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The Binax NOW Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. It is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.

The Binax NOW Streptococcus pneumoniae Test is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and CSF. Rabbit anti-S. pneumoniae antibody, the Sample Line, is adsorbed onto nitrocellulose membrane. Control antibody is adsorbed onto the same membrane as a second stripe. Both rabbit anti-S. pneumoniae and anti-species antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and striped membrane are combined to construct the test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, book-shaped test device (U.S. patent No. 2 U.S. 91/214051). To perform the test (2 U.S. patents pending), a swab is dipped into the specimen, removed, and then inserted into the test device. Reagent A, a buffer solution, is added from a dropper bottle. The device is then closed, bringing the sample into contact with the test strip. Pneumococcal antigen present in the sample reacts to bind anti-S. pneumoniae conjugate antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae 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 within 15 minutes.

Here's an analysis of the provided text regarding the Binax NOW Streptococcus pneumoniae Test, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Study Details for Binax NOW Streptococcus pneumoniae Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the performance of the device in comparison to a predicate device, rather than explicit numerical acceptance criteria for sensitivity, specificity, or predictive values. The primary acceptance criterion implied is "substantial equivalence" to the predicate device, the Wellcogen Bacterial Antigen Kit (K854852).

Regarding CSF, the application "focusses on performance of the Binax Now Streptococcus pneumoniae Test in diagnosis of meningitis." The performance study was done using freshly-collected CSF specimens. |

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

The document does not explicitly state the sample size used for the test set related to the CSF meningitis application. It only mentions that the study used "freshly-collected CSF specimens."

The document does not specify the country of origin. The study appears to be prospective given the mention of "freshly-collected CSF specimens."

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth of the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

The document does not mention an MRMC comparative effectiveness study involving human readers. The comparison is between two in-vitro diagnostic devices (Binax NOW and the Wellcogen predicate device).

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

Yes, the study described is a standalone performance study of the Binax NOW Streptococcus pneumoniae Test. This is an in vitro diagnostic assay that provides a visual result, which is then interpreted by a human, but the performance evaluation is of the test's ability to detect the antigen itself.

7. The Type of Ground Truth Used

The ground truth used for the study is culture and other methods. The intended use states that the test acts "in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis." This implies that bacterial culture results from CSF samples would be the primary ground truth, supplemented by other clinical and laboratory findings.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of in vitro diagnostic device, especially at this stage of development (immunochromatographic assay), typically does not involve machine learning models with distinct "training sets" in the modern sense. The development and optimization of such assays rely on biochemical and immunological principles, followed by performance validation against clinical samples.

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

As no training set is described in the context of machine learning, this question is not applicable based on the provided document. The ground truth for the performance evaluation (test set) is established through "culture and other methods."

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The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture.

The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

   • Accuracy Study (Test Set 1): 501 fresh throat samples. Data provenance is not explicitly stated regarding country of origin, but it is a retrospective or concurrent collection as it was tested "both in the immunoassay and by routine culture."
   • Comparison to Predicate Device (Test Set 2): 501 total specimens tested. Data provenance is not explicitly stated.
   • Culture Confirmation Study (Test Set 3):
     • Initial: 109 samples visually positive for Strep A on blood agar plates.
     • Second part (non-Strep A confirmation): 224 samples, of which 117 were identified as non-Strep A.
     • Third part (blinded and duplicate testing): 6 samples (2 Group A beta-haemolytic, 4 non-Group A beta-haemolytic).
   • All these studies appear to be "test sets" as they are used to evaluate the device's performance directly.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

   • For the core clinical accuracy and comparison studies, the "routine culture" is considered the ground truth. There is no specific mention of "experts" adjudicating these results, as routine culture itself serves as the reference standard in these diagnostic tests.
   • For the Culture Confirmation Study (third part), "2 independent physicians" conducted blinded, duplicate testing. Their qualifications are not further specified beyond "physicians."

4. Adjudication Method for Test Set:

   • In the primary clinical accuracy study, the Uni-Gold™ Strep A results were compared directly against "routine culture." There isn't an explicit adjudication method described beyond this direct comparison.
   • For the comparison between Uni-Gold™ Strep A and the predicate device, discordant results were later "resolved against culture" when calculating relative sensitivity/specificity/agreement. This implies that if the two devices disagreed, a third reference (culture) was used to determine the true positive/negative status for performance calculation. This is a form of an adjudication process, likely a 2+1 type (two devices, one gold standard for resolution).

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The device is an immunoassay, not an imaging device that would typically involve human readers interpreting results with or without AI assistance. The studies performed compare the device's performance against a reference standard (culture) and a predicate device.

6. Standalone (Algorithm Only) Performance:

   • Yes, the performance values presented (sensitivity, specificity, agreement, concordance) are for the Uni-Gold™ Strep A test kit operating as a standalone device, without human-in-the-loop assistance in its core detection mechanism. The human interaction is usually limited to performing the test and reading the results, which is inherent to the use of such a diagnostic kit.

7. Type of Ground Truth Used:

   • Primary Ground Truth: Routine culture (specifically for Group A Streptococcus). This is a well-established laboratory method for identifying bacterial presence and is considered a high-quality reference standard for infectious disease diagnostics.
   • Secondary Ground Truth (for Culture Confirmation): Initial culture results confirmed by "Beta-haemolysis and morphology" and "Streptococcal latex grouping test" for further confirmation.

8. Sample Size for Training Set:

   • The document does not provide information about a separate "training set" for the Uni-Gold™ Strep A test kit. As an immunoassay (lateral flow assay), it is a biochemical test, not a machine learning algorithm that typically requires a distinct training phase with a dedicated dataset. The device's components and assays are developed and validated during the manufacturing process, rather than "trained" on data.

9. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no explicit "training set" in the context of this immunoassay device. The scientific principles and reagents are developed based on known biological interactions and established laboratory methods. Analytical studies (sensitivity, specificity) ensure the components function as intended.

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The Binax NOW Streptococcus pneumoniae Urinary Antigen Test is a rapid immunochromatographic assay for the detection of S. pneumoniae antigen in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of pneumococcal pneumonia in conjunction with culture and other methods.

The Binax Now Streptococcus pneumoniae Antigen Test is a urinary immunochromatographic membrane assay used to detect Streptococcus pneumoniae (S. pneumoniae) antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-S. pneumoniae antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A 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. Pneumococcal antigen present in the urine sample reacts to bind anti-S. pneumoniae antibody conjugated to gold. The resulting antigen-conjugate complexes are captured by immobilized anti-S. pneumoniae antibody, forming the Sample Line. Immobilized goat anti-rabbit IgG captures excess visualizing conjugate, forming the Control Line.

Here's a breakdown of the acceptance criteria and the study details for the Binax NOW® Streptococcus pneumoniae Urinary Antigen Test, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for diagnostic devices like this are typically infered from the demonstrated performance that the FDA deems sufficient for market clearance, often in comparison to a predicate device. For this submission, the performance results are presented as the device's demonstrated capabilities.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Sizes and Data Provenance for Test Set:

• Retrospective Study:

  • Total Samples: 373 urine specimens
  • Positive Cases: 35 urine specimens from blood culture positive pneumococcal pneumonia patients.
  • Negative Cases: 338 urine specimens from presumed S. pneumoniae negative patients (28 from bacteremic patients, 4 from empyema, 53 from pneumonia, 153 from UTIs, 100 from no known infection).
  • Provenance: Not explicitly stated, but likely from a diverse patient population given the varied sources of negative samples. Described as "freshly collected and characterized frozen urine specimens," suggesting a mix of past and potentially more recent collections. This indicates a retrospective study.

• Multi-center Prospective Study:

  • Total Samples: 215 urine specimens
  • Patients: Hospitalized or out-patients presenting with lower respiratory symptoms or sepsis, suspected of pneumococcal pneumonia.
  • Provenance: "separate multi-center prospective study." This indicates a prospective study from multiple clinical sites. Country of origin not specified.

• Analytic Sensitivity: 44 isolates representing 23 Streptococcus pneumoniae serotypes.

• Analytic Specificity (Cross-Reactivity): 144 potential cross-reactants (organisms associated with pneumonia and urogenital tract flora).

• Interfering Substances: 19 urine specimens with potentially interfering substances (e.g., blood, WBC, protein, glucose, turbidity).

• Pneumococcal Vaccine: Number of study participants not explicitly stated, but implies a group received the vaccine.

• Reproducibility: A panel of coded specimens (negative, low positive, moderate positive, high positive controls) used at 3 separate sites. Number of specimens in the panel is not specified.

• Quality Control: 20 devices with induced defects.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not explicitly mention the use of experts to establish a "ground truth" through consensus or review for the clinical studies.
• The ground truth for the clinical studies relies on blood culture results (see point 7).
• For analytic sensitivity, the "known Streptococcus pneumoniae serotypes" imply a microbiological expert's identification and characterization.
• For analytic specificity, the "known cross-reactants grown in culture" implies microbiological identification.

4. Adjudication Method for Test Set:

• None explicitly stated for the clinical performance studies.
• The ground truth for clinical cases (blood culture positive/negative) is an objective laboratory result, not typically subject to adjudication by multiple human readers for diagnostic accuracy.

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

• No, a MRMC comparative effectiveness study was not conducted.
• The study focuses on the standalone performance of the device against an objective standard (blood culture), not on how human readers' performance improves with or without the device's assistance.

6. Standalone Performance Study:

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The entire clinical performance section (Clinical Sensitivity and Specificity) describes the performance of the Binax NOW® test independently from human interpretation beyond reading the visual result.

7. Type of Ground Truth Used:

• Blood Culture: For both the retrospective and multi-center prospective clinical studies, the primary ground truth used to determine the presence or absence of S. pneumoniae infection was blood culture results.
• Microbiological Culture/Identification: For analytic sensitivity, the ground truth was the presence of known S. pneumoniae serotypes at a specified concentration via culture. For analytic specificity, it was the identification of specific microbial species/isolates.
• Defined Chemical/Cellular Composition: For interfering substances, the ground truth was the known presence of elevated levels of specific substances (e.g., blood, WBC, protein, glucose, turbidity).

8. Sample Size for the Training Set:

• The document does not specify a training set size. This is common for diagnostic device submissions where the device's design is often based on fundamental scientific principles (e.g., antibody-antigen binding) and optimized through iterative development rather than a distinct machine learning "training" phase with a large, labeled dataset in the way an AI algorithm might have. The studies described are performance validation studies.

9. How Ground Truth for Training Set Was Established:

• As no explicit training set is identified, the method for establishing its ground truth is not applicable/not documented in this submission. The "performance verification" used "freshly collected and characterized frozen urine specimens," which were then used in the retrospective study, suggesting these types of samples were used in the development and initial validation process without being formally labeled as a "training set." The development of the assay itself would have involved establishing the optimal antibody pair and concentrations through laboratory testing against known positive and negative samples.

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Abbott TestPack Plus Strep A with On Board Controls (OBC) II is a rapid immunoassay for the qualitative detection of Group A Streptococcal (Group A Strep) antigen in throat swab specimens from patients with suspected Group A Strep associated pharyngitis and for confirmation of presumptive Group A Strep colonies isolated on culture plates.

TestPack Plus Strep A with OBC II is a rapid immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens or confirmation of presumptive Group A Strep colonies recovered from culture. TestPack Plus Strep A with OBC II utilizes an internal on board control system consisting of six control features.

Here's a breakdown of the acceptance criteria and the study details for the Abbott TestPack® Plus™ Strep A with OBC® II, based on the provided text:

Acceptance Criteria and Device Performance

The provided text doesn't explicitly state pre-defined acceptance criteria (e.g., "The device must achieve sensitivity of at least X%"). Instead, it compares the device's performance to that of the predicate methods (SBA culture and SSA culture) to demonstrate substantial equivalence. The reported performance of the device serves as the basis for this comparison.

Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: The acceptance criteria are "implied" because the document focuses on demonstrating substantial equivalence rather than meeting pre-defined quantitative thresholds. The goal was to show that the new device performs comparably to established methods.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 445 throat swabs.
   • Data Provenance:
     • Country of Origin: U.S. (collected at five U.S. clinical sites).
     • Retrospective or Prospective: Prospective. The swabs were collected from "patients seeking medical attention for pharyngitis," and then used to inoculate culture plates within 30 minutes. This indicates a forward-looking collection as part of the study.

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

   • The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "Suspect beta-hemolytic colonies were confirmed as Group A Strep by a latex agglutination test." This implies a standard laboratory procedure performed by trained personnel, but specific numbers or credentials are not provided.

3. Adjudication Method for the Test Set:

   • The document does not describe a specific adjudication method like 2+1 or 3+1. The ground truth was established by laboratory confirmation (latex agglutination test) of suspect colonies from the culture plates, which is a standard diagnostic procedure rather than an expert consensus/adjudication process in the typical sense for imaging or clinical decision scenarios.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This study is for an in-vitro diagnostic (IVD) device that detects a specific antigen, not an imaging or an AI-assisted diagnostic tool that would involve multiple human readers interpreting results with and without AI.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, this was a standalone performance study. The TestPack Plus Strep A with OBC II assay itself provides the result, which is then compared to the culture results. There is no "human-in-the-loop" aspect to the device's performance that is being evaluated in this context. The device directly detects the antigen.

6. The Type of Ground Truth Used:

   • Culture confirmation/Pathology: The primary ground truth was established by isolating Group A Strep colonies on 5% Sheep Blood Agar (SBA) and Strep Selective Sheep Blood Agar (SSA) culture plates, followed by confirmation using a latex agglutination test. This is a microbiological gold standard for identifying Group A Streptococcus.

7. The Sample Size for the Training Set:

   • The document does not mention a training set. This is because the TestPack Plus Strep A with OBC II is a rapid immunoassay (a rapid diagnostic test), not an AI/machine learning model that requires a training set. The device operates based on a pre-defined chemical/biological reaction, not learnable parameters.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there was no training set for this type of device.

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The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

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The provided document is a 510(k) clearance letter for the BioStar STREP A OIA® MAX assay, not a study report. As such, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and a study proving the device meets them.

However, based on the context of a 510(k) clearance, we can infer some general aspects and extract limited information.

Here's what can be answered and what cannot:

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

• Cannot be fully answered from this document. This document is a clearance letter, not a clinical study report. It does not provide specific acceptance criteria values (e.g., minimum sensitivity, specificity) or the reported device performance against those criteria. Such details would typically be found in the 510(k) submission summary or a separate clinical study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from this document. The document does not specify the sample size of any test set or the provenance of the data used for validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Cannot be answered from this document. For an in vitro diagnostic device like this, the "ground truth" would typically be established by a reference method (e.g., bacterial culture) rather than expert consensus on images. The document does not provide details on how ground truth was established, nor does it refer to "experts" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Cannot be answered from this document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data. For an in vitro diagnostic assay, the "ground truth" is usually determined by objective laboratory methods, not by human adjudication of independent expert interpretations.

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

• No. This is not applicable to an in vitro diagnostic device. MRMC studies are relevant for AI-powered image analysis devices where human readers interpret medical images. The BioStar STREP A OIA® MAX is a rapid in vitro diagnostic assay for antigen detection, not an AI-based imaging tool.

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

• Yes, implicitly. The device itself is a standalone in vitro diagnostic assay. Its performance is evaluated on its own ability to detect the Group A Streptococcal antigen. There isn't a "human-in-the-loop" aspect to its fundamental operation or interpretation. Its performance would be assessed as a standalone diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Inferred: For a diagnostic assay like Strep A OIA, the ground truth would almost certainly be established by a bacterial culture of the throat swab specimen. Culture is the gold standard for detecting the presence of Group A Streptococcus.

8. The sample size for the training set

• Not applicable/Cannot be answered from this document. This is an antigen detection assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its development would involve optimization and validation, but not typically a labeled training data set for an algorithm.

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

• Not applicable. As mentioned above, there isn't a "training set" in the AI/ML context for this type of device.

Summary based on available information:

The provided document is limited to a 510(k) clearance letter for the BioStar® STREP A OIA® MAX assay. It indicates the device is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs as an aid in diagnosing streptococcal pharyngitis.

While the letter confirms the device was found substantially equivalent to a predicate device, it does not contain the detailed performance data or study methodology typically found in a clinical study report or the 510(k) summary (which is a separate document). Therefore, most of the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be definitively answered from this document alone. We can infer that its performance as a standalone in-vitro diagnostic was evaluated, with bacterial culture likely serving as the ground truth.

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STREPTOLEX-STAT™ is substantially equivalent to several commercially available products utilizing similar methodology for the identification of streptococcal groups A, B, C, F and G.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state pre-defined acceptance criteria (e.g., "must achieve X% sensitivity"). However, it presents the reported performance of the STREPTOLEX-STAT™ device, implying that these results are considered acceptable for demonstrating safety, efficacy, and substantial equivalence.

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

   • Sample Size for Test Set:
     • Group A: 111
     • Group B: 120
     • Group C: 83
     • Group F: 66
     • Group G: 90
     • Total: 470 isolates
   • Data Provenance: The study was conducted at "three test sites": one clinical laboratory in the US, one in Canada, and one in the UK. This indicates a multi-site, international study. The data appears to be prospective, generated specifically for this comparison.

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

   The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth appears to be based on the results from "commercially available, substantially equivalent grouping kits," implying these kits served as a reference standard.

4. Adjudication Method for the Test Set:

   For discrepancies (e.g., initial negative reactions for Groups B, C, and F), the document states: "Discrepancies were related to insufficient number of colonies used. Discrepancies were resolved upon retest." This suggests a re-testing and re-evaluation approach for identified discrepancies, rather than a formal expert adjudication panel.

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:

   This is not applicable. The device is a diagnostic kit (latex agglutination test for streptococcal grouping), not an AI-powered system that assists human readers.

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

   Yes, the performance data presented is for the STREPTOLEX-STAT™ device itself, functioning as a standalone diagnostic test. Human interpretation is involved in reading the latex agglutination, but the performance metrics are for the device's ability to correctly identify the streptococcal groups.

7. The type of ground truth used:

   The ground truth was established by comparison to the results obtained from "three commercially available, substantially equivalent grouping kits" (Streptex and Streptex - Acid Extraction Kit by Murex Diagnostics, PathoDx® Strep Grouping by Diagnostic Products Corporation, and Streptococcal Grouping Kit by Unipath Limited, Oxoid). This represents a comparator device reference standard. The document specifies that the STREPTOLEX-STAT™ performance was specifically compared to the Unipath (Oxoid) Streptococcal Grouping Kit for the reported data table.

8. The sample size for the training set:

   The document does not mention a separate training set. The study describes a performance comparison against existing similar products, implying the presented data is from a validation or test set.

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

   Not applicable, as a separate training set is not described or implied in the provided text.

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OSOM™ Strep A Test is an immunochromatographic assay for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.

OSOM Strep A Test uses color immunochromatographic dip stick technology with antibodies coated on the membrane. If group A Streptococcus is present in the swab sample, a blue test line will appear to indicate a positive result.

Here's an analysis of the provided text regarding the OSOM™ Strep A Test, focusing on the requested information about acceptance criteria and the study:

The provided document does not contain detailed information about specific acceptance criteria (e.g., sensitivity, specificity thresholds) or a formal clinical study with a specified test set sample size, ground truth establishment, or expert adjudication as typically found in comprehensive medical device submissions.

Instead, it focuses on demonstrating substantial equivalence to an existing method (isolation of Group A Streptococcus colonies on sheep blood agar medium followed by serological grouping). The "performance" described is in the context of this substantial equivalence claim.

However, based only on the provided text, here's what can be extracted and inferred against your questions:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") are not explicitly stated in the provided text, I will delineate the basis of acceptance implied by the substantial equivalence claim and the performance characteristics mentioned.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "serological grouping" but does not detail who performs this or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, not indicated. The document describes a comparison for substantial equivalence, but not a MRMC comparative effectiveness study involving human readers.
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable as no MRMC study or AI assistance is mentioned.

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

• Standalone Performance: Yes, implicitly. The OSOM™ Strep A Test is described as an "immunochromatographic assay" that produces a result (blue test line) without human interpretation of complex images or data beyond reading the presence/absence of the line. This is a standalone diagnostic test where the device itself provides the qualitative result. The "performance" being compared to existing methods would be its standalone diagnostic capability.

7. The Type of Ground Truth Used

• Ground Truth Type: Established by comparative method. The "ground truth" against which the OSOM Strep A Test is being "substantially equivalent" to is "results obtained through isolation of Group A Streptococcus colonies on sheep blood agar medium followed by a serological grouping of presumptive Group A Streptococcus." Serotyping is used to confirm identity. This is a laboratory-based, culture-confirmed method.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document does not mention a "training set" in the context of machine learning or algorithm development. The device is an immunoassay, not an AI/ML-based system.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no mention of a training set or an AI/ML algorithm requiring one, this point is not relevant based on the provided text.

Summary of Limitations Based on Provided Text:

The provided 510(k) Summary focuses heavily on the "Substantial Equivalence" claim, explicitly comparing the OSOM Strep A Test to established laboratory methods. It highlights differences in speed and detection of non-viable organisms as advantages of the new device. However, it lacks the detailed quantitative performance data (e.g., sensitivity, specificity, PPV, NPV with confidence intervals) and the specifics of a rigorous clinical study that would answer many of your detailed questions about sample sizes, expert involvement, and adjudication methods. This kind of detail is typically found in the full submission, not necessarily in the brief 510(k) Summary.

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solid phase migratory chromatography immunoassay in vitro diagnostic test kit

Here's an analysis of the provided text regarding the Excel OneStep Group A Strep Antigen Module Test, structured according to your requested information.

The provided text describes a Summary of Safety and Effectiveness for the Excel OneStep Group A Strep Antigen Module Test, a device used for the qualitative detection of Group A Strep antigen from throat swabs.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device had to meet. Instead, it describes a correlation study where the device's performance was compared against a recognized gold standard (culture). The reported performance metrics from this correlation study serve as the factual performance of the device.

Table of Acceptance Criteria and Reported Device Performance

Note: The provided text describes the study design and the methodologies but does not report the numerical results (sensitivity, specificity, accuracy, etc.) of the correlation study. Therefore, the "Reported Device Performance" column cannot be filled with quantitative values from this document. It only states that the study was conducted.

2. Sample Size and Data Provenance

• Sample Size (Test Set): Not explicitly stated in the provided text. The document refers to "each throat swab" suggesting a collection of samples, but no total number is given.
• Data Provenance: Not explicitly stated. The document refers to "throat swabs" without specifying the country of origin or whether the data was retrospective or prospective. Given the nature of a medical device submission, it is highly likely to be prospective data collected for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the traditional sense of human readers interpreting images. The ground truth for the test set was established through laboratory procedures (culture and latex agglutination), not by human expert interpretation of the test device itself.
• Qualifications of Experts: The ground truth involved standard microbiological laboratory techniques. While personnel performing these tests would be qualified laboratory technicians/microbiologists, the document does not elaborate on their specific qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth for each throat swab was established by a definitive laboratory method (culture followed by latex agglutination for confirmation). This is an objective, multi-step process for determining the presence of Group A Strep, not an interpretative task requiring human adjudication for discrepancies. The "gold standard" here is a sequential laboratory process.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. This study is a standalone performance assessment of the device against a laboratory gold standard, not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was conducted. The entire description in the provided text focuses on the device's ability to detect Group A Strep antigen by itself, independent of human interpretation or assistance beyond performing the test procedure correctly. The device's results were directly compared to the culture-based ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established through a two-step laboratory process:
  1. Culture: Throat swabs were used to inoculate sheep blood (trypticase) soy agar plates for the cultivation and isolation of microorganisms.
  2. Confirmation: Group A Streptococci isolated from the cultures were then confirmed by a latex agglutination assay (using a commercially available strep grouping kit from Diagnostic Product Corporation).

This combination provides a highly accepted and reliable laboratory-based ground truth for the presence of Group A Strep.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. The Excel OneStep Group A Strep Antigen Module Test is a rule-based immunoassay, not an artificial intelligence (AI) or machine learning algorithm. Therefore, it does not have a "training set" in the computational sense. The device's mechanism is based on specific chemical reactions and antibody-antigen binding, which are inherently designed and manufactured, not "trained" on data.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set. The "ground truth" related to its development would involve validation of the chemical and biological components during its manufacturing and quality control, ensuring the antibodies and reagents perform as intended.

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The CARDS Q.S. Strep A/Concise Performance Plus Strep A is a sensitive immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens. This test is to be used to aid in the diagnosis of diseases caused by group A Streptococcus. The test is for use by health care professionals.

The device, CARDS Q.S. Strep A (also sold under the brand name Concise Performance Plus Strep A), is similar to other FDA-cleared devices used for the qualitative detection of group A streptococcal antigen from throat swab specimens, thereby aiding in the diagnosis of diseases caused by group A Streptococcus. To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Reaction Unit. If the sample contains strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If strep A antigen is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result. As the sample continues to move through the test, the procedural Control Window containing strep A antigen becomes pink. Pink color in the Control Window confirms that the test is functionally active and has been performed correctly. The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs within approximately 5 minutes of adding the extracted sample to the Reaction Unit.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Clinical performance relative to standard culture techniques",
        "device_performance": "Not explicitly stated with numerical values for sensitivity, specificity, etc. The document generally states 'excellent intra- and inter-assay precision' and 'reproducibly manufacturable', and concludes 'substantial equivalence' to existing products. Further detail is needed for a comprehensive table."
      },
      {
        "criterion": "Accuracy and reproducibility by office personnel with diverse educational backgrounds",
        "device_performance": "Office personnel could perform the test accurately and reproducibly."
      },
      {
        "criterion": "Non-interference by common bacterial microorganisms and potentially interfering substances",
        "device_performance": "Common bacterial microorganisms and potentially interfering substances were shown not to interfere with the test's performance."
      }
    ],
    "study_details": {
      "sample_size_test_set": "Not specified for the multi-center evaluation. 'Numerous studies' were undertaken.",
      "data_provenance": "Multi-center evaluation: Not explicitly stated, but physicians' office studies were performed at three geographically distinct sites in the United States, implying US data. Retrospective or prospective not specified.",
      "number_of_experts_ground_truth_test_set": "Not specified. Ground truth for the multi-center evaluation was 'standard culture techniques', not expert consensus.",
      "qualifications_experts_ground_truth_test_set": "Not applicable as ground truth was culture-based.",
      "adjudication_method_test_set": "Not applicable.",
      "mrmc_comparative_effectiveness_study": "No, this is a diagnostic immunoassay, not an AI-assisted interpretation device for human readers.",
      "standalone_performance_done": "Yes, 'A multi-center evaluation of the CARDS Q.S. Strep A/Concise Performance Plus Strep A test was conducted to determine the clinical performance of the test relative to standard culture techniques'. This describes standalone performance.",
      "type_of_ground_truth": "Standard culture techniques were used for ground truth in the multi-center clinical evaluation.",
      "sample_size_training_set": "Not applicable. This is not an AI/ML device that requires a training set in the conventional sense.",
      "ground_truth_establishment_training_set": "Not applicable."
    }
  }
}

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