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510(k) Data Aggregation
(258 days)
DEM
The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Human alpha-1 Antitrypsin Kit for use on SPAPLUS". It states that the device is substantially equivalent to a predicate device. However, it does not contain any information about the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide the requested information based on the input document.
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(38 days)
DEM
Dimension Vista™ A1AT Flex® reagent cartridge:
The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L. M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista" A1AT Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing a1antitrypsin (A1AT). C3 complement, C4 complement, immunoglobulin A (IGA). immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liguid, human serum based products containing a1-antitrypsin (A1AT), C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista" A1AT Flex® reagent cartridge:
Acceptance Criteria and Device Performance Study
The submission focuses on establishing substantial equivalence for the Dimension Vista™ A1AT Flex® reagent cartridge by comparing its performance to a legally marketed predicate device, the Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System. The primary method used to demonstrate this is a method comparison study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence in this context are typically demonstrated through strong correlation and agreement between the new device and the predicate device. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum allowable bias) are not directly stated as "acceptance criteria" in the provided document, they are implied by the reported results and the conclusion of equivalence.
For the purpose of this analysis, I will infer the performance metrics from the Method Comparison Study as the "reported device performance," which implicitly met the internal or regulatory acceptance thresholds for demonstrating equivalence.
| Performance Metric | Implied Acceptance Criteria (Typically Good Correlation) | Reported Device Performance |
|---|---|---|
| Sample Size (n) | Sufficient for statistical significance | 139 |
| Slope | Close to 1.0 | 1.000 |
| Intercept (g/L) | Close to 0.0 | 0.070 |
| Correlation Coefficient (r) | Close to 1.0 (ideally > 0.97 for method comparison in analytical assays) | 0.996 |
| Concentration Range | Representative of clinical use | 0.23 g/L to 4.71 g/L (for α1-antitrypsin in human serum and plasma) |
Conclusion from document: "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human α-Antitrypsin assay and the Dimension Vista™ A1AT assay."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 139 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "evaluating serum and plasma samples." Given the nature of a 510(k) submission for an in vitro diagnostic, these samples would typically come from human subjects, either collected retrospectively or prospectively for the purpose of the study. Without further information, we cannot definitively classify the provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for an in vitro diagnostic (IVD) assay typically relies on a "predicate device" as the gold standard or reference for comparison, rather than expert consensus on individual cases. The "ground truth" for the test set is established by the results obtained from the predicate device (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). Therefore, there were no human "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation for this specific method comparison.
4. Adjudication Method
As the "ground truth" or reference method is another automated IVD assay, there is no adjudication method described or necessary in the sense of resolving discrepancies between human readers or interpretations. The comparison is between two quantitative analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices or other tests that involve human interpretation and reader variability. For an automated in vitro diagnostic assay like the Dimension Vista™ A1AT Flex® reagent cartridge, the performance is assessed by analytical comparison to a predicate method, not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The "Method Comparison Study" directly evaluates the performance of the Dimension Vista™ A1AT assay (the new device, effectively "standalone" in its measurement capability) against a predicate device. The reported slope, intercept, and correlation coefficient are standard metrics for evaluating the analytical performance of an IVD assay by itself when compared to a reference method, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
The ground truth used for the comparison was the results obtained from a legally marketed predicate in vitro diagnostic assay (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). This is a common and accepted method for establishing equivalence for new IVD assays.
8. Sample Size for the Training Set
This information is not provided. The document describes a "Method Comparison Study" for the new device against a predicate. For IVD assays, there wasn't a separate "training set" in the context of machine learning, and the study doesn't mention how the assay itself (e.g., reagent formulation, instrument parameters) was developed or optimized. The 139 samples were used for the performance evaluation, not to "train" an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or a machine learning component for this traditional IVD reagent cartridge, this question is not applicable in the context of the provided document. The assay's analytical principles are based on known immunochemical reactions, and its calibration would be established using calibrators with known concentrations (as mentioned for the Dimension Vista™ Protein 1 Calibrator), not through a "training set" and ground truth in the AI sense.
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(147 days)
DEM
In vitro diagnostic reagents for the quantitative determination of a -antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BN™ Systems. The measurement of a-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a r-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes statter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
This document describes the N Antisera to Human α-Antitrypsin Assay, an in vitro diagnostic reagent for the quantitative determination of alpha-1-antitrypsin (α1-AT) in human serum, heparinized, and EDTA plasma using immunonephelometry on the BN™ Systems.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for a specific performance metric. Instead, the "device performance characteristics" section in the K053072 summary focuses on demonstrating equivalence in measurement between different sample types (serum, heparinized plasma, and EDTA plasma) and to a legally marketed predicate device.
The reported device performance is based on method comparison studies:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in measurement between serum and heparinized or EDTA plasma. | Correlation coefficients between 0.97 and 0.99 for method comparisons. |
| Substantial equivalence to the predicate device (N Antisera to Human α-Antitrypsin, K860894). | The modified assay demonstrated equivalent performance to the predicate device for quantitative determination of α-antitrypsin by immunonephelometry on BN™ Systems. |
Study Proving Acceptance Criteria:
The study proving the device meets its implied acceptance criteria of equivalence was a method comparison study.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the test set used in the method comparison studies. It only states that "method comparisons were performed."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that the manufacturer is based in Germany (Dade Behring Marburg GmbH) and the contact information for regulatory submission is in the US (Dade Behring Inc.), the data could be from various global sites.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is an in vitro diagnostic reagent for quantitative measurement of a biomarker. The "ground truth" for method comparison studies would typically be the results obtained from a reference method or the established predicate device, not expert consensus on qualitative interpretation.
4. Adjudication Method:
Not applicable. As described above, this is a quantitative measurement, and adjudication by experts is not a relevant component of its validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. An MRMC study is relevant for devices that involve human interpretation of images or other qualitative data, particularly in the context of diagnostic accuracy. This device is an automated quantitative reagent.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the device's analytical performance (specifically, its ability to yield comparable quantitative results across different sample matrices) was evaluated intrinsically. The method comparison studies demonstrated the performance of the algorithm/reagent by itself in generating the quantitative alpha-1-antitrypsin values. This means the analytical performance of the device without human interpretation was assessed.
7. Type of Ground Truth Used:
The "ground truth" for the method comparison studies would be the quantitative results obtained from:
- Measurements using the predicate device (N Antisera to Human α-Antitrypsin, K860894), for establishing substantial equivalence.
- Measurements from serum samples when comparing performance with heparinized and EDTA plasma. This implies that serum is considered the primary, well-established matrix for α1-AT determination against which other matrices are compared.
8. Sample Size for the Training Set:
Not applicable. This device is a reagent for an immunonephelometry system. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The "training" of such a system would involve calibration curves and reagent optimization, which are part of the manufacturing and method development process, not a distinct training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration and optimization of the reagent and system would follow established laboratory practices for IVD assays, using certified reference materials or well-characterized control sera with known α1-AT concentrations to establish calibration curves. This is an analytical validation process, not a ground truth establishment for a training set.
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(80 days)
DEM
For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure α₁-antitrypsin concentration in human serum. The measurement of α₁-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products AAT Reagent is used in conjunction with the VITROS Chemistry Products Calibrator Kit 99 and VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT) in human serum.
The VITROS AAT Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are automatically diluted in saline from VITROS FS Diluent Pack 2 and mixed with Reagent 1 containing a polymer. Addition of antisera specific for human α₁-antitrypsin (Reagent 2) produces an immunochemical reaction yielding antigen/antibody complexes. The light scattering properties of the antigen/antibody complexes increase solution turbidity proportional to α₁-antitrypsin concentration in the sample. The turbidity is measured spectrophotometrically at 340 nm. Once a calibration has been performed for each reagent lot, the a1-antitrypsin concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.
The VITROS Chemistry Products Calibrator Kit 99 are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These standards are used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of α₁-antitrypsin (AAT).
The VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) is a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5,1 FS System was cleared for market by 510(k) premarket notification (K031924).
The VITROS Chemistry Products AAT Performance Verifiers I, II and III are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added. These are assayed controls used to monitor performance of VITROS AAT Reagent on VITROS 5,1 FS Chemistry Systems.
Here's an analysis of the acceptance criteria and supporting studies for the VITROS Chemistry Products AAT Reagent, Calibrator Kit 99, and Performance Verifiers, based on the provided text.
Note: This document describes an in vitro diagnostic device, not an AI/ML-driven medical device for image analysis as might be typical for some of these questions. Therefore, some of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set) are not directly applicable or are not explicitly detailed in the provided text for this type of device. I will address the relevant sections and note when information is not present or applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria with specific performance targets (like sensitivity/specificity for clinical decisions). Instead, performance is shown through correlation and comparison to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (AAT Reagent) | Passing & Bablock linear regression: y = 0.93x + 2.06 mg/dL (where y = VITROS AAT assay, x = IMMAGE AAT assay) |
| Specificity Validation | Bench testing performed (details not quantified) |
| Expected Values Validation | Bench testing performed (details not quantified) |
| Limit of Detection Validation | Bench testing performed (details not quantified) |
| Dilution Validation | Bench testing performed (details not quantified) |
| Specimen Matrix Validation | Bench testing performed (details not quantified) |
| Reportable Range (AAT Reagent) | 30.00 - 450.00 mg/dL (VITROS AAT assay) vs. 10 - 3,600 mg/dL (IMMAGE AAT assay). Note: This is a difference, not necessarily an "acceptance criterion" per se, but a characteristic acknowledged. |
| Intended Use Equivalence (AAT Reagent) | Quantitative measurement of α₁-antitrypsin in human samples to aid in diagnosis of α₁-antitrypsin deficiency. |
| Intended Use Equivalence (Performance Verifiers) | Assayed controls used to monitor performance on VITROS Chemistry Systems. |
| Assay Method Equivalence (AAT Reagent) | Immunoturbidimetric (New) vs. Nephelometric (Predicate). Note: This is a difference, but overall equivalence was demonstrated. |
| Calibrator Levels & Format Equivalence (AAT Reagent) | Five levels, Liquid (New) vs. Single level, Lyophilized (Predicate). Note: Differences acknowledged, but overall equivalence demonstrated. |
| Analyte Equivalence (Performance Verifiers) | α₁-Antitrypsin (AAT) (New) vs. Several including C3, C4, IgA, IgG, IgM, transferrin (Predicate). Note: Difference acknowledged, but specific for AAT. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that equivalence was demonstrated "using a commercially available assay along with patient samples." However, the exact number of patient samples used in the correlation studies (test set) is not specified in the provided text.
- Data Provenance: The data provenance is stated as "patient samples," but the country of origin or whether it was retrospective or prospective data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this in vitro diagnostic device. The "ground truth" for an AAT assay would typically be established by comparing its results to a well-established reference method or a predicate device on patient samples, based on quantitative measurements rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This question is not applicable for this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where experts disagree), not for quantitative chemical measurements.
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. MRMC studies are typically used for diagnostic imaging devices where human readers interpret cases, and performance with/without AI assistance is evaluated. This document describes a chemical assay, not an imaging device with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance study was done. The entire submission describes the performance of the VITROS AAT assay system (reagent, calibrator, verifiers, and instrument) as a standalone device to measure α₁-antitrypsin concentration in human serum. Its performance is compared to a predicate device and validated through various bench tests (specificity, expected values, limit of detection, dilution, specimen matrix). The "algorithm" in this context is the immunoturbidimetric chemical reaction and the spectrophotometric measurement by the VITROS 5,1 FS Chemistry System.
7. The Type of Ground Truth Used
The ground truth for validating the VITROS Chemistry Products AAT assay was established through comparison to a predicate device (IMMAGE® Immunochemistry Systems AAT assay) using patient samples, and through bench testing for various analytical performance characteristics (specificity, limit of detection, etc.). For a quantitative chemical assay, the "ground truth" is typically a known, well-characterized value or the result obtained from a recognized reference method.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/ML algorithm. For an IVD assay like this, product development involves a series of experiments and optimizations to establish reagent formulations, calibration curves, and analytical procedures. The phrase "training set" doesn't directly apply in the same way it would for AI model development. The development data used to optimize the assay would implicitly serve this purpose, but its sample size is not specified.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" ground truth as applied to AI/ML isn't directly applicable here. The development of the assay would involve establishing the expected concentrations of AAT in various samples, using reference methods or characterized materials, to ensure the assay accurately measures the analyte. The specific methodology or exact sample sizes for this developmental phase are not provided in the summary.
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(66 days)
DEM
The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antitrypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.
Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.
The Quantia A1-AT is intended for the in vitro quantitative determination of alpha-1-antityypsin concentration in human serum or plasma (heparin with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.
Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia A1-AT reagents by turbidimetry. For in vitro diagnostic use.
Here's an analysis of the provided text regarding the Quantia A1-AT device, structured to answer your questions about acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Quantia A1-AT) |
|---|---|---|
| Method Comparison | Substantially equivalent to predicate device (N Antisera to Human alpha-1-Antitrypsin). Implies acceptable correlation, slope, and intercept. | Slope: 1.002 (vs. predicate device) |
| Correlation Coefficient (r): 0.9890 (vs. predicate device) | ||
| Precision (CV%) - Low Control | Acceptable precision for clinical use (specific thresholds not stated, but implied by predicate equivalence). | Within Run: 1.2% |
| Between Run: 0.2% | ||
| Total: 1.4% | ||
| Precision (CV%) - Control (I + II) | Acceptable precision for clinical use. | Within Run: 0.7% |
| Between Run: 0.1% | ||
| Total: 0.8% | ||
| Precision (CV%) - High Control | Acceptable precision for clinical use. | Within Run: 1.3% |
| Between Run: 0.6% | ||
| Total: 1.8% |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" to a predicate device. For in-vitro diagnostic devices like this, substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves showing comparable performance across key metrics. The specific numerical acceptance criteria (e.g., minimum 'r' value, maximum CV%) are not explicitly stated in the summary but are implied by the successful demonstration of substantial equivalence and the comparison to the predicate. The provided performance data (slope, correlation, precision) would have met the FDA's unstated, but understood, thresholds for equivalence.
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 (Test Set): 111 samples
- Data Provenance: Not explicitly stated. The submitting company (Biokit S.A.) is located in Barcelona, Spain. It's not clear from this summary if the samples themselves were from Spain, generated in specific clinical settings, or their origin. It is also not specified if the study was retrospective or prospective.
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)
- This device is an in-vitro diagnostic test for quantitative determination of alpha-1-antitrypsin concentration. The "ground truth" in this context is established by the predicate device's measurement and the assigned values of control materials, not by expert human interpretation of images or other subjective assessments.
- Therefore, the concept of "experts" to establish ground truth as described in the prompt (e.g., radiologists) is not applicable here. The comparison is made against the performance of an established, legally marketed device (N Antisera to Human alpha-1-Antitrypsin) and standardized control materials with known A1-AT levels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication of cases. The comparison is between the quantitative results of two different assay methods (the new device vs. the predicate device).
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance study effectively represents a "standalone" assessment of the device's accuracy and precision. The "method comparison study" directly compares the results of the Quantia A1-AT system (algorithm/reagents only) to the predicate device's results. The precision studies also evaluate the device in isolation, without human-in-the-loop performance influencing the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the method comparison study was the results obtained from the predicate device (N Antisera to Human alpha-1-Antitrypsin). For the precision studies, the ground truth was the known, assigned values of the control materials (Low Control, Control (I + II), High Control).
8. The sample size for the training set
- The document does not mention a separate "training set." For an in-vitro diagnostic device like this, the development process (which would include internal validation and optimization) would involve various samples, but a distinct "training set" in the machine learning sense is not typically described in 510(k) summaries for such devices unless AI/ML is a core component, which is not the case here. The 111 samples described were for the performance evaluation (test set) to demonstrate equivalence.
9. How the ground truth for the training set was established
- Not applicable, as a distinct "training set" in the context of an AI/ML system with its associated ground truth establishment is not mentioned or relevant for this type of device. The device's calibration and performance would be based on established reference materials and comparison to a predicate, rather than a "training set" with expert-derived ground truth.
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(80 days)
DEM
The Bayer ADVIA Chemistry Alpha-1-antitrypsin assay is an in vitro diagnostic device intended to quantitatively measure Alpha-1-antitrypsin concentration in human serum and plasma on the ADVIA® Chemistry system. Measurement of alpha-1-antitrypsin levels aid in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.
Not Found
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics. Instead, it presents performance data for the new device alongside a predicate device (Roche) for comparison (for imprecision) and reports correlation with another comparison system (Hitachi) without direct acceptance values. The "acceptance" can be inferred by the FDA's clearance, which implies the device's performance was deemed substantially equivalent to a legally marketed predicate.
However, we can infer some criteria from the data provided:
| Performance Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (ADVIA 1650) | Comparison/Predicate Performance |
|---|---|---|---|
| Imprecision (CV%) | Similar or better within-run CV% compared to predicate, and generally low. | Level 91.83: 1.1% | Roche Level 67.5: 3.9% |
| Level 188.39: 0.83% | Roche Level 496.8: 0.7% | ||
| Level 346.99: 0.85% | Roche Level 574.8: 7.33% | ||
| Correlation ($R^2$) vs. a comparison system | Strong linear correlation (r value close to 1) | r = 0.965 | Not applicable (comparison system) |
| Interference (% Recovery) | % Recovery close to 100% (within a reasonable range, e.g., 90-110%) | Hemoglobin: 109.88% | Not applicable |
| Bilirubin conj: 102.83% | Not applicable | ||
| Bilirubin unconj: 98.84% | Not applicable | ||
| Intralipid: 109.05% | Not applicable | ||
| TRIG concentrate: 106.37% | Not applicable | ||
| Analytical Range | A suitable range for clinical diagnostic use. | 5.37 mg/dL to 510 mg/dL | Not applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Imprecision: Not explicitly stated, but typically involves multiple replicates over several runs. The levels noted (e.g., 91.83 ug/dL) likely represent specific control or patient samples tested multiple times.
- Correlation:
- Sample Size: N = 44 (for serum specimens)
- Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective as these are existing samples being tested on two different systems.
- Interference: Not explicitly stated, but based on the table, 5 different interfering substances were tested. For each substance, it appears one AAT concentration was spiked with the interferent.
- Analytical Range: Not explicitly stated, but typically involves testing a series of diluted and concentrated samples to determine linearity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) for quantitative measurement of a biomarker does not rely on expert interpretation for ground truth in the same way an imaging AI or diagnostic algorithm might.
- For Imprecision, the "ground truth" is the established reference value of the control material or the sample's true concentration, measured meticulously in a laboratory setting.
- For Correlation, the "ground truth" for the comparison is the measurement obtained from the chosen comparison system (Hitachi AAT in this case).
- For Interference, the "ground truth" is the known concentration of alpha-1-antitrypsin in the sample before the interferent is added.
- For Analytical Range, the "ground truth" is the known concentration of standard solutions or diluted samples.
Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic interpretation is not relevant here. The ground truth is inherent in the chemical and analytical properties of the samples and the established reference methods.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this is a quantitative measurement, not a diagnostic interpretation that requires adjudication among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic assay (a laboratory test), not an AI-assisted diagnostic imaging or interpretation system that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (imprecision, correlation, interference, analytical range) reflect the standalone performance of the device/method (Bayer ADVIA Chemistry Alpha-1-antitrypsin assay). This device is an automated chemical analyzer component, and its "performance" is its ability to accurately and precisely measure the analyte without human interpretive intervention.
7. The Type of Ground Truth Used
- For Imprecision: Reference material values or meticulously measured sample concentrations.
- For Correlation: Measurements from a predicate/comparison device (Hitachi AAT).
- For Interference: Known spiked concentrations and baseline measurements of the unspiked sample.
- For Analytical Range: Gravimetrically or volumetrically prepared standard solutions.
8. The Sample Size for the Training Set
Not applicable in the context of an IVD assay's analytical validation. This device is not an AI/ML model that requires a distinct "training set." The development of the assay (e.g., reagent formulation, assay parameters) would involve extensive R&D and optimization, but not a "training set" in the machine learning sense. The data presented are for verification and validation of the final assay.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no "training set" in the AI/ML context for this type of device. The accuracy of the assay itself is validated against established analytical principles and reference methods.
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(62 days)
DEM
This assay is designed for the in vitro quantitation of a-1 Antitrypsin in serum using the Minineph®, as an aid in the diagnosis of several conditions, including juvenile and adult cirrhosis of the liver. In addition, a-1 Antitrypsin deficiency has been associated with pulmonary emphysema.
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This is a medical device approval letter and Indications for Use statement for the Minineph® α-1 Antitrypsin Antiserum. Therefore, it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined. This document is a regulatory approval, not a clinical study report.
Here's why I cannot fulfill your request with the provided input:
- No Study Described: The document is a 510(k) clearance letter from the FDA. It states that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined it's safe and effective based on its similarity to existing, approved products, rather than requiring new, extensive clinical trials for this specific version.
- No Acceptance Criteria: The letter refers to regulatory compliance and substantial equivalence, not specific performance acceptance criteria for a clinical study.
- No Performance Data: There are no tables of device performance, sample sizes, ground truth information, or details about study design (retrospective/prospective, MRMC, standalone).
To answer your request, I would need a clinical study report or a summary of performance data for the Minineph® α-1 Antitrypsin Antiserum. This document merely confirms its regulatory clearance.
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(66 days)
DEM
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(43 days)
DEM
The K-ASSAY Alpha-1 AT Assay is intended to be used for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay. Measurement of Alpha-1-Antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, Alpha-1-Antitrypsin deficiency has been associated with pulmonary emphysema. FOR IN VITRO DIAGNOSTIC USE.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the K-ASSAY Alpha-1 AT device. It confirms the device's substantial equivalence to a legally marketed predicate device for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the actual 510(k) submission document, which this letter is a response to.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.
The document states the "Indications for Use" for the device, which are:
- Quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay.
- Aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver.
- In addition, Alpha-1-Antitrypsin deficiency has been associated with pulmonary emphysema.
To answer your request thoroughly, I would need to review the actual 510(k) submission for K993444, not just the FDA's response letter.
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(178 days)
DEM
Immunological in vitro immunoturbidometric test for the quantitative determination of x -1antitrypsin in human serum and plasma.
The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.
The α -1-antitrypsin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing α -1-antitrypsin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human α -1-antitrypsin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the α -1-antitrypsin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of α -1-antitrypsin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of α-1-antitrypsin in the sample is directly proportional to the amount of turbidity formed.
The Boehringer Mannheim Tina-quant® α-1-Antitrypsin Assay is an immunoturbidometric assay for the quantitative in-vitro determination of α-1-antitrypsin. The device was deemed substantially equivalent to the currently marketed Behring BN® α-1-Antitrypsin assay.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on comparative performance against a predicate device rather than pre-defined acceptance criteria. However, we can infer performance characteristics evaluated for equivalence.
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Tina-quant® α-1-Antitrypsin) |
|---|---|---|
| Precision | Comparable to Behring BN® α-1-Antitrypsin | Intra-Assay (%CV): Low: 3.1, Pool: 2.5, High: 2.5 |
| (Behring BN® provided only a combined %CV of 5.3 for Inter-Assay) | Inter-Assay (%CV): Sample 1: 2.1, Sample 2: 2.0 | |
| Lower Detection Limit | Comparable to Behring BN® α-1-Antitrypsin (30 mg/dL) | 10 mg/dL (Better than predicate) |
| Method Comparison | Good correlation with Behring BN® α-1-Antitrypsin | Vs Behring BN®: |
| (Behring BN®: y = 0.88x + 30.2, r = 0.967, N = 59) | Passing/Bablok: y = 0.993x + 9.9, r = 0.967, SEE = 9.7, N = 123 | |
| Least Squares: y = 0.971x + 12.2, r = 0.967, SEE = 11.4, N = 123 | ||
| Interfering Substances | No significant interference with common substances | No interference (≤ 10% error) at: Bilirubin 60 mg/dL, Hemoglobin 1000 mg/dL, Lipemia 1000 mg/dL, Rheumatoid Factor 100 IU/mL |
| Specificity | Specific for α-1-antitrypsin | Specific for α-1-antitrypsin |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision Test Set (Intra-Assay): N = 21 for each of the three levels (Low, Pool, High).
- Precision Test Set (Inter-Assay): Not explicitly stated, but "Sample 1" and "Sample 2" are mentioned. The Behring BN® Inter-Assay tested 244 samples.
- Method Comparison Test Set: N = 123 for comparison against the Behring BN® α-1-Antitrypsin.
- Interfering Substances Test Set: Not explicitly stated, but specific concentrations of bilirubin, hemoglobin, lipemia, and rheumatoid factor were tested.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) summary for a diagnostic test, it's highly likely to be prospective clinical or analytical studies conducted in a controlled lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an immunoturbidometric assay, the "ground truth" would typically be established by reference methods or validated quantitative measurements rather than expert human interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable as the ground truth is established by quantitative laboratory measurements, not through expert review that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic tools that rely on human interpretation. This device is an in-vitro diagnostic assay for quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, this is a standalone performance study. The device is an automated in-vitro diagnostic assay that provides a quantitative measurement of α-1-antitrypsin. Its performance is evaluated purely based on its analytical capabilities, not on human interpretation or interaction beyond sample handling.
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is based on quantitative analytical measurements from reference methods or established predicate devices. For instance, the method comparison directly compares the results of the Tina-quant® assay to those obtained with the Behring BN® α-1-Antitrypsin assay, which serves as a widely accepted reference for this analyte.
8. The Sample Size for the Training Set:
The document does not specify a separate training set size. For an in-vitro diagnostic assay, development and calibration would involve various samples, but a distinct "training set" in the context of machine learning (where this question typically applies) is not explicitly mentioned as relevant. The performance characteristics described are typically for validation/testing.
9. How the Ground Truth for the Training Set Was Established:
As no explicit "training set" is mentioned in the context of machine learning models, the method for establishing ground truth for such a set is not applicable or described. For the development and calibration of the assay, ground truth would be established through the use of characterized calibrators and controls with known α-1-antitrypsin concentrations, often traceable to international reference standards.
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