21 CFR 866.1640 — Susceptibility Test Powders, Antimicrobial
Microbiology (MI) · Part 866 Subpart B—Diagnostic Devices · § 866.1640
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JTT | Susceptibility Test Powders, Antimicrobial | 2 | 24 | 3rd Party |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 | 441 | 3rd Party |
| LIE | Reagent/Device, Inoculum Calibration | 2 | 7 | 3rd Party |
| LOP | Solution, Antimicrobial | 2 | 3 | 3rd Party |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 2 | 45 | 3rd Party |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 2 | 52 | 3rd Party |
| LTW | Susceptibility Test Cards, Antimicrobial | 2 | 17 | 3rd Party |
| MJA | Susceptibility Test Powders, Antimycobacterial | 2 | 5 | |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 2 | 10 | 3rd Party |
| NGZ | Susceptibility Test Plate, Antifungal | 2 | 21 | |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | 2 | 6 | |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 2 | 24 | |
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | 2 | 3 | |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 2 | 3 | |
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | 2 | 3 |
