Search Results

A rapid slide latex test for the detection of penicillin binding protein 2' and the confirmation of Methicillin Resistant Staphylococcus aureus.

Rapid slide latex kit for confirmation of Methicillin-resistant Staphylococcus aureus (MRSA).

The kit tests for the mecA gene coding for methicillin resistance, by detecting its product, PBP2' (penicillin binding protein 2'). Organisms grown on suitable culture medium and believed to be Staphylococcus aureus, are emulsified in an extraction reagent, boiled for a set period of time under alkaline conditions, neutralised and centrifuged. A specified volume of supernatant liquid is mixed with a drop of test latex sensitised with a monoclonal antibody directed against PBP2' and control (unsensitised) latex on a test card. The cards are rotated for a defined length of time and examined for agglutination. A positive reaction observed with the test latex only indicates that the organism contains PBP2' and should be reported as a presumptive methicillin-resistant Staphylococcus aureus (MRSA).

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets them. Instead, it describes a 510(k) summary for the MASTALEX MRSA rapid slide latex kit, stating its equivalence to a predicate device and noting that no new performance data was submitted because the device's reagents are identical to the predicate.

Therefore, most of the requested information cannot be extracted from this document. However, based on the principle of substantial equivalence described, we can infer some details.

Here's a summary of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document explicitly states: "The determination of substantial equivalence is not based on performance data. No comparisons are necessary because the device reagents are identical to the predicate device." This means no new performance data for MASTALEX MRSA is reported, nor are specific acceptance criteria for a new study. The device is deemed substantially equivalent based on its identical nature to an already approved predicate device (MRSA-SCREEN, K011400).

2. Sample size used for the test set and the data provenance

• Cannot be provided. No new test set data was generated or submitted for this 510(k) application. The substantial equivalence relies on the predicate device's performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cannot be provided. No new test set data was generated or submitted.

4. Adjudication method for the test set

• Cannot be provided. No new test set data was generated or submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This device is a rapid slide latex test for pathogen identification, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This device is a manual rapid slide latex test, not an algorithm.

7. The type of ground truth used

• Cannot be provided for MASTALEX MRSA directly. However, for the predicate device (MRSA-SCREEN), the ground truth for confirming MRSA would typically be established through molecular methods (e.g., PCR for mecA gene) or possibly conventional culture and methicillin susceptibility testing if the mecA gene detection was not the primary confirmation method for that predicate.

8. The sample size for the training set

• Cannot be provided. No new training set data was generated or submitted as it's not an AI/machine learning device.

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable as it's not an AI/machine learning device.

In summary, the provided document focuses on substantiating equivalence to a predicate device (MRSA-SCREEN), rather than presenting new performance data for the MASTALEX MRSA kit itself. This approach means that details about specific acceptance criteria and detailed study parameters for the MASTALEX MRSA are not included in this 510(k) summary. The performance of the predicate device is implicitly accepted as meeting the required criteria.

Ask a specific question about this device