(83 days)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8ug/ml to the Sensitire HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactia Streptococcus anginosus
The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/mL
This is a 510(k) premarket notification for "The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/ml." This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically for testing Streptococcus spp. The document you provided is an FDA clearance letter and an Indications for Use statement, not a detailed study report. Therefore, much of the requested information regarding the study design and acceptance criteria specifically for the device's performance is not available in these documents.
However, based on the information provided and general knowledge of FDA clearances for antimicrobial susceptibility testing (AST) devices, I can construct a partial answer.
Please note: The provided documents are limited. A full study report, often found in the 510(k) summary or detailed submission, would contain the complete information. The following response is an interpretation based on the given text and common practices for AST device clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list the acceptance criteria or reported device performance in a table format. However, for AST devices, FDA typically expects specific agreement rates between the investigational device and a reference method. The Indications for Use states that the device is for susceptibility testing of Streptococcus spp., and the clearance implies that the device met the FDA's criteria for substantial equivalence to a predicate device.
Typical Acceptance Criteria for AST Devices (Based on FDA Guidance for 510(k)s):
| Metric | Acceptance Criteria (Typical) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% (Agreement between MIC values within +/- 1 two-fold dilution interval of the reference method) | (Not provided in the document) |
| Category Agreement (CA) | ≥ 90% (Agreement in categorical interpretation: Susceptible, Intermediate, Resistant) | (Not provided in the document) |
| Major Discrepancies (MD) |
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
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.(b)
Classification. Class II (performance standards).