BC-5D Hematology Control
Device Facts
| Record ID | K160606 |
|---|---|
| Device Name | BC-5D Hematology Control |
| Applicant | R&D Systems, Inc. |
| Product Code | JPK · Hematology |
| Decision Date | Sep 1, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
Indications for Use
BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.
Device Story
BC-5D is a stabilized in vitro diagnostic quality control product; consists of three levels (Low, Normal, High). Composed of human erythrocytes, mammalian leukocytes, and platelets in plasma-like fluid with preservatives. Used in clinical laboratory settings to monitor performance of Mindray BC-5390 Auto Hematology Analyzer. Healthcare providers analyze control samples alongside patient samples; results compared against assigned assay ranges to verify instrument accuracy and precision. Benefits patient by ensuring reliability of complete blood count and 5-part leukocyte differential results.
Clinical Evidence
No clinical data. Bench testing only. Precision/reproducibility evaluated via multisite study (80 measurements per lot/level over 20 days). Stability verified via real-time studies for 14-day open-vial and 75-day closed-vial claims per CLSI EP05-A3 and EP25-A.
Technological Characteristics
Stabilized in vitro diagnostic product; human erythrocytes, mammalian leukocytes, and platelets in plasma-like fluid. Three levels (Low, Normal, High). Designed for Mindray BC-5390 Auto Hematology Analyzer. Standards: CLSI EP05-A3 (precision), CLSI EP25-A (stability).
Indications for Use
Indicated for use as an assayed whole blood control to monitor the accuracy and precision of the Mindray BC-5390 Auto Hematology Analyzer. 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
- R&D Systems CBC-XE Hematology Control (K042094)
Related Devices
- K024173 — CDS 3-PD HEMATOLOGY CONTROLS · Clinical Diagnostic Solutions, Inc. · Jan 14, 2003
- K983032 — CBC-5D HEMATOLOGY CONTROL · R&D Systems, Inc. · Feb 17, 1999
- K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 · R&D Systems, Inc. · Aug 20, 2007
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
K160606
B. Purpose for Submission:
New quality control device to support the performance of the BC-5390 Auto Hematology Analyzer (K160429)
C. Measurand:
Complete blood count: WBC (10³/μL), RBC (10⁶/μL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW-CV (%), RDW-SD, PLT (10³/μL), MPV (fL). Leukocyte 5-part differential: Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%.
D. Type of Test:
Quantitative
E. Applicant:
R&D Systems, Inc.
F. Proprietary and Established Names:
BC-5D Hematology Controls
G. Regulatory Information:
1. Regulation section:
21 CFR § 864.8625 Hematology quality control mixture
2. Classification:
Class II
3. Product code:
JPK
4. Panel:
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Hematology (81)
## H. Intended Use:
1. Intended use(s):
BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, and MPV.
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Mindray BC-5390 Auto Hematology Analyzer
## I. Device Description:
The BC-5D Hematology Control (also referred to as BC-5D) consists of three levels of controls (Low, Normal, and High). BC-5D is a stabilized in vitro diagnostic product composed of the following: human erythrocytes, mammalian leukocytes, and platelets suspended in a plasma-like fluid with preservatives.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
CBC-XE Hematology Control
2. Predicate 510(k) number(s):
K042094
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Storage Conditions | Open-vial: 14 days
Closed-vial: 75 days | Same |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, and MPV. | R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to assay sheet for specific instrument models. |
| Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Bas#, Bas%, Neu#, Neu%, Eos#, Eos%, Lym#, Lym%, Mon#, Mon%, RDW-CV, RDW-SD, and MPV | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, PDW, MPV, P-LCR, IRF, Bas#, Bas%, Neu#, Neu%, Eos#, Eos%, Lym#, Lym%, Mon#, Mon%, RDW-CV, RDW-SD, NRBC%, and Ret% |
## K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
## L. Test Principle:
The BC-5D Hematology Control is a quality control material designed to monitor the performance of the BC-5390 Auto Hematology Analyzer.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Estimates of precision were obtained from a multisite study where each site analyzed all levels of one lot of BC-5D Hematology Controls. At each site, each control level was analyzed over 20 days, two runs per day and two replicates per run. The final
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dataset resulted in a total of 80 measurements per lot and control level (low, normal and high). The precision profile included the following variance components: repeatability (within-run), between-run, between-day, and total variability. The results of the precision studies met the performance specifications for each BC-5D Hematology Control level.
BC-5D Hematology Control Lot BC3V4
| Parameter | Control Level | Mean | Within-run | | Between-run | | Between-day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC (103/μL) | Low | 3.393 | 0.061 | 1.80 | 0.038 | 1.10 | 0.017 | 0.50 | 0.074 | 2.20 |
| | Normal | 7.511 | 0.137 | 1.80 | 0.075 | 1.00 | 0.093 | 1.20 | 0.182 | 2.40 |
| | High | 16.011 | 0.217 | 1.40 | 0.082 | 0.50 | 0.16 | 1.00 | 0.282 | 1.80 |
| Neu# (103/μL) | Low | 1.726 | 0.043 | 2.50 | 0.017 | 1.00 | 0 | 0.00 | 0.047 | 2.70 |
| | Normal | 4.389 | 0.092 | 2.10 | 0.022 | 0.50 | 0.06 | 1.40 | 0.112 | 2.60 |
| | High | 10.327 | 0.17 | 1.60 | 0 | 0.00 | 0.1 | 1.00 | 0.197 | 1.90 |
| Lym# (103/μL) | Low | 1.324 | 0.039 | 3.00 | 0 | 0.00 | 0.015 | 1.10 | 0.042 | 3.20 |
| | Normal | 2.16 | 0.049 | 2.30 | 0.039 | 1.80 | 0 | 0.00 | 0.062 | 2.90 |
| | High | 3.071 | 0.068 | 2.20 | 0.052 | 1.70 | 0.013 | 0.40 | 0.087 | 2.80 |
| Mon# (103/μL) | Low | 0.185 | 0.016 | 8.70 | 0 | 0.00 | 0.005 | 2.50 | 0.017 | 9.10 |
| | Normal | 0.402 | 0.022 | 5.60 | 0.012 | 3.00 | 0 | 0.00 | 0.025 | 6.30 |
| | High | 0.965 | 0.039 | 4.00 | 0 | 0.00 | 0.016 | 1.60 | 0.042 | 4.30 |
| Eos# (103/μL) | Low | 0.158 | 0.012 | 7.90 | 0.008 | 5.00 | 0 | 0.00 | 0.015 | 9.30 |
| | Normal | 0.561 | 0.027 | 4.80 | 0.014 | 2.50 | 0.017 | 3.10 | 0.035 | 6.20 |
| | High | 1.647 | 0.065 | 3.90 | 0.042 | 2.60 | 0.01 | 0.60 | 0.078 | 4.70 |
| Bas# (103/μL) | Low | 0.787 | 0.017 | 2.20 | 0.016 | 2.10 | 0 | 0.00 | 0.023 | 3.00 |
| | Normal | 2.021 | 0.041 | 2.00 | 0.019 | 0.90 | 0.021 | 1.00 | 0.05 | 2.50 |
| | High | 4.916 | 0.069 | 1.40 | 0.012 | 0.20 | 0.05 | 1.00 | 0.086 | 1.80 |
| Neu% | Low | 50.77 | 0.93 | 1.80 | 0 | 0.00 | 0.23 | 0.50 | 0.96 | 1.90 |
| | Normal | 58.42 | 0.52 | 0.90 | 0.3 | 0.50 | 0 | 0.00 | 0.6 | 1.00 |
| | High | 64.52 | 0.45 | 0.70 | 0.3 | 0.50 | 0 | 0.00 | 0.55 | 0.80 |
| Lym% | Low | 38.97 | 0.96 | 2.50 | 0 | 0.00 | 0 | 0.00 | 0.96 | 2.50 |
| | Normal | 28.74 | 0.5 | 1.80 | 0.14 | 0.50 | 0.11 | 0.40 | 0.54 | 1.90 |
| | High | 19.19 | 0.38 | 2.00 | 0.18 | 0.90 | 0 | 0.00 | 0.41 | 2.20 |
| Mon% | Low | 5.51 | 0.43 | 7.90 | 0 | 0.00 | 0.09 | 1.50 | 0.44 | 8.00 |
| | Normal | 5.37 | 0.26 | 4.90 | 0.13 | 2.40 | 0 | 0.00 | 0.29 | 5.40 |
| | High | 6.02 | 0.25 | 4.10 | 0 | 0.00 | 0.06 | 1.00 | 0.26 | 4.30 |
| Eos% | Low | 4.75 | 0.33 | 6.90 | 0.21 | 4.40 | 0 | 0.00 | 0.39 | 8.20 |
| | Normal | 7.48 | 0.32 | 4.20 | 0.14 | 1.90 | 0.13 | 1.80 | 0.37 | 5.00 |
| | High | 10.27 | 0.37 | 3.60 | 0.23 | 2.20 | 0 | 0.00 | 0.43 | 4.20 |
| Bas% | Low | 23.19 | 0.39 | 1.70 | 0.17 | 0.70 | 0.1 | 0.40 | 0.43 | 1.90 |
| | Normal | 26.91 | 0.28 | 1.00 | 0.09 | 0.30 | 0 | 0.00 | 0.29 | 1.10 |
| | High | 30.7 | 0.14 | 0.50 | 0.03 | 0.10 | 0.08 | 0.30 | 0.17 | 0.50 |
| RBC (10^6/μL) | Low | 2.555 | 0.024 | 0.90 | 0 | 0.00 | 0.028 | 1.10 | 0.037 | 1.50 |
| | Normal | 4.7 | 0.046 | 1.00 | 0.37 | 0.80 | 0.074 | 1.60 | 0.094 | 2.00 |
| | High | 5.293 | 0.062 | 1.20 | 0 | 0.00 | 0.071 | 1.30 | 0.094 | 1.80 |
| HGB (g/dL) | Low | 6.05 | 0.06 | 0.90 | 0.04 | 0.60 | 0.07 | 1.20 | 0.1 | 1.70 |
| | Normal | 13.44 | 0.09 | 0.70 | 0.13 | 1.00 | 0.22 | 1.60 | 0.27 | 2.00 |
| | High | 16.89 | 0.15 | 0.90 | 0.1 | 0.60 | 0.25 | 1.50 | 0.31 | 1.90 |
| HCT (%) | Low | 19.19 | 0.18 | 1.00 | 0.16 | 0.80 | 0.18 | 1.00 | 0.3 | 1.60 |
| | Normal | 40.88 | 0.39 | 1.00 | 0.48 | 1.20 | 0.71 | 1.70 | 0.95 | 2.30 |
| | High | 50.91 | 0.56 | 1.10 | 0.26 | 0.50 | 0.89 | 1.80 | 1.09 | 2.10 |
| MCV (fL) | Low | 75.13 | 0.18 | 0.20 | 0.53 | 0.70 | 0 | 0.00 | 0.56 | 0.70 |
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BC-5D Hematology Control Lot BC3V1
| Parameter | Control Level | Mean | Within-run | | Between-run | | Between-day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC (103/μL) | Low | 3.169 | 0.072 | 2.3 | 0.042 | 1.3 | 0.048 | 1.5 | 0.097 | 3.0 |
| | Normal | 7.784 | 0.105 | 1.4 | 0.067 | 0.9 | 0.043 | 0.6 | 0.132 | 1.7 |
| | High | 16.176 | 0.150 | 0.9 | 0.130 | 0.8 | 0.000 | 0.0 | 0.199 | 1.2 |
| Neu# (103/μL) | Low | 1.675 | 0.051 | 3.1 | 0.038 | 2.3 | 0.030 | 1.8 | 0.071 | 4.2 |
| | Normal | 4.347 | 0.084 | 1.9 | 0.053 | 1.2 | 0.044 | 1.0 | 0.109 | 2.5 |
| | High | 10.465 | 0.128 | 1.2 | 0.135 | 1.3 | 0.005 | 0.0 | 0.186 | 1.8 |
| Lym# (103/μL) | Low | 1.175 | 0.040 | 3.4 | 0.000 | 0.0 | 0.013 | 1.1 | 0.042 | 3.6 |
| | Normal | 2.360 | 0.050 | 2.1 | 0.000 | 0.0 | 0.018 | 0.8 | 0.053 | 2.3 |
| | High | 3.074 | 0.066 | 2.2 | 0.053 | 1.7 | 0.032 | 1.0 | 0.091 | 2.9 |
| Mon# (103/μL) | Low | 0.157 | 0.015 | 9.4 | 0.005 | 2.9 | 0.000 | 0.0 | 0.015 | 9.8 |
| | Normal | 0.464 | 0.040 | 8.5 | 0.000 | 0.0 | 0.021 | 4.6 | 0.045 | 9.7 |
| | High | 1.046 | 0.041 | 3.9 | 0.004 | 0.4 | 0.016 | 1.5 | 0.044 | 4.2 |
| Eos# (103/μL) | Low | 0.161 | 0.018 | 11.1 | 0.000 | 0.0 | 0.004 | 2.4 | 0.018 | 11.4 |
| | Normal | 0.614 | 0.024 | 3.9 | 0.016 | 2.6 | 0.000 | 0.0 | 0.029 | 4.7 |
| | High | 1.591 | 0.051 | 3.2 | 0.000 | 0.0 | 0.032 | 2.0 | 0.060 | 3.8 |
| Bas# (103/μL) | Low | 0.719 | 0.021 | 2.9 | 0.010 | 1.4 | 0.010 | 1.4 | 0.026 | 3.6 |
| | Normal | 2.031 | 0.034 | 1.7 | 0.024 | 1.2 | 0.008 | 0.4 | 0.042 | 2.1 |
| | High | 4.943 | 0.052 | 1.1 | 0.047 | 1.0 | 0.000 | 0.0 | 0.071 | 1.4 |
| Neu% | Low | 52.77 | 0.99 | 1.9 | 0.57 | 1.1 | 0.00 | 0.0 | 1.14 | 2.2 |
| | Normal | 55.83 | 0.68 | 1.2 | 0.29 | 0.5 | 0.22 | 0.4 | 0.77 | 1.4 |
| | High | 64.71 | 0.53 | 0.8 | 0.37 | 0.6 | 0.25 | 0.4 | 0.69 | 1.1 |
| Lym% | Low | 37.02 | 1.06 | 2.9 | 0.36 | 1.0 | 0.20 | 0.5 | 1.14 | 3.1 |
| | Normal | 30.32 | 0.52 | 1.7 | 0.17 | 0.6 | 0.30 | 1.0 | 0.63 | 2.1 |
| | High | 19.03 | 0.40 | 2.1 | 0.35 | 1.8 | 0.07 | 0.4 | 0.53 | 2.8 |
| Mon% | Low | 5.03 | 0.41 | 8.2 | 0.08 | 1.5 | 0.00 | 0.0 | 0.42 | 8.3 |
| | Normal | 5.96 | 0.50 | 8.4 | 0.00 | 0.0 | 0.27 | 4.5 | 0.57 | 9.6 |
| | High | 6.44 | 0.24 | 3.7 | 0.07 | 1.2 | 0.10 | 1.6 | 0.27 | 4.2 |
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| Parameter | Control Level | Mean | Within-run | | Between-run | | Between-day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Eos% | Low | 5.18 | 0.53 | 10.2 | 0.00 | 0.0 | 0.00 | 0.0 | 0.53 | 10.2 |
| | Normal | 7.89 | 0.27 | 3.4 | 0.21 | 2.6 | 0.00 | 0.0 | 0.34 | 4.3 |
| | High | 9.82 | 0.31 | 3.1 | 0.00 | 0.0 | 0.24 | 2.4 | 0.39 | 4.0 |
| Bas% | Low | 22.69 | 0.41 | 1.8 | 0.22 | 1.0 | 0.00 | 0.0 | 0.46 | 2.0 |
| | Normal | 26.09 | 0.29 | 1.1 | 0.11 | 0.4 | 0.03 | 0.1 | 0.31 | 1.2 |
| | High | 30.56 | 0.20 | 0.6 | 0.00 | 0.0 | 0.04 | 0.1 | 0.20 | 0.7 |
| RBC (10^6/μL) | Low | 2.178 | 0.020 | 0.9 | 0.000 | 0.0 | 0.010 | 0.5 | 0.022 | 1.0 |
| | Normal | 4.229 | 0.034 | 0.8 | 0.034 | 0.8 | 0.034 | 0.8 | 0.059 | 1.4 |
| | High | 5.019 | 0.039 | 0.8 | 0.038 | 0.8 | 0.047 | 0.9 | 0.072 | 1.4 |
| HGB (g/dL) | Low | 5.84 | 0.05 | 0.8 | 0.03 | 0.5 | 0.03 | 0.4 | 0.06 | 1.0 |
| | Normal | 12.10 | 0.06 | 0.5 | 0.07 | 0.6 | 0.12 | 1.0 | 0.16 | 1.3 |
| | High | 15.76 | 0.08 | 0.5 | 0.11 | 0.7 | 0.13 | 0.8 | 0.19 | 1.2 |
| HCT (%) | Low | 18.53 | 0.17 | 0.9 | 0.06 | 0.3 | 0.10 | 0.5 | 0.20 | 1.1 |
| | Normal | 37.79 | 0.29 | 0.8 | 0.31 | 0.8 | 0.36 | 1.0 | 0.56 | 1.5 |
| | High | 49.89 | 0.39 | 0.8 | 0.45 | 0.9 | 0.51 | 1.0 | 0.78 | 1.6 |
| MCV | Low | 85.12 | 0.17 | 0.2 | 0.28 | 0.3 | 0.39 | 0.5 | 0.51 | 0.6 |
| | Normal | 89.37 | 0.16 | 0.2 | 0.28 | 0.3 | 0.29 | 0.3 | 0.43 | 0.5 |
| | High | 99.42 | 0.18 | 0.2 | 0.31 | 0.3 | 0.18 | 0.2 | 0.40 | 0.4 |
| MCH | Low | 26.86 | 0.23 | 0.8 | 0.00 | 0.0 | 0.12 | 0.4 | 0.26 | 1.0 |
| | Normal | 28.62 | 0.21 | 0.7 | 0.10 | 0.4 | 0.00 | 0.0 | 0.24 | 0.8 |
| | High | 31.41 | 0.21 | 0.7 | 0.00 | 0.0 | 0.09 | 0.3 | 0.22 | 0.7 |
| MCHC (g/dL) | Low | 31.56 | 0.27 | 0.9 | 0.00 | 0.0 | 0.19 | 0.6 | 0.33 | 1.1 |
| | Normal | 32.03 | 0.23 | 0.7 | 0.09 | 0.3 | 0.12 | 0.4 | 0.28 | 0.9 |
| | High | 31.60 | 0.22 | 0.7 | 0.12 | 0.4 | 0.06 | 0.2 | 0.26 | 0.8 |
| RDW-CV (%) | Low | 14.27 | 0.15 | 1.1 | 0.14 | 1.0 | 0.17 | 1.2 | 0.26 | 1.9 |
| | Normal | 14.03 | 0.09 | 0.7 | 0.10 | 0.7 | 0.15 | 1.0 | 0.20 | 1.4 |
| | High | 14.24 | 0.10 | 0.7 | 0.12 | 0.9 | 0.10 | 0.7 | 0.19 | 1.3 |
| RDW-SD (fL) | Low | 44.04 | 0.41 | 0.9 | 0.09 | 0.2 | 0.24 | 0.5 | 0.49 | 1.1 |
| | Normal | 45.41 | 0.40 | 0.9 | 0.11 | 0.2 | 0.11 | 0.2 | 0.43 | 0.9 |
| | High | 50.08 | 0.38 | 0.8 | 0.00 | 0.0 | 0.16 | 0.3 | 0.42 | 0.8 |
| PLT (10^3/μL) | Low | 68.7 | 5.3 | 7.7 | 0.0 | 0.0 | 2.9 | 4.2 | 6.0 | 8.8 |
| | Normal | 253.7 | 5.5 | 2.2 | 3.7 | 1.5 | 7.0 | 2.8 | 9.6 | 3.8 |
| | High | 479.3 | 6.9 | 1.4 | 5.7 | 1.2 | 6.7 | 1.4 | 11.2 | 2.3 |
| MPV (fL) | Low | 11.59 | 0.66 | 5.7 | 0.00 | 0.0 | 0.33 | 2.9 | 0.74 | 6.4 |
| | Normal | 13.01 | 0.12 | 1.0 | 0.00 | 0.0 | 0.10 | 0.7 | 0.16 | 1.2 |
| | High | 12.94 | 0.12 | 0.9 | 0.00 | 0.0 | 0.02 | 0.2 | 0.12 | 0.9 |
BC-5D Hematology Control Lot BC3V3
| Parameter | Control Level | Mean | Within-run | | Between-run | | Between-day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| WBC (10^3/μL) | Low | 3.736 | 0.090 | 2.4 | 0.000 | 0.0 | 0.051 | 1.4 | 0.103 | 2.8 |
| | Normal | 8.392 | 0.117 | 1.4 | 0.066 | 0.8 | 0.038 | 0.5 | 0.140 | 1.7 |
| | High | 18.255 | 0.229 | 1.3 | 0.000 | 0.0 | 0.155 | 0.9 | 0.277 | 1.5 |
| Neu# (10^3/μL) | Low | 1.987 | 0.050 | 2.5 | 0.020 | 1.0 | 0.034 | 1.7 | 0.064 | 3.2 |
| | Normal | 4.778 | 0.079 | 1.7 | 0.023 | 0.5 | 0.024 | 0.5 | 0.086 | 1.8 |
| | High | 11.187 | 0.178 | 1.6 | 0.000 | 0.0 | 0.088 | 0.8 | 0.199 | 1.8 |
| Lym# (10^3/μL) | Low | 1.348 | 0.057 | 4.2 | 0.000 | 0.0 | 0.011 | 0.8 | 0.058 | 4.3 |
| | Normal | 2.654 | 0.055 | 2.1 | 0.054 | 2.0 | 0.013 | 0.5 | 0.078 | 2.9 |
| | High | 4.283 | 0.137 | 3.2 | 0.000 | 0.0 | 0.019 | 0.4 | 0.138 | 3.2 |
| Mon# (10^3/μL) | Low | 0.254 | 0.017 | 6.9 | 0.011 | 4.4 | 0.005 | 1.9 | 0.021 | 8.4 |
| | Normal | 0.534 | 0.040 | 7.5 | 0.017 | 3.1 | 0.022 | 4.2 | 0.049 | 9.1 |
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| Parameter | Control Level | Mean | Within-run | | Between-run | | Between-day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | High | 1.345 | 0.090 | 6.7 | 0.048 | 3.6 | 0.000 | 0.0 | 0.102 | 7.6 |
| Eos# (103/μL) | Low | 0.147 | 0.015 | 10.0 | 0.000 | 0.0 | 0.005 | 3.5 | 0.016 | 10.6 |
| | Normal | 0.425 | 0.023 | 5.3 | 0.012 | 2.8 | 0.011 | 2.6 | 0.028 | 6.5 |
| | High | 1.440 | 0.044 | 3.1 | 0.012 | 0.8 | 0.054 | 3.8 | 0.071 | 4.9 |
| Bas# (103/μL) | Low | 0.877 | 0.027 | 3.1 | 0.003 | 0.3 | 0.001 | 0.1 | 0.027 | 3.1 |
| | Normal | 2.172 | 0.032 | 1.5 | 0.028 | 1.3 | 0.016 | 0.7 | 0.045 | 2.1 |
| | High | 5.310 | 0.072 | 1.4 | 0.022 | 0.4 | 0.040 | 0.8 | 0.086 | 1.6 |
| Neu% | Low | 53.09 | 0.93 | 1.8 | 0.43 | 0.8 | 0.00 | 0.0 | 1.03 | 1.9 |
| | Normal | 56.93 | 0.53 | 0.9 | 0.32 | 0.6 | 0.00 | 0.0 | 0.62 | 1.1 |
| | High | 61.30 | 0.52 | 0.9 | 0.05 | 0.1 | 0.41 | 0.7 | 0.67 | 1.1 |
| Lym% | Low | 36.05 | 1.07 | 3.0 | 0.00 | 0.0 | 0.37 | 1.0 | 1.13 | 3.1 |
| | Normal | 31.61 | 0.48 | 1.5 | 0.34 | 1.1 | 0.23 | 0.7 | 0.63 | 2.0 |
| | High | 23.48 | 0.70 | 3.0 | 0.07 | 0.3 | 0.00 | 0.0 | 0.71 | 3.0 |
| Mon% | Low | 6.85 | 0.44 | 6.4 | 0.29 | 4.3 | 0.00 | 0.0 | 0.53 | 7.7 |
| | Normal | 6.38 | 0.45 | 7.1 | 0.21 | 3.4 | 0.28 | 4.3 | 0.57 | 9.0 |
| | High | 7.35 | 0.50 | 6.8 | 0.22 | 3.0 | 0.00 | 0.0 | 0.54 | 7.4 |
| Eos% | Low | 4.01 | 0.38 | 9.6 | 0.00 | 0.0 | 0.12 | 2.9 | 0.40 | 10.0 |
| | Normal | 5.08 | 0.27 | 5.3 | 0.12 | 2.4 | 0.13 | 2.5 | 0.32 | 6.3 |
| | High | 7.87 | 0.23 | 3.0 | 0.06 | 0.7 | 0.25 | 3.2 | 0.35 | 4.4 |
| Bas% | Low | 23.47 | 0.37 | 1.6 | 0.00 | 0.0 | 0.23 | 1.0 | 0.44 | 1.9 |
| | Normal | 25.88 | 0.26 | 1.0 | 0.15 | 0.6 | 0.11 | 0.4 | 0.32 | 1.2 |
| | High | 29.09 | 0.18 | 0.6 | 0.00 | 0.0 | 0.02 | 0.1 | 0.18 | 0.6 |
| RBC (10^6/μL) | Low | 2.532 | 0.029 | 1.2 | 0.013 | 0.5 | 0.010 | 0.4 | 0.034 | 1.3 |
| | Normal | 5.273 | 0.051 | 1.0 | 0.026 | 0.5 | 0.020 | 0.4 | 0.060 | 1.1 |
| | High | 5.536 | 0.044 | 0.8 | 0.021 | 0.4 | 0.034 | 0.6 | 0.060 | 1.1 |
| HGB (g/dL) | Low | 6.03 | 0.07 | 1.1 | 0.04 | 0.7 | 0.03 | 0.5 | 0.09 | 1.4 |
| | Normal | 13.75 | 0.08 | 0.6 | 0.04 | 0.3 | 0.07 | 0.5 | 0.12 | 0.9 |
| | High | 17.12 | 0.10 | 0.6 | 0.09 | 0.5 | 0.07 | 0.4 | 0.15 | 0.9 |
| HCT (%) | Low | 18.32 | 0.21 | 1.1 | 0.13 | 0.7 | 0.20 | 1.1 | 0.31 | 1.7 |
| | Normal | 41.94 | 0.40 | 0.9 | 0.30 | 0.7 | 0.32 | 0.8 | 0.59 | 1.4 |
| | High | 51.38 | 0.42 | 0.8 | 0.29 | 0.6 | 0.42 | 0.8 | 0.66 | 1.3 |
| MCV (fL) | Low | 72.38 | 0.14 | 0.2 | 0.28 | 0.4 | 0.58 | 0.8 | 0.66 | 0.9 |
| | Normal | 79.53 | 0.15 | 0.2 | 0.24 | 0.3 | 0.44 | 0.6 | 0.52 | 0.7 |
| | High | 92.81 | 0.17 | 0.2 | 0.19 | 0.2 | 0.53 | 0.6 | 0.58 | 0.6 |
| MCH (pg) | Low | 23.85 | 0.27 | 1.1 | 0.17 | 0.7 | 0.00 | 0.0 | 0.32 | 1.4 |
| | Normal | 26.07 | 0.21 | 0.8 | 0.10 | 0.4 | 0.04 | 0.1 | 0.23 | 0.9 |
| | High | 30.94 | 0.21 | 0.7 | 0.03 | 0.1 | 0.06 | 0.2 | 0.22 | 0.7 |
| MCHC (g/dL) | Low | 32.96 | 0.38 | 1.1 | 0.24 | 0.7 | 0.15 | 0.5 | 0.47 | 1.4 |
| | Normal | 32.79 | 0.24 | 0.7 | 0.19 | 0.6 | 0.19 | 0.6 | 0.36 | 1.1 |
| | High | 33.33 | 0.23 | 0.7 | 0.03 | 0.1 | 0.16 | 0.5 | 0.28 | 0.9 |
| RDW-CV (%) | Low | 14.16 | 0.12 | 0.9 | 0.07 | 0.5 | 0.08 | 0.6 | 0.16 | 1.2 |
| | Normal | 14.21 | 0.09 | 0.7 | 0.07 | 0.5 | 0.10 | 0.7 | 0.16 | 1.1 |
| | High | 11.66 | 0.09 | 0.8 | 0.07 | 0.6 | 0.07 | 0.6 | 0.14 | 1.2 |
| RDW-SD (fL) | Low | 38.44 | 0.33 | 0.9 | 0.00 | 0.0 | 0.19 | 0.5 | 0.38 | 1.0 |
| | Normal | 41.78 | 0.32 | 0.8 | 0.00 | 0.0 | 0.21 | 0.5 | 0.38 | 0.9 |
| | High | 40.85 | 0.29 | 0.7 | 0.12 | 0.3 | 0.03 | 0.1 | 0.32 | 0.8 |
| PLT (10^3/μL) | Low | 50.6 | 2.9 | 5.7 | 0.0 | 0.0 | 1.4 | 2.7 | 3.2 | 6.3 |
| | Normal | 265.1 | 5.5 | 2.1 | 0.0 | 0.0 | 3.1 | 1.2 | 6.4 | 2.4 |
| | High | 509.2 | 8.1 | 1.6 | 0.0 | 0.0 | 4.7 | 0.9 | 9.3 | 1.8 |
| MPV (fL) | Low | 9.60 | 0.34 | 3.5 | 0.12 | 1.3 | 0.26 | 2.7 | 0.44 | 4.6 |
| | Normal | 10.43 | 0.13 | 1.2 | 0.04 | 0.4 | 0.04 | 0.4 | 0.14 | 1.3 |
| | High | 10.48 | 0.08 | 0.7 | 0.04 | 0.4 | 0.03 | 0.3 | 0.09 | 0.9 |
{7}
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
**Stability**
To verify the 14-day open-vial stability claim, a real-time stability study was performed by testing three separate BC-5D lots on a single BC-5390 Auto Hematology Analyzer. The BC-5D lots were selected near the end of the established shelf-life. Two lots were analyzed at 14 different time points; whereas one lot was analyzed at 13 time points. The specified time points extended one day beyond the claimed stability.
To verify the BC-5D Hematology Control 75-day closed-vial stability claim, a real-time stability study was also performed to verify the 75-day closed-vial stability claim. Three separate lots were analyzed at several different time points extending well beyond the claimed stability. Stability was assessed in terms of measurand drift for each control level and lot in accordance with CLSI EP25-A.
**Expected Values**
Value assignment was performed for each BC-5D Hematology Control level on calibrated BC-5390 Auto Hematology Analyzers. Three replicates were performed per control level and vial over two days. The expected assay ranges were based on ± 2.0 SD.
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.
{8}
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:
Not applicable.
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 does support a substantial equivalence decision.
9
