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510(k) Data Aggregation
(31 days)
The ABX MICROS CRP 200 is an open tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or or in CBC & Creactive protein (CRP) mode. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. For the CRP mode, the MICROS CRP 200 uses dedicated HoribaABX reagents (ABX CRP REA), controls (ABX CRP TROL I & III) and calibrator (ABX CRP STD). The MICROS CRP 200 may be coupled, on option, with an information management (iM) system.
ABX MICROS CRP 200 is an automated hematology analyzer that was developed by Horiba ABX (Montpellier, France). It utilizes cytochemistry, focused flow imredance, light scattering, and turbidity to provide quantitative information on complete blood cell and differential counts, in addition to other hematology parameters and conventional CRP. CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lysed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
Acceptance Criteria and Device Performance for ABX MICROS CRP 200
The ABX MICROS CRP 200, its associated CRP reagent (ABX CRP REA), controls (ABX CRP TROL I-III), and calibrator (ABX CRP STD) have demonstrated substantial equivalence to the predicate device ABX MICROS CRP (cleared under K002646) through internal and external clinical studies and internal validation procedures. The device's fundamental scientific technology for hematology parameters remains consistent with the predicate. The primary modification addressed in this 510(k) was the provision of a higher linearity limit for the C-Reactive Protein (CRP) parameter using a new reagent and calibrator, and the addition of an optional information management system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Precision | Not explicitly stated but generally refers to reproducibility of results. | "Good precision in accordance with EP5-A (NCCLS guidelines) and is entirely acceptable for all available parameters." | Clinical Studies (Internal & External) |
| Linearity | WBC: 0 - 80 x 10^3/μL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies |
| RBC: 0 - 7.5 x 10^9/μL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| HGB: 0 - 23g/dl | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| HCT: 0 - 62.4% | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| PLT: 0 - 900 x 10^3/pL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| Conventional CRP (Whole Blood): 0 - 200 mg/L | "Entirely supported by the clinical data provided in this submission." (Higher linearity limit for CRP was a key modification) | Clinical Studies | |
| Conventional CRP (Plasma): 0 - 150 mg/L | "Entirely supported by the clinical data provided in this submission." (Higher linearity limit for CRP was a key modification) | Clinical Studies | |
| Accuracy (Inter-procedural Correlation) | No significant bias expected compared to predicate devices. | "Showed no evidence of significant bias between the ABX MICROS CRP 200 and the predicate devices." | Clinical Studies |
| Sample Stability | Leukocyte counts and 3-part leukocyte differential: Acceptable for over 48 hours at room temperature and 4°C. | "Acceptable for over a 48 hour period from the time of blood collection at both room temperature and 4°C." | Clinical Studies |
| C-Reactive Protein determinations: Acceptable for over 72 hours at room temperature and 4°C. | "Assures there is sample stability over a 72 hour period at both room temperature and 4°C." | Clinical Studies | |
| Carryover | < 2.0% for WBC, RBC, HGB, PLT & CRP parameters. | No effect of contamination (carryover < 2.0%) was dissimulated by clinical data. | Clinical Studies |
| Safety (Electrical/EMC) | Compliance with IEC 61010-1 standard. | "The device meets with the IEC 61010-1 standard." | Non-clinical Tests |
| Compliance with EN 61326 standard. | "As well as the EN 61326 standard for Electromagnetic Compatibility." | Non-clinical Tests |
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 in the clinical studies. It broadly refers to "internal & external clinical studies" and "clinical data provided in this submission."
The data provenance is not specified in terms of country of origin. The studies are referred to as "internal & external clinical studies" and "internal validation procedures," suggesting a mix of internal development and potentially external verification. The submission originated from Horiba ABX Montpellier, France, implying the internal studies were conducted there. Whether external studies involved other countries or sites is not detailed. The studies were likely retrospective and prospective as they cover initial validation and performance for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies focus on instrument performance (precision, linearity, accuracy, stability, carryover) rather than an expert-adjudicated diagnostic task.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of the device (automated hematology analyzer and CRP measurement), the evaluation primarily involves comparing measurements obtained by the device against reference methods or predicate devices, and internal quality control standards, rather than expert consensus on diagnostic interpretations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. The effectiveness studies focused on the analytical performance of the device itself.
6. Standalone Performance Study
Yes, a standalone study was done. The entire submission details the performance of the ABX MICROS CRP 200 device in a standalone capacity (algorithm only, without human-in-the-loop performance, in the context of an automated analyzer) for generating quantitative measurements of hematology parameters and CRP. The "Discussion of Performance Data" focuses entirely on the device's analytical capabilities.
7. Type of Ground Truth Used
The ground truth for the performance studies was implicitly established through:
- Reference Methods/Predicate Devices: For accuracy, the new device's results were compared against "predicate devices," implying the predicate served as the reference standard.
- Established Analytical Standards: Precision and linearity were assessed against NCCLS guidelines (EP5-A), which set the standard for acceptable performance.
- Control Materials: Precision and stability studies would use assayed control materials with known target values.
- Calibrators: CRP measurements rely on calibration against known standards.
Therefore, the ground truth is based on reference methods, established analytical standards, and control/calibrator materials rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic interpretation task.
8. Sample Size for the Training Set
This information is not provided in the document. The document refers to "internal & external clinical studies" without differentiating between training and testing data sets in detail. For an in vitro diagnostic device of this type, the "training" (development and optimization) often involves iterative testing and refinement with a variety of samples rather than a formally defined, distinct "training set" like in machine learning. However, the exact sample numbers used for developing the original algorithms or optimizing the CRP reagent/calibrator are not disclosed.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the specific methodology and ground truth establishment for a "training set" are not explicitly described. For an automated analyzer, the development and "training" process typically involves:
- Internal R&D Testing: Using a large number of patient samples, spiked samples, and control materials to optimize algorithms, reagent formulations, optical systems, and fluidics.
- Comparative Analysis: Ensuring the device's measurements align with established reference methods or existing, validated analyzers (predicate devices).
- Verification and Validation Studies: Conducting extensive internal testing to challenge the system across its entire analytical range and various conditions.
The ground truth during this developmental phase would be established by reference laboratory methods, validated predicate devices, and gravimetrically/volumetrically prepared standards, similar to the ground truth used for the final performance validation.
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