CSF AUTOMATED CONTROL, MODELS CSF001, CSF003

K072846 · R&D Systems, Inc. · JPK · Nov 26, 2007 · Hematology

Device Facts

• Record ID: K072846
• Device Name: CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

CSF Automated Control is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

Device Story

CSF Automated Control is an in vitro diagnostic reagent used to monitor the performance of hematology instruments analyzing cerebrospinal fluid (CSF). The device consists of human erythrocytes and bovine leukocytes suspended in a preservative-containing, CSF-like fluid. It serves as an assayed whole blood control, providing target values for WBC and RBC counts, as well as differential cell percentages (neutrophils, lymphocytes, monocytes, eosinophils, mononuclear, and polymorphonuclear cells). Healthcare providers use the control to verify the precision and accuracy of hematology analyzers in clinical laboratory settings. By comparing instrument results against the control's target values, clinicians ensure the reliability of patient CSF analysis, which is critical for diagnosing neurological conditions.

Clinical Evidence

No clinical data. Bench testing established stability for 105 days (closed vial) and 14 days (open vial) at 2-8° C, validated across three lots of two levels.

Technological Characteristics

In vitro diagnostic reagent; human erythrocytes and bovine leukocytes in CSF-like fluid with preservatives. Storage: 2° C to 8° C. Open vial stability: 14 days. Closed vial stability: 105 days.

Indications for Use

Indicated for use as an assayed control to monitor values obtained using hematology instruments that measure cerebrospinal fluid (CSF) samples. For in vitro diagnostic 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

• Bayer Diagnostics ADVIA TESTpoint™ CSF Controls (K022968)

Submission Summary (Full Text)

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

A. 510(k) Number:
K072846

B. Purpose for Submission:
Traditional submission for a new device.

C. Measurand:
WBCs and RBCs in cerebrospinal fluid (CSF) using hematology analyzers.

D. Type of Test:
Differential cell count of human spinal fluid

E. Applicant:
R & D Systems, Inc.

F. Proprietary and Established Names:
CSF Automated Control

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625
2. Classification:
Class II
3. Product code:
JPK
4. Panel:
Hematology (81)

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H. Intended Use:

1. Intended use(s):

CSF Automated Control is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

2. Indication(s) for use:

N/A

3. Special conditions for use statement(s):

N/A

4. Special instrument requirements:

N/A

I. Device Description:

CSF Automated Control is an in vitro diagnostic reagent composed of human erythrocytes and bovine leukocytes suspended in a cerebrospinal like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained using hematology instruments that measure CSF (cerebro spinal fluid) samples.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bayer Diagnostics ADVIA TESTpoint™ CSF Controls

2. Predicate K number(s):

K022968

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Whole Blood | Same |
| Storage (unopened) | 2° C to 8° C until expiration date | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Stabilizers | Contains stabilizers | Same |
| Analytes | Level 1-WBC and RBC
Level 2-WBC, RBC, %
Neut, % % Lymph, %
Mono, % Eos, %
Mononuclear cell count, %
Polymorphonuclear cell count | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended to monitor values obtained using hematology instruments that measure CSF samples. Refer to assay table for specific instrument models. | Intended to monitor the precision and accuracy of ADVIA 120 Hematology Systems when analyzing CSF samples. |
| Base Matrix | Composed of human erythrocytes and bovine leukocytes suspended in a cerebrospinal like fluid with preservatives. | Composed of red blood cells and white blood cells derived from human sources stored in a stabilizing medium. |
| Open Vial Claim | 14 days | 10 days |

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

N/A

L. Test Principle:

N/A

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
N/A
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical Sensitivity:
N/A

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b. Clinical specificity:

N/A

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

Expiration dating is established at 105 days (closed vial) and 14 days (open vial) when stored at 2-8° C and handled according to instructions for use. Three lots of two levels were tested for open and closed vial testing.

4. Clinical cut-off:

N/A

5. Expected values/Reference range:

The target mean values for manufacturing are initially specified at 3-7 cells/μL for the WBCs 5-15 cells/μL for the RBCs for level 1, and 180-220 cells/μL for the WBCs, 10-20 % Mononuclears, 70-90% Polymorphonuclears, ~5% Monocytes, and 180-220 cells/μL for the RBCs for level 2. Each different analyzer will have its own protocol to establish ranges.

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.