MAS IMMUNOSUPPRESSANT CONTROLS

K051074 · Microgenics Corp. · LAS · Jun 6, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051074
• Device Name: MAS IMMUNOSUPPRESSANT CONTROLS
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

Device Story

MAS Immunosuppressant Controls are liquid, processed human whole blood-based quality control materials; used by laboratory professionals to monitor precision of clinical assays for cyclosporine, sirolimus, and tacrolimus. Device consists of three levels with specific analyte concentrations; targets established via gravimetric primary reference standards and confirmed by LC-MS/MS. Controls are stored at -20°C; once thawed, stable for 14 days at 2-8°C. Healthcare providers use these controls to verify assay performance; results ensure reliability of patient immunosuppressant drug monitoring.

Clinical Evidence

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

Technological Characteristics

Processed human whole blood matrix; liquid form; contains cyclosporine, sirolimus, and tacrolimus; three levels; 14-day open-vial stability at 2°C to 8°C; stored at -20°C until expiration.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus. Intended for prescription use in clinical laboratory 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

• Lyphochek® Whole Blood Control (K022041)

Submission Summary (Full Text)

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

A. 510(k) Number:
k051074

B. Purpose for Submission:
Notification of intent to manufacture and market the device: MAS Immunosuppressant Control Kit into interstate commerce.

C. Measurand:
Three assayed levels of cyclosporine, tacrolimus and sirolimus

D. Type of Test:
Quality Control Material

E. Applicant:
Microgenics Corporation

F. Proprietary and Established Names:
Proprietary – MAS Immunosuppressant Control Kit
Established Name – Toxicology Quality Control Material

G. Regulatory Information:
1. Regulation section:
21 CFR 862.3280 Clinical Toxicology Control Material
2. Classification:
Class I, reserved
3. Product code:
LAS

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4. Panel:
91, Toxicology

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The MAS Immunosuppressant Controls, consisting of Levels 1 through 3, are in-vitro diagnostic devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus and tacrolimus.

3. Special conditions for use statement(s):
The MAS Immunosuppressant Controls are for professional use only.

4. Special instrument requirements:

I. Device Description:

The MAS Immunosuppressant Controls are prepared from whole blood with stabilizers added to increase stability. The MAS Immunosuppressant Controls include three separate controls known as Level I, Level II, and Level III with approximately 70, 200, 350 ng/mL of cyclosporine, 5.5, 10, and 15 ng/mL of tacrolimus, and 5.5, 10 and 15 ng/mL of sirolimus.

Human source material from which this product has been derived has been tested at the donor level for the Human Immunodeficient Virus (HIV1, HIV2) antibody, Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) and found to be non-reactive. FDA approved methods have been used to conduct these tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Bio-Rad Lyphochek Whole Blood Control

2. Predicate 510(k) number(s):
k022041

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3. Comparison with predicate:

| Device Characteristics | Subject Device | Predicated Device (K022041) |
| --- | --- | --- |
| Intended Use | The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus. | Lyphochek® Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, lead, red cell folate, tacrolimus, and sirolimus. |
| Matrix | Processed Human Whole Blood | Processed Human Whole Blood |
| Form | Liquid | Lyophilized |
| Analytes | Cyclosporine, Sirolimus, Tacrolimus | Cyclosporine, Lead, Red Cell Folate, Tacrolimus, Sirolimus |
| Levels | Three (3) Levels | Three (3) Levels |
| Open Vial Claim | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C. Exception: Red cell folate is stable for 3 days at 2°C to 8°C |
| Storage | -20°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date noted on vial label. | Until expiration date noted on vial label. |

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

None stated

L. Test Principle:

Not applicable

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Not applicable

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods)
Target values are set to create three distinct levels, which are obtained by spiking each level to different analyte concentrations. Target values take clinical needs, assay range, imprecision profile and CEDIA specifications into account. Control targets are traceable to gravimetrically prepared primary reference standards and are confirmed by LC-MS/MS.

The MAS Immunosuppressant Controls open vial stability was established by thawing each control level and testing the controls on day 0 and day 14 using the CEDIA Cyclosporine Plus, Sirolimus and Tacrolimus assays. The thawed controls were stored at 2 - 8°C between days 0 and 14; Controls tested on day 14 recover within the established range of the respective CEDIA immunoassay as compared to day 0.

Real-time stability of the controls is established by periodically testing samples to determine recovery. The mean of the LC-MS/MS result on test recovery must fall within ± 2 SD of the LC-MS/MS initial value. Real-time stability studies support a claim of 24 months when stored as directed.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

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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:
Not applicable

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.