HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

K073178 · R&D Systems, Inc. · JPK · Dec 27, 2007 · Hematology

Device Facts

• Record ID: K073178
• Device Name: HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

HCT Extended is a control designed to monitor values obtained from automated, semiautomated and manual methods. Please refer to the for specific instrument models.

Device Story

HCT Extended Hematology Control; in-vitro diagnostic reagent; human erythrocytes in plasma-like fluid with preservatives. Used as quality control material to monitor hematocrit measurement performance. Sampled like patient specimen; processed via automated, semi-automated, or manual hematology methods. Provides stable reference values to verify diagnostic test accuracy; helps laboratories detect instrument calibration shifts or performance degradation. Supplied in two levels (Abnormal I and II) in 3.0 mL vials.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility testing across three lots yielded average CV < 5%. Value assignment performed using HemataSTAT II, Microhematocrit Centrifuge, and Sysmex XE-2100. Stability validated for 21 days (open vial) and 75 days (closed vial) at 2-8°C.

Technological Characteristics

In-vitro diagnostic reagent; human erythrocytes in plasma-like fluid with preservatives. Two levels (Abnormal I and II). 3.0 mL vial form factor. Storage 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed laboratory control to monitor the performance of diagnostic tests for hematology, specifically hematocrit, using automated, semi-automated, or manual methods.

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

• R&D Systems CBC-7 Hematology Control (K843962)

Submission Summary (Full Text)

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

A. 510(k) Number:
K073178

B. Purpose for Submission:
New Device

C. Measurand:
Hematocrit (HCT)

D. Type of Test:
Quantitative

E. Applicant:
R&amp;D Systems, Inc.

F. Proprietary and Established Names:
HCT Extended 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)

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H. Intended Use:

1. Intended use(s):

HCT Extended Hematology Control is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods.

2. Indication(s) for use:

It is established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods.

3. Special conditions for use statement(s):

Not applicable.

4. Special instrument requirements:

Not applicable.

I. Device Description:

HCT Extended Hematology Control is an in-vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods. It is sampled in the same manner as a patient specimen. It is supplied in two levels as Abnormal I and Abnormal II. Each vial contains 3.0 mL.

J. Substantial Equivalence Information:

1. Predicate device name(s):

R&amp;D Systems CBC-7 Hematology Control

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

K843962

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | HCT Extended Hematology Control | R&D Systems CBC-7 Hematology Control |
| Intended use | An assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods. | Same |
| Biological Source | Human Red Cells | Human Red Cell, Porcine |
| Closed Vial Stability | 2-8°C until expiration date | Same |
| Differences | | |
| --- | --- | --- |
| | Device | Predicate |
| | HCT Extended Hematology Control | R&D Systems CBC-7 Hematology Control |
| Base Matrix | Human erythrocytes suspended in plasma like fluid with preservatives. | Human erythrocytes and simulated leukocytes suspended in plasma like fluid with preservatives. |
| Analytes | Hematocrit only | Hematocrit, WBC, RBC, HGB, MCV, MCH, MCHC |
| Open Vial Stability | 21 days | 14 days |

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

Not applicable.

L. Test Principle:

It is established laboratory practice to use a stable control to monitor the performance of diagnostic tests. This control is composed of stable material that provides a mean of monitoring the performance of automated, semi-automated and manual hematocrit methods. It is sampled in the same manner as the patient specimen.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Three lots of control material were tested between 31 and 41 times to yield an average of less than 5% CV.

b. Linearity/assay reportable range:

Not applicable

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

Value assignment: The HCT Hematology Value Assignment protocol is based on current R&amp;D assay ranges for the same or similar instrumentation on other R&amp;D products. One HemataSTAT II, one Microhematocrit Centrifuge, and one Sysmex XE-2100 Automated Hematology Analyzer were used for the value assignment. Means and ranges are chosen at extended stability of the parameter and shifts in instrument calibration. Three lots each of Level I and II were tested by the three methods (with multiple vials and replicate testing) over approximately 4 days. The data was analyzed using linear regression. All CV values were acceptable.

Open vial stability testing was performed using three lots of Level I and Level II controls on one instrument of each method. Each lot was stored at 2-8°C, allowed to warm to room temperature for 15 minutes, analyzed, and returned to 2-8°C. Data was collected for 6-10 days over the 21 day period. All levels were within the established range.

Closed vial stability testing was performed on three lots of Level I and Level II (stored at 2-8°C) and tested at real time points on one instrument of each method. All levels were within the established range. Expiration dating reflects the validated time period that assures adequate device performance throughout shelf life of 75 days.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

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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 (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The target mean values are initially specified at a hematocrit 57-63% for Level I and 66-74% for Level 2. Ranges around the mean are set at ±5% for Level 1 and ±6% for Level 2. Users are instructed to refer to the assay table in the labeling for specific instrument models ranges. It is recommended for greater sensitivity that each laboratory should establish its own mean and acceptable range.

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

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O. Conclusion:

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

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