COULTER 4C-EX 300 CELL CONTROL
Device Facts
| Record ID | K100607 |
|---|---|
| Device Name | COULTER 4C-EX 300 CELL CONTROL |
| Applicant | Beckman Coulter, Inc. |
| Product Code | JPK · Hematology |
| Decision Date | Nov 18, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
Indications for Use
4C®-EX 300 Cell Control is a hematology quality control material used to monitor the performance of COULTER® hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your instrument specific instructions for use). The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
Device Story
4C®-EX 300 Cell Control is a stabilized human blood-based quality control mixture; contains treated erythrocytes, platelet-sized components, and fixed erythrocytes simulating leukocytes. Used in clinical laboratories to monitor daily performance of automated hematology analyzers (DxH™ 300/300C). Provided in three levels (Abnormal Low, Normal, Abnormal High). Laboratory personnel run the control through the analyzer; instrument measures counting, sizing, and hemoglobin determination. Output is compared against assigned values and expected ranges provided in the Table of Expected Results. Monitoring ensures instrument accuracy and precision; allows laboratories to establish their own mean. Benefits include verification of system performance and reliability of patient test results.
Clinical Evidence
No clinical data. Bench testing only. Precision/reproducibility studies were conducted on DxH 300 and DxH 300C analyzers across three sites over 20 days, following CLSI EP05-A2. Results met all pre-defined acceptance criteria for CV% across all levels (Abnormal Low, Normal, Abnormal High). Stability studies (open and closed vial) confirmed performance over the claimed shelf life.
Technological Characteristics
Stabilized human blood-based mixture; contains treated erythrocytes, stabilized platelet-sized components, and fixed erythrocytes. Liquid, ready-to-use reagent. Three levels of concentration. Analyzed via automated cell/differential counters using counting, sizing, and hemoglobin determination principles. Storage at 2-8°C. Open vial stability: 35 days/20 events; Closed vial stability: 145 days.
Indications for Use
Indicated for use as a hematology quality control material to monitor the performance of specific COULTER hematology analyzers and to establish laboratory means.
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
- COULTER® 4C®-ES Cell Control (k010064)
Related Devices
- K060464 — COULTER 5C CELL CONTROL · Beckman Coulter, Inc. · Mar 28, 2006
- K082162 — COULTER BODY FLUID CONTROL · Beckman Coulter, Inc. · Feb 3, 2009
- K024173 — CDS 3-PD HEMATOLOGY CONTROLS · Clinical Diagnostic Solutions, Inc. · Jan 14, 2003
- K081822 — COULTER 6C CELL CONTROL, MODELS 628027 & A59925 · Beckman Coulter, Inc. · Jan 21, 2009
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
k100607
B. Purpose for Submission:
Addition of a new parameter - RDW-SD (Red Cell Distribution Width-Standard Deviation) to the COULTER® 4C®-EX 300 Cell Control.
C. Measurand:
WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, RDW-SD, Plt, MPV and [LY (%)/#), MO (%)/#), GR (%)/#)].
D. Type of Test:
Quantitative
E. Applicant:
Beckman Coulter, Inc.
F. Proprietary and Established Names:
COULTER® 4C®-EX 300 Cell 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:
Hematology (81)
H. Intended Use:
1. Intended use(s):
4C®-EX 300 Cell Control is a hematology quality control material used to monitor the performance of COULTER® hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your instrument specific instructions for use).
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
2. Indication(s) for use:
Same as Intended Use
3. Special conditions for use statement(s):
Not applicable
4. Special instrument requirements:
For use on Coulter DxH™ 300 and DxH™ 300C analyzers
I. Device Description:
4C®-EX 300 Cell Control is a hematology quality control mixture intended to be used with automated cell and differential cell counters. It is prepared from stabilized human blood so that repeated measurements by an automated cell or differential cell counter can be made to monitor instrument daily performance. 4C®-EX 300 Cell
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Control consists of treated, stabilized human erythrocytes, a stabilized platelet sized component, and fixed erythrocytes that simulate leukocytes. Three levels of varying component concentrations (Abnormal Low, Abnormal High, and Normal) are offered.
# J. Substantial Equivalence Information:
1. Predicate device name(s): COULTER® 4C®-ES Cell Control
2. Predicate 510(k) number(s): k010064
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | 4C®-EX 300 Cell Control | 4C®-ES Cell Control |
| Product Description | Consists of treated, stabilized human erythrocytes in an isotonic medium. It also contains a stabilized platelet-sized component, and fixed erythrocytes to simulate leukocytes. | Same |
| Intended Use | A hematology quality control material used to monitor the performance of Beckman Coulter instruments listed in the Table of Expected Results in conjunction with specific Coulter reagents (Refer to your instrument specific instructions for use). The assigned values and expected ranges on the Table of Expected Results can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean. | Same |
| Cellular Populations | White blood cells (Leukocytes), Red blood cells (Erythrocytes), Platelets, Lymphocytes, Monocytes, and Granulocytes | Same |
| Assayed Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, MO%, GR%, LY#, MO#, GR#. | Same except RDW-SD |
| Final Product Form | Three levels. Liquid, ready to use reagent. | Same |
| Open Vial Stability | 20 events over 35 days when stored at 2 - 8°C. | Same |
| Differences | | |
| --- | --- | --- |
| Item | 4C®-EX 300 Cell Control | 4C®-ES Cell Control |
| Closed Vial Stability | 145 days when stored at 2 - 8°C | 154 days when stored at 2 - 8°C. |
| Analyzers | DxH™ 300 COULTER® Cellular Analysis System/DxH™ 300C COULTER® Cellular Analysis System capable of analyzing the RDW-SD parameter. | ONYX™, ONYX™ with Autoloader, MD™ Series, MD™ II, Ac•T™ 8/10, Ac•T diff™, Ac•T diff2™, JT™, JT2, JT3 and T Series. |
# K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline
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L. Test Principle:
COULTER® 4C®- EX 300 Cell Control is a reference product prepared from stabilized human blood cells. 4C®- EX 300 Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing and hemoglobin determination.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Two separate studies demonstrate the precision/reproducibility of the DxH 300/300C systems.
Study 1: One lot of each level of 4C-EX 300 Cell Control (Abnormal Low, Normal and Abnormal High) was run in duplicate twice each day for a minimum of 20 days on the DxH 300 and DxH 300C analyzers at three test sites. The results were analyzed according to the guidance provided in CLSI EP05-A2. Variance components were estimated for all sources of variability controlled in the experiment based on a nested structure (site, day-within site, within day, and repeatability). Negative values of variance component estimates were defaulted to zero. The individual results are compared against the repeatability/reproducibility specifications. The results met the acceptance criteria as displayed in the tables below.
4C-EX 300 Cell Control Precision Abnormal Low Level
| DxH 300C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 3.8 | 2.1 | 1.0 | 0.8 | 8.0 | 2.0 | 5.0 |
| RBC | 2.47 | 3.5 | 0.5 | 1.1 | 6.2 | 0.9 | 4.0 |
| HGB | 6.8 | 1.0 | 0.7 | 0.7 | 6.4 | 0.7 | 1.5 |
| HCT | 19.5 | 4.7 | 0.0 | 1.3 | N/A | 0.9 | N/A |
| MCV | 79.1 | 1.2 | 0.1 | 0.3 | 3.4 | 0.2 | 1.0 |
| MCH | 27.6 | 2.7 | 0.0 | 0.7 | N/A | 0.8 | N/A |
| MCHC | 34.8 | 3.9 | 0.0 | 0.7 | N/A | 0.8 | N/A |
| RDW | 13.7 | 1.0 | 1.1 | 0.9 | 12.4 | 1.6 | 3.5 |
| RDW-SD | 40.7 | 1.7 | 0.9 | 0.8 | 13.7 | 1.4 | 3.5 |
| PLT | 78 | 3.6 | 3.0 | 1.1 | 18.8 | 4.4 | 15.0 |
| MPV | 9.9 | 2.6 | 1.1 | 0.0 | 9.4 | 2.4 | 3.0 |
| LY% | 34.2 | 1.1 | 1.0 | 1.1 | 12.0 | 3.3 | 4.4 |
| MO% | 12.5 | 1.0 | 2.3 | 2.6 | 21.4 | 5.6 | 24.1 |
| GR% | 53.3 | 0.5 | 0.0 | 0.6 | 6.8 | 1.9 | 5.6 |
| LY# | 1.3 | 1.2 | 1.6 | 0.8 | N/A | 4.4 | N/A |
| MO# | 0.5 | 3.3 | 3.5 | 0.0 | N/A | 8.5 | N/A |
| GR# | 2.0 | 2.2 | 0.8 | 0.6 | N/A | 3.8 | N/A |
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| DxH 300 | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 3.8 | 2.4 | 1.4 | 0.0 | 8.0 | 2.2 | 5.0 |
| RBC | 2.49 | 2.5 | 0.7 | 0.9 | 6.2 | 0.8 | 4.0 |
| HGB | 6.8 | 1.3 | 0.8 | 0.4 | 6.4 | 0.8 | 1.5 |
| HCT | 19.7 | 2.9 | 0.3 | 1.0 | N/A | 0.9 | N/A |
| MCV | 79.1 | 0.8 | 0.1 | 0.3 | 3.4 | 0.2 | 1.0 |
| MCH | 27.2 | 3.2 | 0.0 | 0.6 | N/A | 0.7 | N/A |
| MCHC | 34.4 | 3.8 | 0.0 | 0.8 | N/A | 0.8 | N/A |
| RDW | 13.7 | 1.1 | 0.5 | 1.1 | 12.4 | 1.7 | 3.5 |
| RDW-SD | 40.3 | 0.9 | 0.0 | 0.9 | 13.7 | 1.6 | 3.5 |
| PLT | 80 | 3.2 | 5.6 | 1.8 | 18.8 | 4.1 | 15.0 |
| MPV | 9.9 | 1.9 | 0.0 | 0.0 | 9.4 | 2.8 | 3.0 |
| LY% | 34.5 | 0.4 | 0.0 | 1.6 | 12.0 | 3.3 | 4.4 |
| MO% | 12.4 | 0.0 | 2.1 | 0.5 | 21.4 | 5.8 | 24.1 |
| GR% | 53.2 | 0.2 | 0.3 | 0.7 | 6.8 | 1.8 | 5.6 |
| LY# | 1.3 | 2.4 | 1.3 | 1.7 | N/A | 4.4 | N/A |
| MO# | 0.5 | 2.9 | 2.5 | 0.0 | N/A | 9.2 | N/A |
| GR# | 2.0 | 2.2 | 1.3 | 0.0 | N/A | 3.7 | N/A |
4C-EX 300 Cell Control Precision Normal Level
| DxH 300C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 8.7 | 2.4 | 0.6 | 0.9 | 4.9 | 1.4 | 3.0 |
| RBC | 4.17 | 3.0 | 0.0 | 1.3 | 3.6 | 0.6 | 2.0 |
| HGB | 12.9 | 0.3 | 0.8 | 0.8 | 4.3 | 0.8 | 1.5 |
| HCT | 36.8 | 4.2 | 0.0 | 1.5 | N/A | 0.2 | N/A |
| MCV | 88.2 | 1.2 | 0.0 | 0.4 | 3.1 | 0.1 | 1.0 |
| MCH | 31.0 | 2.8 | 0.0 | 0.8 | N/A | 0.5 | N/A |
| MCHC | 35.2 | 4.0 | 0.0 | 1.1 | N/A | 0.0 | N/A |
| RDW | 12.0 | 0.6 | 0.1 | 0.5 | 12.7 | 1.1 | 3.5 |
| RDW-SD | 41.6 | 1.3 | 0.5 | 0.3 | 13.6 | 1.3 | 3.5 |
| PLT | 224 | 3.8 | 2.2 | 0.0 | 15.4 | 2.5 | 5.0 |
| MPV | 10.3 | 2.6 | 0.9 | 0.0 | 12.6 | 1.1 | 3.0 |
| LY% | 45.8 | 0.7 | 0.7 | 0.0 | 6.6 | 1.8 | 3.3 |
| MO% | 12.8 | 1.5 | 1.3 | 0.0 | 18.1 | 4.0 | 23.4 |
| GR% | 41.5 | 0.7 | 0.6 | 0.0 | 9.0 | 1.6 | 7.2 |
| LY# | 4.0 | 1.9 | 1.3 | 1.0 | N/A | 2.6 | N/A |
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| MO# | 1.1 | 2.5 | 0.6 | 0.0 | N/A | 5.4 | N/A |
| --- | --- | --- | --- | --- | --- | --- | --- |
| GR# | 3.6 | 3.0 | 1.1 | 0.0 | N/A | 2.4 | N/A |
| DxH 300 | | | | | | | |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 8.7 | 2.3 | 1.0 | 0.3 | 4.9 | 1.4 | 3.0 |
| RBC | 4.19 | 2.1 | 0.8 | 0.6 | 3.6 | 0.8 | 2.0 |
| HGB | 12.9 | 1.3 | 0.7 | 0.4 | 4.3 | 0.6 | 1.5 |
| HCT | 37.0 | 2.6 | 0.6 | 0.8 | N/A | 0.8 | N/A |
| MCV | 88.3 | 0.8 | 0.0 | 0.3 | 3.1 | 0.1 | 1.0 |
| MCH | 30.5 | 3.0 | 0.0 | 0.6 | N/A | 0.8 | N/A |
| MCHC | 34.9 | 3.6 | 0.0 | 0.8 | N/A | 0.7 | N/A |
| RDW | 12.0 | 0.8 | 0.5 | 0.0 | 12.7 | 1.0 | 3.5 |
| RDW-SD | 41.4 | 1.2 | 0.4 | 0.0 | 13.6 | 1.2 | 3.5 |
| PLT | 227 | 2.9 | 3.0 | 0.4 | 15.4 | 2.9 | 5.0 |
| MPV | 10.3 | 2.0 | 0.9 | 0.4 | 12.6 | 1.0 | 3.0 |
| LY% | 45.9 | 0.3 | 0.7 | 0.5 | 6.6 | 1.7 | 3.3 |
| MO% | 12.8 | 0.1 | 1.8 | 0.0 | 18.1 | 4.4 | 23.4 |
| GR% | 41.3 | 0.3 | 0.5 | 0.8 | 9.0 | 1.4 | 7.2 |
| LY# | 4.0 | 2.5 | 1.2 | 0.1 | N/A | 2.4 | N/A |
| MO# | 1.1 | 1.6 | 1.3 | 0.0 | N/A | 5.3 | N/A |
| GR# | 3.6 | 2.3 | 1.3 | 1.1 | N/A | 2.1 | N/A |
4C-EX 300 Cell Control Precision Abnormal High Level
| DxH 300C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 18.0 | 2.3 | 0.9 | 0.9 | 4.0 | 0.9 | 3.0 |
| RBC | 5.34 | 2.8 | 0.7 | 0.8 | 3.4 | 0.8 | 2.0 |
| HGB | 18.3 | 0.7 | 0.7 | 0.8 | 3.1 | 0.5 | 1.5 |
| HCT | 51.6 | 4.1 | 0.5 | 0.9 | N/A | 0.7 | N/A |
| MCV | 96.7 | 1.3 | 0.0 | 0.3 | 3.1 | 0.0 | 1.0 |
| MCH | 34.3 | 2.3 | 0.0 | 0.4 | N/A | 0.7 | N/A |
| MCHC | 35.5 | 3.6 | 0.0 | 0.4 | N/A | 0.6 | N/A |
| RDW | 11.6 | 0.5 | 0.4 | 0.5 | 13.2 | 0.8 | 3.5 |
| RDW-SD | 44.2 | 1.5 | 0.6 | 0.6 | 14.3 | 1.2 | 3.5 |
| PLT | 436 | 4.5 | 1.5 | 1.3 | 11.4 | 1.5 | 5.0 |
| MPV | 10.3 | 2.8 | 0.8 | 0.0 | 12.4 | 0.7 | 3.0 |
| LY% | 50.5 | 0.7 | 0.4 | 0.3 | 6.1 | 1.1 | 5.9 |
| MO% | 15.7 | 1.4 | 0.7 | 0.5 | 18.3 | 2.6 | 19.1 |
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| GR% | 33.8 | 0.7 | 0.2 | 0.0 | 9.1 | 1.3 | 8.9 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| LY# | 9.1 | 2.1 | 1.0 | 0.7 | N/A | 1.6 | N/A |
| MO# | 2.8 | 2.3 | 1.2 | 0.8 | N/A | 2.6 | N/A |
| GR# | 6.1 | 2.9 | 0.8 | 1.2 | N/A | 1.6 | N/A |
| DxH 300 | | | | | | | |
| Parameter | Mean | CV% | | | | | |
| | | Site/Instrument | Day | Within Day | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 18.0 | 2.4 | 0.8 | 0.7 | 4.0 | 0.8 | 3.0 |
| RBC | 5.34 | 1.9 | 0.8 | 0.8 | 3.4 | 0.8 | 2.0 |
| HGB | 18.2 | 1.5 | 0.6 | 0.5 | 3.1 | 0.5 | 1.5 |
| HCT | 51.6 | 2.4 | 0.8 | 0.8 | N/A | 0.7 | N/A |
| MCV | 96.7 | 0.8 | 0.1 | 0.2 | 3.1 | 0.2 | 1.0 |
| MCH | 34.0 | 3.1 | 0.0 | 1.2 | N/A | 0.7 | N/A |
| MCHC | 35.2 | 3.7 | 0.0 | 0.6 | N/A | 0.6 | N/A |
| RDW | 11.7 | 0.0 | 0.7 | 0.0 | 13.2 | 0.9 | 3.5 |
| RDW-SD | 44.0 | 0.6 | 0.8 | 0.0 | 14.3 | 1.3 | 3.5 |
| PLT | 443 | 2.9 | 2.8 | 1.4 | 11.4 | 1.8 | 5.0 |
| MPV | 10.3 | 2.2 | 1.0 | 0.4 | 12.4 | 0.7 | 3.0 |
| LY% | 50.6 | 0.5 | 0.5 | 0.5 | 6.1 | 1.0 | 5.9 |
| MO% | 15.7 | 1.1 | 1.3 | 0.0 | 18.3 | 2.3 | 19.1 |
| GR% | 33.7 | 0.3 | 0.2 | 0.5 | 9.1 | 1.2 | 8.9 |
| LY# | 9.1 | 2.5 | 0.7 | 0.8 | N/A | 1.5 | N/A |
| MO# | 2.8 | 2.4 | 1.4 | 0.9 | N/A | 2.5 | N/A |
| GR# | 6.1 | 2.5 | 1.0 | 1.0 | N/A | 1.6 | N/A |
Study 2: An analysis of a subset of the 4C-EX 300 Cell Control stability data was performed to assess the precision/reproducibility of multiple lots of the product over time. The data was collected, and included three lots of each level of 4C-EX Cell Control (Abnormal Low, Normal and Abnormal High). For each lot, five replicates per day for a total of four days were obtained on one DxH 300 and one DxH 300C analyzers. The analysis of all the lots spanned throughout approximately 45 days. All sources of variability were considered to be random. The estimates with negative values were defaulted to zero. The individual results are compared against the repeatability/reproducibility specifications. The results met the acceptance criteria as displayed in the tables below.
4C-EX 300 Cell Control DxH 300/300C Precision Abnormal Low Level
| Parameter | Mean | CV% | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Day | Instrument | Lot | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 3.7 | 1.6 | 2.5 | 3.1 | 8.0 | 2.3 | 5.0 |
| RBC | 2.46 | 0.0 | 2.3 | 3.4 | 6.2 | 1.2 | 4.0 |
| HGB | 6.6 | 0.0 | 1.4 | 3.4 | 6.4 | 0.7 | 1.5 |
| HCT | 10.0 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| MCV | 10.0 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| MCH | 34.0 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| MCHC | 35.2 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| RDW | 11.7 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| RDW-SD | 44.0 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| PLT | 443 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| MPV | 10.3 | 0.0 | 0.0 | 3.4 | 6.4 | 0.7 | 1.5 |
| LY% | 50.6 | 0.5 | 0.5 | 0.5 | 6.1 | 1.0 | 5.9 |
| MO% | 15.7 | 1.1 | 1.3 | 0.0 | 18.3 | 2.3 | 19.1 |
| GR% | 33.7 | 0.3 | 0.2 | 0.5 | 9.1 | 1.2 | 8.9 |
| LY# | 9.1 | 2.5 | 0.7 | 0.8 | N/A | 1.5 | N/A |
| MO# | 2.8 | 2.4 | 1.4 | 0.9 | N/A | 2.5 | N/A |
| GR# | 6.1 | 2.5 | 1.0 | 1.0 | N/A | 1.6 | N/A |
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4C-EX 300 Cell Control DxH 300/300C Precision Normal Level
| Parameter | Mean | CV% | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Day | Instrument | Lot | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 8.5 | 0.0 | 3.3 | 2.0 | 4.9 | 1.1 | 3.0 |
| RBC | 4.20 | 0.0 | 2.1 | 0.6 | 3.6 | 1.1 | 2.0 |
| HGB | 12.6 | 0.0 | 1.1 | 0.5 | 4.3 | 0.6 | 1.5 |
| HCT | 37.1 | 0.0 | 2.4 | 0.7 | N/A | 1.1 | N/A |
| MCV | 88.4 | 0.0 | 0.5 | 0.8 | 3.1 | 0.2 | 1.0 |
| MCH | 29.9 | 0.0 | 1.1 | 0.7 | N/A | 1.0 | N/A |
| MCHC | 33.9 | 0.0 | 1.4 | 1.1 | N/A | 1.0 | N/A |
| RDW | 12.0 | 0.0 | 0.8 | 1.2 | 12.7 | 1.2 | 3.5 |
| RDW-SD | 40.4 | 0.0 | 1.6 | 1.8 | 13.6 | 1.5 | 3.5 |
| PLT | 217.7 | 0.0 | 3.0 | 1.2 | 15.4 | 2.4 | 5.0 |
| MPV | 10.0 | 1.1 | 0.4 | 0.8 | 12.6 | 0.8 | 3.0 |
| LY% | 45.6 | 0.0 | 0.7 | 0.6 | 6.6 | 1.7 | 3.3 |
| MO% | 13.7 | 1.7 | 2.5 | 3.2 | 18.1 | 3.6 | 21.9 |
| GR% | 40.7 | 0.9 | 0.6 | 1.5 | 9.0 | 1.6 | 7.4 |
| LY# | 3.9 | 0.0 | 3.9 | 2.5 | N/A | 1.7 | N/A |
| MO# | 1.2 | 3.8 | 0.0 | 4.9 | N/A | 4.1 | N/A |
| GR# | 3.5 | 0.0 | 3.7 | 0.4 | N/A | 2.0 | N/A |
4C-EX 300 Cell Control DxH 300/300C Precision Abnormal High Level
| Parameter | Mean | CV% | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Day | Instrument | Lot | Reproducibility Specification | Repeatability | Repeatability Specification |
| WBC | 18.2 | 0.0 | 3.6 | 1.9 | 4.0 | 1.0 | 3.0 |
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| RBC | 5.34 | 0.0 | 1.7 | 0.7 | 3.4 | 1.1 | 2.0 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| HGB | 17.7 | 0.0 | 0.9 | 0.5 | 3.1 | 0.5 | 1.5 |
| HCT | 51.8 | 0.0 | 2.1 | 1.3 | N/A | 1.0 | N/A |
| MCV | 97.0 | 0.0 | 0.5 | 0.7 | 3.1 | 0.2 | 1.0 |
| MCH | 33.2 | 0.0 | 1.1 | 0.6 | N/A | 0.9 | N/A |
| MCHC | 34.2 | 0.0 | 1.4 | 1.3 | N/A | 0.9 | N/A |
| RDW | 11.6 | 0.5 | 0.3 | 0.6 | 13.2 | 0.8 | 3.5 |
| RDW-SD | 42.9 | 0.0 | 2.0 | 1.4 | 14.3 | 1.1 | 3.5 |
| PLT | 436.9 | 0.0 | 3.4 | 1.3 | 11.4 | 1.9 | 5.0 |
| MPV | 10.2 | 2.6 | 0.3 | 2.1 | 12.4 | 0.7 | 3.0 |
| LY% | 49.7 | 0.0 | 0.1 | 0.3 | 6.1 | 1.0 | 6.0 |
| MO% | 16.7 | 0.6 | 1.2 | 1.0 | 18.3 | 2.3 | 18.0 |
| GR% | 33.7 | 0.6 | 0.0 | 0.6 | 9.1 | 1.1 | 8.9 |
| LY# | 9.0 | 0.0 | 3.8 | 1.8 | N/A | 1.5 | N/A |
| MO# | 3.0 | 2.4 | 2.2 | 2.8 | N/A | 2.3 | N/A |
| GR# | 6.1 | 0.0 | 3.7 | 1.7 | N/A | 1.5 | N/A |
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value assignment: 4C®- EX 300 Cell Control assigned values are determined on validated systems using specific Beckman Coulter reagents. One hundred (100) vials from each lot are taken randomly throughout the production run. For the value assignment process, two assay runs are required on two separate instruments. Four to seven sample vials are analyzed for each assay run. An assay computer system is used to determine the number of replicates required for each assay run and analyze the data in real-time. Zero biased, equilibration adjusted data and the raw data from the instrument assay run data is used to determine the final value assignment. The value assignments are confirmed by performing a verification test of the product on the instruments for which the cell control is intended to be used.
Open and Closed Vial Stability: Three lots of each level (Abnormal Low, Normal, and Abnormal High) were processed on both DxH™ 300 and DxH™ 300C analyzers. Testing was conducted throughout the proposed shelf life. Open Vial Stability was determined to be 20 events over 35 days when stored at 2 - 8°C. Closed Vial Stability was determined to be 145 days when stored at 2 - 8°C. The RDW-SD recovered values were compared to assay values established at the beginning of the test interval and the expected ranges to assess the product's stability.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
{8}
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 expected ranges for RDW-SD were calculated based upon the assigned values and expected ranges of MCV and RDW parameters, and the mathematical relationship between these parameters for each level of 4C®- EX 300 Cell Controls. This methodology allows for the preservation of the same variability built in the MCV and RDW specifications. The expected ranges are provided in the Table of Expected Results.
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.
