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510(k) Data Aggregation
(191 days)
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. 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). For in-vitro diagnostic use only. For Professional use only.
The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease.
For in-vitro diagnostic use only. For Professional Use Only.
Not Found
Here's a summary of the acceptance criteria and study information for the EasyRA Calcium Reagent and EasyRA Cholesterol Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicit or Implied) | EasyRA Calcium Reagent Performance | EasyRA Cholesterol Reagent Performance |
|---|---|---|---|
| Linearity | Must be linear within specified ranges. | Linear from 1mg/dL to 15mg/dL. | Linear from 10mg/dL to 600mg/dL. |
| Within Run Precision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 12.81 mg/dL: SD 0.23 mg/dL, CV 1.8% | |
| QC Level 9.73 mg/dL: SD 0.19 mg/dL, CV 1.9% | |||
| QC Level 5.24 mg/dL: SD 0.17 mg/dL, CV 3.3% | QC Level 215.90 mg/dL: SD 4.13 mg/dL, CV 1.9% | ||
| QC Level 168.05 mg/dL: SD 1.76 mg/dL, CV 1.0% | |||
| QC Level 105.70 mg/dL: SD 1.34 mg/dL, CV 1.3% | |||
| Total Imprecision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 11.78 mg/dL: SD 0.16 mg/dL, CV 1.33% | |
| QC Level 9.03 mg/dL: SD 0.13 mg/dL, CV 1.46% | |||
| QC Level 5.95 mg/dL: SD 0.12 mg/dL, CV 1.95% | QC Level 168.5 mg/dL: SD 2.5 mg/dL, CV 1.5% | ||
| QC Level 302.9 mg/dL: SD 3.6 mg/dL, CV 1.2% | |||
| QC Level 106.2 mg/dL: SD 1.3 mg/dL, CV 1.2% | |||
| Method Comparison | "Correlated excellently" with the predicate device (Roche COBAS MIRA analyzer). | Correlated excellently with the predicate device. | Correlated excellently with the predicate device. |
| Sample Carryover | No evidence of sample carryover. | No evidence of sample carryover. | No evidence of sample carryover. |
| Interference Testing | No interference from specified substances up to certain concentrations. | Hemoglobin: no interference up to 500 mg/dL | |
| Bilirubin: no interference up to 20 mg/dL | |||
| Triglycerides: no interference up to 2250 mg/dL | Hemoglobin: no interference up to 500 mg/dL | ||
| Bilirubin: no interference up to 5 mg/dL | |||
| Lipemia: no interference up to 2250 mg/dL | |||
| Glucose: no interference up to 600 mg/dL | |||
| Ascorbic Acid: no interference up to 9 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity: The number of unique samples is not specified, but the study used "NIST-traceable commercial linearity standards." The data provenance (country, retrospective/prospective) is not explicitly stated.
- Within Run Precision: Twenty replicates of three levels of commercial human-based QC material were tested. The provenance of the QC material is not specified, but it's "commercial human-based."
- Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days. This means 3 levels * 2 replicates/day * 20 days = 120 measurements per reagent. The provenance of the QC material is not specified.
- Method Comparison: At least 40 samples for each analyte were tested. The data provenance is not specified.
- Sample Carryover: 11 samples (L, M, H) in a predefined sequence, tested twice in a single day. The data provenance is not specified.
- Interference Testing: The number of samples for each interfering substance is not explicitly stated, but it involved testing Hemoglobin, Bilirubin, Lipemia (Intralipid), Glucose, and Ascorbic Acid up to specified concentrations. The data provenance is not specified.
In general, the data provenance (country of origin, retrospective/prospective) for these studies is not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The device is an in-vitro diagnostic reagent for quantitative measurement of analytes (Calcium and Cholesterol) in serum. The "ground truth" is established by reference methods, certified materials (like NIST-traceable standards), or comparison to a legally marketed predicate device, rather than human expert consensus on interpretations of images or complex clinical scenarios.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on analytical performance of a quantitative reagent, not on classifying or interpreting results where human adjudication would be necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic imaging or interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable to a chemical reagent. The device itself is the reagent used in an automated analyzer. The "standalone" performance refers to the analytical performance of the reagent on the EasyRA Chemistry Analyzer, which is precisely what the performance data describes (linearity, precision, interference, carryover). There is no "human-in-the-loop" aspect to the measurement itself; human operators are involved in running the analyzer and interpreting the quantitative results in a clinical context.
7. The Type of Ground Truth Used
- Linearity: NIST-traceable commercial linearity standards.
- Precision (Within Run & Total): Commercial human-based QC material with known (or established) values.
- Method Comparison: Analytical results obtained from the predicate device (Roche COBAS MIRA analyzer), which serves as the comparative "truth" for substantial equivalence.
- Interference Testing: Known concentrations of interfering substances added to samples to assess their impact on the measurement.
8. The Sample Size for the Training Set
This information is not applicable. This device is a chemical reagent and does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance specifications are determined through analytical validation studies as detailed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
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(176 days)
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
The provided text describes the ATAC Calcium Reagent Kit and studies demonstrating its performance. However, it does not explicitly define "acceptance criteria" as a set of specific thresholds for the reported performance metrics. Instead, it presents the results of various validation studies and implicitly suggests that these results are deemed acceptable for the device's intended use and demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, framed to address your request for acceptance criteria and the supporting study, even if the "acceptance criteria" are implied rather than explicitly stated.
Interpretation of Acceptance Criteria:
Given that this is a 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to a predicate device (HiChem™ Calcium Reagent Kit) and proving that the device performs safely and effectively for its intended use. While explicit numerical cut-offs aren't listed as "acceptance criteria," the reported performance metrics in the studies are implicitly deemed acceptable by the manufacturer for this purpose.
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explicit "acceptance criteria" are not provided, the table below lists the performance parameters evaluated and their reported results. The implied acceptance is that these results are clinically acceptable and demonstrate substantial equivalence to the predicate device.
| Performance Parameter | Implied Acceptance Criteria (based on common IVD standards and predicate equivalence) | Reported Device Performance (ATAC Calcium Reagent Kit) |
|---|---|---|
| Linearity/Recovery | Demonstrated linearity across the usable range; high correlation (r > 0.99) | Linear from 0.2 to 15 mg/dL; r = 0.9984; (ATAC Recoveries) = 1.069 x (Standard Value); sy.x = 0.32 mg/dL; n = 21 (for regression) |
| Precision (Within Run) | Low %CV for different serum levels (e.g., 0.95) and good agreement with a predicate or established method | ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent; r = 0.942; n = 120; range = 6.4 - 11.5 mg/dL |
| Detection Limit | Ability to detect low clinically relevant concentrations | 0.2 mg/dL (documented by repetitive assay of a diluted serum pool; SD of 30 replicates was 0.05 mg/dL) |
| Reagent Stability (On-board) | Demonstrated stability for claimed period; imprecision within acceptable limits | 14-day stability documented; total imprecision of calcium recoveries over test period was |
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(25 days)
MODIFICATION TO RAICHEM CALCIUM REAGENT
RAICHEM® Calcium Reagent ia an in vitro diagnostic intended to measure the calcium level in serum and heparinized plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetani (intermittent muscular contractions or spasms).
Not Found
This document is a 510(k) clearance letter for the Raichem® Calcium Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot provide the requested information based on the provided text.
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(69 days)
HICHEM CALCIUM REAGENT KIT
HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. 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).
The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.
Here's a breakdown of the acceptance criteria and study information for the HiChem Calcium Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided text describes two main scenarios for the HiChem Calcium Reagent: the manual procedure and its use on the Beckman® SYNCHRON CX® Systems (secondary reagent application). The acceptance criteria are largely implied by the reported performance, as the study aims to demonstrate substantial equivalence to an existing predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Performance Measure | Acceptance Criteria (Implied) | HiChem Calcium Reagent (Manual Procedure) Reported Performance | HiChem Calcium Reagent (SYNCHRON CX® Systems) Reported Performance |
|---|---|---|---|
| Linearity | Demonstrate linearity over a specific range. | Linear between 0.1 to 16 mg/dL. Regression: (HiChem) = -0.1 + 0.980 x (Standard Conc.), r² = 1.000, sy.x = 0.14 mg/dL. | Linear from at least 2.0 mg/dL to 15.0 mg/dL. Regression: (HiChem) = 0.0 + 0.967 x (Standard Conc.), r² = 1.000, sy.x = 0.08 mg/dL. |
| Precision | Meet specified SD for various control levels. | Serum Control 1 (6.69 mg/dL): within-run SD 0.21 mg/dL, total SD 0.24 mg/dL | |
| Serum Control 2 (12.68 mg/dL): within-run SD 0.29 mg/dL, total SD 0.30 mg/dL | |||
| Urine Pool 1 (2.41 mg/dL): within-run SD 0.11 mg/dL, total SD 0.11 mg/dL | |||
| Urine Pool 2 (11.10 mg/dL): within-run SD 0.13 mg/dL, total SD 0.16 mg/dL | Serum Control 1 (6.89 mg/dL): within-run SD 0.056 mg/dL, total SD 0.064 mg/dL | ||
| Serum Control 2 (10.03 mg/dL): within-run SD 0.085 mg/dL, total SD 0.089 mg/dL | |||
| Serum Control 3 (13.21 mg/dL): within-run SD 0.088 mg/dL, total SD 0.090 mg/dL | |||
| Urine Pool 1 (3.24 mg/dL): within-run SD 0.048 mg/dL, total SD 0.059 mg/dL | |||
| Urine Pool 2 (11.64 mg/dL): within-run SD 0.075 mg/dL, total SD 0.095 mg/dL | |||
| Method Comparison (Serum/Plasma) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | n=92. Regression: (HiChem) = -0.3 + 1.020 × (BMD® Results), r² = 0.887, s(y.x) = 0.21 mg/dL. | n=153. Regression: (HiChem) = -0.3 + 1.005 x (Beckman® Results), r² = 0.924, s(y.x) = 0.20 mg/dL. |
| Method Comparison (Urine) | Substantial equivalence to Beckman® SYNCHRON® Calcium Reagent. | Regression: (HiChem) = 0.2 + 1.022 × (BMD® Results), r² = 0.998, s(y.x) = 0.15 mg/dL. | Regression: (HiChem) = 0.1 + 1.031 x (Beckman® Results), r² = 0.996, s(y.x) = 0.16 mg/dL. |
| Chemical Additives (Interference) | Biases less than a specified threshold (e.g., |
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(32 days)
CALCIUM REAGENT
Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.
Calcium Reagent
The provided text is a 510(k) premarket notification letter from the FDA regarding a Calcium Reagent device. It does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
This document is a regulatory approval letter, explicitly stating "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent...You may, therefore, market the device..." It confirms the device's classification, product code, and indications for use.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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(83 days)
CALCIUM REAGENT
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