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The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test İs intended for the qualitative determination of cardiac troponin I in human whole blood, plasma or serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

The BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test is a colloidal gold/antibody conjugatebased immunoassay designed for the detection of cTnl in human whole blood, plasma and serum samples. To perform the BioCheck Whole Blood/Plasma/Serum cTnl Rapid Test, the sample is dispensed into the sample well. The red cells in the whole blood will react with certain biochemical reagents (such as anti-red blood cells) which are immobilized in the sample pad. This reaction will cause the red blood cells to bind to the sample pad, allowing only the plasma to travel forward. CTnl that is present in the specimen is bound by a gold-antibody conjugate forming a gold-antibody-antigen complex. This complex migrates across the membrane by capillary action and reacts with three anticTnl monoclonal antibodies immobilized in the test region to produce a pink color band when the cTnl concentration is equal to or greater than 1.5 ng/ml. If cTnl is not present in the specimen, there is no line in the test line area. The mixture continues to migrate to the procedural control line area and produce a pink color band. If no procedural control line is present, the sample is invalid and should be retested.

This document describes the test performance characteristics of the BioCheck Whole Blood/Plasma/Serum cTnI Rapid Test. Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate section with predefined targets. Instead, it presents various test performances which implicitly serve as the criteria the device met.

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

• Precision (Serum & Whole Blood):
  • Each of 4 labs tested 5 blind replicates of 3 different cTnI concentrations (0, 1.5, 3.0 ng/ml).
  • Total tests per site = 15. Total over 4 sites = 60. Manufacturer's lab also tested.
  • Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. and collaborating labs. Retrospective from spiked samples.
• Recovery Study (Serum & Whole Blood):
  • 6 replicates for each of 5 cTnI concentrations (0, 0.5, 1.0, 1.5, 3.0 ng/ml).
  • Total replicates per sample type = 30. Total for both serum and whole blood = 60.
  • Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.
• Interference:
  • Amount not specified, but various analytes and drugs were tested at specified concentrations.
  • Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.
• Clinical Correlation (Serum):
  • Test Set Size: 245 patient serum samples.
  • Data Provenance: Not explicitly stated, but implies patient samples, likely retrospective. Country of origin not specified.
• Correlation (Whole Blood vs. Plasma):
  • Test Set Size: 68 paired whole blood and plasma samples from patients.
  • Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
• Clinical Studies (Confirmed MI Patients - Whole Blood):
  • Test Set Size: 24 whole blood specimens from confirmed MI patients.
  • Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
• Clinical Studies (Non-MI Patients - Whole Blood):
  • Test Set Size: 44 whole blood specimens from non-MI patients.
  • Data Provenance: Patient samples, likely retrospective. Country of origin not specified.
• Correlation (Whole Blood vs. Serum - Spiked Samples):
  • Test Set Size: 20 individuals provided paired whole blood and serum samples, spiked with cTnI.
  • Data Provenance: Not explicitly stated, likely internal to BioCheck Inc. Retrospective from spiked samples.

3. Number of Experts and Qualifications for Ground Truth:

• For the Clinical Correlation Study and Clinical Studies (confirmed MI and non-MI patients), the reference method for confirming cTnI levels was a "commercially available quantitative ELISA assay for cTnI" and the "BioCheck cTnI ELISA Test."
• For the "Confirmed MI Patients" and "Non-MI Patients" studies, the ground truth refers to "patient status" as confirmed MI or non-MI. This implies clinical diagnosis, likely involving medical professionals, but the number and qualifications of these experts are not specified in the document. The ELISA assay serves as the reference for the cTnI concentration in these studies.

4. Adjudication Method for the Test Set:

• The document describes comparisons to existing methods (ELISA for cTnI, clinical status for MI). There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth or resolving discrepancies in any of the studies. The reference methods are assumed to be definitive.

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

• No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test for qualitative determination of cTnI, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. Standalone Performance:

• Yes, standalone performance was done. All the reported performance metrics (precision, recovery, interference, clinical correlation, and clinical studies) assess the performance of the BioCheck Whole Blood/Plasma/Serum cTnI Rapid Test on its own, without human-in-the-loop assistance. It is designed to provide a direct qualitative result.

7. Type of Ground Truth Used:

• Expert Consensus / Reference Assay and Clinical Outcomes:
  • For assays confirming cTnI levels, the ground truth was established by comparison to a commercially available quantitative ELISA assay for cTnI (implicitly considered a gold standard for cTnI concentration).
  • For the "Clinical Studies" on confirmed MI and non-MI patients, the ground truth for patient status was based on clinical diagnosis ("confirmed MI patients" and "non-MI patients"), likely supported by the ELISA results, which falls under clinical outcomes/diagnosis, implicitly representing expert medical consensus.
  • For spiked samples, the ground truth was the known, introduced concentration of cTnI.

8. Sample Size for the Training Set:

• The document does not mention a training set or indicate that the device used machine learning or AI algorithms requiring a training set. This is a traditional immunoassay. The studies described are validation and performance testing, not model training.

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

• Not applicable, as there is no mention of a training set for this device.

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The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed for the detection of CRP in human serum samples. To perform the serum CRP test, serum is added to the Sample Well. CRP in the specimen is bound by a gold-antibody conjugate forming a gold-antigen complex. This complex migrates across the membrane by capillary action and reacts with a goat anti-human CRP polyclonal antibody immobilized in the test region to produce a pink color band when the CRP concentration is equal to or greater than 4.0 mg/L. If the CRP concentration is less than 4.0 mg/L, there is no line in the test line area. The gold-conjugate continues to migrate to the control line area and produce a pink color band, indicating a valid test.

BioCheck CRP Rapid Test Study Analysis

Here's a breakdown of the acceptance criteria and the study proving the BioCheck CRP Rapid Test meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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The BioCheck Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

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The provided text is a 510(k) premarket notification letter for a Myoglobin Enzyme Immunoassay Test Kit. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Acceptance Criteria: Not explicitly stated in this document. The 510(k) process focuses on demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Specific performance acceptance criteria are typically detailed in the full 510(k) submission, not in the FDA's decision letter.
• Reported Device Performance: Not included in this document. The letter confirms review and determination of substantial equivalence, but it doesn't present the actual performance data (e.g., sensitivity, specificity, accuracy, precision) that led to that determination.

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

• Sample Size: Not mentioned in this document.
• Data Provenance: Not mentioned in this document.

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)

• Number of Experts: Not mentioned in this document.
• Qualifications of Experts: Not mentioned in this document.

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

• Not mentioned in this document.

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 device is an in-vitro diagnostic (IVD) immunoassay test kit, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader multi-case (MRMC) study involving human readers and AI assistance is not applicable.

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

• This question is not applicable as the device is an immunoassay test kit, not an algorithm. Its performance is inherent to the assay chemistry and instrumentation, not an "algorithm only" in the context of AI.

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

• For an immunoassay for myoglobin, the "ground truth" would typically be established by a reference method for myoglobin quantification or clinical diagnosis of heart or renal disease, confirmed by other established clinical markers or gold standard diagnostic procedures. However, the specific method used is not mentioned in this document.

8. The sample size for the training set

• This device is an immunoassay, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.

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

• This question is not applicable as the device is an immunoassay, not a machine learning model.

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The BioCheck cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Not Found

This document is a 510(k) clearance letter for the BioCheck, Inc. Human Cardiac Troponin I Enzyme Immunoassay Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information from this document.

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The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, etc.), or expert involvement. The document is a 510(k) clearance letter from the FDA for a medical device called "BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit," approving its marketing. It primarily focuses on the regulatory aspects and indications for use, without detailing the performance study methodology or results.

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The BioCheck IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.

BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)

The provided text is a 510(k) clearance letter from the FDA for the BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA). This document primarily focuses on regulatory approval and does not contain the detailed study information typically found in a clinical study report or a scientific publication.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not available in the provided text.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not specified in this document. The FDA letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets established performance characteristics, but the specific criteria are not listed.
• Reported Device Performance: Not included in this regulatory letter. This information would typically be in a separate study report submitted to the FDA as part of the 510(k) application.

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

• Not available in the provided text.

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/available. This device is an in vitro diagnostic (IVD) test kit, not an imaging AI device that typically relies on expert interpretation for ground truth. The "ground truth" for an IVD kit would likely be established through reference methods or clinical diagnosis, not expert consensus on interpretations.

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

• Not applicable/available. Adjudication methods like 2+1 are typically used in studies involving human interpretation (e.g., radiology readers) where there might be disagreement. For an IVD kit, performance is usually assessed against a reference standard.

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. MRMC studies are used for evaluating AI-assisted human performance, primarily in imaging. This device is an immunoassay test kit, which is a standalone diagnostic test performed in a lab, not an AI assisting a human reader.

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

• Yes, implicitly. As an in vitro diagnostic test kit, the BioCheck IgE ELISA operates as a standalone diagnostic tool. Its performance (e.g., sensitivity, specificity, accuracy, precision, linearity) would have been assessed independently. However, the details of such a standalone performance study are not provided in this document.

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

• For an IgE assay, the ground truth would likely be established through:
  • Clinical diagnosis of hypersensitive/allergic reactions: Based on patient history, symptoms, other diagnostic tests, and potentially positive responses to allergy testing (e.g., skin prick tests, challenge tests).
  • Reference methods: Comparison to a legally marketed predicate device or a well-established laboratory method for IgE quantification.
  • Not explicitly stated in the provided text.

8. The sample size for the training set

• Not applicable/available. This device is a chemical immunoassay kit, not an AI algorithm that requires a "training set" in the machine learning sense. Its development would involve analytical and clinical validation studies, but not a training set.

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

• Not applicable/available for the same reasons as point 8.

In summary, the provided FDA 510(k) clearance letter confirms the device's regulatory approval as "substantially equivalent" but does not contain the detailed technical and clinical study data requested. That information would be found in the applicant's 510(k) submission, specifically in the performance data sections.

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The BioCheck hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) in serum. This assay is to be used for the early detection of pregnancy in a clinical laboratory setting.

BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA)

The provided text is a 510(k) premarket notification letter from the FDA regarding the BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA). It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study information based on the given input. The letter primarily confirms that the device has been reviewed and found substantially equivalent to a legally marketed predicate device, allowing it to proceed to market under general controls and applicable special controls.

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