IMMUNICON CELLTRACKS AUTOPREP SYSTEM

K040077 · Immunicon Corp. · GKH · Mar 12, 2004 · Hematology

Device Facts

• Record ID: K040077
• Device Name: IMMUNICON CELLTRACKS AUTOPREP SYSTEM
• Applicant: Immunicon Corp.
• Product Code: GKH · Hematology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5240
• Device Class: Class 1

Indications for Use

The intended use for the Immunicon CellTracks™ AutoPrep System is as a generalpurpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Device Story

Immunicon CellTracks AutoPrep System is a semi-automated laboratory instrument for processing whole blood samples; utilizes immunomagnetic reagents (ferrofluid conjugated with monoclonal antibodies) to capture/enrich target cells; fluorescence-labeled monoclonal antibodies differentiate captured cells. Process: ferrofluid added to sample; magnetic field isolates target cells; blood aspirated; cells re-suspended; fluorescent reagents added; secondary magnetic separation/re-suspension performed. System processes up to 8 samples per batch; requires user-performed pre-processing (dilution/centrifugation). Output: prepared analysis cartridge for downstream identification/enumeration by cell analyzers, flow cytometers, or microscopes. Used in laboratory settings by trained personnel. Benefits: standardized, automated sample preparation; improved throughput compared to manual methods; error detection capabilities.

Clinical Evidence

Clinical trial performed at three sites using 20-day precision study (NCCLS EP5-A). Results: reproducible removal of control cells from 7.5 ml whole blood (CV 11.72%–16.8%). Nonclinical testing: sensitivity of ~1 cell per 7.5 ml; linear recovery range 2–906 cells (slope 1.0221, r=0.9946). Method comparison vs. predicate (NCCLS EP9-A): correlation coefficient 0.99, slope 1.0935, intercept 4.0344, r=0.9801.

Technological Characteristics

Semi-automated laboratory instrument; immunomagnetic separation principle using ferrofluid-conjugated monoclonal antibodies; batch processing (8 samples); barcode specimen identification; software-controlled reagent addition; error detection system; requires Immunicon CellSave Preservative Tubes.

Indications for Use

Indicated for use as a general-purpose laboratory instrument for the immunomagnetic capture, enrichment, and labeling of target cells in whole blood samples for subsequent identification and enumeration via cell analyzers, flow cytometers, or microscopes.

Regulatory Classification

Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Predicate Devices

• Immunicon CellPrep™ Sample Preparation system

Submission Summary (Full Text)

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number: K040077

B. Manufacturer and Instrument Name: Immunicon Corporation, Immunicon CellTracks™ AutoPrep System

C. Type of Test or Tests performed: The device is a semi-automated sample-handling instrument

D. System Descriptions:

a. Device Description: The Immunicon CellTracks Auto Prep System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CellTracks AutoPrep System processes up to 8 samples in a batch, performing all required process steps, including red cell detection, plasma aspiration and final transfer to the analysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation.

b. Principles of Operation: Immunicon has developed reagents that include ferrofluid conjugated with monoclonal antibodies that immunomagnetically separate the cells of interest and fluorescence-labeled monoclonal antibodies to further differentiate the captured cells. The first reagent added is ferrofluid which consists of a magnetic core surrounded by a polymeric layer coated with antibodies for capturing cells. Ferrofluid particles are colloidal and when mixed with a sample containing the target cells, the antibodies conjugated to the magnetic core bind the antigen associated with the target cells. The ferrofluid/sample mixture is placed in a strong magnetic field, which causes the labeled target cells to move to the side of the tube. The blood is aspirated, the magnetic field is removed and the cells are re-suspended in a small volume of buffer. Fluorescent reagents are added for identification and enumeration of target cells. Another magnetic separation step and re-suspension is performed before the final sample is ready for analysis.

c. Modes of Operation: Batch

{1}

Page 2 of 5

d. Specimen Identification:
Barcode on sample tube

e. Specimen Sampling and Handling:
Whole blood samples are processed as described in # 2 above. Immunicon CellSave Preservative Tubes (K030596) must be used to collect blood samples.

f. Calibration:
N/A

g. Quality Control:
The CellTracks Auto Prep system incorporates a self-check procedure when the instrument is turned on. There is a System lock-out that prevents only authorized users to access the program to make changes.

Software:
The computer-user interface utilizes radio buttons and highlight bars as selection tools.
FDA has reviewed the applicant's Hazard Analysis and software
Documentation: Yes ☐ X ☐ or No ☐

E. Regulatory Information:

h. Regulation Section:
21 CFR 864.5240, Automated blood cell diluting apparatus
Classification:
Class I
Product Code:
GKH

i. Panel:
Hematology (81)

F. Intended Use:

Indication(s) for Use:
The intended use for the Immunicon CellTracks AutoPrep System is as a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use. Special Condition for use Statement(s)

{2}

Page 3 of 5

G. Substantial Equivalence Information:

j. Predicate device name(s) and 510(k) numbers: Immunicon CellPrep™ Sample Preparation System (K02212)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Function | Blood specimen preparation | Same |
| Sample Treatment | Cells of interest isolated and plasma aspirated | Same |
| Cell Separation | Magnetic separation | Same |
| Blood Sample Size | 7.5 ml | Same |
| Differences | | |
| Item | Device | Predicate |
| Sample Handling | 8 samples | 2 samples |
| Reagent Addition | Programmed on board reagent pack | Manual addition; computer prompt |
| Quality Checks | Error detection capability | No error detection capability |

H. Standard/Guidance Document Referenced (if applicable) N/A

I. Performance Characteristics:

1. Analytical Performance:

k. Accuracy:

An accuracy study defined the % recovery of epithelial cell concentrations. The slope of 0.85 demonstrates 85% accuracy using 973 SKBr-3 tissue culture cells.

l. Precision/Reproducibility:

Control cells were tested over a total of 20 days at 1 inside and two outside clinical sites using NCCLS EP5-A. Results show that CellTracks Auto Prep System was capable of removing small numbers of control cells reproducibly from 7.5 ml of whole blood (38 cell spike level CV=16.8, 264 cell spike level CV=11.72).

m. Linearity:

The CellTracks AutoPrep System demonstrated consistent, linear, recovery of epithelial cells over a broad, clinically relevant range. The % recovery may differ from donor to donor; however, the

{3}

Page 4 of 5

slope of 1.0 confirms that, within a donor, the % recovery is constant over the range of cell concentrations tested. The high R²=0.9953 and 0.9946 establish that the linearity of response to the System is suitable to its intended use.

n. Carryover:
Whole blood was collected in CellSave and spiked with one of 6 levels (100, 250, 1000, 5000, 10,000, 20,000 per 7ml) of SKBr-3 tissue culture cells. Cell carryover was observed with some samples; however significant carryover was observed only when very high epithelial cell levels were encountered. The carryover observed when using the CellTracks AutoPrep System was found to be low enough to be suited to its intended use.

o. Interfering Substances:
N/A

2. Other Supportive Instrument Performance Data Not Covered Above:
N/A

J. Conclusion:
The Immunicon CellTracks AutoPrep System is substantially equivalent to the Immunicon CellPrep Sample Preparation System.

{4}

Page 5 of 5