(229 days)
The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.
The ABX MICROS ES 60 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting, quality control, calibration, and cleaning. The system is a microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. It operates in complete blood count (CBC) and Differential (DIFF) mode using a combination of focused flow impedance and light transmission technologies. It is available in Closed (CT) or Open Tube (OT) sampling versions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for ABX Micros ES 60
1. Table of Acceptance Criteria and Reported Device Performance
The document provides acceptance criteria for various analytical performance characteristics. Here's a summary:
| Performance Characteristic | Measurand | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Limit of Blank (LoB) | WBC | N/A (implied clinical relevance) | $0.1 \times 10^3/mm^3$ |
| RBC | N/A | $0.01 \times 10^6/mm^3$ | |
| HCT | N/A | 0.1 % | |
| PLT | N/A | $1 \times 10^3/mm^3$ | |
| Limit of Detection (LoD) | WBC | N/A (implied clinical relevance) | $0.2 \times 10^3/mm^3$ |
| RBC | N/A | $0.01 \times 10^6/mm^3$ | |
| HGB | N/A | 0.5 g/dL | |
| HCT | N/A | 0.2 % | |
| PLT | N/A | $4 \times 10^3/mm^3$ | |
| Limit of Quantitation (LoQ) | WBC | % Total-error |
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”