← Product Code [JPK](/productcode/JPK) · K050721

# ABX ERYTROL (K050721)

_Horiba Abx · JPK · Jun 1, 2005 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K050721

## Device Facts

- **Applicant:** Horiba Abx
- **Product Code:** [JPK](/productcode/JPK.md)
- **Decision Date:** Jun 1, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8625
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

ABX Erytrol is a tri-level control designed for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for NRBC parameter.

## Device Story

ABX Erytrol is an in-vitro diagnostic hematology quality control mixture; composed of human erythrocytes and mammalian leukocytes in a plasma-like fluid with preservatives. Used in clinical laboratory settings to monitor the performance of HoribaABX hematology analyzers. The control is processed by the analyzer to verify the accuracy and precision of the nucleated red blood cell (NRBC) count parameter. Healthcare professionals compare analyzer results against established assay ranges to ensure instrument reliability. Benefits include validated instrument performance, ensuring accurate patient diagnostic results.

## Clinical Evidence

No clinical data. Bench testing only; three validation lots tested to determine precision and stability, with results found to be within acceptable limits.

## Technological Characteristics

In-vitro diagnostic control; human erythrocytes and mammalian leukocytes in plasma-like fluid with preservatives. Tri-level formulation. Designed for use with HoribaABX hematology analyzers. No electronic or software components.

## Regulatory Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

## Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Predicate Devices

- PENTRA 5D Hematology control ([K003534](/device/K003534.md))

## Submission Summary (Full Text)

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

A. 510(k) Number:
k050721

B. Purpose for Submission: New device

C. Measurand: WBC (GB), NRBC (ERB) %, NRBC (ERB)#

D. Type of Test: Not applicable

E. Applicant:
HORIBA ABX, Inc.

F. Proprietary and Established Names:
ABX Erytrol

G. Regulatory Information:

1. Regulation section:
864.8625 Hematology Quality Control Mixture

2. Classification:
Class II

3. Product code:
JPK

4. Panel:
81 Hematology

H. Intended Use:

1. Intended use(s):
ABX Erytrol is a tri-level control designed for use in monitoring the accuracy and

{1}

precision of the HoribaABX hematology blood cell counters for NRBC parameter.

2. Indication(s) for use:

Same

3. Special conditions for use statement(s):

None

4. Special instrument requirements:

For use with ABX Hematology Analyzers

## I. Device Description:

The ABX Erytrol is an in-vitro diagnostic blood control composed of human erythrocytes and mammalian leukocytes in a plasma-like fluid with preservatives. The ABX erythrol is composed of stable materials that provide a means of monitoring the performance of ABX hematology analyzers offering the nucleated red blood cell count (NRBC) parameter.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

PENTRA 5D Hematology Control, R & D Systems, Inc.

2. Predicate 510(k) number(s):

K003534

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | PENTRA 5D | ABX ERYTROL  |
|  Intended Use | For 5 diff parameters | For NRBC parameters  |
|  Summary | Similar | Similar  |
|  Principle | Similar | Similar  |
|  Reagents | Human RBCs
Different species of WBC
Platelets | Human RBCs
Different species of WBC  |
|  Storage | Similar | Similar  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | PENTRA 5D | ABX ERYTROL  |
|  Stability | Closed: 74 days shelf
60 customer
Open: 14 days | Similar  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Parameters | 5 part diff | NRBC  |

# K. Standard/Guidance Document Referenced (if applicable):

Not applicable

# L. Test Principle:

Not applicable

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

A non-clinical study testing 3 validation lots to determine precision and stability was found to be within acceptable limits

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

A non-clinical study testing 3 validation lots to determine precision and stability was found to be within acceptable limits

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

{3}

Not applicable

2. Comparison studies: Not applicable
a. Method comparison with predicate device:
b. Matrix comparison:

3. Clinical studies: Not applicable
a. Clinical Sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off: Not applicable

5. Expected values/Reference range:

Assigned values are presented as a Mean Value that is derived from replicate testing on instruments operated and maintained according to the manufacturer instructions. The Range is an estimate of variation between laboratories and also takes into account expected biological variability of the control material.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

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

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**Source:** [https://fda-staging.innolitics.com/device/K050721](https://fda-staging.innolitics.com/device/K050721)

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