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510(k) Data Aggregation
(187 days)
The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The D3 Hematology Analyzer is a stand-alone benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using the impedance & spectrophotometry techniques.
The D3 Hematology Analyzer is a stand-alone benchtop clinical laboratory instrument that analyzes in-vitro samples of whole blood to provide complete blood count and leukocyte differential count using impedance and spectrophotometry techniques.
The following information regarding the acceptance criteria and the study proving the device meets these criteria is extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list a table of "acceptance criteria" with quantitative values. Instead, it states that "Accuracy, Repeatability, Linearity, Carryover, Sample Stability studies demonstrated acceptable performance per the manufacturers specifications." It also highlights substantial equivalence to the predicate device, DATACELL 18MS (K945678). The key performance aspect is that the device "meets all acceptance criteria and demonstrating that the devices are substantially equivalent to the predicate device."
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Repeatability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Linearity | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Carryover | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Sample Stability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Electrical Safety | UL 61010-1 standard compliance. | Meets UL 61010-1 standard. |
| EMC | IEC 60601-1-2 standard compliance. | Compliant with IEC 60601-1-2 standard. |
| Substantial Equiv. | Equivalent to predicate device (DATACELL 18MS, K945678) in performance. | Demonstrated substantial equivalence and met all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The non-clinical studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a "D3 Hematology Analyzer," suggesting an automated instrument rather than an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
The D3 Hematology Analyzer is described as a "fully automated (microprocessor controlled) quantitative hematology analyzer." This indicates that its performance is standalone (algorithm only) without human-in-the-loop directly influencing the output measurements. The performance studies listed (Accuracy, Repeatability, Linearity, Carryover, Sample Stability) describe the standalone performance of the device.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the document. For hematology analyzers, ground truth is typically established through reference methods, manual microscopic differentials performed by trained technologists/pathologists, or validated control materials. However, the document does not specify which of these was used.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. Given that the device is a hematology analyzer, and the phrase "training set" is usually associated with AI/machine learning models, it's possible that traditional calibration and validation methods were used rather than an AI-specific training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, the method for establishing its ground truth is also not detailed.
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(122 days)
TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to montor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.
The TRILOGY Analyzer is a fully automated, multi-purpose analyzer used for analysis in clinical chemistry with optional ion selective electrode (ISE) module. The analyzer is intended for the in vitro measurement of various analytes in serum and urine.
The analyzer incorporates robotics, computer and communication technology to perform integrated tasks from pipetting and diluting of patient specimens, assaying specimens in Routine or STAT modes, performing spectrophotometric, and potentiometric modes simultaneously and analyzing data using multiple curve-fitting parameters.
The TRILOGY Analyzer is an open system for multiple disciplines including clinical chemistry and an optional ISE module.
Here's a breakdown of the acceptance criteria and study information for the TRILOGY Analyzer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state specific quantitative acceptance criteria or detailed numerical performance achievements for each analyte (Glucose, Creatinine, Urea Nitrogen, Sodium, Potassium, Chloride). It rather states that the "results of all studies demonstrated that the TRILOGY Analyzer performed according to its specifications."
However, based on the performance testing mentioned, the categories of performance assessed would implicitly be the acceptance criteria:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Method Comparison | Results should be comparable to predicate devices for all specified analytes. | Performed according to its specifications (implies comparability to predicates was met). |
| Precision | Demonstrated acceptable repeatability and reproducibility for all specified analytes. | Performed according to its specifications (implies acceptable precision was met). |
| Linearity | Accurately measure analytes across their relevant clinical range. | Performed according to its specifications (implies linearity across the clinical range was met). |
| Interference | Minimal impact from common interfering substances on analyte measurements. | Performed according to its specifications (implies interference was within acceptable limits). |
| Limit of Quantitation | Able to reliably quantify analytes at low clinically relevant concentrations. | Performed according to its specifications (implies the ability to quantify at the required low concentrations was met). |
2. Sample Size Used for the Test Set and Data Provenance:
The document
- Does not specify the exact sample size used for the test set in the performance studies.
- Does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth. This is a common characteristic of in vitro diagnostic device (IVD) submissions for automated analyzers, where the "ground truth" is typically established by reference methods or validated predicate devices, rather than expert interpretation of results.
4. Adjudication Method for the Test Set:
Not applicable, as expert-based ground truth and adjudication are not described for this type of IVD device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for imaging devices or AI-assisted diagnostic tools where human reader performance is a key outcome. The TRILOGY Analyzer is an automated chemical analyzer, and its performance is evaluated against chemical reference methods and predicate devices, not human readers.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the performance testing described ("method comparison, precision, linearity, interference, and limit of quantitation") represents a standalone study of the device's performance. The TRILOGY Analyzer operates as an automated system without direct human intervention in the analytical process once initiated. The results are generated solely by the analyzer.
7. The Type of Ground Truth Used:
The ground truth for the performance studies was implicitly established by:
- Reference analytical methods: For assessing accuracy and linearity.
- Validated predicate devices: For method comparison studies, where the predicate device's results serve as the comparison standard.
- Known concentrations/samples: For evaluating precision, linearity curves, and limits of quantitation.
8. The Sample Size for the Training Set:
The document does not specify a separate training set or its sample size. For automated chemistry analyzers like the TRILOGY, the "training" (calibration and optimization) is typically part of the development and manufacturing process, where internal quality controls and calibrators are used, rather than a distinct "training set" in the context of machine learning. The provided text describes validation/verification studies demonstrating the device's performance post-development.
9. How the Ground Truth for the Training Set Was Established:
As above, the concept of a "training set" with ground truth in the machine learning sense is not explicitly applicable or described for this traditional automated chemistry analyzer. The ground truth for internal calibration and verification would be established using:
- Certified reference materials.
- Calibrators with known concentrations traceable to international standards.
- Internal quality control samples with established target values.
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