LIQUICHEK HEMATOLOGY CONTROL (A)

K041457 · Bio-Rad · JPK · Jun 28, 2004 · Hematology

Device Facts

• Record ID: K041457
• Device Name: LIQUICHEK HEMATOLOGY CONTROL (A)
• Applicant: Bio-Rad
• Product Code: JPK · Hematology
• Decision Date: Jun 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Liquichek™ Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology instruments that provide a WBC differential.

Device Story

Liquichek™ Hematology Control (A) is a tri-level, liquid, whole blood hematology control; used in clinical laboratories to evaluate the precision of automated hematology instruments. Composition includes stabilized human white cells, lysable human red cells, and simulated human platelets of animal origin, plus stabilizers and preservatives. Device is processed on Abbott Cell-Dyn 3200, 3500, and 3700 instruments. Healthcare providers use the control to verify instrument performance by comparing measured values against assigned ranges; ensures accuracy and reliability of patient hematology results (WBC, RBC, PLT, etc.).

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated across 4 labs using 2 Abbott Cell-Dyn instruments; results for all parameters (BASO, EOS, HCT, HGB, LYMPH, MCH, MCHC, MCV, MONO, MPV, NEU, PLT, RBC, RDW, GRAN, MID, WBC) showed CVs ranging from 0–10%.

Technological Characteristics

Tri-level liquid control; matrix consists of stabilized human white cells, lysable human red cells, and simulated human platelets of animal origin. Designed for use on Abbott Cell-Dyn 3200, 3500, and 3700 instruments. Open-vial stability is 7 days at 2–8°C.

Indications for Use

Indicated for use as an assayed whole blood control to evaluate the precision of hematology instruments providing white blood cell differentials. Intended for professional clinical laboratory use.

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

• Tri-Count 20 Hematology Whole Blood Control (K960471)

Submission Summary (Full Text)

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

A. 510(k) Number:
K041457

B. Purpose for Submission:
New device

C. Analyte(s):
BASO, EOS, HCT, HGB, LYMPH, MCH, MCHC, MCV, MONO,
MPV, NEU, PLT, RBC, RDW, GRAN, MID, and WBC (NOC, WIC, WOC)

D. Type of Test:
N/A

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek™ Hematology Control (A), (Low, Normal, High); Hematology Quality
Control (QC) Mixture

G. Regulatory Information:
1. Regulation section: 21 CFR 864.8625 – Hematology Quality Control (QC)
Mixture
2. Classification: Class II
3. Product Code(s): JPK - Hematology QC Mixture; JCN - Cell Counter
Control, Normal/Abnormal
4. Panel: Hematology (81)

H. Intended Use:
1. Intended use(s): Liquichek™ Hematology Control (A) is an assayed whole
blood control for evaluating precision of hematology

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instruments that provide a WBC differential.
[See C. Analyte(s) above]

2. Indication(s) for use: Same as Intended Use.
3. Special condition for use statement(s): N/A
4. Special instrument Requirements: Assayed for use on the Abbott Cell-Dyn 3200, 3500 and 3700 instruments.

I. Device Description:
Liquichek™ Hematology Control (A) is a tri-level whole blood hematology control for in vitro diagnostic use in evaluating precision of hematology instruments that provide a white blood cell differential. It is a suspension of stabilized human white cells, lysable human red cells, simulated human platelets of animal origin, stabilizers and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s): Bio-Rad Tri-Count 20 Hematology Whole Blood Control
2. Predicate K number(s): #K960471
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Assay instrumentation | Automated hematology instruments | Same |
| Form | Liquid | Same |
| Matrix | Human whole blood base | Same |
| Levels | Tri-level | Same |
| Differences | | |
| Item | Device | Predicate |
| Assayed for use instrument | Abbott Cell-Dyn hematology line | Coulter hematology line |
| Stability (Open vial) at 2 – 8° C. | (7) days | (14) days |

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

L. Test Principle: Abbott Cell-Dyn instrumentation

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: Replicates of the tri-level control were run at (4) different labs, on (2) members of the Cell-Dyn line of instruments. Results for all parameters ranged 0 – 10% CV.

b. Linearity/assay reportable range: N/A

c. Traceability, Stability, Expected values (controls, calibrators, or method): Value assignment was performed using the Abbott Cell-Dyn counting methods.

d. Detection limit: N/A

e. Analytical specificity: N/A

f. Assay cut-off: N/A

2. Comparison studies: N/A

a. Method comparison with predicate device:

b. Matrix comparison:

3. Clinical studies: N/A

a. Clinical sensitivity:

b. Clinical specificity:

c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

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N. Conclusion:

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

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