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510(k) Data Aggregation
(34 days)
CIC
The S TEST Reagent Cartridge Calcium (CA) is intended for the quantitative determination of calcium in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Calcium is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
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 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 Cartridge Calcium.
Chemistry reactions: Calcium in the sample combines with o-cresolphthalein complexone to form a purple-red complex. The concentration of calcium can be determined by measuring the absorbance of the resulting purple-red color. (With this method, the influence of magnesium is excluded by the addition of 8-hydroxyquinoline.)
Here's a breakdown of the acceptance criteria and study information for the Hitachi S TEST Reagent Cartridge Calcium, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance characteristic. Instead, it presents the results of various studies (precision, linearity, method comparison, interference, matrix comparison) and implies that these results meet regulatory and performance expectations for substantial equivalence. For the purpose of this analysis, I will infer the implied acceptance by comparing the device performance to the predicate device where applicable, or noting the performance demonstrated without a direct comparative statement if no specific target is given.
| Performance Characteristic | Implied Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (LOD) | Quantitation limit similar to predicate (0.4 mg/dL) and appropriate for clinical use. | LOD: 0.19 mg/dL; Quantitation Limit: 0.4 mg/dL |
| Linearity | Range similar to or exceeding predicate (0.4 to 20.0 mg/dL) and sufficient for clinical use. | 0.4 to 17.1 mg/dL |
| Reportable Range | Similar to or exceeding predicate (0.4 to 20.0 mg/dL) and sufficient for clinical use. | 0.5 to 15.0 mg/dL |
| In-house Precision (%CV) | Comparable to predicate (%CVs range from 0.3% to 1.4%). | %CVs range from 0.7% to 1.9% (Total Precision) |
| External Site Precision (%CV) | Acceptable for physician's office laboratory (POL) setting. (No specific %CV range given as acceptance criteria) | %CVs range from 1.4% to 7.2% (Total Precision across sites and levels) |
| Interference | Recoveries between 90% and 110% of neat value with noted interfering substances. | Unconjugated bilirubin, Lipemia, Ascorbic acid, Hemoglobin showed no interference at tested levels. |
| Method Comparison (n=97) | Good correlation (r close to 1), slope close to 1, and y-intercept close to 0 when compared to a standard laboratory system. | r = 0.976; Slope = 0.99 (95% CI: 0.94 to 1.03); y-intercept = -0.25 (95% CI: -0.68 to 0.18). |
| Matrix Comparison (Plasma) | Good correlation (r close to 1), slope close to 1, and y-intercept close to 0 when compared to serum. | Na Citrate Plasma: r = 0.993; Slope = 0.98; y-intercept = -0.14. |
| Heparinized Plasma: r = 0.988; Slope = 0.96; y-intercept = -0.02. | ||
| External Method Comparison (POL Sites) | Good correlation (r close to 1), slope close to 1, and y-intercept close to 0 when compared to a comparative method. | Site 1: r=0.986, y=0.96x-0.2. |
| Site 2: r=0.984, y=0.97x-0.1. | ||
| Site 3: r=0.987, y=0.99x-0.1. |
Study Details
This device is an in vitro diagnostic (IVD) chemistry analyzer for calcium, not an AI/ML device. Therefore, several of the requested sections regarding AI-specific studies (experts, adjudication, MRMC, training set) are not applicable.
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Sample size used for the test set and the data provenance:
- Analytical Sensitivity (LOD): Not explicitly stated, but the study followed CLSI EP17-A.
- Linearity: Not explicitly stated, but the study followed CLSI EP-6A.
- 20-day In-house Precision: Three levels of samples, each tested in two runs, twice a day, for 20 days. (Total of 120 measurements per level).
- Interference Testing: Two serum pools.
- In-house Method Comparison: 97 clinical specimens (spanning 1.2 to 14.8 mg/dL).
- Matrices Comparisons: 44 matched serum/plasma samples (spanning 0.9 to 14.7 mg/dL).
- External Site Precision (Clinical Data): Three blinded serum samples (low, middle, high calcium concentrations) tested at each of three external POL sites. Each sample was assayed 6 times per day for 5 days, resulting in 30 results per level per site.
- External Method Comparison (Clinical Data): Approximately 55 serum specimens (ranging from 1.3 to 14.6 mg/dL) at each of three external POL sites.
- Data Provenance: Not explicitly stated for specific samples, but the studies were conducted by "Hitachi Chemical Diagnostics, Inc." (in-house) and at "three external POL-type sites." The specimens are clinical specimens (serum and plasma). The country of origin is not specified but implicitly the US given the FDA submission. All data appears to be prospective collection for the validation of this device.
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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):
- Not applicable. This is an IVD device for quantitative chemical analysis; ground truth is established by the analytical reference methods or comparative methods used.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is an IVD device for quantitative chemical analysis.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. All studies (precision, linearity, method comparisons, interference, matrix comparisons) evaluate the performance of the device itself (Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridge Calcium) in an automated or semi-automated standalone fashion, generating quantitative results. Human intervention is limited to sample loading, programming, and result interpretation, not in the analytical process itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Method Comparison studies, "ground truth" is established by a "standard laboratory system" or "comparative method" (predicate or other established analyzer), generating quantitative calcium values.
- For Analytical Sensitivity, Linearity, Precision, Interference, and Matrix Comparison studies, "ground truth" refers to the expected or known concentrations of calcium in control samples, calibrators, or spiked samples, verified through established analytical methods.
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The sample size for the training set:
- Not applicable. This is an IVD device for quantitative chemical analysis, not an AI/ML device requiring a training set in the typical sense. The "training" of the device is its calibration and quality control procedures, which are part of standard IVD practices.
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How the ground truth for the training set was established:
- Not applicable. (See above.)
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(117 days)
CIC
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessorcontrolled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.
Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The Dimension® RxL Max® Chemistry System is a continuous operation chemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens and is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The Dimension® RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546)
The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory. AMAS is available as two products ADVIA® LabCell® and ADVIA® WorkCell. These LAS systems are made up of the same components and are controlled by common software. The systems differ in their expansion capabilities:
ADVIA® WorkCell is an ADVIA® Automation solution that is limited to three fixed configurations supporting up to a total of five interface stations.
ADVIA® LabCell® is customizable ADVIA® Automation solution that is configurable with up to 16 interface stations.
Dimension® RxL Max® Chemistry System (Dimension) with Sample Transfer Module and the ADVIA® Modular Automation System combines the features of both the analyzer and the laboratory automation system.
The ADVIA® Modular Automation System (AMAS) routes samples to the Dimension analyzer based on test request information received from the Laboratory Information System (LIS) and the test map established for the Dimension analyzer. AMAS and Dimension communicate sample and analyzer status via Dimension's Laboratory Automation System (LAS) interface. Via its Laboratory Information System (LIS) interface, the Dimension analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Dimension's test instructions and test results for each sample are not processed through the AMAS.
AMAS performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the Dimension) .
- Sample transport and tracking (pre-Analytical) .
- Sample centrifugation (optional functionality) .
- Sample de-capping (optional functionality) .
- Sample transport and tracking (post-Analytical) .
The Dimension continues to perform the following functions, when connected to AMAS.
- All functions except reading the sample tube bar code. When Dimension is . connected to AMAS, samples can be loaded directly onto Dimension and/or loaded onto AMAS and routed to Dimension. For samples loaded onto the AMAS, which reads the sample tube bar code (sample identification) and passes it electronically to Dimension via the LAS interface.
The document describes the Dimension® RxL Max® Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System and its substantial equivalence to a predicate device for measuring Calcium in human serum or plasma.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds for metrics like correlation coefficient, slope, intercept, or bias. Instead, it presents results of a method comparison study for the Calcium assay and aims to demonstrate substantial equivalence to the predicate device.
The study's implicit "acceptance criteria" appear to be that the performance metrics of the proposed device are within an acceptable range compared to the predicate device, as concluded by the statement of substantial equivalence.
| Metric | Reported Device Performance (Calcium assay) | Implicit Acceptance/Comparison to Predicate |
|---|---|---|
| n | 98 | Sample size for method comparison |
| r (correlation coefficient) | 0.989 | Very strong correlation between methods |
| Slope | 1.05 | Close to 1.0, indicating good agreement |
| Intercept | -0.4 | Close to 0, indicating minimal constant bias |
| Syx | 0.3 | Measure of scatter around the regression line |
| 95% CI Slope | 1.02 to 1.08 | Range includes 1.0, supporting agreement |
| 95% CI Intercept | -3.5 to 2.7 | Range includes 0, supporting agreement |
| % Mean Bias | -0.1 | Very low, indicating minimal systematic difference |
Conclusion from document: "The proposed Dimension® RxL MAX® with ADVIA® Modular Automation System and the predicate Dimension® RxL Max® (K043546) are substantially equivalent in design, modes of operation, assay performance and intended use."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 98 samples were used for the method comparison study ("n" = 98 in the table).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is generally assumed for such 510(k) submissions that data is generated from studies conducted in a controlled environment, likely a clinical laboratory, but specific details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a chemistry analyzer for Calcium levels) typically uses quantitative chemical analysis as its "ground truth" rather than expert interpretation of images or clinical assessments. The reference method for comparison (the predicate device) serves as the standard against which the proposed device is evaluated. Therefore, no human experts are explicitly mentioned for establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of quantitative measurements from two analytical instruments (proposed device vs. predicate device) on the same samples. There is no mention of human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. The described study is a method comparison for a quantitative chemistry analyzer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the method comparison presented is a standalone performance study of the device (analyzer) itself. The results (n, r, Slope, Intercept, Syx, % Mean Bias) directly reflect the analytical performance of the Dimension® RxL MAX® with AMAS for Calcium measurement when compared to the predicate Dimension® RxL MAX® without AMAS functionality. There is no human-in-the-loop component for this performance evaluation; it's a direct comparison of the instrument's quantitative output.
7. The Type of Ground Truth Used
The "ground truth" for the test set was established by the results obtained from the legally marketed predicate device, the Dimension® RxL Max® (K043546). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is compared directly to an already cleared device for the equivalent measurement. The study used a "split-sample method comparison," meaning the same clinical samples were analyzed on both the predicate and proposed devices.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This is a common omission in 510(k) summaries for in vitro diagnostic (IVD) devices like chemistry analyzers. These devices are typically developed, calibrated, and validated through internal processes by the manufacturer, rather than through a public "training set" as understood in machine learning contexts. The presented method comparison study (n=98) serves as the "test set" for regulatory clearance purposes.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or described in the provided summary, there is no information on how its ground truth would have been established. It's likely that development and internal validation used various known standards, controls, and patient samples, but these are not disclosed as part of the 510(k) summary focused on the substantial equivalence study.
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CIC
ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. 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).
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic 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 Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Creatinine 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 bi-reagent cassette, with two 28 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.
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. The assigned values of the control components are given in the enclosed annexe, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
The provided text describes the performance data for new urine sample indications for four reagents (ABX PENTRA Calcium CP, ABX PENTRA Creatinine CP, ABX PENTRA Phosphorus CP, and ABX PENTRA Amylase CP) when used with the ABX PENTRA 400 Clinical Chemistry Analyzer. The study aims to demonstrate substantial equivalence to predicate devices and establish performance characteristics for urine samples.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the reported performance characteristics for each reagent on urine samples. While explicit "acceptance criteria" are not listed as pass/fail thresholds, the reported values represent the achieved performance that allowed for the 510(k) clearance.
ABX PENTRA Calcium CP (Urine)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sample type | Urine | Urine |
| Detection limit | Not explicitly defined | 0.12 mg/dl |
| Accuracy and Precision | Not explicitly defined | CV Total |
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(108 days)
CIC
The SPOTCHEM II Chemistry Basic 1 Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcum 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 SPOTCHEM II Chemistry Basic 1 Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the glucose concentration in serum, plasma, and whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.
The SPOTCHEM II Chemistry Basic 1 Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. 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.
The SPOTCHEM II Chemistry Basic 2 ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidray, or oo ne marrow, as well as other metabolic and nutritional disorders.
The SPOTCHEM II Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma, and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and head formants
The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma, and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Arkray SPOTCHEM II Chemistry Basic 1 and Arkray SPOTCHEM II Chemistry Basic 2 devices, outlining their indications for use. It does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
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(34 days)
CIC
The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum 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 SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The SpotChem II Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Arkray SpotChem II Calcium, Magnesium, and Blood Urea Nitrogen Tests. This type of document declares substantial equivalence to a predicate device and does not typically include detailed studies proving device performance against specific acceptance criteria. The information requested, such as sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is usually found within the 510(k) submission itself (which is not provided) or in detailed clinical study reports, not in the FDA's clearance letter.
Therefore,Based on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria.
Here's why:
- Nature of the Document: This document is an FDA clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain the detailed study results, acceptance criteria, or methodological specifics that were submitted to the FDA to demonstrate this substantial equivalence. These details would be in the original 510(k) submission, which is not provided.
- Information Not Present: The letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or expert qualifications for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) studies or standalone performance.
- Details on the type of ground truth used or the sample size and ground truth establishment for the training set.
The letter mentions that the FDA reviewed the premarket notification, implying that such studies and acceptance criteria were part of that submission. However, the clearance letter itself only states the FDA's decision based on that review.
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(67 days)
CIC
This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only.
This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The intended patient population may be adult, pediatric, and neonatal.
Not Found
Response to Request for Information on Device Acceptance Criteria and Study Details:
This document, K041009, is a 510(k) premarket notification for a Calcium (oCPC) test system. The information provided in this 510(k) letter is limited to the clearance of the device based on substantial equivalence to a predicate device. It does not contain the detailed study information or acceptance criteria that would typically be found in a more comprehensive submission or a clinical study report.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment cannot be extracted from this document alone. A 510(k) primarily focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (the predicate).
However, I can extract what is explicitly stated or indirectly implied:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not report specific acceptance criteria or detailed device performance metrics such as sensitivity, specificity, accuracy, or precision. It states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance (accuracy, precision, linearity, etc.) is expected to be comparable to or within acceptable limits of the predicate device, but those specific values aren't listed here.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: Not specified in this document. 510(k) submissions often include in-house validation data, but the details are not provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: Not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). MRMC studies are typically used for imaging devices where human readers interpret results.
6. Standalone Performance Study (Algorithm Only):
- Standalone Performance: While the "Calcium (oCPC) test system" is an in vitro diagnostic device that produces a quantitative result, the document does not provide standalone performance data in terms of accuracy, precision, or other performance characteristics. The 510(k) process primarily evaluates substantial equivalence rather than requiring a detailed standalone clinical performance study to establish de novo effectiveness. Performance data would have been part of the full 510(k) submission, but is not included in this letter.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not specified in this document. For an in vitro diagnostic like a calcium test, the ground truth would typically be established by a reference method (e.g., atomic absorption spectroscopy) or comparison to an accepted, well-established clinical chemistry analyzer.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable in the context of this device and the information provided. This device is a chemical reagent-based test system, not an AI/algorithm-based system that uses a "training set" in the machine learning sense. Its performance is based on the chemical reactions and optical detection methods it employs.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable (see point 8).
In summary: This 510(k) clearance letter confirms that the Calcium (oCPC) test system was deemed "substantially equivalent" to a predicate device for its intended use (quantitative determination of Calcium in serum, heparinized plasma, or urine, for in vitro diagnostic use, to aid in diagnosis and treatment of conditions like parathyroid disease). However, it does not provide the detailed study results, specific performance metrics, or method validation data that would be found within the full 510(k) submission.
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(176 days)
CIC
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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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.
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(54 days)
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The calcium reagents: Buffer/Chromogen(R1), product No. CA110-01 and EDTA Reagent (R2), product No. CA110-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of calcium in serum, plasma and urine.
Buffer Chromogen (R1), EDTA Reagent (R2)
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) clearance letter from the FDA for a device named "Buffer Chromogen (R1), EDTA Reagent (R2)" for the quantitative determination of calcium. It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain a study report or details of performance testing.
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