Definition: An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
| Device Type ID | 3564 |
| Device Name | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Physical State | May Include Automated/manual Isothermal Nucleic Acid Amplification, Polymerase Chain Reaction, Ligase Chain Reaction, Sequence-based Amplification |
| Technical Method | Uses Nucleic Acid Amplification Technology To Detect Groups A, C And G Sreptococci |
| Target Area | Throat Swab Specimen |
| Regulation Description | Streptococcus Spp. Nucleic Acid-based Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.2680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3564 |
| Device | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Product Code | PGX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Streptococcus Spp. Nucleic Acid-based Assay. |
| CFR Regulation Number | 866.2680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALERE SCARBOROUGH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FOCUS DIAGNOSTICS, INC.: DBA DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IQUUM INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 3 | |
QUIDEL CORPORATION | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 3 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Focus Diagnostics Inc | I | Apr-02-2016 |