(83 days)
The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens.
Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually.
This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for:
Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)
Not Found
The information provided is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8ug/mL). This document primarily contains the regulatory approval status and indications for use. Key information about the device's performance study and acceptance criteria is not explicitly detailed in the provided text.
Specifically, the document states:
- The device is an in vitro diagnostic product for susceptibility testing.
- The 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates.
- The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for Streptococcus pneumoniae (Penicillin susceptible stains only).
To address your request, I will outline the typical information that would be found in a study report for such a device, and explicitly state what is missing from this FDA letter.
Missing Information:
The provided text does not contain any details about the acceptance criteria, the specific study conducted, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not included here.
Therefore, the following sections will indicate where the requested information would normally be found or what typical approaches are used for such devices, and will explicitly state that the specific details are not available in the provided document.
Acceptance Criteria and Reported Device Performance
Specific data for acceptance criteria and reported device performance are NOT available in the provided text.
For an antimicrobial susceptibility test (AST) device like the Sensititre® plates, the acceptance criteria would typically focus on agreement rates with a predicate method (e.g., broth microdilution) for categorical agreement (Sensitive, Intermediate, Resistant) and essential agreement (within +/- 1 dilution).
A hypothetical table showing typical acceptance criteria and what would be reported for an AST device:
| Performance Metric | Acceptance Criteria (Typical) | Reported Device Performance (Specifics NOT in provided text) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% | Not provided in the document |
| Categorical Agreement (CA) | ≥ 90% | 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).