CDS HEMATOLOGY CALIBRATOR (CDS CAL)

K041130 · Clinical Diagnostic Solutions, Inc. · KRZ · Jun 10, 2004 · Hematology

Device Facts

• Record ID: K041130
• Device Name: CDS HEMATOLOGY CALIBRATOR (CDS CAL)
• Applicant: Clinical Diagnostic Solutions, Inc.
• Product Code: KRZ · Hematology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.8165
• Device Class: Class 2

Indications for Use

The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that establishes red cell, white cell and platelet counts in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including the Coulter S-Plus series, STKR, JS, JR, ST and JT series, STKS, MAXM, Coulter OnyX, T series and A.C.T and A.C.T diff series analyzers; the Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 analyzers used to count red cells, white cells and platelets. It is a suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.

Device Story

CDS Hematology Calibrator is a suspension of stabilized human red blood cells, stabilized white cells (or surrogates), and stabilized platelets (or surrogates) in a synthetic plasma-like solution. It serves as a calibration standard for impedance-based automated hematology analyzers. The device is used in clinical laboratory settings by laboratory technicians. The calibrator is processed by the analyzer using the same impedance-based counting principles as patient blood samples. The resulting values are compared against the manufacturer-assigned assay values for the specific lot. If the analyzer's output deviates from the assigned values, the clinician adjusts the instrument's calibration settings to ensure accuracy. This process ensures the analyzer provides precise and accurate measurements for patient blood parameters (WBC, RBC, HGB, MCV, PLT, MPV), directly impacting the reliability of clinical diagnostic results.

Clinical Evidence

No clinical data. Bench testing included a 15-sample precision study comparing fresh blood to the CDS calibrator, showing comparable coefficients of variation (CV) for WBC, RBC, HGB, HCT, MCV, PLT, and MPV. Method comparison studies were performed on Coulter and Abbott analyzers, confirming that assigned assay values were equivalent to reference methodologies.

Technological Characteristics

Suspension of stabilized human RBCs, stabilized white cells/surrogates, and stabilized platelets/surrogates in synthetic plasma. Supplied in glass tubes with polypropylene screw caps. Traceable to ICHS HiCN Standard for hemoglobin. Complies with NCCLS H15-A02 and H07-A02 standards. Operates via impedance-based hematology analyzer calibration.

Indications for Use

Indicated for use as a calibration standard for automated hematology analyzers to establish red cell, white cell, and platelet counts in whole blood specimens.

Regulatory Classification

Identification

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

Special Controls

*Classification.* Class II (special controls). 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.

Submission Summary (Full Text)

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

A. 510(k) Number:
K041130

B. Purpose for Submission:
New device

C. Analyte:
Red Blood Cells, White Blood Cells, Platelets, Hemoglobin

D. Type of Test:
Instrument Calibration

E. Applicant:
Clinical Diagnostics Solutions, Inc.

F. Proprietary and Established Names:
CDS Hematology Calibrator

G. Regulatory Information:
1. Regulation section:
864.8150
864.8165
864.8175
864.8185
2. Classification:
Class II
3. Product Code:
KRZ, KRY, KSA
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use:
CDS Hematology Calibrator is intended to be used as a calibrator for WBC, RBC, HGB, MCV and PLT parameters on impedance based hematology instruments such as:
Abbott: CD1400, CD1600, CD1700, CD1800
CDS Hematology Calibrator is intended to be used as a calibrator for WBC, RBC, HGB, MCV, PLT, and MPV parameters on impedance based hematology instruments such as:
ABS: Micros

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Beckman Coulter: STKS, MAXM, STKR, S-Plus Series, MD, OnyX, T, JT, Ac●T

Boule: CA530/620

Danam: Excell 16

Sysmex K series

2. Indication for use:

CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter S Plus II-VI series, STKR, JS, JR, ST, and JT series, STKS, MAXM, HmX, Gen● S, MD series, OnyX, T series and A^c ●T and A^c ●T diff series analyzers; the Abbott Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 analyzers intended to count red cells, white cells and platelets. It is a suspension of particles or cells whose size, shape, concentration and other characteristics have been precisely and accurately determined.

3. Special condition for use statement(s):

Not applicable

4. Special instrument Requirements:

CDS Hematology Calibrator serves as a calibration standard for automatic hematology analyzers, including Beckman Coulter S Plus II-VI series, STKR, JS, JR, ST, and JT series, STKS, MAXM, HmX, Gen● S, MD series, OnyX, T series and A^c ●T and A^c ●T diff series analyzers: the Abbott Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 analyzers.

I. Device Description:

CDS Hematology Calibrator is a suspension of stabilized human red blood cells, stabilized white cells or surrogates of human or animal origin and stabilized platelets or surrogates of animal origin, suspended in a synthetic plasma-like solution. The size, shape and concentration of the cells in the suspension have been precisely and accurately determined. Each calibrator is supplied with assay values assigned by a procedure tied to standard reference methods. The calibrator is supplied in glass tubes with polypropylene screw caps. The tubes are packaged in PVC clamshells.

J. Substantial Equivalence Information:

1. Predicate device names:

Streck Cal Chex

R&D CBC Cal Plus

Coulter S-Cal

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2. Predicate K numbers:
K840261
K897060
K862122

3. Comparison with predicate:

| Similarities | | | | |
| --- | --- | --- | --- | --- |
| Item | Device | Predicates | | |
| | CDS Cal | Streck Labs Cal Chex | R&D Systems CD-CAL | Beck-Coulter S-Cal |
| RBC | Human RBC | Same | Same | Same |
| Differences | | | | |
| Item | Device | Predicate | | |
| | CDS Cal | Streck Labs Cal Chex | R&D Systems CD-CAL | Beck-Coulter S-Cal |
| WBC | Human /Animal RBC | Human WBC | Animal WBC | Human/ Animal RBC |
| PLT | Animal RBC | Animal RBC | Animal PLT | Animal RBC |

K. Standard/Guidance Document Referenced (if applicable):
H15-A02 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard-Third Edition, NCCLS
Hemoglobin value is traceable to ICHS HiCN Standard
H07-A02 Procedure for Determining Packed Cell Volume by the Microhematocrit Method-Third Edition; Approved Standard, NCCLS

L. Test Principle:
The calibration procedure uses replicates of the calibrator run on a hematology instrument to provide an average result for each parameter (WBC, RBC, HGB, MCV, PLT, MPV). The average values are then compared to published assay values for the specific lot of calibrator. If the results are outside of the published tolerance range, the instrument calibration can be adjusted to meet these values

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
A 15 sample precision study was performed comparing fresh blood to a CDS calibrator (Lot #2).

| | WBC CV | RBC CV | HGB CV | HCT CV | MCV CV | PLT CV | MPV CV |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Fresh Blood Sample | 0.17 | 0.05 | 0.11 | 0.62 | 0.97 | 8.57 | 0.26 |
| CDS Calibrator | 0.15 | 0.04 | 0.09 | 0.34 | 0.32 | 6.88 | 0.29 |

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b. Linearity/assay reportable range:
N/A

c. Traceability (controls, calibrators, or method):
N/A

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
A study was performed comparing fresh blood reference calibration with 2 predicate calibrators and three lots of CDS calibrator, which were manufactured at different times using different raw materials. The calibrators were run on two instruments (Coulter Aᵉ • T and Abbott CD1700). The assigned assay values were compared to the average value recovered from a calibration run. The results for the commercial calibrators were equivalent to the reference methodology.
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:
Value assignment data and the value assignment protocol were provided.

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