LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5

K042324 · Bio-Rad · JJY · Oct 7, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042324
• Device Name: LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing. For Prescription Use only

Device Story

Lyphochek Elevated Immunosuppressant Control is a processed human whole blood lysate quality control material; provided in lyophilized form for stability. Used in clinical laboratories to monitor the precision of cyclosporine testing procedures. The control is reconstituted by laboratory personnel and used to verify assay performance. It does not contain sodium azide; utilizes a broad-spectrum anti-microbial cocktail. Stability claims include 14 days at 2-8°C after reconstitution and 30 days at -10 to -20°C after reconstitution and freezing. The device provides a bi-level (Levels 4 and 5) control for cyclosporine, serving as a quality assurance tool to ensure accurate clinical decision-making based on patient immunosuppressant drug levels.

Clinical Evidence

No clinical data. Evidence consists of bench testing to establish shelf life and open-vial stability. Stability protocols confirmed 14-day open-vial stability at 2-8°C and 30-day stability at -10 to -20°C after reconstitution and freezing.

Technological Characteristics

Processed human whole blood lysate; lyophilized. Contains broad-spectrum anti-microbial cocktail (<0.1% concentration). Bi-level (Levels 4 and 5) control for cyclosporine. Storage: 2°C to 8°C. No software or electronic components.

Indications for Use

Indicated for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Lyphochek Whole Blood Control (k022041)

Submission Summary (Full Text)

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

A. 510(k) Number:
k042324

B. Purpose for Submission:
New Device

C. Analyte:
Quality Control Material (Assayed and unassayed)

D. Type of Test:
Quantitative

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Lyphochek Elevated Immunosuppressant Control

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality control material (assayed and unassayed).
2. Classification:
I (Reserved)
3. Product Code:
JJY
4. Panel:
75

H. Intended Use:
1. Intended use(s):
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
2. Indication(s) for use:
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
3. Special condition for use statement(s):
For Prescription Use only

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4. Special instrument Requirements:
None Reported

I. Device Description:
Lyphochek Elevated Immunosuppressant Control is a bi-level (levels 4 and 5) with 2 mL per level of solution containing cyclosporine. The base matrix for these solutions is processed human whole blood lysate. The human donor unit used to produce this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAG), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Lyphochek Whole Blood Control
2. Predicate K number(s):
k022041
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing | Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Matrix | Human Whole Blood | Human Whole Blood |
| Stability | 14 days at 2 to 8 °C after reconstituting | 14 days at 2 to 8 °C after reconstituting |
| Shelf-Life | 3 years and 3 months expiration | 3 years and 3 months expiration |
| | | |
| Differences | | |
| Item | Device | Predicate |
| Levels | Bi-level control 4 and 5 | Tri-level control 1,2 and 3 |
| Components | Cyclosporine Only | Cyclosporine, Led, Red Cell Folate, Tacrolimus and Sirolimus |

K. Standard/Guidance Document Referenced (if applicable):
None Referenced

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L. Test Principle:
Not Applicable

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):
Cyclosporine raw material was purchased at a predetermined concentration and the concentration is verified and the control is gravimetrically prepared.

Stability
Real-time stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek Elevated Immunosuppressant Control. Product claims the control material is stable when reconstituted for 14 days at 2-8 °C and has a shelf life of 3 years and 3 months when stored at 2-8 °C.

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): Not Applicable

4. Clinical cut-off: Not Applicable

5. Expected values/Reference range: The concentrations in the Lyphochek Elevated Immunosuppressant Control has lot specific values. The concentrations for level 4 that has a target concentration of 700 ng/mL fall within the range of 586-880 ng/mL. The concentration for level 5 that has a target concentration of 1500 ng/mL fall with the range of 1112- 1668 ng/mL.

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