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510(k) Data Aggregation
(31 days)
ABX MICROS CRP 200, OPTION IM
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 |
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(63 days)
ABX MICROS CRP
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