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510(k) Data Aggregation
(90 days)
Chaska, Minnesota 55318
Re: K234052
Trade/Device Name: Access Ferritin Regulation Number: 21 CFR 866.5340
(952) 465-1914
Trade Name: Access Ferritin Common Name: Ferritin Classification Regulation: 21 CFR 866.5340
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.
The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
Device Name: Access Ferritin
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Design Goal) | Reported Device Performance |
|---|---|---|
| Method Comparison | ||
| R² | ≥ 0.90 | 0.99 |
| Slope | 1.00 ± 0.09 | 0.96 (95% CI: 0.95-0.97) |
| Intercept | Not explicitly stated as a numerical acceptance criterion, but implied to be near zero. | 0.23 (95% CI: -0.34-1.1) |
| Precision (Within-Laboratory Imprecision) | ||
| Concentrations ≤ 5 ng/mL (µg/L) | ≤ 0.5 ng/mL (µg/L) SD | Sample 1 (1.2 ng/mL): 0.2 ng/mL SD (17.3% CV). Note: While the SD (0.2) is below 0.5, the CV (17.3%) is high. The acceptance criterion is specifically for SD, so it meets the criterion numerically, but the CV suggests variability at this low concentration. |
| Concentrations > 5 ng/mL (µg/L) | ≤ 10.0% CV | Sample 2 (13 ng/mL): 4.7% CV |
| Sample 3 (147 ng/mL): 5.3% CV | ||
| Sample 4 (289 ng/mL): 4.3% CV | ||
| Sample 5 (560 ng/mL): 4.6% CV | ||
| Sample 6 (1276 ng/mL): 5.3% CV | ||
| (All samples well within the 10.0% CV criterion) | ||
| Linearity | Linear throughout the analytical measuring interval of 0.6-1,500 ng/mL | Linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 0.6-1,500 ng/mL. (Implied to meet the criterion) |
| Limit of Blank (LoB) | ||
| Claimed LoB | 0.2 ng/mL | The claimed LoB for Access Ferritin assay is 0.2 ng/mL on Dxl 9000 Access Immunoassay Analyzer. (Implied to meet, as this is the stated claim derived from the study) |
| Limit of Detection (LoD) | ||
| Claimed LoD | 0.4 ng/mL | The claimed LoD estimate for the Access Ferritin assay is 0.4 ng/mL on Dxl 9000 Access Immunoassay Analyzer. (Implied to meet, as this is the stated claim derived from the study) |
| Limit of Quantitation (LoQ) | ||
| Maximum claimed LoQ (@ ≤ 20% within-lab CV) | 0.6 ng/mL | The maximum claimed LoQ (≤ 20% within-lab CV) determined for the Access Ferritin assay is 0.6 ng/mL on Dxl 9000 Access Immunoassay Analyzer. (Implied to meet, as this is the stated claim derived from the study) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size (Method Comparison): 147 samples
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison samples. It only mentions "patient samples" in the context of the CLSI guidance document referenced (CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples).
- Test Set Sample Size (Precision, LoB, LoD, LoQ):
- Precision: 80 replicates for each of the 6 concentration levels (1.2, 13, 147, 289, 560, 1276 ng/mL) are reported in the table. The study design mentions "tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which would result in 80 measurements (2 replicates x 2 runs/day x 20 days).
- LoB: 75 replicates of native samples.
- LoD: Five to nine serum samples containing low levels of Ferritin analyte, tested over five days with one run per day and nine replicates per run for each pack lot (resulting in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested).
- LoQ: Eight to twelve serum samples containing low levels of Ferritin analyte, tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument (resulting in a minimum of 40 replicates for each sample on each pack lot).
- Provenance for Precision, LoB, LoD, LoQ: Not specified, other than "native samples" or "serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in-vitro diagnostic (IVD) immunoassay for quantitative determination of ferritin levels. Ground truth for such devices is typically established through reference methods or established laboratory gold standards rather than expert consensus on interpretive tasks. The document does not mention any involvement of human experts or radiologists in establishing ground truth for the test set performance evaluation. The "ground truth" here would be the actual ferritin concentration as determined by the predicate device (for method comparison) or highly controlled, characterized samples (for precision, linearity, limits).
4. Adjudication Method for the Test Set
Not applicable. As an IVD immunoassay, the "ground truth" or reference values are determined by laboratory measurements, not by human expert adjudication in the traditional sense (e.g., 2+1 for image interpretation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging or similar interpretive tasks involving multiple human readers. This document describes the performance evaluation of an automated immunoassay system, which does not involve human readers interpreting results in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes. The entire study describes the standalone performance of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer. This is an automated system; the performance metrics (method comparison, precision, linearity, limits) are intrinsic to the assay and instrument combination without human intervention in the result generation or interpretation other than standard lab operating procedures.
7. The Type of Ground Truth Used
- Method Comparison: The "ground truth" or reference values for the method comparison study were obtained from the predicate device, the Access Ferritin assay run on the Access Immunoassay System (K926221/K052082).
- Precision, Linearity, LoB, LoD, LoQ: Ground truth for these studies was established using characterized samples (e.g., samples with known or carefully prepared concentrations, native low-level samples, or blank samples). These are standard practices in IVD analytical performance evaluation.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. This is an immunoassay, not a device that uses AI models that require traditional training data. The development of the assay and its associated reagents/software would have involved internal R&D studies, but these are not described as a "training set" in the common AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device with a distinct "training set" as described in AI development. The "ground truth" for developing the assay itself would have involved extensive biochemical and analytical characterization in a laboratory setting.
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(624 days)
Stillwater, Minnesota 55082
Re: K193650
Trade/Device Name: LIAISON Ferritin Regulation Number: 21 CFR 866.5340
Regulatory Information:
Regulation Section: 21 CFR 866.5340 Classification: Class II Product Code: DBF
The DiaSorin LIAISON® Ferritin assay is a quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin in human serum, serum separator tubes (SST), or lithium (Li) heparin plasma to aid in the diagnosis of iron deficiency anemia and iron overload.
This assay must be performed on the LIAISON® XL Analyzer.
The chemiluminescence immunoassay method for the quantitative determination of ferritin is a sandwich immunoassay.
A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody (mouse) is linked to an isoluminol derivative (isoluminolantibody conjugate).
During the incubation, ferritin present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently the antibody conjugate reacts with ferritin already bound to the solid phase.
After incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody coniugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of ferritin concentration present in calibrators, samples or controls.
The provided document is a 510(k) Summary for the DiaSorin LIAISON® Ferritin assay, a chemiluminescent immunoassay for the quantitative determination of ferritin in human serum, serum separator tubes (SST), or lithium (Li) heparin plasma. Its intended use is to aid in the diagnosis of iron deficiency anemia and iron overload.
This document details the performance characteristics required to demonstrate substantial equivalence to a legally marketed predicate device (Roche Elecsys® Ferritin assay), rather than defining and proving against acceptance criteria in the context of an AI/ML device or a complex diagnostic with multiple discrete outcomes. The data presented are for an in vitro diagnostic immunoassay, which relies on analytical performance metrics rather than clinical outcome studies of the type implied by the original request's questions about expert consensus, MRMC studies, human-in-the-loop performance, etc.
Therefore, many of the requested elements are not applicable to the type of device and study described in this document.
Below, I've addressed the applicable points from your request based on the provided text.
Device: DiaSorin LIAISON® Ferritin assay (K193650)
Type of Device: Quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin.
Purpose of the Study (as presented in the 510(k) Summary): To demonstrate substantial equivalence of the DiaSorin LIAISON® Ferritin assay to the predicate device, Roche Elecsys® Ferritin assay, based on analytical performance characteristics.
Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic assay, acceptance criteria typically relate to analytical performance metrics to ensure accuracy, precision, linearity, and other factors. While the document does not explicitly list "acceptance criteria" against each performance metric in a table format, it reports the results of various studies (e.g., method comparison, precision) which would have been previously agreed upon with the FDA as sufficient to demonstrate substantial equivalence.
Here's a summary of the reported performance. The implied "acceptance criteria" are that these results fall within acceptable ranges for diagnostic assays of this type, often relative to a predicate device or industry standards (e.g., CLSI guidelines).
| Performance Metric | Reported Device Performance (LIAISON® Ferritin) | Implied Acceptance Criteria (based on context of 510(k)) |
|---|---|---|
| Method Comparison (vs. Reference Method) | Regression Analysis (Passing & Bablok): |
- Slope: 0.965 (95% CI: 0.95 - 0.98)
- Intercept: -1.12 (95% CI: -2.13 to -0.32)
- R²: 0.995 | Slope close to 1, Intercept close to 0, and R² close to 1, indicating strong agreement with the reference method (likely the predicate or another validated method), within pre-defined acceptable limits for analytical measurements. |
| Sample Matrix Comparison | Serum vs. SST: - Slope: 1.002 (0.9727 to 1.038)
- Intercept: 0.0179 (-0.7744 to 0.6374)
Serum vs. Li Heparin: - Slope: 0.984 (0.9413 to 0.9905)
- Intercept: -1.732 (-2.137 to -0.5159) | Slopes near 1 and intercepts near 0 for different matrix types compared to serum, demonstrating equivalence across specified sample types. |
| Precision (Total %CV) | Kit Control 1 (32.81 ng/mL): 4.3%
Kit Control 2 (300 ng/mL): 5.4%
Panel 1 (5.84 ng/mL): 5.6%
Panel 2 (18.26 ng/mL): 4.6%
Panel 3 (178 ng/mL): 4.1%
Panel 4 (1093 ng/mL): 5.6%
Panel 5 (404.9 ng/mL): 4.6%
Panel 6 (1883 ng/mL): 6.4% | Total CV (Coefficient of Variation) within acceptable limits for a quantitative immunoassay across its measuring range, demonstrating reproducibility and reliability of results. These limits are typically defined by regulatory bodies or industry standards (e.g., CLSI EP5-A3). |
| Linearity | Equation for 2000 ng/mL sample:
Observed Ferritin = -1.402 + 1.006 * Expected Ferritin
R²=1.000 | R² close to 1, and slope near 1 with intercept near 0, demonstrating accurate measurement across the assay’s claimed analytical measuring range (0.46 – 2,200 ng/mL). |
| Recovery | Average Recovery: 101% (Individual recoveries ranging from 98% to 104% for spiked samples) | Recovery values typically between 90-110% (or tighter, depending on the analyte and assay sensitivity) for spiked samples, indicating the assay accurately measures the target analyte when added to a sample. |
| Limit of Blank (LoB) | 0.004 ng/mL | LoB consistent with the lower end of the claimed analytical measuring range and adequate for the intended clinical application. |
| Limit of Detection (LoD) | 100.0%
Human spleen ferritin: 78.8% | Specificity for the intended analyte (ferritin) without significant cross-reactivity with closely related substances or other components that could lead to false results. |
Applicable Information from the Request (Based on provided document):
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample sizes used for the test set and the data provenance:
- Method Comparison: 173 samples. Provenance not specified (e.g., country of origin, retrospective/prospective), but it usually implies clinical samples collected for analytical validation purposes.
- Sample Matrix Comparison: 37 matched patient sets (serum, Li Heparin plasma) and 6 contrived matched patient samples. Provenance not specified.
- Expected Values/Reference Range: 78 human serum samples; 39 healthy female, 39 healthy male subjects (age 18+). Provenance not specified.
- Precision: 2 kit controls and 6 samples assayed 320 times each (twice per day in duplicate, over 20 operating days on two LIAISON® XL Analyzers using two reagent lots). Provenance: DiaSorin GmbH, implying internal lab testing.
- Linearity: Dilution series of 4 samples.
- Recovery: 4 representative human serum samples. Provenance not specified.
- Interference, Cross-Reactivity, LoB/LoD/LoQ studies also involved specific numbers of samples/replicates, but detailed sample sizes for each are not individually listed beyond the overall study design (e.g., "controlled studies... at Ferritin level of approximately 20 ng/mL and 2000 ng/mL").
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes an in vitro diagnostic device measuring a quantitative biomarker (Ferritin). Ground truth is established through reference methods, calibration materials traceable to international standards (e.g., NIBSC 94/572 for Ferritin), and gravimetric/dilution/spiking studies, not by expert interpretation of images or clinical outcomes that require human experts for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. This is an automated analytical test.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic assay, not an AI/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm" as typically referred to in AI/ML. The device itself is an automated analyzer that performs the "standalone" measurement of ferritin. No human interpretation is involved in the measurement process after sample loading.
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The type of ground truth used:
- For Method Comparison, the "Reference Method" was used as ground truth. This would typically be a highly accurate and precise method, often the predicate device itself or a laboratory developed test that is well-validated.
- For Linearity and Recovery, ground truth was established by preparing samples with known concentrations through spiking and dilution from a characterized stock solution or pool.
- For Precision, samples with known (or previously characterized) ferritin concentrations were used.
- For Traceability, the calibrators are traceable to an internal reference standard "oriented at the 2nd reference standard NIBSC 94/572." This international standard serves as a form of ground truth for absolute concentration.
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The sample size for the training set: Not applicable. This is a traditional immunoassay, not an AI/ML device that requires a "training set" in the computational sense. The "training" of such a system involves calibrating it with known standards, which were traceable to an international reference standard (NIBSC 94/572).
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML sense. Calibration is performed using materials traceable to an international reference standard.
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(267 days)
C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor Regulation Number: 21 CFR 866.5340
: | Class II / 510(k) required |
| Classification Name: | §866.5340
Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro diagnostic determination of Ferritin in human serum by latex-enhanced immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, hemochromatosis (iron overload) and iron deficiency anemia.
Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro diagnostic determination of transferrin in human serum and lithium heparin plasma by turbidimetry.
Measurement of transferrin levels ads in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative in vitro diagnostic determination of rheumatoid factor in human serum by latex-enhanced immunoturbidimetric assay. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Not Found
The document describes the analytical performance characteristics of three devices: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, and Yumizen C1200 Rheumatoid Factor. Each device is intended for the quantitative in vitro diagnostic determination of specific substances in human serum, and sometimes plasma, using immunoturbidimetric or turbidimetric assays.
Here's an analysis of the acceptance criteria and study details for each device:
Yumizen C1200 Ferritin
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 10 to 450 ng/mL |
| Limit of Detection (Serum) | N/A (determined according to CLSI EP17-A2) | 6.30 ng/mL |
| Limit of Quantitation (Serum) | N/A (determined according to CLSI EP17-A2) | 9.39 ng/mL |
| Linearity (Serum) | N/A (determined according to CLSI EP06-A) | Evaluated from 13.3 to 426.6 ng/mL (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 8.0% | |
| Middle level: ≤ 6.0% | ||
| High level: ≤ 6.0% | Level 1 Control (47.58 ng/mL): 3.6% | |
| Level 2 Control (279.31 ng/mL): 1.1% | ||
| Sample 1 (29.56 ng/mL): 5.5% | ||
| Sample 2 (50.87 ng/mL): 4.1% | ||
| Sample 3 (172.63 ng/mL): 1.4% | ||
| Sample 4 (328.60 ng/mL): 1.3% | ||
| Sample 5 (403.21 ng/mL): 1.0% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 10.0% | |
| Middle & High level: ≤ 8.0% | Level 1 Control: 4.9% | |
| Level 2 Control: 2.1% | ||
| Sample 1: 7.9% | ||
| Sample 2: 5.1% | ||
| Sample 3: 1.9% | ||
| Sample 4: 4.3% | ||
| Sample 5: 1.4% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 8.0% | |
| Middle level: ≤ 6.0% | ||
| High level: ≤ 6.0% | Level 1 Control (52.84 ng/mL): 4.6% | |
| Level 2 Control (281.87 ng/mL): 0.9% | ||
| Sample 1 (19.09 ng/mL): 8.8% | ||
| Sample 2 (34.05 ng/mL): 6.5% | ||
| Sample 3 (51.53 ng/mL): 3.6% | ||
| Sample 4 (192.31 ng/mL): 1.4% | ||
| Sample 5 (407.38 ng/mL): 0.9% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 10.0% | |
| Middle & High level: ≤ 8.0% | Level 1 Control: 6.4% | |
| Level 2 Control: 1.6% | ||
| Sample 1: 11.8% (above criterion, but "pvalue with 5% acceptable remains acceptable") | ||
| Sample 2: 6.5% | ||
| Sample 3: 3.8% | ||
| Sample 4: 2.8% | ||
| Sample 5: 1.4% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 270.42 mg/dL | ||
| Total Bilirubin: up to 29.5 mg/dL | ||
| Direct Bilirubin: up to 25.87 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Prozone / Antigen Excess Effect | Detect and flag samples with underestimated results due to high concentration | Antigen excess observed > 5043 ng/mL; an alarm will flag and re-run these samples. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.999 (for 103 samples, 16.74 - 413.00 ng/mL range) |
| Closed Stability | N/A (defined by statement) | 18 months, stored at 2-10°C, protected from light. |
| Open Stability (On-board) | N/A (defined by statement) | 2 months |
| Reference Range Verification | Support establishing ranges vs. literature | Women: 10 - 120 ng/ml (µg/l) |
| Men: 20 - 250 ng/ml (µg/l) |
2. Sample Size and Data Provenance (for test set)
- Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum specimens".
- Method Comparison: 103 native sera samples. Origin: "Anonymous remnants of human serum specimens collected from blood bank." Retrospective.
- Reference Range: Women: 50 "normal samples". Men: 95 "normal samples". Origin: "blood bank." Retrospective.
3. Number of experts and qualifications (for ground truth)
- Not applicable as this is an in vitro diagnostic device for quantitative measurement, not an AI evaluation requiring expert adjudication. Ground truth is instrument-derived or defined by reference methods/literature.
4. Adjudication method (for test set)
- Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
- No, not applicable for this type of IVD device.
6. Standalone performance (algorithm only)
- Yes, the performance data presented is for the device operating in standalone mode (algorithm only) as a quantitative measurement system.
7. Type of ground truth used
- Analytical Performance (LOD, LOQ, Linearity, Precision, Interferences, Prozone/Antigen Excess): The "ground truth" is established through well-defined laboratory analytical methods and standards (CLSI guidelines EP17-A2, EP06-A, EP05-A3, EP07-A2). It relies on the accuracy of the reference materials and methods used in these studies.
- Method Comparison: Comparison against a legally marketed predicate device (Beckman Coulter Ferritin (OSR61203) [K092505]) is used as the reference, with correlation analysis.
- Reference Range: Verification against established literature references (e.g., TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics).
8. Sample size for the training set
- Not applicable. This is not a machine learning model that requires a "training set" in that sense. The device's calibration curve establishment and internal parameters would be set by the manufacturer using validated reference materials and methodologies.
9. How the ground truth for the training set was established
- Not applicable.
Yumizen C1200 Transferrin
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum/Plasma) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 0.10 to 5.20 g/L |
| Limit of Detection (Serum/Plasma) | N/A (determined according to CLSI EP17-A2) | 0.002 g/L |
| Limit of Quantitation (Serum/Plasma) | N/A (determined according to CLSI EP17-A2) | 0.07 g/L |
| Linearity (Serum/Plasma) | N/A (determined according to CLSI EP06-A) | Evaluated from 0.15 to 4.61 g/L (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (1.24 g/L): 1.2% | |
| Level 2 Control (3.35 g/L): 1.5% | ||
| Sample 1 (0.78 g/L): 1.0% | ||
| Sample 2 (1.02 g/L): 1.2% | ||
| Sample 3 (1.83 g/L): 1.3% | ||
| Sample 4 (3.78 g/L): 1.5% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 3.6% | |
| Level 2 Control: 3.6% | ||
| Sample 1: 4.5% | ||
| Sample 2: 3.2% | ||
| Sample 3: 2.3% | ||
| Sample 4: 2.7% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (1.29 g/L): 3.5% | |
| Level 2 Control (3.41 g/L): 1.7% | ||
| Sample 1 (0.77 g/L): 4.2% | ||
| Sample 2 (1.08 g/L): 1.5% | ||
| Sample 3 (1.96 g/L): 1.3% | ||
| Sample 4 (3.54 g/L): 2.6% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 6.6% | |
| Level 2 Control: 3.0% | ||
| Sample 1: 5.4% | ||
| Sample 2: 3.3% | ||
| Sample 3: 3.4% | ||
| Sample 4: 3.4% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 353.28 mg/dL | ||
| Total Bilirubin: up to 43.84 mg/dL | ||
| Direct Bilirubin: up to 23.86 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Anticoagulant Study (Serum vs. Heparin Plasma) | No significant difference between serum and plasma | Correlation (r) = 0.995, Intercept = 0.04833, Slope = 0.9691 (59 paired samples) |
| Prozone / Antigen Excess Effect | No antigen excess detected within claimed range | No antigen excess detected up to 40 g/L. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.993 (for 115 samples, 0.37 - 4.81 g/L range) |
| Closed Stability | N/A (defined by statement) | 24 months, stored at 2-8°C, protected from light. |
| Open Stability (On-board) | N/A (defined by statement) | 6 weeks |
| Reference Range Verification | Support establishing ranges vs. literature | Normal range Transferrin - Serum: 2 - 3.6 g/l (200 - 360 mg/dl) |
2. Sample Size and Data Provenance (for test set)
- Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum/plasma".
- Method Comparison: 115 native samples. Origin: "Anonymous remnants of human serum specimens collected from CHU Nîmes (University Hospital Center)." Retrospective.
- Anticoagulant Study: 59 paired serum/plasma samples. Origin: "single donors." Not specified if retrospective or prospective.
- Reference Range: 85 "normal samples" (28 women + 57 men). Origin: "blood bank." Retrospective.
3. Number of experts and qualifications (for ground truth)
- Not applicable.
4. Adjudication method (for test set)
- Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
- No, not applicable.
6. Standalone performance (algorithm only)
- Yes, the performance data presented is for the device operating in standalone mode (algorithm only).
7. Type of ground truth used
- Analytical Performance: Established through CLSI guidelines (EP17-A2, EP06-A, EP05-A3, EP07-A2).
- Method Comparison: Comparison against a legally marketed predicate device (Roche Diagnostics Transferrin Model :TRSF2 [K012393]).
- Reference Range: Verification against established literature references (e.g., Dati et al., Eur. J Clin Chem. Cli Biochem. 1996).
8. Sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
Yumizen C1200 Rheumatoid Factor
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 10 to 120 IU/mL |
| Limit of Detection (Serum) | N/A (determined according to CLSI EP17-A2) | 4.07 IU/mL |
| Limit of Quantitation (Serum) | N/A (determined according to CLSI EP17-A2) | 7.41 IU/mL |
| Linearity (Serum) | N/A (determined according to CLSI EP06-A) | Evaluated from 13.2 to 118.8 IU/mL (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (40.99 IU/mL): 0.5% | |
| Level 2 Control (63.93 IU/mL): 0.4% | ||
| Sample 1 (22.24 IU/mL): 1.2% | ||
| Sample 2 (34.28 IU/mL): 0.8% | ||
| Sample 3 (49.41 IU/mL): 0.5% | ||
| Sample 4 (70.16 IU/mL): 0.5% | ||
| Sample 5 (103.42 IU/mL): 0.8% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 2.2% | |
| Level 2 Control: 2.5% | ||
| Sample 1: 2.0% | ||
| Sample 2: 2.2% | ||
| Sample 3: 1.8% | ||
| Sample 4: 1.6% | ||
| Sample 5: 1.4% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (41.70 IU/mL): 1.8% | |
| Level 2 Control (67.05 IU/mL): 1.4% | ||
| Sample 1 (17.30 IU/mL): 2.9% | ||
| Sample 2 (30.88 IU/mL): 1.4% | ||
| Sample 3 (53.08 IU/mL): 1.4% | ||
| Sample 4 (70.24 IU/mL): 1.1% | ||
| Sample 5 (102.14 IU/mL): 1.0% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 1.9% | |
| Level 2 Control: 2.2% | ||
| Sample 1: 3.1% | ||
| Sample 2: 1.8% | ||
| Sample 3: 3.2% | ||
| Sample 4: 1.3% | ||
| Sample 5: 1.8% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 526.75 mg/dL | ||
| Total Bilirubin: up to 31.32 mg/dL | ||
| Direct Bilirubin: up to 25.34 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Prozone / Antigen Excess Effect | Detect and flag samples with underestimated results due to high concentration | Antigen excess observed > 229 IU/mL; an alarm will flag and re-run these samples. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.992 (for 113 samples, 16.79 - 118.81 IU/mL range) |
| Closed Stability | N/A (defined by statement) | 18 months, stored at 2-10°C. |
| Open Stability (On-board) | N/A (defined by statement) | 1 month |
| Reference Range Verification | Support establishing ranges vs. literature | Normal range Rheumatoid Factor: Adult |
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(235 days)
| Clinical
Chemistry |
| Ferritin immunological test
system | 866.5340
The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.
The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.
This document focuses on the substantial equivalence of the DxA 5000 automated sample handling system and related immunoassay tests (Ferritin, Folate, TSH, Vitamin B12) to previously cleared devices. It describes engineering performance studies rather than clinical efficacy studies. Therefore, many of the typical clinical study criteria requested (like multi-reader multi-case studies, effect size of human improvement with AI, number of experts for ground truth, sample size for training sets) are not applicable or detailed in this submission.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document states that "The acceptance criteria were met for all method comparisons thereby demonstrating the following:"
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Equivalence (DTS barcode identification process) | Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of the DTS barcode identification process was demonstrated. (Specific metrics for "equivalence" are not detailed in the provided text, but it's stated as "met"). |
| Equivalence (pre-analytical processing) | Equivalence between the predicate lab automation system Power Processor and the candidate one, DxA 5000 in terms of pre-analytical processing was demonstrated. (Specific metrics for "equivalence" are not detailed, but it's stated as "met"). |
| Method Comparison (TSH, Ferritin, Folate, B12 Assays) | For all method comparisons (TSH (3rd IS), Ferritin, Folate and B12 assays), results were within the specifications when the candidate (DxA 5000 connected to UniCel DxI 800 Access Immunoassay System) was compared to the predicate (Power Processor connected to UniCel DxI 800 Access Immunoassay System). (Specific specifications are not provided, but compliance is affirmed). |
| Software Design, Development, and Verification | All software design, development, and verification activities have been completed. (This is a qualitative statement of completion rather than a specific performance metric). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for the method comparison studies. It mentions that the studies utilized CLSI EP09, which is a guideline for method comparison and bias estimation using patient samples, but the number of samples is not disclosed.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for an in vitro diagnostic device, the studies are typically conducted in a controlled laboratory setting, often in a prospective manner or using banked samples that meet specific criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The acceptance criteria and performance relate to the comparability of the new automation system and immunoassay tests against predicate devices, not against a "ground truth" established by experts for diagnostic accuracy in a clinical setting in the way an AI imaging device might. The "ground truth" here is the performance of the predicate device/system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are interpreting data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is an engineering/analytical performance study for a laboratory automation system and immunoassay tests.
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 not provided. MRMC studies are relevant for imaging devices where human readers are involved in the diagnostic process. This document concerns a laboratory automation system and immunoassay tests, not an AI-assisted diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The studies described are for the performance of the integrated system (DxA 5000 connected to the DxI 800 Access Immunoassay System running specific assays). While the system operates largely automatically (an "algorithm only" in the sense that the mechanical and analytical processes are automated), its performance is compared to a human-operated predicate system or another automated system. This is not an "AI algorithm only" study in the context of diagnostic decision support, but rather an automated analytical system comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance of the legally marketed predicate devices/systems:
- Power Processor Sample Processing System (K110413) for the DxA 5000's automation features.
- Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (K023764), Access® Ferritin assay (K926221), Access® Folate assay (K060774), Access® HYPER sensitive hTSH assay (K042281), and Access® Vitamin B12 assay (K955436) for the immunoassay performance in conjunction with the automation system.
The study aimed to demonstrate that the new device system yielded results "within specifications" when compared to the predicate, implying the predicate's performance served as the benchmark or "ground truth" for equivalence.
8. The sample size for the training set
This information is not applicable and not provided. This is a 510(k) submission for laboratory equipment and assays, not a machine learning/AI device requiring a "training set" in the computational sense. The "development" for such systems involves rigorous engineering, analytical validation, and verification based on established chemical, biological, and mechanical principles.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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(90 days)
TARRYTOWN NY 10591
Re: K171642
Trade/Device Name: Atellica IM Ferritin Assay Regulation Number: 21 CFR 866.5340
Regulation Number: 866.5340 Classification: Class II Product Code: DBF Atellica IM Ferritin Assay Trade
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (
Here's a breakdown of the acceptance criteria and study details for the Atellica IM Ferritin Assay, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | CLSI EP05-A3 guidelines (Evaluation of Precision Performance of Quantitative Measurement Methods) | Repeatability (Within-run): CV ranges from 1.2% to 3.5% for samples (4.2 ng/mL to 1453.6 ng/mL) and 1.2% to 1.6% for controls (51.8 ng/mL to 374.0 ng/mL). |
| Within-Lab (Total Imprecision): CV ranges from 4.0% to 7.2% for samples and 4.5% to 5.5% for controls. | ||
| Linearity/Assay Reportable Range | CLSI EP06-A (linearity of Quantitative Measurement Procedures). Implied: Acceptable percentage difference between observed and predicted values. | The linearity data supports an analytical measuring range of 0.9 - 1650 ng/mL. |
| Predicted % Difference (Y-Ŷ)/Ŷ*100: values ranged from -8.88% to 9.47% (excluding the lowest observed value of 0.20 ng/mL which was |
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(201 days)
| Clinical
Chemistry |
| Ferritin immunological test
system | 866.5340
The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.
The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.
The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.
The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.
A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."
Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:
| Acceptance Criterion (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Functional Equivalence of Software: All new and modified software features (Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery) perform their intended functions as safely and effectively as the predicate's software. | "Software design testing of: Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery" completed and passed. This implies the software functions as intended and supports the system's overall operation for sample processing and immunoassay integration. |
| System Operations: The overall system, including new hardware components (e.g., increased throughput, new control panel, more modules), processes samples reliably and correctly. | "System verification and validation testing of: System Functions, System operations, Maintenance, Error conditions, Error codes, Problem description and solution in the system instructions for use" completed and passed. This indicates that the integrated system operates as designed, handles various operational scenarios, and maintains user guidance for errors. The comparison table confirms improved throughput (1200 tubes/hour vs. 450 tubes/hour) and enhanced features (e.g., touch screen, improved cybersecurity, mixed tube sizes, dual aliquots, more centrifuges). |
| Assay Performance Maintenance: The performance of the integrated Access Immunoassays (Ferritin, Folate, HYPERsensitive hTSH, Vitamin B12) is not adversely affected by the Power Express system. | The document states, "Based on the risk analysis, the modifications to the Power Processor did not introduce any new risks to the performance of the assays through the chemistry analyzer connections; therefore there was no requirement for Verification and Validation Testing." This implies that the prior proven performance of these assays when run on the predicate system is maintained, and no new studies were deemed necessary to re-verify assay performance due to the nature of the system modifications. The device "functions as intended, meeting the requirements of the design specifications." |
| Safety and Effectiveness: The Power Express is as safe and effective as the predicate device. | "Performance testing of the device demonstrates that the device functions as intended... The changes to the device do not constitute a new intended use and any differences in technological characteristics have been tested to demonstrate that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.
- Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
- Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.
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 is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.
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. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:
- Expected software behaviors and outputs.
- Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
- Correct communication protocols with connected instruments and the LIS.
- Adherence to performance metrics like throughput.
- The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.
8. The sample size for the training set
Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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(259 days)
. § 866.5340)
Product Code DBF |
| Predicate
Devices:
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.
ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (µmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE Axcel Clinical Chemistry System. The test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
The ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sites of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
Prior to the ACE Hemoglobin A1c (HbA1c) Reagent assay, whole blood samples require a pretreatment step, which is done on-board the analyzer. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the agglutinator (synthetic polymer containing the immunoreactive portion of HbA1c) in the HbA1c Agglutinator Reagent and the antibody-coated microparticles in the HbA1c Antibody Reagent will agglutinate. The presence of HbA1c in the sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monitored monochromatically at 592 nm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution, which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA1c and total hemoglobin are measured, the ratio is calculated and the result reported as percent HbA1c.
The CEDIA T Uptake assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme which, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, enzyme donor thyroxine conjugate binds directly to the unoccupied thyroxine-binding sites in the sample, preventing the spontaneous re-association of the enzyme fragments to form the active enzyme. Thus, thyroxine-binding proteins regulate the amount of β-galactosidase formed from the reassembly of the remaining donor and enzyme acceptor as monitored by the hydrolysis of the substrate o-nitrophenyl-β-galactopyranoside.
The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NAD+) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD+ does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry System using a logarithmic calibration curve established with calibrators, which are provided separately.
In the Ferritin Assay, serum ferritin, in the presence of anti-ferritin conjugated latex micorparticles, and a buffer promoting aggregation, initiates an antigen-antibody reaction, resulting in the agglutination of the latex microparticles. The agglutination is detected turbidometrically by an absorbance change measured at a wavelength of 592 nm. The magnitude of the absorbance change is proportional to the ferritin concentration in the sample.
The provided text is a 510(k) summary for the Alfa Wassermann Diagnostic Technologies ACE Axcel Clinical Chemistry System and several associated reagents. It describes the devices, their intended uses, and technological characteristics. However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The content of the document focuses on:
- Identification of the device and reagents: Trade names, classifications, common names, and product codes.
- Predicate devices: Listing the previously approved systems and reagents used for comparison in the 510(k) submission.
- Device descriptions: Detailed explanations of the ACE Axcel Clinical Chemistry System's functionality and the biochemical principles of each reagent (HbA1c, CEDIA T Uptake, T4, Ferritin).
- Intended Use/Indications for Use: What each device/reagent is designed to measure and for what clinical purpose.
- Technological Characteristics: Specifications of the analyzer (throughput, reagent capacity, cooling, sample handling, optical system).
- Regulatory approval notice: A letter from the FDA indicating substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria from the provided text. The requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance studies is not present in this document.
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(30 days)
Regulation section: 21 CFR §866.5340 Ferritin immunological test system 21 CFR $862.1150 Calibrator
Trade/Device Name: K-Assay® Ferritin Reagent, K-Assay® Ferritin Calibrator Regulation Number: 21 CFR 866.5340
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.
The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.
The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Between-lot CV% |
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(154 days)
br>Reagent | N Latex Ferritin
reagent | K993273 | Class II | 866.5340
| ADVIA® Chemistry Liquid Specific Protein Calibrator |
| Regulation Number: | 21 CFR §866.5340
The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.
The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL. Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572
The document describes the Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Ferritin (FRT) Reagent and ADVIA® Chemistry Liquid Specific Protein Calibrator. The study presented focuses on the Ferritin Reagent and its comparison to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly based on the correlation between the new device and the predicate device. The primary performance metric reported is a method comparison study.
| Acceptance Criteria | Reported Device Performance (ADVIA 1650 Chemistry Ferritin vs. N Latex Ferritin) |
|---|---|
| Close correlation to predicate device | Slope: 1.00 (95% CI: 0.97 – 1.03) |
| Intercept: 0.00 (95% CI: -3.4 – 3.4) |
The reported performance, with a slope of 1.00 and an intercept of 0.00 (both with narrow confidence intervals that include these ideal values), indicates a very strong correlation and agreement with the predicate device, thereby meeting the implicit acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 47 patient samples
- Data Provenance: Not explicitly stated whether the samples were retrospective or prospective, nor their country of origin. The term "patient samples" is general.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The ground truth in this context is established by the measurements from the predicate device (N Latex Ferritin assay), which is an established, legally marketed device. There is no mention of experts establishing a separate ground truth for these samples.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study is a quantitative measurement comparison between two devices, not a diagnostic interpretation or classification that would typically involve an adjudication process by experts. Performance is determined by statistical correlation, not expert consensus on individual case interpretations.
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/provided. This device is an in vitro diagnostic reagent and calibrator for automated chemistry systems, not an imaging or interpretive AI device that involves human readers/interpreters. Therefore, an MRMC study or AI assistance comparison is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was done. The method comparison data presented is for the ADVIA 1650 Chemistry Ferritin assay (the new device) operating as an algorithm/system, without human interpretation influencing the measurement results directly. The output is a quantitative ferritin concentration.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the comparison study was effectively established by the predicate device's measurements (N Latex Ferritin assay). The new device's performance is being assessed against the established performance of the predicate device, assuming the predicate device provides accurate measurements within its validated range.
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes a comparison study for a fully developed reagent and calibrator, not a software algorithm that typically undergoes a training phase with a distinct training set. The development of the assay itself would involve internal validation and optimization, but details of such a "training set" are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable in the context of a reagent-based IVD requiring predicate comparison. For the development and internal validation of such a system, ground truth would typically be established through highly accurate reference methods, certified reference materials, or correlation with established laboratory methods to ensure accuracy and precision. However, details of this process for the new device's internal development are not part of the publicly available 510(k) summary.
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(117 days)
|
| | Regulation: 21 CFR 866.5340
JUN 2 2 2010
Re: K100538
Trade/Device Name: Tina-Quant Ferritin Gen. 4 Regulation Number: 21 CFR § 866.5340
Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.
The Tina-quant Ferritin Gen. 4 assay employs an immunoturbidimetric test in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 570/800 nm.
Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ferritin Gen. 4 Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Tina-quant Ferritin Gen. 4 Assay) |
|---|---|---|
| Precision (Repeatability - Within Run %CV) | (Generally, 0.95 or similar Passing-Bablok parameters demonstrating equivalence) | Passing Bablok: y = 0.987x + 0.040, tau = 0.983; Linear regression: y = 0.987x + 0.591, r = 0.999 |
| Measuring Range | Roche/Hitachi 902: 5 - 800 ng/mL; Roche/Hitachi 912/917/Modular P: 5 - 1000 ng/mL | Roche/Hitachi 902: 5 - 800 ng/mL; Roche/Hitachi 912/917/Modular P: 5 - 1000 ng/mL |
Note on Acceptance Criteria: The provided text explicitly states the "reported device performance" and sometimes compares it to the predicate device's performance, but it does not explicitly define quantitative acceptance criteria for each metric. The "Acceptance Criteria (Implied)" column above reflects the common expectations for these types of assays and the comparison points given in the document. The fact that the device received 510(k) clearance implies that the reported performance met the FDA's requirements for substantial equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision: The sample size for precision studies is not explicitly stated as a single number but lists 7 different samples (PNP, PPP, HS1-HS5) tested. For the predicate device's imprecision study, n=21. While "human samples and controls" are mentioned for the new device, specific numbers for each sample type are not provided beyond the samples tested.
- Method Comparison: 94 human serum and plasma samples.
- Interferences: No specific sample sizes for interference studies are provided; the results are reported as thresholds (e.g., "up to an I index of 60").
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "human samples and controls."
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 is an in vitro diagnostic (IVD) quantitative assay, not a device requiring expert interpretation of images or clinical data for ground truth. The "ground truth" for method comparison and precision in IVDs is typically established by measurements from a reference method (in this case, the predicate device) or by spiking known concentrations of the analyte. Therefore, the concept of "experts" establishing ground truth in the way described is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic assay, not an imaging or clinical decision support AI device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described (Precision, Analytical Sensitivity, Functional Sensitivity, Analytical Specificity, Interferences, Method Comparison) are all standalone performance evaluations of the assay itself, without human-in-the-loop performance being a variable. The "algorithm" here is the biochemical reaction and the instrument's measurement system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Precision: Internal analysis using human samples and controls. The "ground truth" here is the mean concentration determined by repeated measurements of the same sample.
- Analytical Sensitivity: Established internally through method validation, typically by analyzing blank samples and low-concentration samples.
- Functional Sensitivity: Established internally, usually based on the lowest concentration at which acceptable precision (e.g.,
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