COULTER A T 5DIFF CAP PIERCE (CP)

K042173 · Beckman Coulter, Inc. · GKZ · Oct 12, 2004 · Hematology

Device Facts

• Record ID: K042173
• Device Name: COULTER A T 5DIFF CAP PIERCE (CP)
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Oct 12, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The Coulter AcT 5diff Cap Pierce (CP) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed vial or open vial mode.

Device Story

The Coulter AcT 5diff Cap Pierce is an automated hematology analyzer for clinical laboratories. It processes whole blood samples via open or closed vial modes. The system utilizes aperture impedance for cell counting (WBC, RBC, Plt, Hct) and spectrophotometry for hemoglobin determination. Differential analysis employs aperture impedance, cytochemistry, and light transmission from a halogen source. A microprocessor-driven PC manages data processing and storage. The device provides 26 hematology parameters, including a five-part leukocyte differential. It is operated by laboratory personnel to assist in clinical hematological assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance comparisons to legally marketed predicate devices.

Technological Characteristics

Automated hematology analyzer; aperture impedance, cytochemistry, and light transmission (halogen source) sensing; microprocessor-driven PC workstation; open and closed vial sampling; barcode specimen identification; software version 1.29.

Indications for Use

Indicated for use as an automated differential cell counter to identify, count, and classify formed elements of blood, including immature or abnormal hematopoietic cells in blood or bone marrow. Intended for clinical use to separate normal patients from those requiring additional diagnostic studies.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• COULTER® HmX with Autoloader (K922704/A1)
• COULTER® Ac•TTM 5diff Autoloader (AL) (K030291, K032013)

Submission Summary (Full Text)

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

A. 510(k) Number:
K042173

B. Manufacturer and Instrument Name:
Beckman Coulter, Inc., Coulter A°-T™ 5diff Cap Pierce (CP)

C. Type of Test or Tests performed:

D. System Descriptions:

1. Device Description:
The Coulter AcT 5diff Cap Pierce is a quantitative, automated hematology analyzer and leukocyte differential analyzer capable of analyzing samples in a closed vial or open vial modes. The system consists of the Analyzer, a personal computer workstation and a printer. The AcT 5diff CP is a device manufactured for Beckman Coulter, inc. under an OEM agreement by ABX Diagnostics (ABX) of Montpellier, France. The AcT 5diff CP with version 1.29 software is currently marketed as an OEM device using the ABX Pentra C+ instrument cleared under K003677.

2. Principles of Operation:
The CBC analysis is based on the established Coulter Principles of automated cell counting and spectrophotometric hemoglobin determination. The differential analysis uses the principles of aperture impedance, cytochemistry, focused flow impedance, and light transmission from a halogen light source. The instrument is a microprocessor driven with a PC that performs data processing and data management activities.

3. Modes of Operation:
Open tube and Closed tube

4. Specimen Identification:
Barcode

5. Specimen Sampling and Handling:
Open tube, pierced cap

6. Calibration:
Coulter AcT 5 diff commercial calibrators

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7. Quality Control:
Multiple quality control techniques using Coulter AcT 5diff Control Plus Reference control.

8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☑ or No ☐

E. Regulatory Information:

1. Regulation Section:
21 CFR 864.5220, Automated differential cell counter

2. Classification:
Class II

3. Product Code:
GKZ

4. Panel:
81 Hematology

F. Intended Use:

1. Indication(s) for Use:
The Coulter AcT 5diff Cap Pierce (CP) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed vial or open vial mode.

2. Special Condition for use Statement(s):
N/A

G. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
a. Beckman Coulter AcT 5diff AL (k032013)
b. Beckman Coulter HmX with AL (k922704/A1)

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2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| # of Parameters | AcT 5diff CP=26 | AcT 5diff AL=26 |
| Principles of Measurement | WBC= Aperture Impedance | Same |
| | RBC= Aperture Impedance | Same |
| | Hgb= Spectrophotometric | Same |
| | MCV= Calculated from Hct | AcT 5diff AL= Same |
| | Hct= Aperture Impedance | AcT 5diff AL= Same |
| | Plt= Aperture Impedance | Same |
| | Differential= Aperture | Act 5diff AL= Same |
| | Impedance, Light scattering | AcT 5diff AL= Same |
| Metrics=N/A | AcT 5diff AL= Same | |
| Sample Volume | Open and Closed Vial Modes: | AcT 5diff AL= Same |
| | CBC profile=30μL | |
| | CBC/DIFF profile=53μL | |
| Differences | | |
| Item | Device | Predicate |
| # of Parameters | AcT 5diff CP=26 | HmX with AL=25 |
| Principles of Measurement | MCV= Calculated from Hct | HmX with AL= Aperture Impedance |
| | Hct= Aperture Impedance | HmX with AL= Calculated from MCV |
| | Differential= Aperture | HmX with AL= Aperture Impedance, Conductivity, Laser Light Scatter (VCS) |
| | Impedance, Light Scattering | |
| | Return= N/A | HmX with AL= Laser Light Scatter |
| Sample Volume | Open and Closed Vial Modes: | HmX with AL: |
| | CBC profile=30μL | Open Vial Mode=125μL |
| | CBC/DIFF profile=53μL | Closed Vial Mode=185μL |
| Throughput | Open and Closed Vial Modes: Up to 80 samples /hour | AcT 5diff AL=Open and Closed Vial Modes: Up to 60 samples/hour |
| | | HmX with AL=Open and |
| | | closed Vial Mode: Up to 60 samples/hour |

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| | | Closed Vial Modes: 75 samples / hour, Retics=30 samples/hour |
| --- | --- | --- |

## H. Standard/Guidance Document Referenced (if applicable)

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.

## I. Performance Characteristics:

### 1. Analytical Performance:

#### a. Accuracy:

Accuracy testing was performed in accordance with NCCLS EP9-A, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Acceptance criteria for the WBC, RBC, Hgb, Hct, and Plt parameters will be a correlation coefficient "R" of >0.95 when assessed by duplicate analysis and compared to an automated hematology analyzer that has been calibrated and maintained to the manufacturer's recommendations. Acceptance criteria were met.

#### b. Precision/Reproducibility:

Precision testing was performed in accordance with NCCLS EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. Acceptance Criteria for the WBC, RBC, Hgb, Hct, and Plt parameters was listed in the Summary Report in Section 3.3 Precision—Within-Run (Reproducibility). In two verification studies, precision was verified by the analysis of n=20 replicates of a single fresh normal sample on two different AcT 5diff CP analyzers. Twenty-one replicates were analyzed, with the first replicate deleted as prime. Acceptance criteria were met.

#### c. Linearity:

Linearity testing was performed using a commercially available low range and full range linearity test kit. A minimum of six dilutions were used, with each dilution analyzed four times and a mean determined. The obtained mean was compared to the expected result for each dilution. Acceptance criteria for the WBC, RBC, Hgb, Hct, and Plt parameters were listed in the Summary Report in Section 3.5 Linearity. Acceptance criteria were met.

#### d. Carryover:

Carryover testing was performed in accordance with the ICSH guideline referenced in the FDA special control. Carryover is

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assessed by analyzing a whole blood sample with high cell concentrations followed by a whole blood sample having low cell concentrations. Each sample is analyzed in triplicate. Acceptance criteria for the WBC, RBC, Hgb, and Plt parameters will be <2.0%. Acceptance criteria were met.

e. Interfering Substances:
N/A

2. Other Supportive Instrument Performance Data Not Covered Above:
a. Specimens: Anticoagulant
Specimen anticoagulant testing was performed in accordance with the ICSH guideline Recommendations of the International Council for Standardization in Hematology for ethylenediaminetetraacetic acid anticoagulation of blood for blood cell counting and sizing. The acceptance criterion was the ability of the instrument to meet product labeling using both K₃ and K₂ EDTA. Acceptance criteria were met.

J. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.