Search Results
Found 1 results
510(k) Data Aggregation
(45 days)
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
The "Wiener lab. Ca-Color AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).
Calcium reacts with o-Cresolphtalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. magnesium 8-hydroxyquinoline is added to remove interference.
This document describes the WIENER LAB. CA-COLOR AA test system, a quantitative in vitro diagnostic device for the determination of calcium in human sera, heparinized plasmas, and urine. The submission is a 510(k) premarket notification claiming substantial equivalence to predicate devices. The study presented focuses on demonstrating equivalence through performance characteristics of the new device and comparing them to those of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the provided text. Instead, the study aims to show that the performance of the WIENER LAB. CA-COLOR AA test system is "substantially equivalent" to the predicate devices. Therefore, the "acceptance criteria" are implicitly defined by the reported performance of the predicate devices and the similarity of the WIENER LAB. CA-COLOR AA system's performance to these benchmarks.
A direct comparison is provided against two predicate devices: POINTE CALCIUM REAGENT SET (for serum/plasma) and DMA CALCIUM test system (for urine).
| Performance Characteristic | Predicate: POINTE Test System (Serum/Plasma) | Predicate: DMA Test System (Urine) | WIENER LAB. CA-COLOR AA Test System (Reported Performance) |
|---|---|---|---|
| Intended Use | Quantitative determination of calcium in human serum and heparinized plasma. | Quantitative determination of calcium in human serum and urine. | Quantitative determination of calcium in human serum, heparinized plasma, and urine. |
| Test Principle | Calcium reacts with o-Cresolphthalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. 8-hydroxyquinoline is added to remove magnesium interference. | Calcium reacts with o-Cresolphthalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. | Calcium reacts with o-Cresolphthalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. 8-hydroxyquinoline is added to remove magnesium interference. |
| Essential Components | o-CPC, 8-hydroxyquinoline | o-CPC | o-CPC, 8-hydroxyquinoline |
| Reagents | R1: o-CPC / 8-hydroxyquinoline, R2: 2-Amino-2-Methyl-1-Propanol / Potassium Cyanide | R1: o-CPC / surfactant, R2: Diethylamine / Potassium Cyanide | R1: o-CPC / 8-hydroxyquinoline, R2: 2-Amino-2-Methyl-1-Propanol |
| Reagent Storage | Under refrigeration (2-8°C) | Room temperature | Room temperature |
| Reagent Deterioration | Turbid reagent | R1 darkened or with precipitate, R2 turbid or colored, Reagent Blank > 0.500 O.D. | Reagent Blank > 0.400 O.D. |
| Preparation of Working Reagent | Mixture of R1 and R2 (1:1) | Mixture of R1 and R2 (1:1) or they can be used separately. | Mixture of R1 and R2 (1:1) or they can be used separately. |
| Working Reagent Stability | Stable 2 weeks at 2-10°C and 1 week at room temperature. | Stable 3 days at room temperature. | Stable 4 days at 2-10°C |
| Working Temperatures | Room temperature | 30°C - 37°C | Room temperature - 37°C |
| Wavelength of Reading | 570 nm | 550 - 585 nm | 560 - 590 nm |
| Linearity | 20 mg/dl | 15 mg/dl | 20 mg/dl |
| Expected Values | Serum: 8.5 - 10.5 mg/dl; Higher values in children falling to normal with aging. (No urine data provided for POINTE) | Serum: 8.5 - 11.0 mg/dl, Urine: 100-300 mg/24hr | Serum: 8.5-10.5 mg/dl, Urine: 60-200 mg/24hr |
| Within-run precision (Serum) | Normal Serum: CV = 1.5%; Abnormal Serum: CV = 1.0% | Normal Serum: CV = 1.98%; Abnormal Serum: CV = 1.40% | Normal Level Serum: CV = 1.28%; High Level Serum: CV = 1.30% |
| Within-run precision (Urine) | N/A | N/A | Normal Level Urine CV = 1.06%; High Level Urine CV = 0.68% |
| Run-to-run precision (Serum) | Normal Serum: CV = 1.4%; Abnormal Serum: CV = 2.1% | Normal Serum: CV = 1.93%; Abnormal Serum: CV = 2.40% | Normal Level Serum: CV = 1.74%; High Level Serum: CV = 1.70% |
| Run-to-run precision (Urine) | N/A | N/A | Normal Level Urine CV = 2.50%; High Level Urine CV = 1.34% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the precision, linearity, or expected values studies. It only reports the calculated Coefficient of Variation (CV) for precision studies or the linearity range. The provenance of the data (e.g., country of origin, retrospective or prospective nature) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document describes an in vitro diagnostic (IVD) device, specifically a calcium test system. The "ground truth" for such devices is typically established through reference methods or established clinical laboratory best practices for measuring analyte concentrations (e.g., calcium). Experts involved would likely be clinical chemists or laboratory professionals, but the document does not specify the number or qualifications of any experts involved in establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not mention any adjudication method, as it pertains to the performance characteristics of an IVD reagent system rather than image-based diagnostic expert review.
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
No such study was performed or described. This is an IVD reagent system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This document describes the performance of a chemical reagent system. The "standalone performance" refers to the device's ability to measure calcium concentrations accurately and precisely as per its design. The reported precision and linearity data represent the standalone performance of the WIENER LAB. CA-COLOR AA test system. There is no "algorithm" in the sense of machine learning described here; the measurement is photocolorimetric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance characteristics reported (linearity, precision, expected values) would be derived from:
- Known concentrations of calcium in control samples for linearity and precision studies. These would be established using validated reference methods or certified reference materials.
- Clinically established ranges for calcium in serum and urine for the "expected values." These ranges are typically derived from large population studies using validated methods.
The document does not explicitly detail the methodologies used to establish these ground truths, but these are standard practices for IVD device validation.
8. The sample size for the training set
This document describes a chemical reagent system, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The development of the reagent system involves chemical formulation and optimization studies, but these do not typically involve "training sets" in the same way an AI algorithm does.
9. How the ground truth for the training set was established
As there is no "training set" in the context of AI/ML for this device, this question is not applicable. The development of the reagent system relies on established chemical principles for colorimetric assays and analytical validation against known calcium standards.
Ask a specific question about this device
Page 1 of 1