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510(k) Data Aggregation
. § 862.1635)
Product Code CEK | |
| | Trade
ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.
In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.
Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.
Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.
ACE Albumin Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.5-1.6%, Total: 0.6-1.8% |
| Plasma: Within-Run: 0.8-1.7%, Total: 1.1-1.7% | ||
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.956 - 1.002 |
| Intercept: -0.01 - 0.20 | ||
| Correlation: 0.9850 - 0.9905 | ||
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 7.6 g/dL |
| y = 0.980x + 0.01, r^2 = 0.9982 | ||
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.09 g/dL, LoQ: 0.09 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 60 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Total Protein Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.3%, Total: 0.8-1.4% |
| Plasma: Within-Run: 0.5-1.3%, Total: 0.7-1.4% | ||
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.994 - 1.001 |
| Intercept: 0.12 - 0.34 | ||
| Correlation: 0.9798 - 0.9885 | ||
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 15.1 g/dL |
| y=0.991x + 0.04, r^2 = 0.9979 | ||
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.13 g/dL, LoQ: 0.20 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 56.8 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 929 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Calcium-Arsenazo Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.6%, Total: 0.9-2.7% |
| Plasma: Within-Run: 0.5-1.9%, Total: 1.1-2.0% | ||
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.978 - 1.008 |
| Intercept: -0.06 - 0.33 | ||
| Correlation: 0.9793 - 0.9911 | ||
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 16.5 mg/dL |
| y=0.992x +0.27, r^2 = 0.9990 | ||
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.09 mg/dL, LoD: 0.11 mg/dL, LoQ: 0.23 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 58.8 mg/dL, Hemolysis: 1000 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Inorganic Phosphorus U.V. Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.3-4.4%, Total: 0.5-5.0% |
| Plasma: Within-Run: 0.9-5.1%, Total: 0.9-6.1% | ||
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.999 - 1.049 |
| Intercept: -0.28 - 0.04 | ||
| Correlation: 0.9927 - 0.9950 | ||
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 21 mg/dL |
| y=1.001x +0.03, r^2 = 0.9995 | ||
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.25 mg/dL, LoD: 0.35 mg/dL, LoQ: 0.35 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 11.5 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 306 mg/dL, Ascorbic Acid: 6 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."
- In-House Precision (Serum vs. Plasma):
- Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
- In-House Matrix Comparison: Serum vs. Plasma:
- Sample Size:
- Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
- Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
- Sample Size:
- POL (Physician Office Laboratory) - Precision:
- Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
- Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
- POL (Physician Office Laboratory) - Method Comparison:
- Sample Size:
- Albumin: 50 samples for each POL site (x3 POLs)
- Total Protein: 51 samples for each POL site (x3 POLs)
- Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
- Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
- Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
- Sample Size:
- Detection Limits & Linearity (ACE Alera):
- Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
- Data Provenance: In-House, prospective.
- Interference (ACE Alera):
- Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
- Data Provenance: In-House, prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.
- For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
- For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
- For linearity, samples of known, graded concentrations are used.
- For detection limits, the ground truth involves samples with very low, known concentrations.
These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:
- Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
- Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
- Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.
These methods establish the quantitative "truth" against which the performance of the new reagents is measured.
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Name: Routine chemistry analyzer for TP Routine chemistry analyzer for ALB
Classifications: 21 CFR § 862.1635
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| Device Class, Regulation Code | Class II, Exempt, Reserved, 21 CFR
862.1635
The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.
The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters. calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).
System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridges TP and ALB.
Chemistry reactions: (TP) Proteins in samples react with the biuret reagent to form a purplered complex. The concentration of total protein can be determined by measuring the absorbance of the purple-red substance.
(ALB) Albumin in the sample combines with bromcresol green to form a blue-green dye conjugate. The albumin concentration is directly proportional to the color intensity and can be determined photometrically by measuring the absorbance of this resulting blue-green color.
The provided document is a 510(k) summary for the Hitachi S TEST Reagent Cartridge Total Protein (TP) and Albumin (ALB). It details the nonclinical and clinical studies performed to demonstrate the safety and effectiveness of these in-vitro diagnostic devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a singular, formal table. Instead, performance characteristics are presented as results from various studies, often implicitly comparing them to the predicate device or general industry standards (e.g., CLSI guidelines). The performance characteristics are reported as the outcome of the tests performed.
Below is a table summarizing the reported device performance for both TP and ALB, drawing from the "Technological Similarities and Differences to the Predicate" section and the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections. Implicit acceptance is typically shown by these results being deemed "safe and effective for their intended uses."
Hitachi S TEST Reagent Cartridge: Reported Device Performance
| Performance Characteristic | Total Protein (TP) Reported Performance | Albumin (ALB) Reported Performance |
|---|---|---|
| Analytical Sensitivity (Limits of Detection) | 0.2 g/dL | 0.1 g/dL |
| Quantitation Limit | 0.2 g/dL | 0.5 g/dL |
| Linearity/Reportable Range | 0.2 to 11.0 g/dL | 0.1 to 8.0 g/dL (Linearity) / 0.5 to 8.0 g/dL (Reportable Range) |
| In-house Precision (%CV Total) | 1.0% to 2.5% | 1.6% to 4.8% |
| External Site Precision (%CV Total) | 0.7% to 4.4% (across 3 sites) | 0.0% to 4.8% (across 3 sites) |
| Interference (Recovery 90-110%) TP | Unconjugated bilirubin: up to 50 mg/dL | |
| Lipemia: up to 500 mg/dL | ||
| Ascorbic acid: up to 50 mg/dL | ||
| Hemoglobin: up to 1,000 mg/dL | Not applicable | |
| Interference (Recovery 90-110%) ALB | Not applicable | Hemoglobin: up to 250 mg/dL |
| Unconjugated bilirubin: up to 12.5 mg/dL | ||
| Lipemia: up to 500 mg/dL | ||
| Ascorbic acid: up to 50 mg/dL | ||
| Method Comparison (n, r, Slope CI, Y-intercept CI) - Internal | n=115, r=0.989, Slope=1.02 (1.01-1.04), Y-intercept=0.01 (-0.13-0.15) | n=118, r=0.975, Slope=1.01 (0.96-1.06), Y-intercept=0.24 (0.06-0.41) |
| Method Comparison (n, r, Regression Eq.) - External POL Sites | Site 1: n=52, r=0.996, y=0.98x+0.14 | |
| Site 2: n=52, r=0.994, y=1.00x-0.07 | ||
| Site 3: n=53, r=0.996, y=0.96x+0.03 | Site 1: n=87, r=0.982, y=0.99x+0.24 | |
| Site 2: n=81, r=0.979, y=0.95x+0.30 | ||
| Site 3: n=81, r=0.985, y=0.91x+0.35 | ||
| Matrices Comparison (n, r, Slope CI, Y-intercept CI) - TP | Heparinized: n=45, r=0.989, Slope=1.00 (0.96-1.04), Y-int=-0.11 (-0.43-0.21) | |
| EDTA: n=45, r=0.992, Slope=1.00 (0.96-1.04), Y-int=-0.06 (-0.33-0.22) | ||
| Na Citrate: n=45, r=0.987, Slope=0.98 (0.93-1.03), Y-int=-0.09 (-0.45-0.26) | Not applicable | |
| Matrices Comparison (n, r, Slope CI, Y-intercept CI) - ALB | Not applicable | Heparinized: n=41, r=0.992, Slope=0.99 (0.95-1.03), Y-int=-0.01 (-0.20-0.18) |
| EDTA: n=41, r=0.995, Slope=0.95 (0.92-0.98), Y-int=0.22 (0.08-0.36) | ||
| Na Citrate: n=41, r=0.986, Slope=1.00 (0.94-1.05), Y-int=-0.22 (-0.48-0.03) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes test sets for various studies:
- Method Comparison (Internal):
- TP: 115 clinical specimens
- ALB: 118 clinical specimens
- Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Described as "clinical specimens."
- Matrices Comparison:
- TP: 45 matched serum/plasma samples
- ALB: 41 matched serum/plasma samples
- Provenance: Not explicitly stated.
- External Site Precision Study:
- TP: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
- ALB: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
- Provenance: "three external POL-type sites," implying clinical settings, likely within the US given the submission to the FDA. Retrospective/prospective not specified for the samples, but the testing itself was prospective within the study timeframe.
- External Method Comparison Studies (POL Accuracy Data Summary):
- TP: Approximately 50-80 serum specimens per site (n=52, 52, 53). Total around 157.
- ALB: Approximately 50-80 serum specimens per site (n=87, 81, 81). Total around 249.
- Provenance: "three external POL-type sites," implying clinical settings, likely within the US. Retrospective/prospective not specified for samples but the comparative testing was prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This document describes a diagnostic device for quantitative determination of Total Protein and Albumin. For such devices, "ground truth" is typically established by recognized reference methods, not by expert consensus (e.g., radiologists).
- Method Comparison (Internal and External): The comparison was made against a "standard laboratory system" or "comparative method as the reference method (x)." The specific details of this reference method are not given beyond its use for comparison. No information is provided about human expert involvement in establishing this ground truth.
4. Adjudication Method for the Test Set
Not applicable. Diagnostic devices like this establish their accuracy against a reference method, not through human adjudication of results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is an in-vitro diagnostic device that provides quantitative measurements. MRMC studies are relevant for imaging devices or those requiring human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, all studies described (analytical sensitivity, linearity, precision, interference, method comparisons, matrices comparisons) represent the standalone performance of the device (Hitachi Clinical Analyzer E40 with S TEST Reagent Cartridges) in measuring TP and ALB concentrations in samples. These are automated processes without direct human interpretation of results for the purpose of the measurement itself. Human operators are involved in running the analyzer, but the "performance" here refers to the device's analytical capability.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established using:
- Reference Methods/Standard Laboratory Systems: For method comparison studies, the device's results (Y) were compared to a "standard laboratory system" or "comparative method" (X). This is a common approach for establishing accuracy of new in-vitro diagnostic devices.
- CLSI Guidelines: Studies like Analytical Sensitivity, Linearity, and Precision followed CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A, EP-6A, EP5-A2). These guidelines define how to determine these performance characteristics, often involving reference materials or established statistical methods for calculation rather than external ground truth.
- Defined Concentrations: For precision and interference studies, samples were used that represented specific (low, middle, high) or known concentrations of the analytes.
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. This is a traditional in-vitro diagnostic device based on chemical reactions and photometric measurements. Its "development" would involve optimizing reagents and calibration, not "training" an algorithm in the AI sense. Therefore, the concept of a training set as understood in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As noted in #8, there is no "training set" in the context of AI/ML for this device. The ground truth for developing and calibrating such devices typically relies on:
- Primary Reference Materials: Highly characterized materials with known concentrations of analytes.
- Secondary Reference Materials: Materials traceable to primary reference materials.
- Validated Reference Methods: Established and highly accurate methods, often more complex or expensive, used to assign values to control or calibration materials.
The document implicitly refers to these as part of "assay performance claims were established on the HITACHI Clinical Analyzer."
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(240 days)
. § 862.1635 | |
| | Regulation
The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.
In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.
The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.
The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.
The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.
The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.
Acceptance Criteria and Device Performance Study for ACE Reagents
The provided 510(k) summary (K113374) describes the performance of four reagents: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, when used with the Alfa Wassermann ACE Axcel Clinical Chemistry System. The study establishes the substantial equivalence of these devices to their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "CV must be
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(121 days)
| §862.1635
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Creatinine 120 CP and ABX PENTRA Total Protein 100 CP devices, based on the provided text:
Acceptance Criteria and Device Performance
The devices are in vitro diagnostic assays, and their performance is described in terms of analytical characteristics. The stated performance data implicitly serve as the acceptance criteria for the devices to be considered substantially equivalent to their predicate devices.
ABX PENTRA Creatinine 120 CP
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Serum, Plasma and Urine compatibility | Serum, Plasma and Urine |
| Detection limit | Specified limits for serum/plasma and urine | Serum/Plasma: 0.18 mg/dl; Urine: 1.39 mg/dl |
| Accuracy and Precision | CV Total below specified percentages | Serum/Plasma CV Total |
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(31 days)
| JGQ | Total Protein test system | 21 CFR 862.1635
46250-0416
Re: K072638
Trade/Device Name: Roche/Hitachi Urinary/CSF Protein Regulation Number: 21 CFR 862.1635
In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as metabolic or nutritional disorders.
Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.
CSF protein measurements are used in diagnosis and treatment of conditions such as meningitis, brain tumors and infections of the central nervous systems.
The Roche/Hitachi Urinary/CSF Protein reagent is an in vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers.
The modified device includes both the original endpoint assay and the additional rate assay. The new rate assay was developed to provide absorbance limits that will flag high protein samples with high absorbance, thus eliminating the need for prescreening samples for high protein levels. The endpoint assay still requires sample prescreening or inspection of the Reaction Monitor display after completion of the reaction to ensure that high samples are detected and appropriately diluted for rerun. The attached labeling provides a more complete description of this potential high sample / prozone effect.
Here's an analysis of the provided 510(k) summary regarding the Roche/Hitachi Urinary/CSF Protein test, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) Special Modification submission, which focuses on comparing a modified device (with an added "rate" application) to a predicate device (the original "endpoint" application). Therefore, the "acceptance criteria" discussed are largely implicit in demonstrating substantial equivalence to the predicate, with performance characteristics being compared directly.
| Feature / Criteria | Predicate Device Performance (Endpoint Assay, K913615) | Modified Device Performance (Rate Application) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Intended Use | For the quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF). | In vitro test for the quantitative determination of protein in urine and cerebrospinal fluid on Roche automated clinical chemistry analyzers. | Maintain intended use of predicate. |
| Specimen | Urine and CSF | Same | Same specimen types as predicate. |
| Application | Endpoint assay | Endpoint and Rate application | New rate application should be equivalent to or improve upon endpoint. |
| Measuring Range (Urine) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Measuring Range (CSF) | 2-200 mg/dL | 6-200 mg/dL (Rate Assay) | Equivalent or improved measuring range. |
| Lower Detection Limit (Urine) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Lower Detection Limit (CSF) | 2 mg/dL | 6 mg/dL (Rate Assay) | Acceptable detection limit for clinical use, comparable to predicate. |
| Expected Values | Urine Random: |
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(134 days)
| JGQ | Total Protein test system | 21 CFR 862.1635
Test System Regulation Number: 21 CFR 862.1635 Regulation Name: Total Protein test system Regulatory
In vitro test for the quantitative determination of the total protein in urine and cerebrospinal fluid on the COABS INTEGRA systems.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidnev or bone marrow as well as metabolic or nutritional disorders.
Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders, which are characterized by proteinuria or albuminuria.
CSF protein measurements are used in diagnosis and treatment of disease conditions such as meningitis, brain tumors and infections of the central nervous systems.
C.f.a.s. (Calibrator for automated systems) TPUC 200 is for use in the calibration of quantitative determination of protein in urine (U) and cerebrospinal fluid (CSF) on COBAS INTEGRA analyzers and Roche/Hitachi cobas c systems.
The COBAS INTEGRA Total Protein Urine/SCG Gen. 3 reagent is intended for use on the COBAS INTEGRA systems for the quantitative determination of protein in urine and cerebrospinal fluid.
Here's a breakdown of the acceptance criteria and study information for the Total Protein Urine/CSF Gen. 3 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it compares the performance of the modified device (Total Protein Urine/CSF Gen. 3 on COBAS INTEGRA and Roche/Hitachi platforms) against its predicate device (Roche/Hitachi Total Protein Urine/CSF K913615) for various features. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device, meaning the new device performs as well as or better than the predicate for key parameters.
Here's a table summarizing the reported device performance, with the understanding that for most parameters, the 'acceptance' is that the modified device's performance aligns with or improves upon the predicate.
| Feature | Predicate Device Performance (Roche/Hitachi Total Protein Urine/CSF K913615) | Modified Device Performance (Total Protein Urine/CSF Gen. 3) |
|---|---|---|
| Intended Use/Indications for Use | In vitro test for quantitative determination of protein in urine (U) and CSF | Same |
| Specimen | Urine and CSF | Same |
| Application | Endpoint assay | Same |
| Test Principle | Turbidimetric | Same |
| Reagent Composition | R1: Sodium hydroxide 530 mmol/L, EDTA sodium, 74 mmol/L; R2=SR: Benzethonium chloride 32 mmol/L | Same |
| Stability (Shelf-life) | 20-25 °C until expiration date | Roche/Hitachi: 15-25 °C until expiration date |
| Stability (On-board) | R1: 3 weeks on board at 2-12 °C; R2: 3 weeks on board at 2-12 °C | Roche/Hitachi: R1: 21 days on board and refrigerated; R2: 21 days on board and refrigerated |
| COBAS INTEGRA 400/400 plus: 12 weeks on board at 10 to 15°C | ||
| COBAS INTEGRA 700/800 plus: 6 weeks on board at 10 to 15°C | ||
| Quality Control | Commercially available urine and CSF protein controls | Roche/Hitachi: Same |
| COBAS INTEGRA: Same | ||
| Traceability | Standardized against National Bureau of Standards Reference Material SRM 927 using the biuret method. | Same |
| Precision (Urine - Within Run) | 2.25% @ 17.9 mg/dL; 0.5% @ 102.2 mg/dL | Roche/Hitachi: 1.9% @ 21 mg/dL; 1.0% @ 67.3 mg/dL |
| COBAS INTEGRA: 2.8%@ 89 mg/L; 1.4% @ 227 mg/L; 0.4% @ 616 mg/L | ||
| Precision (Urine - Total/Between day) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL | Roche/Hitachi: 1.7% @ 34.5 mg/dL; 1.1% @ 114.37 mg/dL |
| COBAS INTEGRA: 1.3% @ 91 mg/L; 1.0% @ 229 mg/L; 0.6% @ 613 mg/L | ||
| Precision (CSF - Within Run) | 3.05% @ 17.9 mg/dL; 0.8% @ 102.2 mg/dL * (Listed as Urine, likely a typo) | Roche/Hitachi: 0.9% @ 23.1 mg/dL; 0.7% @ 53.6 mg/dL |
| COBAS INTEGRA: 0.5% @ 345 mg/L; 0.3% @ 867 mg/L | ||
| Precision (CSF - Total/Between day) | 1.9% @ 18.1 mg/dL; 1.03% @ 102.4 mg/dL | Roche/Hitachi: 1.0% @ 29.3 mg/dL; 0.6% @ 90.2 mg/dL |
| COBAS INTEGRA: 0.9% @ 346 mg/L; 0.6% @ 867 mg/L | ||
| Measuring Range (Linearity) | Analyzer specific linearity claims: 2-200 mg/dL (Hitachi 717) | Roche/Hitachi: 2-200 mg/dl (20-2000 mg/l) with dilution capability |
| COBAS INTEGRA: 40-2000 mg/L (Extended to 40-6000 mg/L with post dilution factor of 3) | ||
| Lower Detection Limit | Not specified | Roche/Hitachi: 20 mg/L |
| COBAS INTEGRA: 40 mg/L | ||
| Expected Values | Urine 24h: |
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(469 days)
Class Classification Name: Product Code:
ABX PENTRA Total Protein CP
Total Protein Class II §862.1635
Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.
Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.
The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.
The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.
The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.
The provided text describes performance data for a set of reagents, controls, and calibrators used with the ABX PENTRA 400 clinical chemistry analyzer. The studies conducted are in vitro diagnostic assay performance evaluations, not studies involving human readers or clinical outcomes in the same way an AI-powered diagnostic device would be evaluated. As such, several requested items (MRMC study, expert ground truth, adjudication methods) are not applicable to this type of submission.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The provided tables summarize the performance characteristics. The document states that "The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." While specific numeric acceptance criteria for each metric (e.g., "CV Total must be
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862.1035 |
| Total Protein | 903511 | II | Mkted prior 5/76 | 862.1635
Protein | 862.1635
The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.
The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.
The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.
However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."
| Performance Metric | Acceptance Criteria (Implied/Referenced) | Reported Device Performance |
|---|---|---|
| Imprecision | Acceptable/equivalent results (Implied) | Serum controls give acceptable/equivalent results using the described procedure for within run and total imprecision with each of the representative test methods (Synermed, Medical Analysis Systems, and STANBIO Laboratory Reagents, as shown in Table 1 and Table 2 vs insert values). |
| Correlation | Acceptable results (Implied) | Slopes, Intercepts and Correlation Coefficients show acceptable results. The regression (slope and intercept) and correlation coefficients are shown in Table 3 and Graphs 1-21. Acceptable results are shown between both methods (STANBIO Laboratory Reagents vs. Synermeds® or Medical Analysis Systems Reagents). |
| Linearity | Not exceeding Manufacturers' claim | Linearity did not exceed the Manufacturers' claim (shown in Table 4 vs insert values). A comparison is made between STANBIO Laboratory Reagents and the Least Square line to establish linearity. |
| Recovery | Acceptable results for assigned ranges | Acceptable results are shown between both methods (using assigned control serums ranges, shown in Table 5). |
| Normal Range | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
| Sensitivity | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
| Stability | Remains as recommended by manufacture | Parameters were not tested, assumed to remain as recommended by manufacture as no modifications to STANBIO Laboratory Reagents or packaging. |
2. Sample Size Used for the Test Set and Data Provenance:
- Imprecision: Two control serums were used for both within-run and total precision.
- Within-run: Up to 20 repeats.
- Total precision: Duplicates for up to 20 days.
- Correlation: "about 100 serums" were used.
- Linearity: "Commercially available linearity material" was assayed.
- Recovery: "Commercial available Controls with assigned values" were used.
Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.
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" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.
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 is not applicable as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established by:
- Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
- Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.
This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.
8. The Sample Size for the Training Set:
This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).
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(58 days)
| 862.1635
The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ANALETTE™ clinical chemistry analyzer and Medical Analysis Systems Reagents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a submission for substantial equivalence (510(k)) for the ANALETTE™ clinical chemistry analyzer using Medical Analysis Systems (MAS) Reagents, comparing it to the same ANALETTE™ analyzer using Synermeds® 072 reagents (the predicate device). The core of the acceptance criteria here is the demonstration of "substantial equivalence" of the new reagent system to the predicate. Specific quantitative acceptance criteria are not explicitly detailed in the provided text in the form of numerical thresholds for accuracy, precision, or comparison studies. Instead, the performance section broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to the predicate device (ANALYETTE™ with Synermeds® 072 reagents) | "Substantially equivalence was established in comparative studies. It was concluded from these results that this product is safe and effective." |
| Effective performance for the quantitative determination of various analytes in solution (serum, plasma, or urine). | The device is intended for the quantitative determination of a comprehensive list of analytes (Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol (includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lipase, Chloride). The statement of substantial equivalence implies effective performance. |
| Safety of the device. | "It was concluded from these results that this product is safe and effective." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "comparative studies" were conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a clinical chemistry analyzer, the ground truth is typically established by reference methods or highly accurate laboratory instruments rather than expert adjudication in the way it would be for image-based diagnostics.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable in the context of a clinical chemistry analyzer's performance evaluation as described. Ground truth is established through analytical measurements, not through human adjudication of diagnostic findings. Therefore, no adjudication method like 2+1 or 3+1 would be used.
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. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component, often comparing human readers with and without AI assistance. This device is a clinical chemistry analyzer, which provides quantitative measurements directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described for the ANALETTE™ clinical chemistry analyzer with MAS reagents is inherently a standalone performance in the context of the instrument measuring analyte concentrations. There is no "human-in-the-loop" performance component in the direct measurement by the analyzer. The comparison is between two reagent systems on the same analyzer, assessing the analytical performance.
7. The Type of Ground Truth Used
The ground truth for this type of device (a clinical chemistry analyzer) would typically be established by:
- Reference standard methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine clinical tests.
- Certified reference materials: Samples with known, validated concentrations of the analytes.
- Comparison to the predicate device: For a 510(k) submission seeking substantial equivalence, the performance of the new device (or reagent system) is directly compared to the legally marketed predicate device using patient samples and/or quality control materials. The predicate device's results serve as the pragmatic "ground truth" for demonstrating equivalence in a clinical setting.
The document implies the latter, stating "Substantially equivalence was established in comparative studies," meaning performance was compared against the predicate system.
8. The Sample Size for the Training Set
This information is not provided in the document. Clinical chemistry analyzers and their associated reagents are developed through analytical validation, which involves extensive testing, but the term "training set" is more commonly associated with machine learning algorithms. If there were any computational models or algorithms within the analyzer's software that required training (which is not explicitly indicated as relevant here beyond basic instrument calibration), the details of such a training set are absent.
9. How the Ground Truth for the Training Set Was Established
Since no "training set" in the machine learning sense is explicitly mentioned or detailed, and the focus is on analytical performance comparison (substantial equivalence), the method for establishing ground truth for a training set is not applicable or provided. The development of a clinical chemistry reagent kit involves rigorous analytical validation, where performance characteristics like accuracy, precision, linearity, and interference are established using known standards and patient samples, rather than a "ground truth for training" in the way an AI model would be trained.
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(21 days)
866.5510 862.1410 862.1415 862.1440 862.1465 862.1495 866.5040 866.5680 862.1580 862.1600 866.5060 862.1635
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.
While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.
The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.
Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.
Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:
1. Table of Acceptance Criteria and Reported Device Performance
-
Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:
- Accuracy: Agreement with a reference method.
- Precision (Reproducibility & Repeatability): Consistency of results.
- Linearity: Accuracy across the analytical measurement range.
- Detection Limits: Lowest concentration that can be reliably measured.
- Interference: Lack of significant impact from common interfering substances.
- Carry-over: Minimal contamination between samples.
- Stability: Reagent and calibration stability.
- Correlation: Strong correlation with predicate device or reference method.
-
Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
- Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
- Reference interval studies: Involving a statistically significant number of healthy individuals.
- Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
- Control materials and calibrators: With known, certified values.
- Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.
7. The Type of Ground Truth Used
- Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
- Reference methods: Highly accurate and validated analytical methods.
- Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
- Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
- Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.
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