MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 · Microgenics Corp. · LAS · Oct 17, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032842
• Device Name: MICROGENICS CYCLOSPORINE CONTROL KIT
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Device Story

Microgenics Cyclosporine Controls are lyophilized human whole blood-based quality control materials; used to monitor precision of cyclosporine laboratory testing procedures. Device consists of five levels with target concentrations ranging from 70 to 1600 ng/mL. Intended for use by laboratory personnel to verify assay performance. Value assignment performed via replicate analysis using CEDIA Cyclosporine Plus Assay on Hitachi 900 series analyzers. Users are advised to establish laboratory-specific means and ranges.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of physical properties and intended use to legally marketed predicate devices.

Technological Characteristics

Matrix: Processed human whole blood. Form: Lyophilized. Analytes: Cyclosporine. Stability: 14 days at 2°C to 8°C when reconstituted. Storage: 2°C to 8°C until expiration. Five levels provided.

Indications for Use

Indicated for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine in clinical settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616)
• 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:
K032842

B. Analyte:
Cyclosporine Control Material

C. Type of Test:
Control Material

D. Applicant:
Microgenics Corporation

E. Proprietary and Established Names:
Microgenics Cyclosporine Controls

F. Regulatory Information:
1. Regulation section:
21CFR862.3280
2. Classification:
Class I
3. Product Code:
LAS
4. Panel:
91

G. Intended Use:
1. Intended use(s):
2. Indication(s) for use:
The Microgenics Cyclosporine Controls, consisting of levels 1 through 5 are in vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
3. Special condition for use statement(s):
4. Special instrument Requirements:

H. Device Description:
The Microgenics Cyclosporine whole blood controls are prepared from human whole blood, lyophilized, with stabilizers. Target concentrations for the five control levels are approximately 70, 200, 350, 700 and 1600 ng/ml of cyclosporine.

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# I. Substantial Equivalence Information:

1. Predicate device name(s):
CEDIA Cyclosporine High Range Controls
Bio-Rad Lypochek Whole Blood Control

2. Predicate K number(s):
K030616, K022041

3. Comparison with predicate:
This control material is similar to the predicate in terms of intended use, matrix, and reconstituted stability. Additional cyclosporine levels are included in these controls, compared to the predicate devices.

# J. Standard/Guidance Document Referenced (if applicable):

# K. Test Principle:

N/A. This 510(k) describes control material only.

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Intra-assay reproducibility was evaluated using the CEDIA Cyclosporine Plus Assay. Twenty one replicates were analyzed in three runs on two Hitachi 911 analyzers. Results are shown below:

| | Run1 | Run2 | Run3 |
| --- | --- | --- | --- |
| Control 1: avg | 63.2 | 63.8 | 59.1 |
| SD | 6.0 | 5.4 | 5.6 |
| Control 2: avg | 175.6 | 183.8 | 170.1 |
| SD | 4.8 | 7.8 | 7.8 |
| Control 3: avg | 314.8 | 321.8 | 326.5 |
| SD | 10.5 | 7.1 | 7.9 |
| Control 4: avg | 643.7 | 668.4 | 641.9 |
| SD | 31.4 | 24.7 | 25.9 |
| Control 5: avg | 1435.2 | 1419.9 | 1480.1 |
| SD | 33.6 | 43.6 | 48.6 |

b. Linearity/assay reportable range:
N/A

c. Traceability (controls, calibrators, or method):
Stability of the reconstituted controls was established by reconstituting each control level with the diluent supplied to users, storing at 2-8 degrees C and testing between days 0 and 14. Acceptance criteria for recovery are $\pm 10\%$.
Stability of lyophilized material is based on evaluation of the previously cleared Microgenics controls, which are identical in formulation and on ongoing real-time stability studies.

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Value assignment is based on replicate analyses of control solutions using the Microgenics CEDIA Cyclosporine Plus Assay on Hitachi 900 series analyzers. The manufacturer recommends that each laboratory establish its own means and acceptable ranges and use the ones provided only as guides.

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
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:

5. Expected values/Reference range:

M. Conclusion:
I recommend the Microgenics Cyclosporine controls are substantially equivalent to the predicate device.