Free Carnitine, And Acylcarnitines Using Tandem Mass Spectrometry. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1055 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 636 |
| Device | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Product Code | NQL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Newborn Screening Test System For Amino Acids, Free Carnitine, And Acylcarnitines Using Tandem Mass Spectrometry. |
| CFR Regulation Number | 862.1055 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | PerkinElmer Life And Analytical Sciences, Wallac, OY | II | May-04-2018 |