RETIC-CHEX FOR CELL-DYN

K042587 · Streck Laboratories, Inc. · JPK · Oct 19, 2004 · Hematology

Device Facts

• Record ID: K042587
• Device Name: RETIC-CHEX FOR CELL-DYN
• Applicant: Streck Laboratories, Inc.
• Product Code: JPK · Hematology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting. It is designed for use on the following automated reticulocyte counting. It is designed for use on the following reticulocyte analyzers: Abbott Cell-Dyn 4000, 3700, 3500, and 3200,

Device Story

Retic-Chex for Cell-Dyn is an in vitro diagnostic hematology control; consists of stabilized human red blood cells and simulated human reticulocytes in 1.0ml plastic vials. Used in clinical laboratory settings to validate performance of automated reticulocyte counting on Abbott Cell-Dyn analyzers. Provides two levels of reticulocyte percentage ranges (1.5-2.0% and 3.9-5.8%). Laboratory technicians process the control through the analyzer similarly to patient samples; output is a reticulocyte count value. Comparison of output against established assay ranges allows verification of instrument accuracy and precision; ensures reliable patient testing results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Suspension of stabilized human red blood cells and simulated human reticulocytes. Packaging: 1.0ml plastic vials with injection-molded polypropylene screw-top caps. Multi-level control (two levels). No electronic, software, or energy-based components.

Indications for Use

Indicated for use as an assayed quality control material for laboratories performing reticulocyte counting via automated, semi-automated, or manual methods.

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

• Retic-Chex® Linearity (K000115)

Submission Summary (Full Text)

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

A. 510(k) Number:
K042587

B. Purpose for Submission:
New device

C. Analyte:
Reticulocyte

D. Type of Test:
Quantitative

E. Applicant:
Streck Laboratories

F. Proprietary and Established Names:
Retic-Chex for Cell-Dyn®

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)

H. Intended Use:
1. Intended use(s):
Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting.
2. Indication(s) for use:
Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting.

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3. Special condition for use statement(s):
Not applicable

4. Special instrument Requirements:
Retic-Chex is designed for use on the following reticulocyte analyzers: Abbott Cell-Dyn 3200, 3500/3700 and 4000.

I. Device Description:
Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0 ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5-2.0. Control II reticulocyte percent range will be 3.9-5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a vacuum molded clam-shell box.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Retic-Chex® Linearity
2. Predicate K number(s):
K000115
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Retic-Chex for Cell-Dyn® | Retic-Chex Linearity |
| Intended Use | Used as an assayed control for evaluating the accuracy and precision of automated, semi-automated, and manual methods of reticulocyte counting. | Same |
| Contents | Stabilized human red blood cells | Same |
| Analyzers | Abbott Cell-Dyn 3200, 3500/3700,and 4000 | Abbott Cell-Dyn 3500/3700 and 4000
Bayer Advia 120
Beckman STKS/MAXM/HmX
Sysmex R-3000/R-3500/R-1000/RAM-1
XE-2100
XT-2000i |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Control Levels | Two levels | Five levels |
| Stability | 55 days after shipping
14 days after opening | 45 days after shipping
5 days after opening |

K. Standard/Guidance Document Referenced (if applicable):
Not provided

L. Test Principle:
Laboratories require material for quality control of automated, semi-automated, and manual procedures that measure whole blood parameters.

Use of stabilized cell preparations for controlling laboratory testing is an established procedure. When handled like a patient sample and assayed on a properly calibrated and functioning instrument or manual methods, the whole blood control will provide values within the expected range indicated on the assay sheet.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
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

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Control values should fall within the Expected Range indicated on the accompanying assay sheet. Upon receipt of a new control lot, it is recommended that each individual laboratory establish its own mean limits for each parameter.

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

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