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510(k) Data Aggregation
(94 days)
Tina-quant Transferrin ver.2 (urine application)
Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems.
A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically.
Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent.
The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the "Tina-quant Transferrin ver.2 (urine application) assay." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive human studies often seen with novel medical devices. Therefore, the information regarding acceptance criteria and study design will be primarily focused on analytical performance validation rather than multi-reader multi-case clinical studies involving human interpretation of images, as this is a laboratory reagent.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely implicit in the fact that "All data passed the predetermined acceptance criteria" for each analytical study. The performance is reported as the results of these studies.
| Performance Characteristic | Acceptance Criteria (Implicit: "All data passed the predetermined criteria") | Reported Device Performance |
|---|---|---|
| Precision | CV% and SD values within predefined limits. | Repeatability (within-run precision) |
| - PreciControl ClinChem Multi 1 | Not explicitly stated, but results passed. | Mean: 1.98 mg/dL, SD: 0.0140 mg/dL, CV: 0.7% |
| - PreciControl ClinChem Multi 2 | Not explicitly stated, but results passed. | Mean: 3.05 mg/dL, SD: 0.0242 mg/dL, CV: 0.8% |
| - Human Urine 1 | Not explicitly stated, but results passed. | Mean: 0.435 mg/dL, SD: 0.00979 mg/dL, CV: 2.3% |
| - Human Urine 2 | Not explicitly stated, but results passed. | Mean: 0.737 mg/dL, SD: 0.00920 mg/dL, CV: 1.2% |
| - Human Urine 3 | Not explicitly stated, but results passed. | Mean: 1.27 mg/dL, SD: 0.0107 mg/dL, CV: 0.8% |
| - Human Urine 4 | Not explicitly stated, but results passed. | Mean: 2.52 mg/dL, SD: 0.0184 mg/dL, CV: 0.7% |
| - Human Urine 5 | Not explicitly stated, but results passed. | Mean: 3.30 mg/dL, SD: 0.0252 mg/dL, CV: 0.8% |
| Intermediate Precision (within-lab precision) | Not explicitly stated, but results passed. | |
| - PreciControl ClinChem Multi 1 | Not explicitly stated, but results passed. | Mean: 1.98 mg/dL, SD: 0.0158 mg/dL, CV: 0.8% |
| - PreciControl ClinChem Multi 2 | Not explicitly stated, but results passed. | Mean: 3.05 mg/dL, SD: 0.0267 mg/dL, CV: 0.9% |
| - Human Urine 1 | Not explicitly stated, but results passed. | Mean: 0.435 mg/dL, SD: 0.0111 mg/dL, CV: 2.5% |
| - Human Urine 2 | Not explicitly stated, but results passed. | Mean: 0.737 mg/dL, SD: 0.0112 mg/dL, CV: 1.5% |
| - Human Urine 3 | Not explicitly stated, but results passed. | Mean: 1.23 mg/dL, SD: 0.0130 mg/dL, CV: 1.1% |
| - Human Urine 4 | Not explicitly stated, but results passed. | Mean: 2.52 mg/dL, SD: 0.0215 mg/dL, CV: 0.9% |
| - Human Urine 5 | Not explicitly stated, but results passed. | Mean: 3.30 mg/dL, SD: 0.0289 mg/dL, CV: 0.9% |
| Analytical Sensitivity | ||
| - Limit of Blank (LoB) | LoB Claim: 0.10 mg/dL (highest measurement for blank sample with stated prob.) | Lot #1: 0.0150 mg/dL, Lot #2: 0.0130 mg/dL, Lot #3: 0.0150 mg/dL |
| - Limit of Detection (LoD) | LoD Claim: 0.15 mg/dL (lowest detectable analyte concentration with 95% prob.) | Lot #1: 0.0382 mg/dL, Lot #2: 0.0331 mg/dL, Lot #3: 0.0353 mg/dL |
| - Limit of Quantitation (LoQ) | LoQ Claim: 0.22 mg/dL with 20% CV (lowest quantifiable concentration) | Lot #1: 0.124 mg/dL, Lot #2: 0.137 mg/dL, Lot #3: 0.143 mg/dL |
| Linearity/Assay Reportable Range | Linear relationship across the measuring range. | |
| - Measuring Range Claim | 0.22 to 3.5 mg/dL. | Confirmed. |
| - Pearson Correlation Coefficient (r) | Close to 1. | Lot 1: 0.9999, Lot 2: 0.9999, Lot 3: 0.9997 |
| Endogenous Interferences | No interference at specified concentrations. | |
| - Albumin | No interference ≤ 5000 mg/L. | Passed (tested at 5 g/L). |
| - Calcium | No interference ≤ 8 mmol/L. | Passed (tested up to 9.92/9.80 mmol/L). |
| - Citrate | No interference ≤ 10 mmol/L. | Passed (tested up to 11 mmol/L). |
| - Creatinine | No interference ≤ 44 mmol/L. | Passed (tested up to 88 mmol/L). |
| - Glucose | No interference ≤ 111 mmol/L. | Passed (tested up to 388 mmol/L). |
| - Hemoglobin | No significant interference up to 100 mg/dL. | Passed (tested up to 146/149 mg/dL). |
| - Immunoglobulin (IgG) | No interference ≤ 500 mg/L. | Passed (tested up to 1.1 g/L). |
| - Magnesium | No interference ≤ 75 mmol/L. | Passed (tested up to 75 mmol/L). |
| - Oxalate | No interference ≤ 2.2 mmol/L. | Passed (tested up to 3.75 mmol/L). |
| - Phosphate | No interference ≤ 40 mmol/L. | Passed (tested up to 130 mmol/L). |
| - Urea | No interference ≤ 1000 mmol/L. | Passed (tested up to 1500/1800 mmol/L). |
| - Uric Acid | No interference ≤ 6 mmol/L. | Passed (tested up to 6 mmol/L). |
| - Urobilinogen | No interference ≤ 15 mg/dL. | Passed (tested up to 15 mg/dL). |
| Exogenous Interferences – Drugs | No interference at therapeutic concentrations (except noted). | |
| - Acetaminophen | Not explicitly stated, but results passed up to 3000 mg/L. | No interference up to 3000 mg/L. |
| - Ascorbic acid | Not explicitly stated, but results passed up to 4000 mg/L. | No interference up to 4000 mg/L. |
| - Cefoxitin | Not explicitly stated, but results passed up to 12000 mg/L. | No interference up to 12000 mg/L. |
| - Gentamicin sulfate | Not explicitly stated, but results passed up to 400 mg/L. | No interference up to 400 mg/L. |
| - Ibuprofen | Not explicitly stated, but results passed up to 500 mg/L. | No interference up to 500 mg/L. |
| - Levodopa | Not explicitly stated, but results passed up to 1000 mg/L. | No interference up to 1000 mg/L. |
| - Methyldopa | Not explicitly stated, but results passed up to 2000 mg/L. | No interference up to 2000 mg/L. |
| - N-Acetylcysteine | Not explicitly stated, but results passed up to 10 mg/L. | No interference up to 10 mg/L. |
| - Ofloxacine | No interference. | Interference observed (artificially high results). Claim adjusted. |
| - Phenazopyridine | Not explicitly stated, but results passed up to 50 mg/L. | No interference up to 50 mg/L. |
| - Salicyluric acid | Not explicitly stated, but results passed up to 100 mg/L. | No interference up to 100 mg/L. |
| - Tetracycline | Not explicitly stated, but results passed up to 300 mg/L. | No interference up to 300 mg/L. |
| Method Comparison to Predicate | Predetermined acceptance criteria met. (e.g. slope near 1, intercept near 0, high r) | y = 1.007x + 0.0052, r = 0.995 (Passing Bablok Regression) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision and Analytical Sensitivity (LoB, LoD, LoQ):
- Precision (Repeatability and Intermediate Precision): 5 human urine sample pools and 2 control samples. Tested for 21 days, 1 run/day, with 2 aliquots per sample in singlicate per part. This setup generates a large number of individual measurements over time to assess variability.
- LoB: One analyte-free sample, measured 10-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
- LoD: Five human urine samples with low-analyte concentration, measured 2-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
- LoQ: A low-level sample set prepared by diluting 5 human urine samples, tested in 5 replicates per sample on 4 days, 1 run per day.
- Linearity/Assay Reportable Range: Dilution series prepared using human urine sample pools (number of pools not specified, but likely at least one concentrated pool), with 13 concentrations measured on 3 lots in triplicate.
- Endogenous Interferences: Two human urine pools (at two transferrin concentrations) were used for each interferent. Each pool was divided into two aliquots (spiked with interferent vs. solvent control). A dilution series of 11 steps was prepared and 3 aliquots per level were tested.
- Exogenous Interferences – Drugs: Two human urine sample pools (spiked with approximately 0.433 and 2.48 mg/dL transferrin concentrations) were used for each drug. Each pool was divided into two aliquots (drug spiked vs. solvent control), measured in triplicate.
- Method Comparison to Predicate: One hundred and seven (107) routine fresh, never-frozen human urine samples. Two samples were excluded (pH >8, value outside measuring range), so 107 samples were truly used in the comparison.
- Data Provenance: The document explicitly states "human urine samples" or "human urine sample pools." For the method comparison, samples were "routine fresh, never-frozen human urine samples." There is no specific mention of the country of origin, but Roche Diagnostics Operations (RDO) is located in Indianapolis, Indiana, USA, and Roche Diagnostics GmbH, Mannheim, Germany is also mentioned as having the establishment registration. The studies are prospective analytical validation studies conducted with collected samples, not retrospective analysis of clinical patient data in the typical sense for imaging.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) aims for quantitative measurement of a biomarker. Therefore, the "ground truth" is established through analytical reference methods, certified reference materials, or highly rigorous internal validation processes tied to metrological traceability, rather than human expert consensus on subjective findings (as would be the case for an imaging AI).
- The ground truth for the test set is established by the analytical measurement on the reference method (for method comparison study), and by the known concentrations/dilutions of samples prepared for analytical studies (e.g., linearity, sensitivity, interference).
- No "experts" in the sense of radiologists interpreting images were involved in establishing the ground truth for these analytical performance studies. The accuracy of measurements is verified against the reference standard or predetermined analytical values.
4. Adjudication Method for the Test Set
Not applicable for this type of analytical performance study. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where multiple human readers independently assess data (like images) and then a consensus or tie-breaking mechanism is needed to establish ground truth or assess agreement. For an IVD, the "truth" is typically defined by the analytical method itself or a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a quantitative laboratory assay (a reagent for measuring transferrin in urine), not an AI imaging algorithm that assists human readers. No MRMC study was performed as it is irrelevant to the device's function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the analytical performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) represent the "standalone" performance of the assay itself (the reagent/instrument system) without human intervention in the result generation beyond operating the analyzer according to instructions. This is the primary form of performance evaluation for an IVD.
7. The Type of Ground Truth Used
- For Precision, Analytical Sensitivity, Linearity, and Interference studies: The ground truth is effectively derived from known concentrations in prepared samples (e.g., analyte-free samples, low-concentration samples, dilution series, spiked samples) or reference materials/controls with established values.
- For Method Comparison: The ground truth is the measurement obtained from the predicate device, the "N Antisera to Human Transferrin (Siemens) on the BN ProSpec analyzer." This establishes substantial equivalence to an already legally marketed device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires "training data" in the conventional sense. It's a chemical reagent for an established analytical method (immunoturbidimetry). The development process would have involved formulation and optimization, but not "training" on a data set in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD, which relies on chemical and immunological principles rather than machine learning from data.
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(54 days)
TINA-QUANT TRANSFERRIN VER.2
The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
Here's an analysis of the provided information regarding the Tina-quant Transferrin ver.2 device, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for Tina-quant Transferrin ver.2 establishes substantial equivalence to a predicate device (COBAS Integra Tina-quant Transferrin). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, against which the new device is compared. The reported performance of the new device demonstrates it meets or surpasses the predicate's performance.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Transferrin ver.2) |
|---|---|---|
| Intended Use | Quantitative immunological determination of human transferrin in serum (and other body fluids, for predicate) | Quantitative immunological determination of human transferrin in serum and plasma |
| Indication for Use | Aids in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia) | Aids in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia) |
| Assay Protocol | Immunoturbidimetric assay | Immunoturbidimetric assay |
| Instrument | COBAS Integra Clinical Chemistry Analyzers | COBAS Integra Clinical Chemistry Analyzers |
| Traceability/Standardization | Standardized against CRM 470 (RPPHS) | Standardized against CRM 470 (RPPHS) |
| Sample Type | Human serum (and plasma, other body fluids for predicate) | Human serum and plasma |
| Measuring Range | 80 – 1280 mg/dL (or 0.8 - 12.8 g/L) | 1.3 - 520 mg/dL (or 0.013 - 5.2 g/L) |
| Intra-assay Precision (% CV) | 1.5% at 1.10 g/L, 0.83% at 3.32 g/L | 0.86% at 1.35 g/L, 0.77% at 3.36 g/L |
| Between Day Precision (% CV) | 1.6% at 1.10 g/L, 0.97% at 3.32 g/L | 1.8% at 1.32 g/L, 1.9% at 3.70 g/L |
| Analytical Sensitivity (LDL) | 0.58 g/L | 0.013 g/L |
| Method Comparison (Correlation) | y = 1.06x + 0.01 g/L, r = 0.958 (vs. nephelometric determination) | y = 1.06x + 0.03, r = 0.996 (vs. predicate device) |
| Limitations (Interference) | Icterus: No significant interference; Hemolysis: No significant interference; Lipemia: No significant interference; Rheumatoid factors: No significant interference | Icterus: No significant interference; Hemolysis: No significant interference; Lipemia: No significant interference up to 500 mg/dL; Rheumatoid factors: No significant interference; Gammopathy (IgM): Flagged "High Act", correctable by post-dilution. |
| Calibration Frequency | After reagent lot change | After reagent lot change |
| Expected Values | 2.0 – 3.6 g/L (200 – 360 mg/dL) | 2.0 – 3.6 g/L (200 – 360 mg/dL) |
Summary of how the device meets acceptance criteria:
The Tina-quant Transferrin ver.2 demonstrates substantial equivalence to the predicate device. It maintains the same intended use, indications for use, assay protocol, and instrument compatibility. Its precision (intra-assay and between-day) is comparable to, and in some cases better than, the predicate. A notable improvement is the significantly lower analytical sensitivity (LDL), indicating better detection of low transferrin levels. The method comparison shows a strong correlation with the predicate device, further supporting its equivalence. The limitations regarding common interferences are similar or explicitly managed (e.g., Gammopathy for the new device).
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to the data as "performance characteristics" and "method comparison."
- Method Comparison: The equation
y = 1.06x + 0.03withr = 0.996implies a regression analysis was performed, comparing the new device (Y) to the predicate device (X). However, the specific sample size (number of patient samples) used for this comparison is not explicitly stated. - Precision (Intra-assay and Between-day): These studies typically involve multiple replicates of control or patient samples. The exact number of samples or replicates is not specified.
- Limitations (Interference): These studies typically involve spiking known interferents into samples. The number of samples used for these interference studies is not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is generally assumed that studies for FDA submissions are conducted under controlled conditions, often in a prospective manner, but details are absent here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic imaging or subjective biomarker interpretation. For an immunological quantitative assay like transferrin, the "ground truth" is established by a reference method or a validated predicate device.
- For Method Comparison: The predicate device itself (COBAS Integra Transferrin) serves as the reference for comparison. The predicate device's performance was, in turn, previously established against a "nephelometric determination" (another analytical method) for its own method comparison, with an
r = 0.958. - For Standardization: Both devices are standardized against the CRM 470 reference preparation, which corresponds to RPPHS (Reference Preparation Protein in Human Serum). This is a primary standard, not derived from expert consensus.
Therefore, the concept of "experts establishing ground truth" as you might see in imaging (e.g., radiologists) is not applicable in the same way for this type of quantitative biochemical assay. The ground truth is the analytically measured concentration against recognized standards.
4. Adjudication Method for the Test Set
Again, for a quantitative biochemical assay, an "adjudication method" (like 2+1 or 3+1 for clinical diagnoses) is not typically employed. The results are numerical values output by the instrument. Any discrepancies between the new device and the predicate are analyzed statistically (e.g., correlation, bias), not through clinical adjudication in the human sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study investigates how human readers (e.g., clinicians, radiologists) perform with and without AI assistance on various cases. The Tina-quant Transferrin ver.2 is a fully automated in-vitro diagnostic reagent system that provides a quantitative measurement; it does not involve human interpretation in a diagnostic workflow that could be "assisted" by AI in the MRMC sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is essentially a standalone system in that it provides a direct quantitative measurement. The "performance characteristics" (precision, analytical sensitivity, measuring range, interference) represent the performance of the algorithm/reagent system without human intervention influencing the measurement itself. The results are then read and interpreted by a human user, but the measurement is algorithmic. So, in essence, its core performance evaluation is "standalone."
7. The Type of Ground Truth Used
The ground truth for evaluating the Tina-quant Transferrin ver.2 is primarily established through:
- Reference Standards: Standardization against the CRM 470 (RPPHS) reference preparation.
- Comparison to a Validated Predicate Device: The performance of the new device is directly compared to an already legally marketed and accepted device (COBAS Integra Tina-quant Transferrin). This predicate device itself had its performance validated against other established analytical methods (e.g., nephelometric determination).
- Analytical Measurement: The inherent analytical capabilities of the immunoturbidimetric assay technology to accurately quantify transferrin concentration.
8. The Sample Size for the Training Set
This document describes a premarket submission for a medical device that is a reagent system for a laboratory assay. It is not an AI/ML-based device in the common sense that would involve a "training set" for model development. The parameters and performance of such a device are determined through chemical and mechanical engineering, and extensive analytical validation. Therefore, the concept of a "training set sample size" as used for AI/ML algorithms does not apply to this specific device.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and associated "ground truth" (in the context of AI/ML) is not applicable to this device. For traditional in-vitro diagnostic assays, the "ground truth" for calibrating the system and establishing its performance involves using precisely characterized reference materials (like CRM 470) and known concentrations of analytes, which are then used to set the instrument's calibration curve and validate its analytical accuracy across its measuring range.
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(55 days)
TINA-QUANT TRANSFERRIN VER.2
Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the reaction to progress rapidly to the end point and increases sensitivity.
This is a submission for a medical device (specifically, an in-vitro diagnostic assay) rather than a software-as-a-medical-device (SaMD) or AI/ML device. Therefore, many of the requested elements (like "experts used to establish ground truth," "adjudication method," "MRMC study," and "training set") are not applicable in the context of this traditional assay. The performance is evaluated through analytical studies, not clinical studies involving human interpretation of AI outputs.
Here's the information that can be extracted from the provided text, adapted for an in-vitro diagnostic assay:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalent or improved performance characteristics compared to the predicate device.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Transferrin ver.2) |
|---|---|---|
| Intended Use | Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. | Equivalent: Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. |
| Indication for Use | Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. | Equivalent: Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. |
| Measuring Range (Roche/Hitachi 704/902) | 80 - 500 mg/dl | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) |
| Measuring Range (Roche/Hitachi 717/747) | 80 - 500 mg/dl (Extended with rerun: 80 - 1000 mg/dl) | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) (Extended with rerun: 0.02 - 7.50 g/l (1-750 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Measuring Range (Roche/Hitachi 904/911/912/917/Modular P) | 15 - 500 mg/dl | Improved: 0.007 - 5.20 g/l (0.7 - 520 mg/dl) (Extended with rerun: 0.007 - 7.80 g/l (0.7 - 780 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Intra-assay precision (% CV) - Human Sera | 0.8% at 169 mg/dl | Comparable/Improved: 1.0% at 1.36 g/l (136 mg/dl), 2.7% at 3.59 g/l (359 mg/dl). Precision is concentration-dependent; the values are generally comparable across similar concentrations but the ver.2 provides more data points. |
| Intra-assay precision (% CV) - Controls | 0.8% at 217 mg/dl, 0.8% at 403 mg/dl | Comparable/Improved: 2.1% at 2.90 g/l (290 mg/dl), 1.0% at 4.31 g/l (431 mg/dl). Similar for controls, concentration-dependent, providing comparable performance across ranges. |
| Between Day Precision (% CV) - Human Sera | 3.0% at 169 mg/dl | Improved: 0.0% at 1.60 g/l (160 mg/dl), 1.4% at 3.38 g/l (338 mg/dl). Shows better or comparable between-day precision at different concentrations to the predicate. |
| Between Day Precision (% CV) - Controls | 1.4% at 217 mg/dl, 1.5% at 403 mg/dl | Comparable/Improved: 1.7% at 2.88 g/l (288 mg/dl), 1.4% at 4.35 g/l (435 mg/dl). Similar between-day precision for controls. |
| Icterus Interference | No significant interference from bilirubin up to an I index of 60 | Equivalent: No significant interference with up to an I index of 60 |
| Hemolysis Interference | No significant interference from hemoglobin up to an H index of 1000 | Equivalent: No significant interference up to an H index of 1000 |
| Lipemia Interference | No significant interference from lipemia up to an L index of 600 | Comparable: No significant interference up to an L index of 500 (slight reduction compared to predicate's L index of 600) |
| Rheumatoid Factors Interference |
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