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510(k) Data Aggregation
(258 days)
ALERE PBP2A SA/CONS CULTURE COLONY TEST
The Alere™ PBP2a SA Culture Colony Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus as an aid in identifying methicillin-resistant Staphylococcus aureus (MRSA).
The Alere™ PBP2a SA Culture Colony Test is a rapid immunochromatographic membrane assay intended for the detection of penicillin-binding protein 2a (PBP2a) in isolates identifies as Staphylococcus aureus as an aid in identification of MRSA. The test uses highly sensitive recombinant monoclonal antibody fragments (rFabs) to detect the PBP2a protein directly from bacterial isolates. The rFab and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a pink/purple conjugate pad, and an absorption pad to form a test strip.
Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the test strip is placed in the assay tube. Results are read visually at 5 minutes.
Here's a breakdown of the acceptance criteria and study information for the Alere PBP2a SA Culture Colony Test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported performance metrics. The study aims to demonstrate substantial equivalence to the predicate device, which itself reports similar performance ranges. The key performance indicators are Sensitivity and Specificity, stratified by plate type.
| Metric | Acceptance Criteria (Implied by Predicate) | Alere™ PBP2a SA Culture Colony Test Performance (Sensitivity and Specificity vs. 30µg cefoxitin disk diffusion) |
|---|---|---|
| Sensitivity | ≥ 91.4% (based on predicate range) | Tryptic Soy Agar (TSA): 99.1% (96.7%, 99.8%) |
| Columbia Agar: 98.6% (96.0%, 99.5%) | ||
| Mueller Hinton Plate: 99.1% (96.7%, 99.8%) | ||
| Specificity | ≥ 92.1% (based on predicate range) | Tryptic Soy Agar (TSA): 99.2% (97.0%, 99.8%) |
| Columbia Agar: 99.2% (97.0%, 99.8%) | ||
| Mueller Hinton Plate: 99.6% (97.7%, 99.9%) | ||
| Primary Plate Sensitivity | Not explicitly stated, but high | 100.0% (129/129) [97.1%, 100.0%] |
| Primary Plate Specificity | Not explicitly stated, but high | 98.5% (134/136) [94.8%, 99.6%] |
Note: The acceptance criteria in the table are inferred from the reported performance of the predicate device. The document does not explicitly state pre-defined acceptance criteria for the Alere™ PBP2a SA Culture Colony Test.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 454 S. aureus isolates were evaluated in the multi-center clinical study.
- Data Provenance: The study was conducted in three (3) geographically-diverse laboratories in 2013, indicating a multi-site prospective clinical study. The country of origin is not explicitly stated but implies the US given the FDA submission. It is a prospective study as isolates were "evaluated" in the test, suggesting real-time testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their specific qualifications.
The ground truth was established by 30 µg cefoxitin disk diffusion interpreted according to Clinical and Laboratory Standards Institute (CLSI) standards. This method is a standardized laboratory procedure, not typically requiring individual expert adjudication in the same way imaging studies might. The interpretation of the disk diffusion results would follow established CLSI guidelines, likely by trained laboratory personnel.
4. Adjudication Method for the Test Set
The ground truth was established by 30 µg cefoxitin disk diffusion interpreted according to CLSI standards. This is a laboratory-based gold standard, not a subjective interpretation requiring an adjudication method like 2+1 or 3+1. Therefore, no multi-reader adjudication method was used for the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test for laboratory use, not an imaging or clinical decision support AI tool designed to assist human readers. Therefore, there is no "human readers improve with AI vs without AI assistance" component.
6. Standalone Performance Study
Yes, the clinical study directly measured the standalone performance of the Alere™ PBP2a SA Culture Colony Test against the ground truth (cefoxitin disk diffusion). The reported sensitivity and specificity values are for the algorithm (device) only, without human-in-the-loop performance.
7. Type of Ground Truth Used
The ground truth used was established by phenotypic susceptibility testing: 30 µg cefoxitin disk diffusion interpreted according to CLSI standards. This is a widely accepted laboratory gold standard for identifying Methicillin-Resistant Staphylococcus aureus (MRSA) and detecting PBP2a expression.
8. Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The studies described are performance validation studies. For IVD devices, a "training set" in the context of machine learning (AI) is not typically described in 510(k) summaries unless the device incorporates AI. This device relies on immunochromatographic assay principles.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the provided text, there is no information on how its ground truth might have been established. Any internal development and optimization of the assay would have likely used characterized isolates with known PBP2a status, similar to what's described in the analytical studies (e.g., using ATCC strains or strains from repositories like NARSA).
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