(301 days)
The intended use for the Immunicon CellTracks™ System is as a general-purpose laboratory bench top scanning cytometer designed to enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned. The system is for in vitro diagnostic use.
To enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned.
The CellTracks Analyzer is used in conjunction with reagents containing ferrofluids and fluorescent conjugates. Depending on the application, samples may be prepared manually or using the CellTracks AutoPrep Sample Preparation System. Ferrofluid consists of a magnetic core surrounded by a polymeric layer coated with antibodies for capturing cells. Ferrofluid particles are colloidal (25-100 nanometers in radius) and when mixed with a sample containing target cells, the antibodies bound to the ferrofluid bind the associated antigens to the target cells. Fluorescent reagents are added for the identification and the enumeration of the target cells. The ferrofluid/sample mixture is placed in a magnetic field (Magnest), to select and align the labeled target cells. The Magnest, containing the fluorescence-labeled magnetically aligned target cells, is placed on the CellTracks analyzer and is ready for analysis.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| CD4 Slope (vs. predicate) | Close to 1.0 | 0.95 |
| CD4 R² (vs. predicate) | High, close to 1.0 | 0.9802 |
| CD3 Slope (vs. predicate) | Close to 1.0 | 0.77 |
| CD3 R² (vs. predicate) | High, close to 1.0 | 0.9375 |
| Linearity | Not explicitly stated but expected to be broad | 0 to 2,000 cells/ul |
| CD3 Normal Control Within-run CV | Not explicitly stated but expected to be low | 3.68% to 4.34% |
| CD3 Low Control Within-run CV | Not explicitly stated but expected to be low | 3.89% to 6.60% |
| Interference from Lipids | No adverse affect | No adverse affect up to 5,000 mg/dL |
| Interference from Hematocrits | No adverse affect | No adverse affect from 43.3% to 76.2% |
| Interference from Platelet Counts | No adverse affect | No adverse affect from 210 x 10² to 2,040 x 10² |
| Interference from WBC Counts | No adverse affect | No adverse affect from 4.1 x 10³ to 25.0 x 10³ |
| Interference from Free Hemoglobin | No adverse affect | No adverse affect from 10.3 to 12.4 g/dL |
| Electrical Safety (IEC 61326-1998, IEC 601010-2-101) | Met requirements | Met requirements |
| Laser Safety (21 CFR Part 1040.10) | Met requirements | Met requirements |
*Note: The document
§ 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.”