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The Binax NOW® Malaria Test is an in vitro immunochromatographic assay for the qualitative detection of Plasmodium antigens circulating in human venous and capillary EDTA whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a pan-malarial antigen, common to all four malaria species capable of infecting humans - P. falciparum, P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from other less virulent malarial infections. Negative results must be confirmed by thin / thick smear microscopy.

The Binax NOW® Malaria Test is for the laboratory diagnosis of malaria in individuals with signs and symptoms consistent with malaria infection.

In vitro immunochromatographic immunoassay

The Binax NOW® Malaria Test is an immunochromatographic membrane assay that uses monoclonal antibodies to detect Plasmodium falciparum antigen and pan-malarial antigen (an antigen shared by all Plasmodium species causing human malaria) in venous and capillary whole blood specimens. These antibodies, and a control antibody, are immobilized on a membrane support as three distinct lines and are combined with a sample pad, which is impregnated with visualizing particles conjugated to control and anti-malarial antibodies, to create a test strip. This test strip is mounted in a book-shaped. hinged test device, along with wash and absorbent pads, intended to aid in the clearing of the membrane when the device is closed.

To perform the test, whole blood is applied to the sample pad. Malarial antigen present in the sample reacts to bind the anti-malaria conjugated antibody. Reagent A is added to the bottom of the test strip and allows the antigen-conjugate complexes to migrate along the test strip, where they are captured by the immobilized antibodies, forming the Test Line(s). Immobilized control antibody captures control conjugate, forming the Control Line. Once the blood sample has migrated the length of the test strip, the device is closed, allowing Reagent A that has been added to the wash pad to clear the test strip of excess blood.

Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive test result, read in 15 minutes, will include the detection of both a Test Line (or Test Lines) and a Control Line. A negative test result, read in 15 minutes, will produce only a Control Line, indicating that malarial antigens were not detected in the sample. Failure of the Control Line to appear, whether the Test Line(s) is present or not, indicates an invalid result.

Here's a breakdown of the acceptance criteria and the supporting study for the Binax NOW® Malaria Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Clinical Efficacy (Endemic Population): 4,122 whole blood specimens collected from patients in regions considered endemic for malaria. Prospective study conducted in 2001 outside the U.S.
   • Clinical Specificity (Low Incidence Population): 100 whole blood specimens from febrile patients. Prospective study conducted in the eastern US in 2006-2007.
   • Precision/Reproducibility: Not explicitly stated as "test set," but involved a panel of blind coded specimens (negative, LOD, low positive for P.f. and P.v.).
   • Analytical Specificity (Microorganisms/Drugs/Components): Number of samples varied per test (e.g., 28 microorganisms, various drug concentrations, 116 specimens for unrelated medical conditions). Provenance not specified but likely lab-generated or commercial controls.

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

   • The primary ground truth for clinical studies was Giemsa malaria microscopy.
   • The document does not specify the number of individual experts who performed the microscopy or their specific qualifications (e.g., "microscopist with X years of experience"). It implies standard laboratory practices for identifying malaria parasites via microscopy.

3. Adjudication method for the test set:

   • The document does not explicitly state an adjudication method for conflicting microscopy results. It simply states "Microscopy was considered positive only when asexual malaria forms were detected." For the Binax NOW® results, interpretation was based on visually detectable pink-to-purple lines, and invalid results were noted if the control line didn't appear.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test, not an AI-powered diagnostic for image interpretation involving human readers. Therefore, there's no mention of "AI assistance" or "human reader improvement." The comparison was between the device (Binax NOW®) and traditional microscopy (human interpretation).

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

   • Yes, a standalone performance study was done. The Binax NOW® test is a lateral flow immunochromatographic assay. Its performance against the ground truth (microscopy) represents its standalone capability as an "algorithm only" in the sense that the test strip itself produces the result, interpreted visually ("visually detectable pink-to-purple colored lines"). There's no human intervention in processing or algorithm output, only in the visual interpretation of the final lines.

6. The type of ground truth used:

   • For the clinical performance studies, the ground truth was expert microscopy (Giemsa malaria microscopy). Specifically, "Microscopy was considered positive only when asexual malaria forms were detected."
   • For analytical specificity regarding microorganisms, the ground truth was the known presence/concentration of those microorganisms.

7. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI. This is an immunoassay, which does not typically involve training sets in the same way an AI model would. Assay development for immunoassays involves reagent optimization and validation, not a "training set" of patient data for an algorithm.

8. How the ground truth for the training set was established:

   • As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

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The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection ("Legionnaires" Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.

The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A Dacron swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing the test device. Legionella urinary antigen captured by immobilized anti-Legionella pneumophila antibody reacts to bind anti-Legionella pneumophila conjugated antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available in 15 minutes.

This document describes the Binax NOW® Legionella Urinary Antigen Test, an immunochromatographic assay for detecting Legionella pneumophila serogroup 1 antigen in urine specimens. The 510(k) submission (K070522) aimed to demonstrate substantial equivalence to the unmodified Binax NOW® Legionella Urinary Antigen Test (K982238) after modifications to the device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):

  • Negative Samples: 70 urine samples
  • Positive Samples: 15 known positive urine specimens
  • Data Provenance: The document states that the negative urine samples were "collected from presumed healthy individuals." The provenance of the positive samples is not explicitly detailed but they are described as "known positive urine specimens." It is retrospective data as it describes samples that were already collected and classified. The country of origin is not specified.

• Test Set (Cross-Reactivity):

  • Number of Organisms Tested: 11
  • Concentrations: Ranged from 1 x 10^6 to 2 x 10^3 (depending on the organism).
  • Data Provenance: Whole organism cross-reactivity testing was performed. The organisms were grown in culture. Details on the origin of the cultures or their geographical provenance are not provided.

• Test Set (Loss of Signal):

  • Positive Urine Specimen: 1
  • Lots Tested: 3 separate lots of the modified device.
  • Data Provenance: Serial two-fold dilutions of a known positive urine specimen. Details on the origin of the specimen are not provided.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test sets. For the method comparison study, "known positive urine specimens" and "presumed healthy individuals" were used, implying prior methods established positivity and negativity. For cross-reactivity, organisms were grown in culture, indicating laboratory-derived ground truth. For loss of signal, a "known positive urine specimen" was used.

4. Adjudication Method

No adjudication method is described for the test sets. The studies rely on direct comparison to the predicate device or established laboratory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This device is an in vitro diagnostic (IVD) test, not an imaging device or an AI application designed to assist human readers in interpretation. Therefore, the concept of human readers improving with AI vs without AI assistance is not applicable here.

6. Standalone Performance

Yes, a standalone performance assessment was conducted for the modified device by comparing its results directly with the unmodified predicate device, and by testing its performance in cross-reactivity and loss-of-signal experiments. The device itself generates a qualitative result (positive/negative) without human interpretation in the loop to determine the primary outcome of the test.

7. Type of Ground Truth Used

The ground truth used appears to be a combination of:

• Predicate Device Comparison: For the method comparison, the results of the unmodified predicate device served as the established "truth" for agreement.
• Pre-classified Samples: "Known positive urine specimens" and urine from "presumed healthy individuals" imply prior diagnostic classification or health status determining the ground truth for these samples.
• Laboratory-derived Standards: For cross-reactivity, the presence or absence of specific cultured organisms at known concentrations served as the ground truth. For loss of signal, the serial dilution of a known positive specimen was used.

8. Sample Size for the Training Set

No training set is mentioned in the provided text. This device is a rapid immunochromatographic assay, not an algorithm that requires a training set in the conventional sense of machine learning. The "training" in this context would refer to the development and optimization of the assay components (antibodies, membrane, etc.) rather than a data-driven model.

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

As no training set is described or applicable in the context of this type of device, the method for establishing ground truth for a training set is not provided.

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