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FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

The FastPack® IP Sex Hormone Binding Globulin Immunoassay employs a sandwich immunoassay principle. Endogenous SHBG in a patient sample, calibrator, or control is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-SHBG antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-SHBG antibody linked to biotin will bind to streptavidin coated paramagnetic particles (PMP). After incubation, washing steps (using a Tris buffer containing detergents) occur to separate bound from unbound anti-SHBG monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of SHBG in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

Here's an analysis of the provided text regarding the FastPack® IP Sex Hormone Binding Globulin Immunoassay's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a separate section. However, based on the comparative effectiveness study against a predicate device and the presented performance data, we can infer some implied acceptance ranges or targets for the new device.

2. Sample Size and Data Provenance for Test Set (Performance Studies)

• Precision: 7 serum patient samples, tested in duplicate over 20 non-consecutive days, resulting in 240 replicate determinations per sample.
• LOB/LOD: 180 replicate determinations of a blank sample (LOB) and 180 replicate determinations of four low-level samples (LOD).
• Linearity: 11 concentration levels generated by intermixing high and low patient samples, each tested in quadruplicate.
• Interferences: Two serum samples (low and high SHBG concentrations) spiked with known interfering concentrations.
• Serum and Plasma Equivalence: Blood collections from 54 volunteers.
• Expected Values/Reference Intervals: N=613 male (n=304) and female (n=309) apparently healthy individuals.
• Method Comparison: 158 human serum samples.

Data Provenance (Implied): The studies refer to "patient samples," "serum samples," and "human serum/plasma." While direct country of origin is not specified, it's generally understood that such studies for FDA submission are conducted under controlled laboratory conditions, likely within the US or by institutions adhering to similar regulatory standards. The data is retrospective in the sense that these are collected samples used for performance evaluation, not part of real-time clinical use for new diagnoses in a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic (IVD) immunoassay that measures a biomarker (SHBG concentration). The concept of "ground truth" here is the true concentration of SHBG in a sample, or the accuracy of the measurement against a reference method.

• No human experts (like radiologists reading images) are used to establish ground truth for individual measurements of SHBG concentration.
• For Method Comparison: The "ground truth" or reference standard for comparison is the predicate device (Beckman Coulter Access Sex Hormone Binding Globulin assay K083867). This predicate device itself had previously established performance.
• For Reference Intervals (Expected Values): "Apparently healthy individuals with no known pre-existing endocrine disorders" were used. The reference intervals (2.5th-97.5th percentiles) are derived statistically from a population, rather than established by individual expert diagnosis for each sample.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for this IVD is either the measurement by a predicate device or statistically derived normal ranges, not expert interpretation requiring adjudication.

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

Not applicable. This is an automated immunoassay for quantitative determination of a biomarker, not an imaging device or AI algorithm that assists human readers in interpreting cases. There is no "human-in-the-loop" component in the direct measurement process to be evaluated for improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the studies presented are all standalone performance evaluations of the FastPack® IP Sex Hormone Binding Globulin Immunoassay system (device + assay + analyzer). The device operates independently to provide quantitative results.

7. Type of Ground Truth Used

• For Method Comparison: The measurements from the predicate device (Beckman Coulter Access Sex Hormone Binding Globulin assay) served as the comparative "truth" or reference.
• For Limit of Quantitation (LOQ): Defined by statistical criteria (lowest concentration with < 20% CV).
• For Linearity: Based on spiked samples with known concentrations and statistical fit to a linear model.
• For Interfering Substances/Cross-reactivity: Based on known spiked concentrations of potential interferents and lack of significant deviation from unspiked controls.
• For Expected Values/Reference Intervals: Statistically derived from a large population of apparently healthy individuals.
• Traceability: The assay is traceable to WHO 082/266 reference material, which serves as a primary reference for SHBG concentration.

8. Sample Size for the Training Set

Not applicable in the typical AI/ML sense. This is a conventional in vitro diagnostic device, not an AI/ML system that requires a "training set" to learn from data. The device's performance characteristics are established through analytical validation studies (precision, linearity, interference, method comparison, etc.) as described. The calibration curve for the assay is established using known calibrator materials, but this is part of the daily operational setup, not a "training set" in the context of AI.

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

Not applicable for the same reasons as #8. The assay relies on known concentrations of calibrators (traceable to WHO reference material) to establish its quantitative scale, not on a "ground truth" established for an AI training set.

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FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use.

FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle. Endogenous CRP in a patient sample, calibrator, control, or verifier is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-CRP antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-CRP antibody linked to biotin. After incubation, immunoreacted complex (Monoclonal anti-CRP antibody-ALP conjugate and anti-CRP antibody linked to biotin reacted with CRP in the sample) is mixed with streptavidin coated paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-CRP monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N'-dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield Nmethylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of CRP in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

The provided document describes the FastPack® High Sensitivity C-Reactive Protein Immunoassay (device) and its performance to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" as a separate section with pass/fail values. Instead, it presents performance characteristics and compares them to the predicate device or established guidelines (e.g., CLSI). Based on the provided sections, a table can be constructed as follows:

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

• Precision Study: 6 serum patient samples were used, each with 320 replicate determinations.
• Limits of blank, detection, and quantitation: Information not provided about the specific "samples" used for these determinations.
• Linearity Study: A high patient sample was intermixed with a low sample to generate 8 concentration levels, each tested in triplicate.
• Interferences: Specific concentrations of various substances were tested. The number of samples/replicates isn't explicitly stated, but implies a controlled study.
• Cross-reactivity: Specific concentrations of substances like Rheumatoid factor, human anti-mouse IgG, and heterophile samples were tested.
• Serum and Plasma Equivalence: Blood collections from 41 volunteers.
• Expected Values/Reference Intervals: Serum samples from 211 subjects.
• Method Comparison: 131 samples.

Data Provenance:
The document states that the reference interval study employed serum samples from "211 subjects representing 4 different geographic regions of the United States." This indicates a prospective or retrospective collection of patient samples within the US for this specific study. For other studies (precision, linearity, interferences, serum/plasma equivalence, method comparison), specific provenance details like country of origin or retrospective/prospective nature are not explicitly stated, but are generally assumed to be carried out under controlled laboratory conditions often using commercially available or anonymized clinical samples.

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

This information is not applicable to this type of device (in-vitro diagnostic immunoassay). The "ground truth" for a C-reactive protein immunoassay is typically the actual concentration of CRP in the sample, which is determined by established reference methods or by the device's own calibrated measurement. There are no human "experts" establishing ground truth in the sense of image interpretation or clinical diagnosis for this kind of analytical device. The "ground truth" for method comparison is the result obtained from the predicate device or a reference method.

4. Adjudication Method for the Test Set:

This information is not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their interpretations need to be resolved for ground truth. For an immunoassay, the results are quantitative measurements, not subjective interpretations requiring adjudication.

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 information is not applicable to this device. An MRMC study is relevant for AI-assisted diagnostic tools where human readers are part of the diagnostic workflow. The FastPack® Immunoassay is an automated analytical device that directly measures CRP concentration, not an AI system assisting human interpretation.

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

The device described, the FastPack® High Sensitivity C-Reactive Protein Immunoassay, is an automated immunoassay system. Its performance is inherently "standalone" in the sense that the analyzer performs the measurement without human intervention influencing the quantitative result. The performance data presented (precision, linearity, limits, interference, method comparison) is the standalone performance of the algorithm/system. There is no "human-in-the-loop" component in terms of result generation for this type of device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance studies of this immunoassay primarily relies on:

• Reference Methods/Predicate Device Results: For method comparison, the results obtained from a legally marketed predicate device (Olympus AU2700 for the method comparison) served as the reference for comparison.
• Known Concentrations: For studies like linearity, limits of detection/quantitation, and precision, samples with known, spiked, or characterized CRP concentrations are used.
• Clinical Samples: For serum and plasma equivalence and reference interval studies, collected human serum and plasma samples are used. The CRP concentrations in these samples, as measured by the device itself or a reference method, serve as the "true" or observed values for evaluating performance parameters.

8. The Sample Size for the Training Set:

This information is not applicable in the context of this document. This device is an immunoassay, not an AI/machine learning system that requires a "training set" in the computational sense. The device's operational parameters, calibration curves, and analytical procedures are established through manufacturing and analytical validation processes, not through machine learning training on a dataset.

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

This information is not applicable as there is no "training set" for this type of immunoassay device in the context of an AI/machine learning system. The "ground truth" for calibrating immunoassays is established using reference materials with assigned values traceable to international standards (e.g., ERM-DA474/IFCC for CRP, as mentioned in the device's traceability). These reference materials are meticulously characterized using highly accurate and precise analytical methods.

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FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer.

FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.

FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.

FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.

The FastPack® Vitamin D Immunoassay employs a competitive immunoassay principle. Endogenous Vitamin D in a patient sample, calibrator, control, or verifier is mixed with pretreatment buffer then added into a FastPack® reagent pack. In the reagent pack, the pre-treated Vitamin D sample binds with a monoclonal (mouse) anti-Vitamin D antibody covalently linked to alkaline phosphatase (ALP). After incubation, a conjugate of Vitamin D-Biotin linked to streptavidin coated paramagnetic particles is added. Monoclonal anti-Vitamin D antibody-ALP conjugate not reacted with Vitamin D in the sample will bind to unoccupied binding sites of the Vitamin D-biotin conjugate bound to the streptavidin paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-Vitamin D monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N.Ndimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are inversely proportional to the concentration of Vitamin D in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

The Qualigen FastPack® Vitamin D Immunoassay is an in-vitro diagnostic device intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma, to be used as an aid in the assessment of vitamin D sufficiency in adults. The device demonstrated substantial equivalence to the LIAISON® 25 OH Vitamin D TOTAL Assay (K112725). The following information details its acceptance criteria and supporting studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from the comparative performance against the predicate device (DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay) and established clinical laboratory guidelines for precision, linearity, limits of detection/quantitation, cross-reactivity, and interference. While explicit acceptance criteria values are not provided in all sections, the reported performance is presented to demonstrate that the device functions comparably or within reasonable assay limits.

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

• Precision Study: 4 samples tested in duplicate on two analyzers, with two reagent lots, over 20 days. This resulted in 160 replicate determinations for each sample (80 replicates per lot/analyzer).
• LOB/LOD/LOQ Determination: Specific sample size not explicitly stated but conducted according to CLSI EP17-A.
• Linearity Study: A high patient sample was intermixed with a low sample to generate 9 concentration levels, each tested in duplicate. Specific number of patient samples not explicitly stated.
• Cross-reactivity Study: Two samples (low and high Vitamin D concentrations) were tested with and without added potential cross-reacting compounds. Specific number of samples per compound not explicitly stated.
• Interference Study: Specific number of samples not explicitly stated; substances were tested at noted concentrations.
• Serum and Plasma Equivalence: 32 volunteers provided blood samples (serum, EDTA plasma, lithium-heparin plasma).
• Expected Values/Reference Intervals: 367 subjects.
• Method Comparison: 137 human serum samples.

Data Provenance:
The document does not explicitly state the country of origin for all samples. However, for the "Expected Values/Reference Intervals" study, serum samples from 367 subjects were acquired from 4 different sources representing 5 different geographic regions of the United States. This suggests at least a portion of the clinical data is from the US. The studies are prospective in nature, designed specifically to evaluate the device performance.

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

The document does not describe the use of human experts to establish "ground truth" for the test sets in the traditional sense of diagnostic image interpretation. This device is a quantitative immunoassay. The "ground truth" for method comparison and equivalence studies is established by comparison to a legally marketed predicate device (LIAISON® 25 OH Vitamin D TOTAL Assay) or by highly controlled analytical methods (e.g., for linearity, LOB/LOD/LOQ, cross-reactivity, interference). Therefore, the concept of "experts" and their qualifications for establishing ground truth as in imaging studies is not directly applicable here. The accuracy of measurements on the predicate device or the analytical standards used would serve as the reference.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative immunoassay, the "adjudication method" in the context of expert consensus (e.g., 2+1, 3+1) is not relevant. The results are quantitative values derived from the immunoassay and compared against analytical standards, reference methods, or statistical criteria.

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 laboratory immunoassay for quantitative measurement of Vitamin D, not an AI-based diagnostic imaging or interpretive tool requiring human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

The performance studies described are inherently "standalone" in the context of the device's function. The FastPack® Vitamin D Immunoassay, run on the FastPack® Analyzer, provides a quantitative result. The studies assess the analytical performance of this automated system directly (e.g., precision, linearity, limits, interference, method comparison with a predicate device), without human interpretive input affecting the direct measurement output. The human involvement would be in operating the instrument and interpreting the resulting quantitative value in a clinical context, which is outside the scope of the device's standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used for various studies includes:

• Predicate Device Measurements: For the method comparison study, results from the LIAISON® 25 OH Vitamin D TOTAL Assay (K112725) were used as the reference "ground truth" for comparison.
• Reference Standards/Known Concentrations: For linearity, LOB/LOD/LOQ, cross-reactivity, and interference studies, the "ground truth" is established by using samples with known, carefully prepared, or spiked concentrations of analytes and interfering substances.
• Paired Sample Measurements: For serum/plasma equivalence, the "ground truth" is the quantitative value obtained from one matrix (e.g., serum) against which measurements from another matrix (e.g., plasma) are compared.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional immunoassay, not an AI/machine learning model that typically requires a "training set." The development of the assay involves chemical and biological optimization, not algorithm training on a dataset.

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

Not applicable, as no training set (in the AI/ML sense) was used for this traditional immunoassay device.

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The FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert:

• Free Thyroxine (FT4)
• Human Chorionic Gonadotropin (hCG)
• Testosterone
• Total Prostate Specific Antigen (tPSA)
• Thyroid Stimulating Hormone (TSH)

FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin. The control is provided in liquid form for convenience.

This document describes a K123725 FastPack® Control Kit, which is a quality control material used to verify the accuracy and precision of immunoassay systems (FastPack® and FastPack® IP Systems). As such, the "acceptance criteria" and "device performance" in this context refer to the stability and value assignment of the control material, not a diagnostic or AI algorithm's performance on patient data.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are related to its stability and the accurate assignment of analyte values.

2. Sample Size and Data Provenance (for test set)

This device is a quality control material, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" in the context of patient data, country of origin, or retrospective/prospective data is not applicable here.

The "test set" for this device would be the samples of the control material itself that are used for the value assignment and stability studies.

• Sample Size for Value Assignment: For each analyte and each of the two control levels, 36 determinations were performed (6 FastPack® analyzers * 3 reagent lots * 2 calibrations = 36 determinations).
• Data Provenance: Not applicable in the sense of patient data. The data originates from the internal testing conducted by Qualigen, Inc., presumably at their facility in Carlsbad, CA, as part of their manufacturing and quality control process. The studies are prospective for the purpose of validating the control material.

3. Number of Experts and Qualifications for Ground Truth (for test set)

Again, this is a quality control material. "Ground truth" for this device is based on analytical measurement results from calibrated instruments and established statistical methods, not expert human interpretation of clinical data. Therefore, experts in the sense of radiologists or clinicians are not involved in establishing the "ground truth" for the performance of the control material itself. The "experts" would be the scientific and technical personnel (e.g., analytical chemists, quality control specialists) at Qualigen, Inc. who perform these measurements and statistical analyses. Their qualifications are inherent in their roles within a medical device manufacturer.

4. Adjudication Method (for test set)

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to conflicts in human expert interpretations of clinical data. The value assignment and stability studies for a control material rely on direct analytical measurements and statistical calculations.

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

No. An MRMC study is designed to assess and compare the performance of human readers, often with and without AI assistance, on diagnostic tasks (cases). This is not relevant to a quality control material.

6. Standalone (Algorithm Only) Performance Study

No. This device is an assayed quality control material, not an algorithm. Its "performance" is its ability to provide stable and accurately assigned values, which is assessed through analytical testing, not by an algorithm's output.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical measurements and statistical calculations from repeated testing on multiple instruments and reagent lots. It involves:

• Quantitative measurements of analyte concentrations using the FastPack® and FastPack® IP Systems.
• Statistical analysis to determine means, standard deviations, and coefficients of variation.
• Defined ranges (e.g., mean ± 3SD) for each analyte and level.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. This device is a biochemical control material, not an AI model. Therefore, there is no "training set" in the conventional sense. The "training" here would refer to the process of manufacturing and calibrating the control material itself, and the data generated during the value assignment process serves to characterize each manufactured lot.

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

As noted above, there is no "training set" for an algorithm. The "ground truth" for the control material's characteristics (its assigned values and stability) is established through rigorous analytical testing and statistical analysis by the manufacturer, as described in section 3 ("Value Assignment of Analytes") of the 510(k) summary. This process quantifies the target values and acceptable ranges for each analyte within the control kit.

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The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma. The FastPack® Testo Immunoassay is designed for use with the FastPack® System. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer. The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components: Paramagnetic Particles, Testosterone Antibody Solution, Wash Buffer, and Substrate. The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.

Here's a breakdown of the acceptance criteria and study information for the Qualigen FastPack® Testo Immunoassay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating equivalence to the predicate device (FastPack® Testo Immunoassay K021972), particularly for the new sample types (lithium heparin plasma and K2 EDTA plasma). The performance data below reflects the device meeting these criteria by achieving comparable results to the predicate, and demonstrating linearity and acceptable precision.

Study Details

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

   • Serum: N = 135
   • Lithium Heparin Plasma: N = 60
   • K2 EDTA Plasma: N = 67
   • Data Provenance: The document does not specify the country of origin. It indicates the studies were "conducted in-house" which typically implies internal testing by the manufacturer. It does not state whether the data was retrospective or prospective, but clinical validation studies for in-vitro diagnostics are generally prospective or use carefully selected archived samples that mimic prospective collection.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention the use of experts to establish ground truth for the test set. For quantitative immunoassays, the "ground truth" is typically established by comparative testing against an established, legally marketed method or a reference method. The comparison study uses the results from the predicate device (FastPack® Testo Immunoassay K021972) or other "established methods" as the reference for comparison, not expert consensus.

3. Adjudication method for the test set:
   Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or imaging-based diagnostics where human interpretation of results is involved and there might be discrepancies. For quantitative laboratory assays, the result is a numerical value, and the comparison is statistical against a reference method.

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:
   Not applicable. This is an in-vitro diagnostic immunoassay for quantitative determination of testosterone, not an imaging device or an AI-assisted diagnostic tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, this is essentially a standalone device performance study. The FastPack® Testo Immunoassay is an automated immunoassay system. Its performance (accuracy, precision, linearity, interference) is evaluated intrinsically, independent of human interpretation or assistance beyond operating the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The ground truth was established by comparison to "Established Methods" and the predicate device (FastPack® Testo Immunoassay K021972) for serum samples, and comparison to serum results for plasma samples. This means the clinical performance of the device was assessed by correlating its quantitative measurements with those obtained from already accepted, legally marketed, or gold-standard laboratory methods.

7. The sample size for the training set:
   The document does not explicitly state the sample size for a "training set." For an immunoassay like this, method development and optimization would occur internally, potentially using numerous samples, but it's not typically referred to as a "training set" in the context of device approval unless machine learning/AI is involved. The listed sample sizes (N=135, N=60, N=67) are for the validation or test sets to demonstrate performance characteristics.

8. How the ground truth for the training set was established:
   Not applicable, as a distinct "training set" with ground truth established in a formal, reported manner (like for an AI algorithm) is not mentioned or relevant for this type of immunoassay device submission. Method development and optimization would rely on established laboratory practices to ensure reagents and assay parameters lead to accurate and precise measurements.

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The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "FastPack TSH Immunoassay." This document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory approval letter that states the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.

Therefore, I cannot extract the information asked for in your prompt from the provided text.

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The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

The FastPack® PSA Method Verification Kit The FastPack® Total PSA Method Verification kit components are in liquid form, in vials, from which the user can directly remove sample. They are formulated at three (3) levels packaged together as a kit.

The provided text is a 510(k) summary for the FastPack® Total PSA Method Verification Kit. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device based on similar features and intended use. The "Method Verification Kit" itself is a quality control material used to verify the calibration and reportable range of another immunoassay (the FastPack® Total PSA Immunoassay), rather than a device that directly measures a patient's analyte. Therefore, the "performance" of this kit is assessed by its characteristics as a quality control material (e.g., PSA concentrations, matrix, form), not by diagnostic accuracy metrics.

Here's a breakdown of the requested information based on the provided text, with explicit statements where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or a numerical performance table for the "FastPack® Total PSA Method Verification Kit" are provided in this document. The document states it is a "Method Verification Kit" and compares its features to a "Predicate Device" in a table. This comparison highlights attributes like intended use, analytes, matrix, form, volume, and levels of PSA concentrations. It does not present performance metrics against predefined acceptance criteria.

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

• Sample size from the test set: Not applicable/Not provided. The kit itself is a quality control material, not a diagnostic test performed on patient samples.
• Data provenance: Not applicable/Not provided.

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

• Number of experts: Not applicable/Not provided. This device is a quality control material, not a diagnostic device requiring expert interpretation of results.
• Qualifications of experts: Not applicable/Not provided.

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

• Adjudication method: Not applicable/None. This device is a quality control material.

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

• MRMC study: No. This device is a quality control material and not an AI-assisted diagnostic tool.

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

• Standalone performance study: No. This device is a quality control material.

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

• Type of ground truth: Not applicable/Not provided in the context of diagnostic accuracy. For the quality control material itself, the specified PSA concentrations (0 ng/mL, 25 ng/mL, 50 ng/mL) would serve as the "true" values for verifying the immunoassay. How these concentrations were established (e.g., gravimetric preparation against a standard) is not detailed in this document.

8. The sample size for the training set

• Training set sample size: Not applicable/Not provided. This document describes a quality control material, not a machine learning model.

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

• Ground truth for training set: Not applicable/Not provided.

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The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System.
The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma.
The FastPack ® Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma.

The FastPack® TSH Immunoassay is a competitive chemiluminescence assay.

• . Primary incubation: Sample, calibrator, or control (100 uL) is added to the antibody solution (100 uL) to start the sequence. The reaction time is 10 minutes at 37° C.
• . Sccondary incubation: The initial reaction mixture (200 µL) is transferred to the magnetic particles and is incubated an additional 2 minutes at 37° C.
• . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
• Substrate addition and detection: Chemiluminogenic substrate [140 . uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® System at 37° C.
• The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of TSH in human plasma.

Here's a summary describing the acceptance criteria and the study outcomes for the FastPack® TSH Immunoassay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) document compares the FastPack® TSH Immunoassay to a predicate device (Abbott Laboratories IMx Ultrasensitive hTSH II) across several performance characteristics. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the comparison serves as the basis for demonstrating substantial equivalence. The reported performance of the FastPack® TSH Immunoassay is presented alongside the predicate device's performance for direct comparison.

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

• Sample Size (Method Comparison): 93 samples were used for the method comparison study against the predicate device.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, given the context of a 510(k) submission for an in vitro diagnostic device, it is typically based on samples collected specifically for the performance evaluation, which could include a mix of retrospective and prospectively collected samples from various sources.

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

This information is not applicable as the FastPack® TSH Immunoassay is an in vitro diagnostic device that measures a quantitative biomarker (TSH levels). The "ground truth" for such devices is established by reference methods or comparison to legally marketed predicate devices, not through expert reading or interpretation of images/data in the same way as medical imaging AI.

4. Adjudication Method for the Test Set

This is not applicable for a quantitative immunoassay device. The performance is assessed by direct comparison of numerical results to a predicate device or reference method, not by expert adjudication of classifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretive diagnostic AI devices where human readers interpret results, and the AI's impact on reader performance is evaluated. The FastPack® TSH Immunoassay is a laboratory assay with an automated result output.

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

Yes, the performance data presented (precision, sensitivity, method comparison, interference, specificity) represents the standalone performance of the FastPack® TSH Immunoassay system. This is the inherent performance of the device and its reagents in generating TSH measurements.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the FastPack® TSH Immunoassay was established by comparison to a legally marketed predicate device, the Abbott Laboratories IMx Ultrasensitive hTSH II. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a reference method is not explicitly stated or available. The predicate device's established performance serves as the benchmark.

8. The Sample Size for the Training Set

The document does not report information on a "training set" in the context of machine learning or AI algorithm development. This 510(k) submission describes a traditional immunoassay device, which relies on chemical and biological reactions rather than a trained algorithm in the modern AI sense. Therefore, the concept of a training set as used in AI development is not applicable here.

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

As noted in point 8, the concept of a "training set" is not applicable to this traditional immunoassay device.

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The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay.
● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C.

• . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C.
• . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
• . Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.

The provided text describes the FastPack® Free T4 Immunoassay on the FastPack® Analyzer System. Here's a breakdown of the acceptance criteria and the study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's performance characteristics in a tabular format. Instead, it presents the performance data of the FastPack® Free T4 Immunoassay and compares it directly to a predicate device (Abbott IMx® Free T4). The implication is that the performance shown met the internal criteria or was considered substantially equivalent to the predicate device.

Here's a table summarizing the reported device performance, with the predicate device's performance for comparison, which implicitly sets a benchmark for acceptance:

Note: The acceptance criteria for the FastPack® device are implicitly demonstrated by its performance being comparable or superior to the predicate device in key metrics, as required for 510(k) clearance based on substantial equivalence.

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

• Sample Size for Method Comparison: n = 131 samples were used for the method comparison study against the Abbott IMx Free T4.
• Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It is implied to be clinical samples used for assay validation.

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

• This information is not applicable to this type of device. The ground truth for an immunoassay like this is established by the reference method (in this case, the predicate device Abbott IMx Free T4) and other analytical validation methods (precision, sensitivity, interference). It does not involve human expert interpretation of images or other subjective data.

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

• This information is not applicable to this type of device. Adjudication methods are typically used when there are subjective interpretations being made by humans (e.g., in medical image analysis). For an in vitro diagnostic immunoassay, the "adjudication" is inherent in the analytical process and result generation, verified against established analytical standards and predicate device 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

• This information is not applicable to this type of device. An immunoassay is an automated analytical test, not an AI-assisted diagnostic tool that involves human readers.

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

• This information is not applicable in the context of an AI algorithm. However, the FastPack® Free T4 Immunoassay itself is a standalone diagnostic test in the sense that the system provides a quantitative result without continuous human intervention in the result generation process once the sample is loaded and the test initiated. The performance characteristics described (precision, sensitivity, method comparison) are all "standalone" performance metrics of the device as an automated system.

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

• The ground truth for this device's performance is established by:
  • Reference Intervals/Ranges: The stated assay range of 0.4 to 6 ng/dL for Free T4, which aligns with clinical understanding of normal/abnormal levels.
  • Comparison to a Legally Marketed Predicate Device: The Abbott IMx Free T4 system served as the primary comparative ground truth, with performance metrics (correlation coefficient, regression equation) indicating agreement.
  • Analytical Validation: Internal studies demonstrating precision, analytical sensitivity, and non-interference from common substances.

8. The sample size for the training set

• This information is not explicitly provided in the document. For an immunoassay, there isn't a "training set" in the machine learning sense. Instead, development and optimization would involve numerous samples during method development, reagent optimization, and calibration curve generation. The 131 samples mentioned were specifically for the method comparison study, which is part of validation.

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

• As mentioned above, there isn't a "training set" in the AI sense. For an immunoassay, the "ground truth" for developing and calibrating the system would be established through a combination of:
  • Known concentration samples: Using gravimetrically prepared or independently validated samples with known Free T4 concentrations to develop the assay and establish its dose-response curve.
  • Reference methods: Comparing early versions of the assay to existing, validated laboratory reference methods.
  • Clinical samples: Using a large panel of clinical samples with clinically confirmed diagnoses or results from established methods to fine-tune the assay's performance and ensure accurate measurement across the intended analytical range.
  • Calibrators: The FastPack® Testo/Free T4 Calibrator is used to calibrate the system, implying that these calibrators have assigned values based on rigorous analytical standards, acting as a form of ground truth for instrument calibration.

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