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The BinaxNOW® Malaria Positive Control is intended for use as an assayed positive external quality control with the qualitative BinaxNOW® Malain Test. It is designed for routine external quality control with the qualitative BinaxNOV® Malaina Test. It is designed for routi proper of the qualitative BinaxNOW "Malana" rest. It is designed for routine use to aid in wisition Test.

The BinaxNOW® Malaria Positive Control is a recombinant antigen control containing a mixture of HRP II (histidine-rich protein II), which is specific for Plasmodium falciparum (P.f.), and a pan-malarial antigen (aldolase), which is common to P.f., P. vivax, P. ovale, and P. malariae. The BinaxNOW® Malaria Positive Control can be used as a quality control sample representative of a positive test result and to verify proper performance of the procedure and reagents of the BinaxNOW® Malaria test, when it is used in accordance with the BinaxNOW® Malaria test product insert. The BinaxNOW® Malaria Positive Control is supplied lyophilized and is reconstituted using deionized water. The reconstituted control is then added to a pool of presumed negative EDTA human whole blood for use in the BinaxNOW® Malaria Test. When run on the BinaxNOW® Malaria Test, the positive control should always generate positive results on both the P.f.specific (HRP II) test line and on the pan malarial test line. This demonstrates that the test reagents are working properly and the operator performed the test procedure correctly.

The provided text describes a 510(k) submission for the BinaxNOW® Malaria Positive Control, a quality control material, not a diagnostic device with performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design parameters for evaluating device performance against ground truth, and human-in-the-loop studies is not applicable to this type of submission.

The "performance summary" section details the stability and shelf life of the control material, which are the relevant performance characteristics for a quality control product.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary "performance" of this device is its stability and its ability to consistently produce a positive result when run with the BinaxNOW® Malaria Test, which verifies the test's proper function.

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

Not applicable. This is a quality control material, not a diagnostic device evaluated against a patient test set. The "testing" referred to in the document is internal stability testing of the control material itself.

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

Not applicable. Ground truth as typically defined for diagnostic devices (e.g., disease presence) is not relevant for a quality control material. The "ground truth" for this control is its consistent positive reactivity.

4. Adjudication method for the test set

Not applicable.

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 is not an AI-assisted diagnostic device, nor is it a multi-reader study.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the BinaxNOW® Malaria Positive Control, the "ground truth" is its designed positive reactivity. When run on the BinaxNOW® Malaria Test, the control is intended to "always generate positive results on both the P.f. specific (HRP II) test line and on the pan-malarial test line." This demonstrates that the control material is functioning as intended, and by extension, that the test reagents and operator procedure are correct.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or diagnostic device for this quality control product.

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

Not applicable.

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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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The ChlamydiaTrol™ Ag is intended for use as an unassayed control reagent with in vitro diagnostic assay procedures for detection of Chlamydia trachomatis, including both chlamydial antigen (MOMP or LPS) and nucleic acid based methods of detection. ChlamydiaTrol Aq reagents are intended to provide a means of estimating precision and reproducibility, and have the potential for detecting systematic deviations from specific laboratory testing procedures. Use of ChlamydiaTrol Ag reagent will monitor assay functionality and not analytical sensitivity of the assay detection limits.

ChlamydiaTrol Ag is a liquid quality control reagent classified under Multi Analyte Controls(assayed and unassayed). ChlamydiaTrol Ag reagent is prepared from Chlamydia trachomatis elementary bodies extracted from infected mouse L cells grown in culture. Optimally infected cells are harvested and disrupted by sonication, and cellular debris is removed by centrifugation. Chlamydia trachomatis elementary bodies used in the preparation of ChlamydiaTrol Ag reagent have been rendered noninfectious by treatment with gamma radiation. The reagent contains human serum albumin(HSA), preservatives and stabilizers.

The provided text describes the acceptance criteria and study for ChlamydiaTrol™ Ag, a liquid unassayed quality control reagent for Chlamydia trachomatis antigen detection.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As an unassayed quality control reagent, ChlamydiaTrol Ag does not have assigned reference values or traditional analytical acceptance criteria like sensitivity, specificity, or accuracy compared to a gold standard. Instead, its performance is assessed based on its reactivity, reproducibility, and stability within various commercial Chlamydia trachomatis diagnostic kits. The acceptance criteria essentially revolve around demonstrating consistent and predictable performance as a control.

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

• Clinical Evaluation Test Set:

  • Sample Size: Not explicitly stated as a single "sample size" of specimens. Instead, the study involved:
    • 2 different lots of ChlamydiaTrol Ag reagent.
    • Evaluated by eight clinical investigators (sites).
    • Using three different commercial test systems.
    • Each "result(n) for ChlamydiaTrol Ag represents a single determination" (Page 5, Section 5.2). The total number of runs/determinations varied among sites and test kit lots.
  • Data Provenance: Prospective, collected from June 1996 through May 1997 ("During the period from June, 1996 through May, 1997, two different lots of ChlamydiaTrol Ag reagent were evaluated by eight clinical investigators..." - Page 5, Section 5.0). The geographic origin of the clinical sites is not specified, but the submission is to the US FDA, implying US-based sites.

• Reproducibility Test Set (Within-run/Between-run):

  • Within-run: 20 replicates of the same sample.
  • Between-run: Single test results of the sample in multiple test runs.
  • Data Provenance: Not explicitly stated, likely internal Blackhawk BioSystems testing.

• Stress Testing (Temperature, Freeze/Thaw, Open Vial):

  • Sample Size: Not explicitly stated as number of replicates, but involved "two different lots of reagent" for temperature and open vial studies.
  • Data Provenance: Not explicitly stated, likely internal Blackhawk BioSystems testing.

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

• N/A (Not Applicable): For this device, ground truth as typically defined (e.g., confirmed disease status) is not used. ChlamydiaTrol Ag is a quality control reagent, not a diagnostic device. Its "performance" is judged by its consistent and reproducible reactivity within various diagnostic assays, as monitored by the clinical laboratories themselves, rather than against a disease endpoint. The "ground truth" for its intended use is its ability to consistently produce a positive reaction within a laboratory's established range.

4. Adjudication Method (for the test set)

• N/A (Not Applicable): As a quality control reagent, there is no "ground truth" in the diagnostic sense to adjudicate against. The results reported by each site were analyzed to determine mean value, standard deviation, and coefficient of variation (Page 5, Section 5.1). Consistency across sites and methods serves as the metric of acceptable performance.

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

• N/A (Not Applicable): This is not an AI-based diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant. The device is a liquid quality control reagent for Chlamydia trachomatis antigen tests.

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

• N/A (Not Applicable): This is not an algorithm or AI device. It's a laboratory reagent. Its "standalone" performance relates to its inherent stability and reactivity, as demonstrated in the reproducibility and stress testing, but not in the context of an algorithm.

7. The type of ground truth used

• For this quality control reagent, the "ground truth" is its inherent property to produce a consistent and measurable positive signal within various commercial Chlamydia trachomatis antigen detection assays. This is affirmed by:
  • Batch consistency: Lots designed to produce a positive reaction within a target range.
  • Analytical reproducibility: Low coefficients of variation in repeated testing.
  • Stability over time and under stress conditions: Maintaining reactivity under various storage and handling conditions.
  • Consistency across different test methods and clinical sites: Showing comparable results when used with different commercial kits by different laboratories.

8. The sample size for the training set

• N/A (Not Applicable): This device is a biochemical reagent, not a machine learning model. Therefore, there is no "training set" in the context of AI/algorithms. The reagent itself is manufactured and formulated using Chlamydia trachomatis elementary bodies and human proteins.

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

• N/A (Not Applicable): As there is no training set for an AI/algorithm, this question is not relevant. The quality of the manufactured reagent (e.g., the concentration of Chlamydia trachomatis elementary bodies and the formulation with stabilizers) is established through manufacturing processes and internal quality control, not by establishing a ground truth for a training set.

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