CELL-CHEX WITH CPPD CRYSTALS

K110718 · Streck · GLQ · May 26, 2011 · Hematology

Device Facts

• Record ID: K110718
• Device Name: CELL-CHEX WITH CPPD CRYSTALS
• Applicant: Streck
• Product Code: GLQ · Hematology
• Decision Date: May 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate (CPPD) Crystals which can be used to monitor the presence of crystals in synovial fluid. Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears.

Device Story

Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells, white blood cells, and calcium pyrophosphate dihydrate (CPPD) crystals in a preservative medium. Used as an assayed quality control in clinical laboratories to validate manual hemocytometer cell counts and Cytospin® smear white blood cell differentiation. Level 1 contains CPPD crystals for monitoring crystal presence in synovial fluid; Level 2 contains no crystals. Product is stored at 2-10°C in glass vials. Laboratory technicians use the control to verify the accuracy and reproducibility of manual body fluid analysis. The control provides a known reference point to ensure consistent performance of manual counting and staining procedures, aiding in the reliable diagnosis of conditions affecting body fluids.

Clinical Evidence

No clinical data. Bench testing only. Precision and reproducibility were evaluated over 20 days at six external sites and internally using hemocytometer and Cytospin® platforms. Results were within ±3SD for WBC differential parameters and ±2SD for RBC/WBC counts. Stability testing (open and closed vial) confirmed performance over 30 and 60 days respectively.

Technological Characteristics

Stabilized suspension of human red/white blood cells and CPPD crystals in preservative medium. Packaged in 2.0ml glass vials with polypropylene screw caps and polyethylene liners. Storage at 2-10°C. No electronic or software components.

Indications for Use

Indicated for use as an assayed quality control for monitoring manual hemocytometer cell counts and Cytospin® smear white blood cell differentiation in cerebrospinal and body fluids (pleural, pericardial, peritoneal, synovial).

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

• Cell-Chex™ (k101335)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k110718

B. Purpose for Submission:
Clearance of a new device

C. Measurand:
Assayed control for Red Blood Cells (RBC), White Blood Cells (WBC), Neutrophils (NEUT) %, Lymphocytes (LYM)%, Monocytes (MONO) %, Eosinophils (EOS) %, and Basophils (BASO) %, Mononuclear %, Polymorphonuclear %, Calcium Pyrophosphate Dihydrate (CPPD) Crystals.

D. Type of Test:
Quantitative and Qualitative

E. Applicant:
Streck Inc.

F. Proprietary and Established Names:
Cell-Chex™ with CPPD Crystals

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 Cell and Red Cell Indices
4. Panel:
81 (Hematology)

H. Intended Use:
1. Intended use(s):
Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples are including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate CPPD crystals which can be used to monitor the presence of crystals in synovial fluid. Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear and Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes) in body fluid samples performed using Cytospin® smears.
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Not applicable

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I. Device Description:

Cell-Chex™ with CPPD Crystals is a stabilized suspension of human red blood cells (RBC), human white blood cells (WBC) and calcium pyrophosphate dihydrate (CPPD) crystals (Level 1 only) in a preservative medium. The product is packaged in glass vials containing 2.0 mL. There are two different levels - Level 1 contains a low cell count and CPPD crystals and Level 2 contains a high cell count and no crystals.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Cell-Chex™

2. Predicate K number(s):
k101335

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Cell-Chex™ with CPPD Crystals | Cell-Chex™ (predicate) |
| Intended Use | Cell-Chex™ with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples are including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dihydrate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex™ with CPPD Crystals is also intended for monitoring white blood cell differentiation (Mononuclear and Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes) in body fluid samples performed using Cytospin® smears. | Cell-Chex is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid including pleural, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid.
Cell-Chex is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears. |
| Final Product Form | There are two different levels. The product is packaged in glass vials containing 2 mL. The vials are packaged in a 6 or 12 welled vacuum formed “clam shell” container with instructions for use and assay sheet. | Same |
| Open vial stability | 30 days when stored at 2 – 10°C | Same |
| Closed vial stability | 60 days when stored at 2 – 10°C | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Cell-Chex™ | Cell-Chex™ (predicate) |
| Reagents | Stabilized human red blood cells and human white blood cells in a preservative medium. Level 1 contains calcium pyrophosphate dihydrate (CPPD) crystals. | Stabilized human red blood cells and human white blood cells in a preservative medium. Level 1 contains monosodium urate crystals. |

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A2, Evaluation of Precision of Quantitative Measurement Methods; Approved Guidelines-Second Edition.

L. Test Principle:
Cell-Chex™ with CPPD crystals is an in-vitro diagnostic product used for quality control procedures associated with body fluid counting protocols. Total cell counts and crystal identification are performed with a hemocytometer using undiluted or diluted body fluid. Crystal analysis can be performed using light or polarized light microscopy following routine lab protocol for crystal identification. Differential cell counts of body fluids are performed using Cytospin® smears stained by means of routine hematology staining techniques.

M. Performance Characteristics:

1. Analytical performance:

a. Precision/Reproducibility:
- Run-to-run repeatability: Data was produced from 10 consecutive runs on three lots of each control level on both the hemacytometer and Cytospin®. Results fell within parameter specific assay value assignment ranges and are reflective of ±3SD for the WBC differential parameters and ±2SD for the red and white blood cell parameters. Level 1 results were positive for crystals. Level 2 results were negative for crystals.
- Precision performance: Data was collected internally and at six external sites in accordance with the product's instructions for use (IFU) using the hemacytometer and Cytospin®. One lot of control was run for 20 days (4 reps/day) over the course of 45 days. The results fell within parameter specific assay value assignment ranges and are reflective of ±3SD for the WBC differential parameters and ±2SD for the red and white blood cell parameters. Level 1 results were positive for crystals. Level 2 results were negative for crystals.

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
- Value assignment: Specific to each lot and level of control, a total of five vials were analyzed in duplicate. The assigned values of the total cell counts are based on the average number of cells per μL counted in the nine large square grids on both sides of the Neubauer Improved hemocytometer counting chamber. The assigned value of the differential cell counts are based on replicate 100-cell differentials. A cumulative mean, standard deviation and %CV were calculated for all measurands reported using Cell-Chex™ with CPPD Crystals with the hemacytometer

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and Cytospin® platforms. Crystals were identified as "positive" if observed microscopically. The parameter specific assay value assignment ranges are reflective of ±3SD for the WBC differential parameters and ±2 SD for the RBC and WBC parameters.

- Open vial stability: Three separate lots were analyzed to verify performance throughout the proposed 30 day open vial dating. At each testing interval the vials of control were analyzed one time with the hemacytometer and Cytospin®. On non-testing days, all vials of control were removed from 2-10°C storage, equilibrated to room temperature and mixed in accordance with the IFU. The results fell within parameter specific assay value assignment ranges and are reflective of ±3SD for the WBC differential parameters and ±2SD for the red and white blood cell parameters. Level 1 results were positive for crystals. Level 2 results were negative for crystals.

- Closed vial stability: Three separate lots were analyzed to verify performance throughout the 60 day expiration dating. At each testing interval the control materials were removed from 2-10°C storage, equilibrated to room temperature, re-suspended and analyzed using both the hemacytometer and Cytospin™. The results fell within parameter specific assay value assignment ranges and are reflective of ±3SD for the WBC differential parameters and ±2SD for the red and white blood cell parameters. Level 1 results were positive for crystals. Level 2 results were negative for crystals.

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):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected value for this control is lot specific as specified by the value assignment procedure. A value assignment sheet is provided with the Package

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Insert accompanying the product. It is recommended that each laboratory establish its own expected mean.

**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.