ABX PENTRA DX 120: OPTION SPS EVOLUTION

K050719 · Horiba Abx · GKZ · Apr 26, 2005 · Hematology

Device Facts

• Record ID: K050719
• Device Name: ABX PENTRA DX 120: OPTION SPS EVOLUTION
• Applicant: Horiba Abx
• Product Code: GKZ · Hematology
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The Horiba ABX, Pentra DX 120/Pentra DX 120 SPS Evolution, is a fully automated hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

Device Story

Bench-top automated hematology analyzer; analyzes whole blood samples via cytochemistry, focused flow impedance, light absorbance, and fluorescence. Microprocessor-driven system provides CBC, differential leukocyte, reticulocyte, and NRBC counts. Optional SPS Evolution module performs automated slide smearing and staining. Used in clinical laboratories by trained personnel. Output displayed for healthcare providers to assess hematological status and monitor erythropoietic activity. Device provides automated quantification of blood parameters to assist in clinical diagnosis and patient management.

Clinical Evidence

Clinical evaluation included precision testing per NCCLS EP5-A guidelines and accuracy studies comparing the device to Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry. Results showed r2 values between 0.96-0.98 for NRBC counts. Carry-over was <1%. Sample stability was validated for 24 hours at room temperature and 4°C. No clinical data regarding patient outcomes provided; evidence focuses on analytical performance and inter-procedural correlation.

Technological Characteristics

Bench-top automated hematology analyzer. Sensing: cytochemistry, focused flow impedance, light absorbance, fluorescence. Slide drying: verticalyser (natural air drying). Connectivity: barcode identification. Software: microprocessor-controlled with hazard analysis and design controls. Sterilization: N/A.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform complete blood counts, differential leukocyte counts, reticulocyte counts (including immature reticulocyte fraction to monitor erythropoietic activity), and nucleated red blood cell counts in patient blood samples. Includes optional automated slide smearing and staining.

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

• ABX PENTRA 120 (K962633, K990311, K991839, K022200)

Submission Summary (Full Text)

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

A. 510(k) Number:
K050719

B. Purpose for Submission:
510(k) for the addition of a new parameter for nucleated red blood cell count (NRBC), and an optional slide smearing and staining unit known as the SPS Evolution.

C. Manufacturer and Instrument Name:
Horiba ABX Pentra DX 120 Hematology Analyzer

D. Type of Test or Tests Performed:
Quantitative

E. System Descriptions:

1. Device Description:
The ABX PENTRA DX 120 Automated Hematology Analyzer is an in vitro, bench-top, clinical laboratory instrument, providing a complete blood count (CBC), leukocyte differential count (DIFF), reticulocyte count (RET), and nucleated red blood cell count (NRBC). The optional slide preparation system (SPS Evolution) smears and stains slides.

2. Principles of Operation:
The instrument is driven by a microprocessor, and uses cytochemistry, focused flow impedance, light absorbance, and fluorescence methodologies.

3. Modes of Operation:
Automatic, open (stat mode)/closed tube modes

4. Specimen Identification:
By keyboard and internal and external barcode

1. Specimen Sampling and Handling:

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Manual-

1. Aspiration of 130 µl of blood through the shear valve
2. The Blood samples goes to detection cell, which triggers the sampling valve switch.
3. Blood volumes contained in the valve loops are transferred to the measurement chambers
4. Internal and external needle rinse

Automatic

1. Cassette mixed
2. Cassette identification and tube detection
3. Tube extraction from the cassette and cap piercing
4. Aspiration of 200 µl of blood
5. Aspiration of specimen through the commutation valve
6. The Blood samples goes to detection cell, which triggers the sampling valve switch.
7. Blood volumes contained in the valve loops are transferred to the measurement chambers
8. Internal and external needle rinse

Calibration:

Commercially available calibration material

7. Quality Control:

Electronic quality control (EQC) and external liquid controls

8. Software:

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:

Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:

- 21 CFR 864.5200
- 21 CFR 864.5220
- 21 CFR 864.3800
- 21 CFR 864.5850

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2. Classification:

Automated cell counter and differential cell counter - Class II

Slide stainer and slide spinner - Class I

3 Product code:

GKZ, KPA, GKJ

4. Panel:

81 Hematology

# G. Intended Use:

1. Indication(s) for Use:

The Horiba ABX, Pentra DX 120/Pentra DX 120 SPS Evolution, is a fully automated hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

2. Special Conditions for Use Statement(s):

# H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

ABX PENTRA 120 (K962633, K990311, K991839, K022200)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | A fully automated hematology analyzer providing complete blood count, differential leucocyte count, retic count, immature reticulocyte fraction and nucleated red blood cell count | Same without the nucleated red blood cell count |
| Parameters | CBC, DIFF, RET | Same |
| Principles of operation | cytochemistry, focused flow impedance, light | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | absorbance, and
fluorescence
methodologies | |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| New Parameter | NRBC | Not available |
| Slide drying Principal | Verticalyser which allows for natural air drying | Halogen lamp |

I. Special Control/Guidance Document Referenced (if applicable):

Evaluation of Precision Performance of Clinical Chemistry Devices; approved Guideline, NCCLS document EP5-A (ISBN 1-56238-145-8) 1999

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, NCCLS document EP9-A2 (ISBN 1-56238-283-7), 2002

Reference Leukocyte Differential (Proportional) and Evaluation of Instrumental Methods, Approved Standard, NCCLS document H20-A (ISBN 1-56238-131-8), 1992

Guidelines for the evaluation of blood cell analysers including those used for differential leukocyte and reticulocyte counting and cell marker applications. International Council for Standardization in Hematology; Clinical Lab. Haemat. 1994, 16,157-174.

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 Document, 2001

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

b. Precision/Reproducibility:

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c. Linearity:

d. Carryover:

e. Interfering Substances:

2. Other Supportive Instrument Performance Data Not Covered Above:
As required for a Special 510(k), the Sponsor has provided a risk analysis as well as a Declaration of Conformity with Design Controls indicating that development activities were conducted under appropriate design controls procedures, and the overall product specifications were met.

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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