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Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically, Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

The Abbott STREP A Controls, K965252 is the same as Abbott STREP A Controls, K922490. The controls are intended for use as external controls to monitor substantial reagent failure and procedural errors in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptoccal antigen.

The provided documents describe the clearance of Abbott STREP A Controls (K972182) as external controls for Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen. The primary study presented focuses on demonstrating substantial equivalence to a predicate device (K922490) and establishing the Relative Limit of Detection for the associated Strep A assays.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Abbott STREP A Controls (K972182):

• TP+SA & TP+SA OBC: 1:1000 dilution of Strep A Stock consistently produced positive results.
• TP+SA OBC II: 1:500 dilution of Strep A Stock consistently produced positive results.
  (Note: This is not an acceptance criterion for the controls themselves, but rather for the assays they are designed to control. The controls are then designed relative to these limits.) |

2. Sample Size Used for the Test Set and Data Provenance

• Positive Controls: Two lots of Strep A positive control were tested. Each positive control lot was tested with three lots of each of the four Abbott Rapid Immunoassays (TPSA, TP+SA, TP+SA OBC, TP+SA OBC II).
• Negative Controls: Four lots of Strep A negative controls were tested with three lots of TestPack Plus Strep A with OBC.
• Relative Limit of Detection Study: Two lots of Strep A Stock were used. For each dilution level, two replicates were assayed on three lots of reaction discs for each of the four assays. This involves multiple individual test runs (2 stock lots * various dilutions * 2 replicates * 3 assay lots * 4 assays).
• Data Provenance: The documents do not explicitly state the country of origin. Given the Abbott Laboratories address provided (Abbott Park, IL, USA) and the submission to the FDA, it is highly likely the study was conducted in the United States. The studies appear to be prospective in nature, designed specifically to demonstrate the performance of the controls and the assays.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device and study. The "ground truth" for these tests is based on the known composition of the positive (containing Strep A antigen) and negative (not containing Strep A antigen) controls, and the established reactivity of the assays to known concentrations of Strep A. The results were "visually read at EOA [End of Assay]" but no mention of expert consensus or qualifications for reading these specific assays is provided, as they are likely standard visual interpretations based on product instructions.

4. Adjudication Method for the Test Set

Not applicable. The results were "visually read at EOA for all assays." There's no mention of a complex adjudication process as the readings are expected to be straightforward positive or negative interpretations, confirming the presence or absence of a visual signal.

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

Not applicable. This device is a diagnostic control material, not an AI-assisted diagnostic tool.

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

Not applicable. The "device" in question is a control material. The assays it controls still involve a human reading the visual results.

7. The Type of Ground Truth Used

The ground truth used is based on the known concentration and presence/absence of Group A Strep antigen in the prepared Strep A Stock dilutions and the positive/negative control materials. The Strep A Stock itself is defined as a "suspension of phenol-killed Strep A organisms." Thus, it's essentially a reference standard/known concentration approach.

8. The Sample Size for the Training Set

Not applicable in the conventional sense for an AI/algorithm. This device is a control material, and the studies performed are for its validation and the determination of the Relative Limit of Detection of the associated assays. There is no "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the performance studies (as described in point 7) was established by the precise formulation of the Strep A Stock and control materials with known concentrations or presence/absence of Strep A antigen.

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