K032214 · Boule Medical AB · GKZ · Jan 29, 2004 · Hematology
Device Facts
Record ID
K032214
Device Name
MEDONIC CA620/530 HEMATOLOGY ANALYZER
Applicant
Boule Medical AB
Product Code
GKZ · Hematology
Decision Date
Jan 29, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 864.5220
Device Class
Class 2
Indications for Use
The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens.
Device Story
Medonic CA620/530 is a fully automated hematology analyzer for in vitro diagnostic testing of whole blood. Device processes whole blood samples to identify and classify formed blood elements. Used in clinical laboratory settings by trained personnel. Output provides automated hematological analysis to assist clinicians in patient diagnosis and monitoring.
Clinical Evidence
No clinical data provided in the document; bench testing only.
Technological Characteristics
Impedance-based cellular enumeration and sizing; spectrophotometric hemoglobin measurement. Automated sampling, dilution, and mixing. Reagent system: isotonic diluent, lytic reagent, cleaner. CA 620 features graphic display and extended print formats. Software performs automated calibration and result calculation. Standalone benchtop analyzer.
Indications for Use
Indicated for in vitro diagnostic testing of whole blood specimens to perform complete blood counts and three-part leukocyte differentials.
Regulatory Classification
Identification
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K032214
B. Analyte:
Ten blood cell count with three part leukocyte differential capability
C. Type of Test:
Complete blood count
D. Applicant:
Boule Medical AB, Stockholm, Sweden, represented by Clinical Diagnostic Solutions, Inc.
E. Proprietary and Established Names:
Medonic CA 620 and CA 530 Hematology Analyzers
F. Regulatory Information:
1. Regulation section:
21 CFR 864.5220 Automated differential cell counter
2. Classification:
Class II
3. Product Code:
GKZ
4. Panel:
Hematology (81)
G. Intended Use:
1. Indication(s) for use:
The Medonic CA 620 and CA 530 are fully automated hematology analyzers for in vitro diagnostic testing of whole blood specimens.
2. Special condition for use statement(s):
n/a
3. Special instrument Requirements:
n/a
H. Device Description:
The Medonic CA620/530 Hematology Analyzers are a single analyzer system, using the same electronic particle counting technology and the same software for calculating and reporting results. The CA620 and CA530 have identical parameter performance in all respects. The CA620 additionally has reporting modes, an extended calibration menu, a graphic display and an extended print format not available on the CA530. Both analyzers report all CBC parameters, but the CA530 may be configured to inhibit reporting of the WBC differential results.
I. Substantial Equivalence Information:
1. Predicate device name(s):
Abbott CELL-DYN 1600 Analyzer (K870233) and Beckman Coulter Ac-T Diff™ (K973634).
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2. Predicate K number(s):
See above
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Uses impedance method for counting and sizing of blood cells | Medonic CA620/530 | Abbott CD 1600
Beckman Coulter Ac•T diff |
| Identical parameters | | |
| Calculates 3 population diff plus absolute numbers | | |
| Automatic sampling, diluting, and mixing devices | | |
| Self cleaning sampling system | | |
| Simultaneous analysis of RBC and WBC parameters | | |
| Single aperture for RBC/PLT counting and sizing | | |
| Single aperture for WBC sizing | | |
| Coincidence correction to accommodate 2 cells entering sensing area simultaneously | | |
| Reagent system includes a diluent, lytic reagent, and cleaner | | |
| Uses a spectrophotometer to measure Hgb | | |
| Stores patient, control, an calibrator results. | | |
| Automatic calibration calculations. | | |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Uses volumetric metering to set aliquot size | Medonic CA620/530 | Abbott CD 1600 |
| Uses precision vacuum and count times to set aliquot size | | Beckman Coulter Ac•T diff |
J. Standard/Guidance Document Referenced (if applicable):
Class II Special Controls Document: Premarket Notifications for Automated Differential Cell counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA
K. Test Principle:
The Medonic CA620/530 uses the applied Coulter impedance counting principle for cellular enumeration and sizing of blood cells. The analyzer automatically aspirates an aliquot of blood specimen, prepares counting and sizing dilutions, and finally adds a lytic reagent for WBC counting and sizing and hemoglobin measurement. In addition, it uses similar reagent systems, consisting of a hematology isotonic diluent and hemolytic lyse reagent.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
| Parameter | CV % |
| --- | --- |
| WBC | 2.0 |
| RBC | 0.85 |
| MCV | 0.5 |
| PLT | 3.3 |
| HGB | 0.8 |
b. Linearity/assay reportable range:
| Linearity +/-1% | Range |
| --- | --- |
| WBC | 0.5-80.0 |
| RBC | 0.5-9.99 |
| MCV | 55-130 |
| PLT | 30-999 |
| HGB | 0.5-55.0 |
| PLT Concentrate Mode (RBC<0.3 and measured on a latex solution) | 30-6999 |
c. Traceability (controls, calibrators, or method):
n/a
d. Detection limit:
n/a
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e. Analytical specificity: n/a
f. Assay cut-off: n/a
2. Comparison studies:
a. Method comparison with predicate device:
| | Ac-T Diff vs CD 1600 | Ac-T Diff vs CA620/530 | CD 1600 vs CA620/530 |
| --- | --- | --- | --- |
| Parameters | | | |
| WBC | 0.99 | 0.99 | 0.99 |
| RBC | 0.98 | 0.99 | 0.98 |
| PLT | 0.95 | 0.94 | 0.92 |
| HGB | 0.99 | 0.99 | 0.98 |
| MCV | 0.98 | 0.99 | 0.97 |
| Diff Parameters | | | |
| GRAN % | 0.94 | 0.93 | 0.95 |
| LYMPH % | 0.93 | 0.94 | 0.94 |
| MID % | 0.24 | 0.26 | 0.35 |
b. Matrix comparison: n/a
3. Clinical studies:
a. Clinical sensitivity: n/a
b. Clinical specificity: n/a
c. Other clinical supportive data (when $a$ and $b$ are not applicable): n/a
4. Clinical cut-off: n/a
5. Expected values/Reference range: n/a
M. Conclusion:
Boule Medical AB has shown the Medonic CA 620 and CA 530 Hematology Analyzers to be substantially equivalent to the Abbott CELL-DYN 1600 and the Beckman Coulter Ac-T Diff Hematology Analyzers
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