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510(k) Data Aggregation
(135 days)
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of ceruloplasmin aids in the diagnosis of cooply of metabolism disorders.
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 relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
This document describes the 510(k) summary for the "N Antisera to Human Ceruloplasmin" device, which is an in vitro diagnostic reagent used for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma. The submission claims substantial equivalence to a legally marketed predicate device (K860894).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific performance metrics like accuracy, precision, or detection limits. Instead, it focuses on demonstrating equivalence to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Equivalence | Substantially equivalent to predicate device (K860894) | Demonstrated equivalent performance to the predicate device. |
| Serum vs. Heparinized Plasma Measurement | Method comparison should show high correlation | 0.99 correlation coefficient between serum and heparinized plasma measurements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "a method comparison was performed" but does not give the number of samples or subjects used in this comparison.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable as this is an in vitro diagnostic reagent claiming equivalence, not a medical imaging or clinical diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable for a chemistry assay where the "ground truth" is typically established by reference methods or comparison to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not performed. This type of study is relevant for devices involving human interpretation of medical images or data. This device is an automated in vitro diagnostic reagent.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, this device operates as a standalone diagnostic reagent on the BN™ Systems. Its performance is evaluated based on its ability to quantitatively determine ceruloplasmin and hemopexin levels, without requiring human interpretation of results beyond reading the quantitative output. The "method comparison" study conducted is essentially a standalone performance evaluation against a comparable method.
7. The Type of Ground Truth Used:
- The ground truth for this device's performance evaluation is established through comparison to a legally marketed predicate device (K860894), and by demonstrating correlation between different sample types (serum and heparinized plasma). The predicate device itself would have been validated against established reference methods or clinical outcomes.
8. The Sample Size for the Training Set:
- Not applicable. This device is an in vitro diagnostic reagent, not an AI/ML algorithm that undergoes a "training" phase with a dataset. Its development likely involved R&D, formulation, and analytical validation.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this traditional in vitro diagnostic reagent.
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(66 days)
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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(48 days)
In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.
Acceptance Criteria and Study for N Antisera to Human Complement Factors (C3c, C4)
This submission describes the acceptance criteria and the study that proves the device meets those criteria for the N Antisera to Human Complement Factors (C3c, C4). The primary focus of this submission is to demonstrate equivalence in performance when expanding the intended use to include heparinized or EDTA plasma as specimen types, in addition to serum.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Serum to Plasma Equivalence | Correlation coefficient between serum and heparinized plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
| Serum to Plasma Equivalence | Correlation coefficient between serum and EDTA plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the test set (number of patient samples) is not explicitly stated in the provided document. The study performed "method comparisons" to demonstrate equivalence.
The data provenance (country of origin, retrospective or prospective) is not explicitly stated. However, given it's a 510(k) submission for a device marketed by Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), it's likely a controlled, prospective validation study conducted in a laboratory setting, potentially using samples from a relevant patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The ground truth for this device is not established by expert clinical review of images or diagnoses. Instead, the accuracy of the device is assessed by its ability to quantitatively determine complement factors, where established laboratory methods serve as the reference for comparison.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical data (e.g., imaging studies) where multiple experts resolve discrepancies. For quantitative assays like this, agreement is assessed statistically.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not relevant for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. This submission focuses on the analytical performance of a quantitative assay.
6. Standalone (Algorithm Only) Performance Study
This is an in vitro diagnostic assay, not an algorithm or AI system in the traditional sense. The "device" itself is the reagent. Therefore, a "standalone algorithm performance" study is not applicable. The performance is intrinsically linked to the assay's ability to accurately measure the target analytes. The study explicitly focuses on the analytical performance of the assay and its reagents in different sample matrices.
7. Type of Ground Truth Used
The ground truth for the test set was established by comparison to serum measurements using the current, legally marketed N Antisera to Human Complement Factors (C3c and C4) assays.
The study essentially compares the quantitative results obtained from heparinized or EDTA plasma samples with the quantitative results obtained from serum samples (which represent the established "ground truth" or reference for this assay type). The correlation coefficients of 0.98-0.99 indicate that the measurements in plasma are highly consistent with those in serum.
8. Sample Size for the Training Set
This information is not applicable. This device is a reagent for a quantitative diagnostic assay. It does not employ machine learning or AI models that require a "training set" in the conventional sense. The "learning" or optimization of the assay's performance would occur during its initial development and validation stages through extensive analytical testing, not through a "training set" like an AI algorithm.
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 in vitro diagnostic device, as explained in point 8.
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(49 days)
Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
This document describes the Tina-quant Apolipoprotein A-1 ver.2 assay and its equivalence to a predicate device, but it does not detail a study with specific acceptance criteria that the device had to meet and prove. Instead, it describes a "substantial equivalence" comparison to an existing, legally marketed device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test set, training set details) are not applicable or cannot be extracted from the provided text, as this type of information is typically associated with studies demonstrating performance against a defined statistical endpoint, not substantial equivalence.
Here's an analysis based on the provided text, focusing on the available information:
Description of Acceptance Criteria and the Study:
The "study" described in the provided text is a substantial equivalence comparison between the Tina-quant Apolipoprotein A-1 ver.2 assay and a predicate device (Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay, K860894). The acceptance criteria for substantial equivalence are implicitly that the new device performs comparably to the predicate device across various characteristics, demonstrating similar safety and effectiveness.
The comparison focuses on:
- Intended Use and Indications for Use: Ensuring they are the same or very similar.
- Assay Protocol: Both are immunoturbidometric.
- Traceability/Standardization: The new device is standardized to IFCC reference preparation SP1-01.
- Calibration Interval: Similar.
- Performance Characteristics: Comparing precision, method comparison, hook effect, analytical sensitivity, and limitations.
The device meets the acceptance criteria by demonstrating performance characteristics that are comparable to or better than the predicate device, or within acceptable clinical ranges where direct comparison might not be feasible (e.g., analytical sensitivity).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance of the predicate device, and the "reported device performance" is how the new device compares. No explicit numerical acceptance criteria (e.g., "CV must be
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(68 days)
COBAS INTEGRA Gamma- Glutamyltransferase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2, y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562).
COBAS INTEGRA Lactate Dehydrogenase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD oxidoreductase ) in serum and plasma (test LDHI, 0-181).
COBAS INTEGRA Total Protein - urine and CSF: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223).
COBAS INTEGRA Lactate: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122).
COBAS INTEGRA Tobramycin: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92).
COBAS INTEGRA Immunoglobulin A: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples.
COBAS INTEGRA Immunoglobulin G: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples.
COBAS INTEGRA Immunoglobulin M: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.
Through this submission it is the intention of Roche to gain clearance of an additional 5 new COBAS INTEGRA Reagent Cassettes and a modified version of 3 previously cleared reagent cassettes. All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8 °C. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number, the expiration date and the number of tests.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
Overview of the Device:
The document describes several COBAS INTEGRA Reagent Cassettes, including 5 new ones and 3 modified versions of previously cleared reagent cassettes, all intended for use with the COBAS INTEGRA Analyzer for quantitative determination of various analytes (Gamma-Glutamyltransferase, Lactate Dehydrogenase, Total Protein, Lactate, Tobramycin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M).
The claims of substantial equivalence are based on comparisons to legally marketed predicate devices. The acceptance criteria are implicit in the performance characteristics and comparisons presented against these predicate devices. The study is a non-clinical in vitro diagnostic reagent system performance evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "Accuracy must be > 0.95"). Instead, the document presents comparative performance data against predicate devices or generally accepted analytical performance metrics (like precision and assay range). The implicit acceptance criterion is that the new or modified COBAS INTEGRA reagents perform equivalently to or better than the identified predicate devices, or demonstrate acceptable analytical performance for their intended use.
Below is a combined table showing the reported device performance, with the implicit acceptance criteria being that these values are acceptable for the intended use and comparable to or better than the predicate devices' performance.
Note: "Acceptance Criteria" here refers to the desirable performance characteristics expected for such diagnostic assays, inferred from the general context and comparison with predicate devices. The document does not explicitly state quantitative "acceptance criteria" but rather presents the performance achieved by the device and a predicate for comparison.
| Analyte / Performance Characteristic | Acceptance Criteria (Inferred / Contextual) | COBAS INTEGRA Reagent Performance (Reported) | Predicate Device Performance (Reported) |
|---|---|---|---|
| Gamma-Glutamyltransferase - IFCC | |||
| Assay Range | Wide, clinically relevant | 0 - 1,200 U/L (0 - 12,000 U/L with post dilution) | 0 - 700 U/L (0 - 2,800 U/L with postdilution) |
| Precision (Within Run %CV) | Low %CV for reliability | Level 1: 1.0%, Level 2: 1.1% | Level 1: 0.67%, Level 2: 0.46% |
| Precision (Total %CV) | Low %CV for reliability | Level 1: 2.7%, Level 2: 2.5% | Level 1: 1.2%, Level 2: 1.4% |
| Accuracy (Correlation to Predicate) | High correlation (r > 0.95) | y = 1.27x - 0.9 U/L, r = 0.999 | y = 1.02x + 0 U/L, r = 0.998 |
| Lactate Dehydrogenase - IFCC | |||
| Assay Range | Wide, clinically relevant | 0 - 1,200 U/L (0 - 12,000 U/L with post dilution) | 0 - 1,000 U/L (0 - 10,000 U/L with postdilution) |
| Precision (Within Run %CV) | Low %CV for reliability | Level 1: 0.65%, Level 2: 0.65% | Level 1: 1.3%, Level 2: 0.99% |
| Precision (Total %CV) | Low %CV for reliability | Level 1: 2.6%, Level 2: 1.9% | Level 1: 2.8%, Level 2: 1.5% |
| Accuracy (Correlation to Predicate) | High correlation (r > 0.95) | y = 1.07x + 0.4 U/L, r = 0.999 | y = 0.95x - 14.3 U/L, r = 0.999 |
| Total Protein - Urine / CSF | |||
| Assay Range | Wide, clinically relevant | 1 - 250 mg/dL (1 - 250 mg/dL with post dilution) | 1 - 200 mg/dL |
| Precision (Urine Total %CV) | Low %CV for reliability | Level 1: 8.2%, Level 2: 2.9%, Level 3: 2.4% | Level 1: 9.37%, Level 2: 6.42%, Level 3: 2.57% |
| Precision (CSF Total %CV) | Low %CV for reliability | Level 1: 1.3%, Level 2: 0.80% | Level 1: 3.47%, Level 2: 2.65%, Level 3: 2.29% |
| Accuracy (Urine, Correlation to Predicate) | High correlation (r > 0.95) | y = 0.89x + 0 mg/L, r = 0.992 | y = 1.005x + 0.458, r = 0.997 |
| Lactate | |||
| Assay Range | Wide, clinically relevant | 0 - 180 mmol/L (0 - 1,800 mmol/L with post dilution) | Up to 100 mg/dL (Up to 199 mg/dL with postdilution) |
| Precision (Control Sera Within Run %CV) | Low %CV for reliability | Level 1: 0.92%, Level 2: 0.62% | Level 1: 2.7%, Level 2: 1.1%, Level 3: 0.7% |
| Precision (Control Sera Total %CV) | Low %CV for reliability | Level 1: 1.2%, Level 2: 1.1% | Level 1: 3.8%, Level 2: 1.3%, Level 3: 0.9% |
| Precision (CSF Within Run %CV) | Low %CV for reliability | Level 1: 0.90%, Level 2: 0.89% | Not specified |
| Accuracy (Correlation to Predicate) | High correlation (r > 0.95) | y = 1.00x - 0.1 mmol/L, r = 0.999 | y = 0.985x - 0.09, r = 0.999 |
| Tobramycin | |||
| Assay Range | Clinically relevant | 0.04 - 10 µg/mL | 0.18 - 10.0 µg/mL |
| Precision (Total %CV) | Low %CV for reliability | Level 1: 6.0%, Level 2: 4.5%, Level 3: 4.0% | Level 1: 5.18%, Level 2: 4.45%, Level 3: 4.62% |
| Accuracy (Correlation to Predicate) | High correlation (r > 0.95) | y = 0.854 + 0.015, r = 0.996 | y = 0.934 + 0.248 µg/mL, r = 0.951 |
| Sensitivity | Clinically appropriate | 0.04 µg/mL | 0.18 µg/mL |
| Immunoglobulin A (Modified) | |||
| Assay Range (Standard) | Wide, clinically relevant | 0.11 - 3.54 g/L (0.04 - 10.6 g/L with rerun) | 0.95 - 15.2 g/L (0.32 - 36.5 g/L with rerun) |
| Precision (Standard, Total %CV) | Low %CV for reliability | Level 1: 2.8%, Level 2: 1.8% | Level 1: 2.8%, Level 2: 1.8% |
| Precision (Pediatric, Total %CV) | Low %CV for reliability | Level 1: 3.0%, Level 2: 1.0% | Not applicable |
| Accuracy (Standard, Correlation to Predicate) | High correlation (r > 0.95) | y = 0.97x - 0.05 g/L, r = 0.989 | Not specified |
| Accuracy (Pediatric, Correlation to Predicate) | High correlation (r > 0.95) | y = 1.01x + 0.01 g/L, r = 0.996 | Not applicable |
| Immunoglobulin G (Modified) | |||
| Assay Range (Standard) | Wide, clinically relevant | 4.0 - 63.8 g/L (1.0 - 153 g/L with rerun) | 4.7 - 75 g/L (1.2 - 180 g/L with rerun) |
| Precision (Standard, Total %CV) | Low %CV for reliability | Level 1: 2.9%, Level 2: 1.9% | Similar to modified IgA |
| Precision (Pediatric, Total %CV) | Low %CV for reliability | Level 1: 3.0%, Level 2: 1.3% | Not applicable |
| Accuracy (Standard, Correlation to Predicate) | High correlation (r > 0.95) | y = 1.02x - 0.9 g/L, r = 0.996 | Not specified |
| Accuracy (Pediatric, Correlation to Predicate) | High correlation (r > 0.95) | y = 0.93x + 0.30 g/L, r = 0.986 | Not applicable |
| Immunoglobulin M (Modified) | |||
| Assay Range (Standard) | Wide, clinically relevant | 0.31 - 5.0 g/L (0.11 - 12.1 g/L with rerun) | 0.47 - 7.5 g/L (0.16 - 18 g/L with rerun) |
| Precision (Standard, Total %CV) | Low %CV for reliability | Level 1: 3.1%, Level 2: 2.2% | Similar to modified IgM |
| Precision (Pediatric, Total %CV) | Low %CV for reliability | Level 1: 4.9%, Level 2: 2.1% | Not applicable |
| Accuracy (Standard, Correlation to Predicate) | High correlation (r > 0.95) | y = 1.12x - 0.06 g/L, r = 0.994 | Not specified |
| Accuracy (Pediatric, Correlation to Predicate) | High correlation (r > 0.95) | y = 1.17x - 0.03 g/L, r = 0.984 | Not applicable |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the studies are provided in the "Accuracy" section for each analyte, indicating the number of samples ($n$) used for method correlation. The data provenance is generally implied as clinical and non-clinical studies for in vitro diagnostic assays. No specific countries of origin are mentioned, nor is it explicitly stated whether the studies were retrospective or prospective, though the nature of these tests (evaluating analytical performance) typically involves prospective or controlled laboratory studies.
- Gamma-Glutamyltransferase - IFCC: n = 202
- Lactate Dehydrogenase - IFCC: n = 106
- Total Protein - urine and CSF: n = 274 (for urine accuracy), no specific n for CSF accuracy is given separately though precision data is provided for CSF.
- Lactate: n = 224
- Tobramycin: n = 196
- Immunoglobulin A (Modified): n = 400 (standard application), n = 204 (pediatric application)
- Immunoglobulin G (Modified): n = 244 (standard application), n = 212 (pediatric application)
- Immunoglobulin M (Modified): n = 400 (standard application), n = 214 (pediatric application)
Data Provenance: "Clinical and nonclinical studies performed using the COBAS INTEGRA Reagent Cassettes." (Page 3). No further detail on country or retrospective/prospective nature.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
This type of submission (510(k) for an in vitro diagnostic reagent cassette) does not typically involve human experts establishing ground truth in the way described for imaging or clinical decision support AI systems. The "ground truth" for these comparative studies is established by the predicate devices and well-established analytical methods. The performance of the new device is compared to these existing, legally marketed and validated methods. Therefore, the concept of "number of experts" and "qualifications of experts" like radiologists is not applicable here.
4. Adjudication Method for the Test Set
Since this is an in vitro diagnostic assay comparing quantitative measurements, adjudication methods like 2+1 or 3+1 (common in medical imaging for clinical endpoints) are not relevant. The "adjudication" is inherent in the analytical methods themselves, where the results from the new device are mathematically compared (e.g., using correlation coefficients and regression equations) against a reference method (the predicate device) or established laboratory standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic tools that involve human interpretation of medical images or other complex data where reader variability is a factor. The COBAS INTEGRA Reagent Cassettes are automated in vitro diagnostic tests, where the result is a quantitative analytical value from an instrument, not a human interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense, the entire performance evaluation presented for each reagent cassette is a "standalone" study of the algorithm (i.e., the reagent's analytical method) without human intervention. The COBAS INTEGRA Analyzer is an automated system, and the reported precision and accuracy directly reflect the performance of the reagent and instrument system, which is analogous to an "algorithm only" performance. The device provides a quantitative result without a human interpreting an image or complex patterns.
7. Type of Ground Truth Used
The ground truth for these studies is established by comparison with legally marketed predicate devices using established analytical methodologies. For each assay:
- Gamma-Glutamyltransferase - IFCC: Compared against Roche COBAS INTEGRA, GGT (TRIS)
- Lactate Dehydrogenase - IFCC: Compared against Roche COBAS INTEGRA, LD (Lactate - Pyruvate)
- Total Protein - urine and CSF: Compared against SIGMA Diagnostics, Microprotein-PR
- Lactate: Compared against Boehringer Mannheim, Lactate
- Tobramycin: Compared against Abbott Diagnostics, TDX / TDX Flex Tobramycin
- Immunoglobulin A, G, M (Modified): Compared against Behring Diagnostics, N and NA Reagents (and implicitly, the previously marketed COBAS INTEGRA versions).
This approach relies on the well-established performance of predicate devices as the "ground truth" or reference standard for analytical accuracy.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or "training set size." This is characteristic of traditional in vitro diagnostic device submissions, which do not typically employ machine learning or AI models that require distinct training and test data sets. The studies described are performance validation studies for the finished reagent product.
9. How the Ground Truth for the Training Set Was Established
As there is no explicitly mentioned "training set" in the context of machine learning, this question is not directly applicable. The performance characteristics of these reagents are validated using standard analytical chemistry and immunoassay principles, with reference to the performance of predicate devices established through similar rigorous analytical validation.
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(42 days)
N Protein Standard SL is intended to be used for the establishment of reference curves.
The proposed standard, N Protein Standard SL is a standard prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) to establish reference curves for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Albumin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, IgG 3, Albumin α1-antitrypsin (α1-proteinase inhibitor) α2-macroglobulin Haptoglobin α1-acid glycoprotein Pre-albumin (transthyretin), laG 3, laG 4, B2-microalobulin, Ferritin, IGE.
Here's the information extracted from the provided text, structured according to your request:
Acceptance Criteria and Study for N Protein Standard SL
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and discussing performance characteristics such as precision and stability, rather than explicitly stating acceptance criteria as a table with numerical targets for a specific clinical outcome or diagnostic accuracy. Instead, the document describes the observed performance of the device, which implicitly serves as the demonstration of its suitability.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | The device should exhibit acceptable levels of precision (low variability) when establishing reference curves for the listed analytes on Behring Nephelometer Systems. (Implicitly, the precision should be comparable to or better than the predicate device, N Protein Standard SY, or within acceptable ranges for clinical nephelometry.) | Precision studies using one lot of N Protein Standard SL on the Behring Nephelometer yielded %CVs ranging from 0.9% to 3.9%. |
| Reproducibility | The device should exhibit acceptable reproducibility when establishing reference curves. (Implicitly, this is covered by the precision study and suggests consistent performance across repetitions.) | Covered by the precision study results (0.9% to 3.9% CVs). |
| Stability (Unopened) | The device should maintain its performance characteristics for a clinically relevant period when stored as packaged. (Implicitly, comparable to the predicate device and sufficient for practical use.) | Found to be stable for at least 12 months at +2 to +8°C, as originally packaged. |
| Stability (Opened) | The device should maintain its performance characteristics for a clinically relevant period after opening and storage. (Implicitly, sufficient for practical laboratory use after initial opening.) | Found to be stable for at least 15 days at +2 to +8°C, once opened. |
| Equivalence to Predicate | The device should demonstrate substantial equivalence in intended use and performance to the legally marketed device, N Protein Standard SY. (This is the overarching acceptance criterion for a 510(k).) | N Protein Standard SL is "substantially equivalent in intended use to the N Protein Standard SY." Both are multi-constituent, blood-based matrix standards for calibrating immunology assays. The primary difference is physical state (liquid vs. lyophilized). Performance characteristics (precision, stability) support this claim of equivalence. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states "Precision studies using one lot of N Protein Standard SL..." This indicates the study was conducted on one lot of the product. The number of individual measurements or replicates within that study is not specified.
- Data Provenance: The study appears to be prospective (generated specifically for this submission) as it describes performance characteristics of the "Proposed Device." There is no mention of country of origin for the data, but it's generated by Behring Diagnostics Inc. (distributed) and Behringwerke AG (manufactured), which are US and German entities, respectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is Not Applicable (N/A). The device is a calibrator, not a diagnostic device that interprets patient data. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy. The performance data (precision, stability) are objective measurements from laboratory testing, not subjective expert interpretations.
4. Adjudication method for the test set
This section is Not Applicable (N/A) for the same reasons as (3). There is no adjudication required for objective laboratory measurements like precision and stability.
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 section is Not Applicable (N/A). The device is a calibrator. It is not an AI-powered diagnostic tool, nor does it directly involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). The device is a physical calibrator standard, not an algorithm.
7. The type of ground truth used
This section is Not Applicable (N/A). As a calibrator, the concept of "ground truth" in the diagnostic accuracy sense (e.g., pathology, outcomes data) does not apply. The "truth" for the calibrator is its manufactured concentration values, which are the basis for its intended use in establishing reference curves. The performance metrics (precision, stability) assess the consistency and integrity of these established values over time and repeated use.
8. The sample size for the training set
This section is Not Applicable (N/A). The device is a calibrator, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is Not Applicable (N/A) for the same reasons as (8).
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(27 days)
N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.
The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, Albumin, alpha1-antitrypsin (alpha1-proteinase inhibitor), 02-macroglobulin, Haptoglobin, alpha1-acid_αλνcoprotein, Pre-albumin (transthyretin), laG 3, laG 4, B2-microglobulin, Ferritin, laE.
This is a 510(k) summary for a quality control material, not a diagnostic device that detects disease. Therefore, many of the typical performance metrics for diagnostic devices (like sensitivity, specificity, AUC) and associated study design elements (like ground truth establishment with experts, training/test sets, MRMC studies) are not applicable here.
The "acceptance criteria" for a control material primarily revolve around its stability and its performance in precision/reproducibility.
Here's an analysis based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Them: N/T Protein Control SL/L, M, and H
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied/Expected for a QC Material) | Reported Device Performance (N/T Protein Control SL) |
|---|---|---|
| Precision (CV%) | Acceptable range for quality control materials for nephelometry systems (typically low single-digit percentages, though specific limits are not stated in the document). | Behring Nephelometer system: 0.6% to 8.2% (range across analytes) |
| TurbiTimeSystem™: 1.6% to 6.1% (range across analytes) | ||
| Reproducibility | Consistent results over time and across different runs (implied by precision study). | Demonstrated by precision study performed on two different systems. |
| Stability (Unopened) | Stable for a specified duration when stored as originally packaged under recommended conditions. | At least 12 months at +2 to +8°C. |
| Stability (Opened) | Stable for a specified duration once opened and stored under recommended conditions. | At least 15 days at +2 to +8°C once opened. |
Note: The document does not explicitly state numerical "acceptance criteria" but presents performance data that would implicitly meet expected standards for a quality control material. For instance, precision (CV%) values in the single digits are generally considered good for these types of assays.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "one lot of N/T Protein Control SL" was used for precision studies. The number of replicates or individual measurements within this lot is not provided.
- Data Provenance: Not specified, but implied to be from internal laboratory testing conducted by Behringwerke AG or Behring Diagnostics Inc. It is retrospective in the sense that the data was collected prior to submission. Country of origin not explicitly stated, but the manufacturer is based in Germany, and the distributor in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. For a quality control material, there isn't a "ground truth" established by experts in the same way there would be for a diagnostic test (e.g., radiologists interpreting images). The purpose is to ensure the control itself provides consistent and reproducible results on the target instruments.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is typically used when human interpretation or a subjective clinical assessment is involved in establishing a ground truth for diagnostic accuracy, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is designed to compare the performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable in the typical sense of a diagnostic algorithm. The "device" is a physical control material. Its performance is evaluated on automated nephelometry systems (which are themselves algorithms/instruments). The precision and stability studies represent the "standalone" performance of the control material when used with these systems.
7. The Type of Ground Truth Used
- For the precision studies, the "ground truth" is essentially the expected consistent performance of a stable control material. The acceptable variation (precision) defines what constitutes "truth" in this context. The reference values for the analytes within the control are established during its manufacturing and characterization, but the study here focuses on its performance as a control.
- For the stability studies, the "ground truth" is the established concentration of the analytes within the control material at the initial time point. Stability is demonstrated by showing that these concentrations remain within acceptable limits over time under specified storage conditions.
8. The Sample Size for the Training Set
- Not applicable. This is a quality control material, not an AI or machine learning algorithm that requires a "training set." The product is manufactured and then its performance (precision, stability) is characterized.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm.
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(74 days)
The 2 COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. These are the COBAS INTEGRA Cassette for Albumin-T in urine and the COBAS INTEGRA Cassette for HbA1c. The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin Alc contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbAlc%) in hemolysate. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Digoxin. The COBAS INTEGRA Reagent Cassette for Digoxin has been modified to include the use of heparinized samples.
The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8ºC. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number, the expiration date and the number of tests.
Here's an analysis of the provided text, focusing on the requested information regarding acceptance criteria and supporting studies:
This document describes the 510(k) summary for Roche COBAS® INTEGRA Reagent Cassettes, specifically for Albumin (ALB-T), HbA1c, and a modification to Digoxin (DIG), claiming substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Device/Parameter | Acceptance Criteria (Implied/Predicate) | COBAS INTEGRA Performance (New Device) |
|---|---|---|
| COBAS INTEGRA Albumin (ALB-T) | ||
| Methodology | Immunoturbidimetric | Immunoturbidimetric |
| Sample type | Serum, umbilical cord serum, CSF, urine | Urine |
| Assay range | Not specified in labeling | 6-193 mg/L; 6-3860 mg/L w/postdilution |
| Precision (Within-run) | Not specified in labeling | 4.3 % at 10 mg/L; 1.2 % at 223 mg/L |
| Accuracy | Not specified in labeling | N = 200; R = 0.997 vs. Behring Albumin (Predicate device: Behring N Antiserum to Human Albumin) |
| Sensitivity (Analytical) | Not specified in labeling | 7 mg/L |
| COBAS INTEGRA HbA1c (HBA1C) | ||
| Methodology | Immunoturbidimetric for HbA1c; Colorimetric for Total Hb | Immunoturbidimetric test for HbA1c; Colorimetric test for Total Hb |
| Sample type | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) |
| Application | Hemolysate or whole blood | Hemolysate |
| Reported measuring units | % HbA1c | % HbA1c |
| Assay range | 2-25 % | 3-30.9 % |
| Precision (Total) | Mean % CV %: 5.3 % (5.3%); 12.9 % (4.9%) (Predicate device: Roche Unimate HbA1c Reagent) | Mean % CV %: 4.8 % (2.8%); 12.1 % (2.4%) |
| Accuracy | N = 208; R = 0.943 vs. BM Tina-quant HbA1c Reagent | N = 240; R = 0.994 vs. Roche Unimate Reagent (Predicate device: Roche Unimate HbA1c Reagent) |
| Sensitivity (Analytical) | 0.76 umol/L for hemoglobin; 0.78 umol/L for HbA1c | 0.90 umol/L for hemoglobin; 0.22 umol/L for HbA1c |
| COBAS INTEGRA Digoxin (Modified) | ||
| Methodology | Kinetic interaction of microparticles in solution | Kinetic interaction of microparticles in solution |
| Sample type | Serum | Serum and heparinized plasma |
| Assay range | 0.17 - 5.0 ng/mL | 0.17 - 5.0 ng/mL |
| Precision (Total) | 14.4 % at 0.81 ng/mL; 5.3 % at 1.57 ng/mL; 3.8 % at 4.1 ng/mL (Predicate device: COBAS INTEGRA Cassette for Digoxin - Cleared) | 9.7 % at 0.87 ng/mL; 6.1 % at 1.64 ng/mL; 3.9 % at 2.82 ng/mL |
| Accuracy | N = 189; R = 0.958 vs. TDx (FPIA) | N = 63; R = 0.967 vs. TDx (FPIA) (Predicate device: COBAS INTEGRA Cassette for Digoxin - Cleared) |
| Sensitivity (Analytical) | 0.17 ng/mL | 0.17 ng/mL |
Note on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to predicate devices, rather than explicit numerical acceptance criteria for the new devices. The "performance characteristics" of the predicate devices implicitly serve as the benchmark for comparability. For the Digoxin modification, the cleared COBAS INTEGRA Cassette for Digoxin serves as its own predicate and its performance metrics represent the baseline for the modification.
2. Sample Sizes Used for the Test Set and Data Provenance
- COBAS INTEGRA Albumin (ALB-T):
- Accuracy: N = 200 samples.
- Data Provenance: Not explicitly stated, but clinical and nonclinical studies are mentioned. It's likely a mix of laboratory-generated samples and potentially clinical samples from various sources. The document does not specify country of origin or whether prospective/retrospective.
- COBAS INTEGRA HbA1c (HBA1C):
- Accuracy: N = 240 samples.
- Data Provenance: Not explicitly stated beyond "clinical and nonclinical studies."
- COBAS INTEGRA Digoxin (Modified):
- Accuracy: N = 63 samples.
- Data Provenance: Not explicitly stated beyond "clinical and nonclinical studies."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for in vitro diagnostic reagents and an analyzer system. The "ground truth" for such devices is established through reference methods or comparison to legally marketed predicate devices, not through expert radiological or clinical interpretation in the traditional sense. Therefore:
- Number of Experts: Not applicable in the context of expert consensus like for imaging devices. Ground truth is inherently derived from the analytical performance of the reference method.
- Qualifications of Experts: Not applicable. The "experts" are the validated methodologies of the predicate devices or reference methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments to resolve discrepancies. For in vitro diagnostic assays, the comparison is quantitative against a reference method or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems where human readers interpret cases, often with and without AI assistance to measure the impact of AI on reader performance. This submission is for laboratory reagents and an analyzer, where the output is quantitative and direct, not an interpretation by a human reader.
- Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Was it done?: Yes, the performance characteristics (assay range, precision, accuracy, sensitivity) presented in Tables 1-3 represent the standalone performance of the COBAS INTEGRA Reagent Cassettes when used with the COBAS INTEGRA Analyzer. There is no human-in-the-loop component for these specific assays; the analyzer performs the test and provides the quantitative result directly. The study essentially demonstrates the algorithm and instrument's performance in producing these quantitative values.
7. Type of Ground Truth Used
The ground truth for these in vitro diagnostic tests is established by:
- For Albumin and HbA1c: Performance against a legally marketed predicate device (Behring N Antiserum to Human Albumin for Albumin, and Roche Unimate HbA1c Reagent for HbA1c). The reference standard for "accuracy" is the results obtained from these predicate devices.
- For Digoxin (Modified): Performance against the previously cleared COBAS INTEGRA Cassette for Digoxin and comparison to TDx (FPIA), which is likely a well-established and accepted reference method for Digoxin measurement.
8. Sample Size for the Training Set
The document does not specify a training set size. For a 510(k) submission detailing reagent cassettes, particularly for established immunological/colorimetric methods, the focus is on validation and verification of the final product's performance against predicate devices or reference methods. The "training" of an AI algorithm in the modern sense is not applicable here, as these are chemical/biological assays, not machine learning algorithms in the typical AI context. The document describes clinical and nonclinical studies and performance characteristics, which refer to the validation data for the device.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and associated ground truth establishment (in the AI/ML sense) is not applicable to this type of in vitro diagnostic device submission, which relies on chemical/biological reactions and analytical performance validation rather than machine learning algorithm development. The "ground truth" for analytical performance is established by comparison to recognized reference methods or existing, legally marketed predicate devices.
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(25 days)
N CRP Standard SY is intended to be used for the establishment of reference curves.
The proposed calibrator, N CRP Standard SY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer 11 K943997) for the calibration of the N Latex CRP mono test.
Here's an analysis of the provided text regarding the N CRP Standard SY device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric / Criterion | Reported Device Performance |
|---|---|---|
| Precision | %CV range | 1.43% to 4.47% |
| Stability (Lyophilized) | Duration | At least 12 months |
| Stability (Reconstituted) | Duration | 4 weeks |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Precision studies using one lot of N CRP Standard SY were run on the Behring Nephelometer." It does not specify a sample size for the test set (e.g., number of replicates, number of runs).
The data provenance is implied to be from internal testing by the manufacturer, Behring Diagnostics Inc. There is no information about the country of origin of the data beyond the manufacturing location (Germany) and distributor location (USA). The study is unequivocally prospective as it involves direct testing of the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this device. This device is a calibrator, and its performance is assessed through its inherent analytical characteristics (precision, stability) rather than by comparison to a "ground truth" derived from expert interpretation of clinical data. There are no clinical images or patient outcomes being evaluated by experts here.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no expert interpretation or consensus-building involved in assessing the performance of this calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human interpretation (e.g., AI for radiology), not for a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable in the context of this device. The device itself is a physical calibrator. Its performance is what is being evaluated directly through analytical studies. There isn't an "algorithm" in the sense of a standalone diagnostic tool.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating this calibrator is its inherent analytical characteristics tested against predefined specifications for precision and stability. It's not based on expert consensus, pathology, or outcomes data. The concentrations of CRP in the calibrator are established during its manufacturing and qualification process, and the tests verify that these characteristics remain within acceptable limits over time and across measurements.
8. The Sample Size for the Training Set:
This information is not applicable. This device is a calibrator, not a machine learning algorithm that requires a "training set."
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 device.
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(25 days)
N Protein Standard PY is intended to be used for the establishment of reference curves.
The proposed calibrator, N Protein Standard PY is a calibrator prepared from human serum (lyophilized) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer Systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) for the calibration of the following tests:
Fibrinogen Antithrombin II Prothrombin Plasminogen alpha1-Antitrypsin C1 Inhibitor
The provided text describes a 510(k) summary for the N Protein Standard PY, a calibrator. It focuses on demonstrating substantial equivalence to a predicate device and includes information on the device's intended use, composition, and basic performance characteristics like precision and stability.
However, the document does not contain the following information required to answer your request:
- Acceptance Criteria Table and Reported Device Performance: While "Precision and reproducibility" and "Stability" are mentioned, no specific acceptance criteria (e.g., "CVs must be less than X%") are provided, nor is a direct comparison in a structured table format against such criteria.
- Sample size and data provenance for a test set: The document mentions "one lot of N Protein Standard PY" for precision studies, but this isn't a "test set" in the context of device performance validation against ground truth. There's no information on data provenance (country, retrospective/prospective).
- Number of experts and qualifications for ground truth: No experts are mentioned, as the device is a calibrator, not a diagnostic tool requiring expert interpretation of results.
- Adjudication method for the test set: Not applicable, as there's no test set requiring adjudication.
- MRMC comparative effectiveness study: Not applicable. The device is a calibrator, not a diagnostic algorithm that would be compared with human readers.
- Standalone (algorithm only) performance: Not applicable. This is a physical calibrator, not an algorithm.
- Type of ground truth used: For a calibrator, the "ground truth" would typically refer to the assigned values of the standards, which are established through a metrological traceability chain, not expert consensus, pathology, or outcomes data. This information is not detailed here.
- Sample size and how ground truth was established for the training set: Not applicable, as this is a calibrator, not an AI model that undergoes "training."
In summary, the provided submission is for a calibrator (a laboratory reagent) and therefore does not contain the type of clinical performance validation studies, ground truth establishment, or AI-related metrics that your request assumes for a diagnostic device or AI algorithm. The information needed to fill out most of your table is not present in the document because it's relevant to a different type of medical device submission.
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