R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL

K101578 · R&D Systems, Inc. · JPK · Apr 28, 2011 · Hematology

Device Facts

• Record ID: K101578
• Device Name: R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.

Device Story

Body Fluid-I is an assayed, in vitro, whole blood control consisting of human and bovine cells in a plasma-like fluid with preservatives. It is packaged in 3 mL tubes and sampled like a patient specimen. Used in clinical laboratories to monitor the accuracy and precision of hematology instruments that measure red and white blood cell counts in body fluids (cerebrospinal, serous, synovial). By providing a known reference, it allows healthcare providers to verify instrument performance, ensuring reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (closed vial 75-day, open vial 30-day) and lot-to-lot reproducibility testing were performed on three lots across three levels of control material. Results confirmed the device remains within established ranges over the product life.

Technological Characteristics

Assayed whole blood control; human and bovine cells in plasma-like fluid with preservatives. 3 mL tube form factor. Stability: 75-day closed vial, 30-day open vial. Storage: 2-8°C.

Indications for Use

Indicated for use as an assayed hematology control to monitor the reliability of hematology instruments measuring red and white blood cell counts in cerebrospinal, serous, and synovial fluids. For prescription use only.

Regulatory Classification

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

• Streck Cell-Chex™ Auto Hematology Control (k053362)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k101578

B. Purpose for Submission:
Clearance of a new device

C. Measurand:
Red Blood Cells (RBC), White Blood Cells (WBC)

D. Type of Test:
Quality Control Material-Assayed

E. Applicant:
R&D Systems Inc.

F. Proprietary and Established Names:
Body Fluid-I Hematology Control

G. Regulatory Information:
1. Regulation section:
21 CFR §864.8625 Hematology quality control mixture
2. Classification:
Class II
3. Product code:
JPK, Mixture, Hematology Quality Control
4. Panel:
81 (Hematology)

H. Intended Use:
1. Intended use(s):
The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.
2. Indication(s) for use:
Same as Intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Coulter® LH-700 Series

I. Device Description:
The R&D Body Fluid-I Control is composed of human erythrocytes and bovine leukocytes in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material.

J. Substantial Equivalence Information:
1. Predicate device name(s) and 510(k) number(s):
Streck Cell-Chex™ Auto Hematology Control (k053362)
2. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | R&D Systems Body Fluid-I Hematology Control | Streck Cell-Chex™ Auto Hematology Control (predicate) |
| Intended Use Statement | The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids. | Same |
| Closed vial stability | 75 days | Same |
| Open vial stability | 30 days | Same |
| Differences | | |
| --- | --- | --- |
| Item | R&D Systems Body Fluid-I Hematology Control | Streck Cell-Chex™ Auto Hematology Control (predicate) |
| Manufacturing process | Body Fluid-I is composed of human red blood cells and bovine white blood cells in a plasma-like fluid with preservatives. | Cell-Chex Auto is formulated with stabilized suspension of human red blood cells and simulated white blood cells in a solution containing biological salts and preservatives. |
| Storage | 2-8°C | 2-10°C |
| Analyzers | Coulter® LH-700 Series | Abbott Cell-Dyn ® 3200, 4000, Sapphire™, Beckman Coulter® LH 750, Sysmex XE-2100™ |
| Final Product Form | Three vials (Level 1, 2, and 3) in tubes containing 3 mL of control material | Three vials (Level 1, 2, and 3) in plastic vials containing 4 mL of control material |

K. Standard/Guidance Document Referenced (if applicable):
Not applicable

L. Test Principle:
Body Fluid-I Control is an in vitro diagnostic product that provides a means of monitoring the accuracy and precision of body fluid WBC and RBC counts performed on automated hematology blood cell counters.

M. Performance Characteristics:
1. Analytical performance:
a. Precision/Reproducibility:
R&D Systems Body Fluid-I control reproducibility studies were conducted at three locations, employing three separate lots run in duplicate, with two runs per day for 20 operating days. Each location used its own Beckman Coulter

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LH750 to run one lot containing 3 levels of control. The results for the study are as follows:

| WBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| --- | --- | --- | --- |
| Level 1 | 15.4 | 7.1 | 6.3 |
| Level 2 | 3.0 | 6.7 | 3.0 |
| Level 3 | 1.8 | 1.9 | 2.0 |
| RBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| Level 1 | 3.8 | 3.8 | 4.2 |
| Level 2 | 1.5 | 1.6 | 1.6 |
| Level 3 | 0.7 | 0.7 | 0.7 |

# b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Value assignment: Specific to each lot and level of control, a total of four vials are analyzed in duplicate. A cumulative mean and standard deviation (SD) are calculated for each measurand reported. The assay ranges are set at $\pm 2\mathrm{SD}$ for level 1 RBC and WBC. Level 2 and level 3 RBC and WBC ranges reflect $\pm 3\mathrm{SD}$ .

Open Vial Stability: Three lots of control material each containing 3 levels were tested near the end of their closed vial shelf life for the purpose of evaluating open vial stability. The controls were stored at $2 - 8^{\circ}\mathrm{C}$ until they were tested. Over the course of 30 days the control was analyzed 9 to11 times. The results for the study are as follows:

| WBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| --- | --- | --- | --- |
| Level 1 | 12.0 | 8.9 | 9.2 |
| Level 2 | 5.1 | 4.3 | 4.5 |
| Level 3 | 2.1 | 3.7 | 3.0 |
| RBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| Level 1 | 10.2 | 9.2 | 8.2 |
| Level 2 | 10.2 | 3.3 | 3.1 |
| Level 3 | 1.5 | 1.3 | 1.5 |

Closed Vial Stability: For the purpose of evaluating closed vial stability, three lots of control material each containing 3 levels were tested 23-26 times over the course of 75 days. The results for the study are as follows:

| WBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| --- | --- | --- | --- |
| Level 1 | 15.5 | 20.3 | 14.4 |
| Level 2 | 4.7 | 10.3 | 4.8 |
| Level 3 | 2.6 | 7.4 | 2.4 |
| RBC | Lot 1 %CV | Lot 2 %CV | Lot 3 %CV |
| Level 1 | 9.6 | 5.8 | 4.5 |
| Level 2 | 2.7 | 2.4 | 4.8 |
| Level 3 | 1.2 | 1.0 | 1.0 |

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d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

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

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data:
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Expected values are provided in the Package Insert accompanying the product.

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.