(21 days)
The MD 700 is a multi-parameter, automated hematology analyzer used to perform in vitro analysis of human peripheral blood in clinical laboratories.
The MD 700 reports on the following parameters:
White Blood Cells (Leukocytes) WBC
Red Blood Cells (Erythrocytes) RBC
Hemoglobin Concentration Hgb
Hematocrit (relative volume of erythrocytes) Hct
Mean Corpuscular (erythrocyte) Volume MCV
Mean Corpuscular (erythrocyte) Hemoglobin MCH
Mean Corpuscular (erythrocyte) Hemoglobin Concentration MCHC
Red Blood Cell (erythrocyte volume) Distribution Width RDW
Platelet or Thrombocyte Count Plt
Granulocyte (number) GR#
Granulocyte (percent of WBC) GR%
Lymphocyte (number) LY#
Lymphocyte (percent of WBC) LY%
Monocyte (number) MO#
Monocyte (percent of WBC) MO%
The MD 700 is a quantitative analyzer of peripheral human blood for in vitro diagnostic use in clinical laboratories. It performs an automated complete blood count (CBC) and a leukocyte differential on peripheral human blood. A sample volume of 20 uL of whole blood is required. The instrument provides a printed report on 15 parameters. The MD 700 consists of five components: (1) A blood analysis instrument, (2) A reagent dispensing unit and four reagents, (3) Calibration and control reagents, (4) Probeclenz™, a cleaning liquid, and (5) A standard, off-the-shelf high resolution printer. The MD 700 analyzes human peripheral blood by passing electronic waves through precisely measured dilutions of the blood, and analyzing the results using software which relies upon a patented mathematical algorithm to determine the count and percent of each parameter reported.
The provided document, K983562, is a 510(k) Summary for the MASCOT MD Hematology Analyzer Model MD 700. It establishes substantial equivalence to a predicate device (MASCOT MD Hematology Analyzer Model MD 800) and describes the device's technical specifications and intended use. However, it does not contain specific acceptance criteria, performance study details, or data proving the device meets acceptance criteria.
Instead of a new study, the document explicitly states: "This is a special 510(k). The non-clinical and clinical studies upon which the 510(k) of the MD 800 and its reagents were cleared are relied upon with respect to the MD 700. The MD 700 is as safe and effective as the MD 800, the predicate device, because the fundamental scientific technology of the MD 700 has not changed from that of the MD 800."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study for the MD 700 directly from this document. The document relies on the prior approval of the predicate device (MD 800) for its safety and effectiveness claims.
I can, however, extract the performance specifications of the MD 700 as stated in the document, which can be inferred as a form of acceptance criteria for the device's operational characteristics.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not present:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, the document does not explicitly state "acceptance criteria" as a separate set of performance targets. Instead, it provides "Significant Performance Characteristics of Device" (Page 5) and "MASCOT ™ MD 700 HEMATOLOGY SYSTEM SPECIFICATIONS" (Page 6), which serve as the reported performance of the device and implicitly as the performance benchmarks it is expected to meet.
| Characteristic | Acceptance Criteria (from document, implicitly) | Reported Device Performance (from document) |
|---|---|---|
| Precision | ||
| WBC |
§ 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.”