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510(k) Data Aggregation
(222 days)
Clare, Ireland
Re: K161508
Trade/Device Name: Ceruloplasmin Regulation Number: 21 CFR 866.5210 Regulation
Device Identification:
Proprietary Names: Ceruloplasmin Common Name: Ceruloplasmin Classification: 866.5210
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.
Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Ireland Inc. Ceruloplasmin reagent, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Meet Criteria |
|---|---|---|
| Method Comparison | ||
| Slope: 0.900-1.100 | 1.056 | Pass |
| Intercept: ≤ ± 30mg/L | -26.10mg/L | Pass |
| r: ≥0.975 | 0.990 | Pass |
| N: ≥100 | 120 | Pass |
| Within Run Precision | ||
| Pool 1 (95.99 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.10% CV (1.042 SD) | Pass |
| Pool 2 (148.36 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.10% CV (1.70 SD) | Pass |
| Pool 3 (254.17 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.90% CV (2.30 SD) | Pass |
| Pool 4 (596.43 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.90% CV (5.46 SD) | Pass |
| Pool 5 (915.61 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.7% CV (6.78 SD) | Pass |
| Pool 6 (1791.94 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.5% CV (9.52 SD) | Pass |
| Total Precision | ||
| Pool 1 (95.99 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 6.7% CV (6.44 SD) | Pass |
| Pool 2 (148.36 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 2.80% CV (4.09 SD) | Pass |
| Pool 3 (254.17 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 2.20% CV (5.70 SD) | Pass |
| Pool 4 (596.43 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.90% CV (11.36 SD) | Pass |
| Pool 5 (915.61 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.6% CV (14.51 SD) | Pass |
| Pool 6 (1791.94 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.4% CV (25.23 SD) | Pass |
Study Details:
-
Sample size used for the test set and the data provenance:
- Method Comparison: 120 samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
- Precision Study: The report lists 6 "pools" with varying concentrations. The number of individual samples within each pool or the total number of samples used for the precision study is not explicitly stated beyond what is implied by the "Pool" structure. The data provenance is also not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a chemistry test system (in vitro diagnostic reagent) for quantitative determination of ceruloplasmin. The ground truth (reference values) for the method comparison study was established using a predicate device, the Siemens N Antisera to Human Ceruloplasmin. For precision, the ground truth is based on the inherent variability measurements of the device itself.
- Therefore, the concept of "experts establishing ground truth" in the way it might apply to image-based diagnostic AI is not directly applicable here. No human experts are explicitly mentioned as establishing the ground truth for these quantitative measurements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This device provides quantitative measurements, which are directly compared to values obtained from a predicate device or assessed for statistical precision, rather than requiring subjective expert adjudication of qualitative interpretations.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, essentially. The stated performance data (Method Comparison, Precision) reflects the standalone performance of the Ceruloplasmin reagent system on Beckman Coulter AU analyzers without direct human intervention in the result generation process, beyond operating the analyzer and performing necessary calibration/quality control.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Method Comparison study, the ground truth was established by another legally marketed predicate device: Siemens N Antisera to Human Ceruloplasmin. This is a form of comparative ground truth against an established method.
- For the Precision study, the ground truth is statistical, derived from repeated measurements of samples to quantify variability relative to the mean of those measurements.
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The sample size for the training set:
- This document describes a 510(k) premarket notification for an in-vitro diagnostic reagent. It does not refer to a "training set" in the context of machine learning or AI. The development process for such a reagent would involve internal verification and validation studies during manufacturing, but these are not typically referred to as "training sets" in the same way as for AI. The document only reports performance data, not development data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" described in the context of AI. For the development and validation of an IVD reagent, ground truth would be established through a combination of using certified reference materials, comparison to existing gold standard methods, and defined analytical protocols to ensure accuracy and precision. However, these specific details are not provided in this 510(k) summary.
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(252 days)
Re: K122965
Trade/Device Name: Human Ceruloplasmin Kit for use on SPAPLUS Regulation Number: 21 CFR 866.5210
The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document describes an FDA 510(k) clearance letter for a "Human Ceruloplasmin Kit for use on SPAPLUS," outlining its intended use and regulatory classifications. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about standalone (algorithm-only) performance.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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(275 days)
MAR 1 8 2010
Re: K091741
Trade/Device Name: Tina-Quant Ceruloplasmin Regulation Number: 21 CFR & 866.5210
Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.
The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.
Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ceruloplasmin Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criterion | Criteria Value / Threshold | Reported Device Performance | Study Type to Demonstrate Performance (Implicit) |
|---|---|---|---|---|
| Precision (Repeatability) | Control Low | SD ≤ 0.4 mg/dL; CV ≤ 1.5% | SD 0.4 mg/dL; CV 1.5% | Internal Verification |
| Control High | SD ≤ 0.9 mg/dL; CV ≤ 0.9% | SD 0.9 mg/dL; CV 0.9% | Internal Verification | |
| Serum Low | SD ≤ 1.2 mg/dL, CV ≤ 1.2% | SD 1.2 mg/dL, CV 1.2% | Internal Verification | |
| Serum Medium | SD ≤ 0.5 mg/dL, CV ≤ 0.8% | SD 0.5 mg/dL, CV 0.8% | Internal Verification | |
| Serum High | SD ≤ 0.9 mg/dL, CV ≤ 0.8% | SD 0.9 mg/dL, CV 0.8% | Internal Verification | |
| Precision (Intermediate/Total) | Control Low | SD ≤ 0.4 mg/dL; CV ≤ 1.6% | SD 0.4 mg/dL; CV 1.6% | Internal Verification |
| Control High | SD ≤ 0.7 mg/dL; CV ≤ 1.1% | SD 0.7 mg/dL; CV 1.1% | Internal Verification | |
| Serum Low | SD ≤ 0.4 mg/dL, CV ≤ 1.6% | SD 0.4 mg/dL, CV 1.6% | Internal Verification | |
| Serum Medium | SD ≤ 0.7 mg/dL, CV ≤ 1.0% | SD 0.7 mg/dL, CV 1.0% | Internal Verification | |
| Serum High | SD ≤ 1.1 mg/dL, CV ≤ 0.9% | SD 1.1 mg/dL, CV 0.9% | Internal Verification | |
| Analytical Sensitivity | Limit of Blank (LoB) | ≤ 2 mg/dL | ≤ 2 mg/dL | Internal Verification |
| Limit of Detection (LoD) | ≤ 3 mg/dL | ≤ 3 mg/dL | Internal Verification | |
| Analytical Specificity | Interference (Common Drugs) | No interference at common therapeutic concentrations | No interference was found at common therapeutic concentrations using common drug panels. | Interference Study |
| Interferences (Recovery) | Icterus | Recovery within ±10% up to I-index 60 | No significant interference up to an I index of 60 (approx. 60 mg/dL conjugated/unconjugated bilirubin) | Interference Study |
| Hemolysis | Recovery within ±10% up to H-index 350 | No significant interference up to an H index of 350 (approx. 350 mg/dL hemoglobin) | Interference Study | |
| Lipemia | Recovery within ±10% up to L-index 400 | No significant interference up to an L Index of 400 mg/dL. | Interference Study | |
| Rheumatoid Factor (RF) | No interference up to RF |
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(69 days)
Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5210
Dimension Vista™ CER Flex® reagent cartridge: The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), 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 C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista™ CER 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 C3 complement, C4 complement, ceruloplasmin (CER), 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, liquid, human serum based products containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the Dimension Vista™ CER assay are based on demonstratincorr correlation and equivalent performance with the predicate device (Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System). While explicit numerical thresholds for acceptance (e.g., minimum correlation coefficient, maximum acceptable slope/intercept deviation) are not provided, the reported performance is presented to demonstrate that these criteria have been met.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | High correlation with predicate system (N Antisera on BN ProSpec®) | 0.994 |
| Slope | Close to 1.0 (relative to predicate system) | 1.009 |
| Intercept (g/L) | Close to 0.0 (relative to predicate system) | 0.008 |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 130 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "evaluating serum and plasma samples," implying collection for the purpose of the study, which could suggest prospective, but this is not explicitly confirmed.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This study involves a direct comparison of a new assay against a legally marketed predicate assay, not against a ground truth established by experts interpreting various forms of data (e.g., images, clinical symptoms). The "ground truth" or reference for comparison is the performance of the predicate device.
4. Adjudication Method:
Not applicable. There was no need for adjudication as the study directly compares quantitative assay results from two different systems.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study is a method comparison for an in vitro diagnostic (IVD) assay, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the Dimension Vista™ CER assay's performance was directly measured and compared against the predicate device. This is typical for IVD device submissions, where the "standalone" performance refers to the device's output without human interpretation in the results generation process. The comparison is between the Dimension Vista™ CER assay results and the predicate assay results for the same samples.
7. Type of Ground Truth Used:
The "ground truth" for this method comparison study is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System. This is a common approach for demonstrating substantial equivalence for new IVD assays.
8. Sample Size for the Training Set:
Not applicable. This is a method comparison study for an IVD device, not a machine learning model that requires a "training set." The device is a reagent cartridge and calibrator system for a laboratory instrument, not an AI algorithm learned from data.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for this type of device and study.
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(191 days)
Re: K062114
Trade/Device Name: COBAS INTEGRA Ceruloplasmin Model 2055953 Regulation Number: 21 CFR 866.5210
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
COBAS INTEGRA:
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Roche/Hitachi cobas c systems:
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992.
Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.
Here's a breakdown of the acceptance criteria and study information for the COBAS INTEGRA Ceruloplasmin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Predicate Device (0.06-1.3 g/L) | COBAS INTEGRA Ceruloplasmin (Acceptance Criteria/Performance) |
|---|---|---|
| Measuring Range | 0.06-1.3 g/L | 0.06-1.26 g/L (Reported performance, implying this is the accepted range for the device) |
| Lower Detection Limit | 0.02 g/L | 0.017 g/L (Reported performance, implying this is the accepted limit for the device). This is an improvement compared to the predicate device. |
| Expected Values | 0.2-0.6 g/L | 0.2-0.6 g/L (Same as predicate, implying this is the accepted range for normal values) |
| Precision (Within run total CV%) | ||
| At ~0.2-0.27 g/L | 1.0% @ 0.27 g/L | 3.88% @ 0.2 g/L (Reported performance) |
| At ~0.34-0.35 g/L | 1.4% @ 0.34 g/L | 2.66% @ 0.35 g/L (Reported performance) |
| At ~0.62 g/L | 1.6% @ 0.62 g/L | (No corresponding data point provided for COBAS INTEGRA Ceruloplasmin) |
| Linearity | 0.06-0.69 g/L | 0.06-1.26 g/L (Reported performance, implying this is the accepted linear range for the device. This is an improvement compared to the predicate device.) |
| Endogenous Interferences | ||
| Hemolysis | no interferences up to 10 g/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Icterus | no interferences up to 600 mg/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Triglycerides/Lipemia | no interferences up to 25 g/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Rheumatoid factors | (Not mentioned) | no significant interferences up to 400 IU/mL (Reported performance) |
| Exogenous Interferences | (Not mentioned) | Gammopathy, in particular IgM, may cause unreliable results in rare cases (Reported, implying this is an accepted limitation) |
| Method Comparison (vs. DakoCytomation Anti Human Ceruloplasmin) | y = 1.0x - 0.0 g/L; r = 0.987 | y = 1.0x - 0.0 g/L; r =0.987 (Reported, implying agreement with the predicate is the accepted criterion) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for validating each performance characteristic (e.g., precision, linearity, interference studies, or method comparison). The data provenance is not specified regarding country of origin or an explicit retrospective/prospective design. However, the context of a 510(k) submission for a new in vitro diagnostic (IVD) device typically implies prospective testing conducted by the manufacturer, likely at their facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic (IVD) assay for a quantitative biomarker (ceruloplasmin). The "ground truth" for such devices is established by analytical methods and comparison to a predicate device or reference material, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as this is an IVD assay, not a device requiring human interpretation and adjudication of results. The method comparison refers to the statistical comparison of results from the new device against 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
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an algorithm-only (standalone) performance. The device is a fully automated immunoturbidimetric assay system that quantitatively determines ceruloplasmin levels. There is no human intervention in the result generation process; the result is directly reported by the instrument.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established through:
- Reference materials: The device "Standardized against IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) for 14 serum proteins." This reference material serves as a "ground truth" for calibrating the assay.
- Comparison to a legally marketed predicate device: The method comparison data shows results against the DakoCytomation Polyclonal Rabbit Anti-Human Ceruloplasmin (K812486), which serves as a clinical benchmark (or "ground truth" in terms of clinical performance equivalence).
8. The Sample Size for the Training Set
Not explicitly stated. For IVD devices, a "training set" in the context of machine learning is not directly applicable. The "training" here refers to the development and optimization of the reagent formulation and assay parameters. The document doesn't provide specific sample sizes for these development phases.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated in the document. For IVD assays, the "ground truth" for development and optimization (analogous to training) would typically involve:
- Using known concentrations of ceruloplasmin (e.g., from purified human ceruloplasmin or spiked samples).
- Testing against established reference methods or highly characterized samples.
- Performing extensive analytical verification during the development phase to ensure the assay performs as intended across its measuring range and with various interference challenges.
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(135 days)
N Antisera to Human Ceruloplasmin Class: Ceruloplasmin Immunological Test System, Class II, 21 CFR 866.5210
19714
Re: K053074
Trade/Device Name: N Antisera to Human Ceruloplasmin Regulation Number: 21 CFR 866.5210
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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(141 days)
Rockville MD 20850
Re: K051456
Trade/Device Name: Sentinel Ceruloplasmin Regulation Number: 21 CFR 866.5210
The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.
Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.
Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Sentinel Ceruloplasmin) |
|---|---|---|
| Method Correlation (Slope) | Close to 1.0 (indicating good agreement) | 1.0256 |
| Method Correlation (Y-intercept) | Close to 0 (indicating no systematic bias) | -1.0205 mg/dL |
| Total %CV (Precision) - Level 1 | Comparable to predicate (not explicitly stated, but generally |
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(149 days)
Ceruloplasmin (CER) Reagent
Classification Name 3.2
Ceruloplasmin immunological test system (21 CFR § 866.5210
The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.
The IMMAGE Immunochemistry System CER Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of ceruloplasmin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong linear correlation (r approaching 1) and minimal bias (slope approaching 1, intercept approaching 0) to a predicate device. | Slope: 0.996, Intercept: -2.43, r: 0.995 (n=104 serum samples) |
| Stability | Reagent maintains performance over time (not explicitly stated, but demonstrated through stability testing). | "Stability Study Results" mentioned, but specific data and criteria are not provided in the excerpt. |
| Imprecision (Within Run) | Low coefficient of variation (%CV) for repeated measurements. | Serum Level 1: 3.1% CV (Mean 13.6 mg/dL) |
| Serum Level 2: 2.4% CV (Mean 49.3 mg/dL) | ||
| Serum Level 3: 3.1% CV (Mean 88.0 mg/dL) | ||
| Low Serum Level 1: 5.8% CV (Mean 1.4 mg/dL) | ||
| Low Serum Level 2: 3.9% CV (Mean 4.3 mg/dL) | ||
| Imprecision (Total) | Low coefficient of variation (%CV) for repeated measurements over multiple runs/days. | Serum Level 1: 3.8% CV (Mean 13.6 mg/dL) |
| Serum Level 2: 3.5% CV (Mean 49.3 mg/dL) | ||
| Serum Level 3: 4.3% CV (Mean 88.0 mg/dL) | ||
| Low Serum Level 1: 6.6% CV (Mean 1.4 mg/dL) | ||
| Low Serum Level 2: 3.9% CV (Mean 4.3 mg/dL) |
Note: The acceptance criteria for stability and imprecision are implied by the nature of these tests in diagnostic device validation. The document states that the data "supports a finding of substantial equivalence," which suggests that these performance metrics met the internal or regulatory thresholds for equivalence.
2. Sample size used for the test set and the data provenance
- Method Comparison Test Set Sample Size: 104 serum samples.
- Imprecision Test Set Sample Size: For each of the five serum levels tested, 80 data points were collected for "Within Run" and "Total" precision, and 30 data points for the "Low Serum Levels". This refers to the number of individual measurements or replicates.
- Data Provenance: The document does not explicitly state the country of origin. It is a submission by Beckman Instruments, Inc. in Brea, California, USA, so it's most likely US-based data, but this is not confirmed. The studies are prospective in nature, as they involve testing the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For an immunochemistry system that quantifies ceruloplasmin, the ground truth would typically be established by a reference method or a predicate device. The document uses a predicate device (Beckman Array Systems CER Reagent) as the reference for the method comparison, rather than expert consensus on individual results.
4. Adjudication method for the test set
- This information is not applicable and therefore not provided in the document. Adjudication is typically used when there are subjective interpretations (e.g., medical imaging) requiring multiple experts to reach a consensus. For a quantitative immunoassay, the "ground truth" is derived from a reference measurement or predicate assay, not through expert adjudication of individual results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable and therefore not provided in the document. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret results, often with and without AI assistance. This device is a fully automated immunochemistry system for quantitative measurement, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the studies presented (Method Comparison and Imprecision) represent the standalone performance of the IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent. The system is designed for automated quantitative determination, meaning it operates without human intervention in the result generation process once the sample is loaded and the assay initiated. The reported performance metrics are for the device itself.
7. The type of ground truth used
- The ground truth for the method comparison study was established by the predicate device, the Beckman Array Systems CER Reagent. This means the IMMAGE System's results were compared against the established results from an already approved and commercially distributed device to demonstrate substantial equivalence. For imprecision, the "ground truth" is internal consistency and reproducibility of the device itself.
8. The sample size for the training set
- This information is not provided in the document. This device is an immunochemistry assay, not a machine-learning or AI-based system that typically requires a distinct "training set" for model development. The development process would involve formulation, optimization, and internal testing, but not in the same sense as an AI algorithm's training phase.
9. How the ground truth for the training set was established
- This information is not provided and is not applicable in the context of this type of diagnostic device. As explained above, there isn't a "training set" in the machine learning sense for this immunochemistry system. The development and validation process would rely on established analytical chemistry principles and performance characteristics, rather than data-driven model training.
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