LIQUICHEK RETICULOCYTE CONTROL (A)

K042836 · Bio-Rad · JPK · Nov 5, 2004 · Hematology

Device Facts

• Record ID: K042836
• Device Name: LIQUICHEK RETICULOCYTE CONTROL (A)
• Applicant: Bio-Rad
• Product Code: JPK · Hematology
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

Device Story

Liquichek Reticulocyte Control (A) is a stabilized human red blood cell product suspended in buffered fluid with animal-derived constituents and preservatives. Supplied in three levels, it serves as an assayed quality control material for clinical laboratories. It is used by laboratory technicians to verify the precision of automated hematology analyzers. By providing known mean values for reticulocyte counts, the control allows laboratories to monitor instrument performance and ensure the accuracy of patient test results over time. The product is stored at 2-8°C and has an open-vial stability claim of 21 days.

Clinical Evidence

No clinical data. Stability studies were performed to establish shelf life (110 days at 2-8°C) and open vial stability (21 days at 2-8°C).

Technological Characteristics

Stabilized human red blood cells in buffered fluid with animal-derived constituents and preservatives. Liquid form. Supplied in three levels. Storage at 2-8°C. Open-vial stability of 21 days at 2-8°C.

Indications for Use

Indicated for use as an assayed whole blood control to evaluate the precision of automated reticulocyte counting methods in clinical laboratory settings.

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

• Liquichek Reticulocyte Control (K993496)

Submission Summary (Full Text)

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

A. 510(k) Number:
K042836

B. Purpose for Submission:
New Device

C. Measurand:
Reticulocyte, Quality Control Material

D. Type of Test:
Not Applicable.

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek Reticulocyte Control (A)

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)

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H. Intended Use:

1. Intended use(s):

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

2. Indication(s) for use:

Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.

3. Special conditions for use statement(s):

Not applicable.

4. Special instrument requirements:

Not applicable.

I. Device Description:

This a fluid product composed of stabilized human red blood cells suspended in a buffered fluid added constituents of animal origin and preservatives. This product is supplied in three levels.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Liquichek Reticulocyte Control

2. Predicate 510(k) number(s):

K993496

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Liquichek Reticulocyte Control (A) | Liquichek Reticulocyte Control |
| Intended Use | Used as an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting. | Used as a whole blood reference control material designed to verify the precision of COULTER instruments equipped with reticulocyte measuring capabilities using VCS technology, and New Methylene Blue Stain. |
| Form | Liquid | Same |
| Storage (Unopened) | 2-8°C Until expiration date | 2-8°C Until expiration date |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Open Vial Claim | 21 days at 2-8°C | 31 days at 2-8°C |

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

Not Applicable.

L. Test Principle:

Not Applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable.

b. Linearity/assay reportable range:

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Not Applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Not Applicable.

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.

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):

4. Clinical cut-off:
Not Applicable.

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5. Expected values/Reference range:

The reagent insert contains mean values derived from replicate analyses and are specific for the lot of product. The tests listed were performed by using manufacturer supported reagents and a representative sampling of the lot of product. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as guides.

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.

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