STAK-CHEX PLUS RETICS

K090137 · Streck · GLQ · Mar 18, 2009 · Hematology

Device Facts

• Record ID: K090137
• Device Name: STAK-CHEX PLUS RETICS
• Applicant: Streck
• Product Code: GLQ · Hematology
• Decision Date: Mar 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.

Device Story

STaK-Chex Plus Retics is a stabilized whole blood control product used in clinical laboratories to verify the accuracy and precision of automated hematology analyzers. The device consists of a suspension of human red blood cells, a nucleated red blood cell (NRBC) analog, a white blood cell component (human and non-human analogs), and a platelet component (non-human analog) in a preservative medium. It is provided in three levels (low, normal, high) in 4.5ml plastic vials. Laboratory personnel process the control identically to a patient sample on a calibrated hematology instrument. The instrument measures the control, and the resulting values are compared against the expected ranges provided on the product assay sheet. This process allows clinicians to confirm that the instrument is functioning correctly, thereby ensuring the reliability of patient test results.

Clinical Evidence

Bench testing only. Studies included closed vial stability, open vial stability, run-to-run reproducibility, and external site recovery of values. Results demonstrated consistent reproducibility and stability for the claimed shelf life.

Technological Characteristics

Stabilized suspension of human/animal blood components in preservative medium. Vials: 5ml plastic with polypropylene screw caps/polyethylene liners. Storage: 2-10°C. No electronic, software, or connectivity components.

Indications for Use

Indicated for use as an assayed whole blood control to evaluate accuracy and precision of automated, semi-automated, and manual blood cell parameter measurement procedures 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

• STaK-Chex Plus Retics (K992887)

Submission Summary (Full Text)

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

A. 510(k) Number:
K090137

B. Purpose for Submission:
New Device

C. Measurand:
Low level Quality Control with Nucleated red Blood cells (NRBC)

D. Type of Test:
Quantitative

E. Applicant:
Streck, Inc.

F. Proprietary and Established Names:
STaK-Chex Plus Retics

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625 Hematology Quality Control mixture
2. Classification:
Class II
3. Product code:
GLQ, Mixture, Control, White Blood and Red-Cell Indices
4. Panel:
Hematology (81)

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H. Intended Use:

1. Intended use(s):

STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated procedures that measure blood cell parameters.

2. Indication(s) for use:

STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated procedures that measure blood cell parameters.

3. Special conditions for use statement(s):

Not Applicable

4. Special instrument requirements:

Not Applicable

I. Device Description:

STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human and non-human analogs and a platelet component consisting of a non-human analog in a preservative medium. This product is packaged in plastic vials containing 4.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert/assay sheet. The product must be stored at 2 – 10° C.

J. Substantial Equivalence Information:

1. Predicate device name(s):

STaK-Chex Plus Retics, Streck, Inc.

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

K992887

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3. Comparison with predicate:

| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated procedures that measure blood cell parameters. | STaK-Chex Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman Coulter GenS series hematology instruments. |
| Contents (Reagents) | Low Level – Stabilized human and animal blood, plus a nucleated red blood cell analog, Normal and High Levels same as Predicate | Stabilized human and animal blood |
| Closed Vial Stability | 75 days | 105 days |
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Open Vial Stability | 14 | 14 |
| Storage Conditions | 2-10°C | 2-10°C |

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

Not Applicable

L. Test Principle:

Laboratories require assayed material for quality control of automated procedures that measure whole blood parameters. Daily use of this whole blood control provides quality control data for confirming the precision and accuracy of instrument operation protocols. Use of stabilized cell preparations for controlling laboratory testing protocols is an established procedure. When handled like a patient sample and assayed on a properly calibrated and functioning instrument this whole blood control will provide values within the expected range indicated on the assay sheet.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Reproducibility Data: Ten consecutive instrument runs performed on the same analyzer with a single vial of control. Resulting product performance data compared to the parameter specific assay ranges. The review of the data was within acceptable limits.

b. Linearity/assay reportable range:

Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Open Vial Stability: A minimum of 14 days stability @ 2- 10°C is required to substantiate the closed vial stability claim. The review of the data was within acceptable limits.

Closed Vial Stability: A minimum of 75 days stability @ 2- 10°C is required to substantiate the closed vial stability claim. The review of the data was within acceptable limits.

Value Assignment: The STaK-Chex Plus Retics (with nRBC) product is manufactured and assigned based on instrument specific requirements. A minimum of three vials per level are tested on the Beckman Coulter LH750, LH500 instruments. Each vial is tested for a minimum of three test events performed on different dates. Referees are requested to run each vial in duplicate on the instrument application consecutively. The data is entered into the validated QC link database program which calculates mean, standard deviation, and coefficient of variation for each parameter analyzed. Final assay assignment values are determined using the data collected and established product performance characteristics. Expected range values assigned to the assay are based on the standard deviation of the assay data.

d. Detection limit:

Not Applicable

e. Analytical specificity:

Not Applicable

f. Assay cut-off:

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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):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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