MSC LIPID CONTROL

K082067 · Maine Standards Co. · JJY · Aug 22, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082067
• Device Name: MSC LIPID CONTROL
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.

Device Story

MSC Lipid Control is human serum-based liquid control material; contains stabilized Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. Used in clinical laboratories to monitor precision of clinical chemistry analyzer systems. Provided in two levels; six vials total. Human source materials tested negative for HIV-1, HIV-2, HCV, and HBsAg. Healthcare providers use control results to verify instrument performance and ensure accuracy of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed via testing at independent laboratories using multiple clinical systems (Roche Hitachi 911, ModP, 917; Dade Dimension Expand; Beckman Coulter LX). Twenty runs performed in singlet per platform to calculate ranges.

Technological Characteristics

Human serum-based liquid control; contains stabilized Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. Compatible with automated, semi-automated, and manual clinical chemistry analyzers.

Indications for Use

Indicated for use as an assayed quality control material in clinical laboratory settings to monitor the precision of Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol assays on automated, semi-automated, or manual chemistry analyzers.

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

• Bio-Rad Liquichek™ Lipids Control Level 1 (K012513)

Submission Summary (Full Text)

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

A. 510(k) Number:
k082067

B. Purpose for Submission:
New device

C. Measurand:
Control material for Multi-Analytes: Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol

D. Type of Test:
Control Materials

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
MSC Lipid Control

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 21 CFR§ 862.1660 | Clinical Chemistry |

H. Intended Use:

1. Intended use(s):
See Indications for Use below.

2. Indication(s) for use:
The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
Instruments listed in the package insert include the following: Roche Hitachi 911, Roche HitachiModP, Roche Hitachi 917, Dade Dimension Expand, and the Beckman Coulter LX.

I. Device Description:

The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin. The device consists of six vials total, three vials at each of two levels (Level 1: 3 x 7mL and Level 2: 3 x 7mL). All human source materials were tested by FDA approved methods and found to be negative for HIV-1, HIV-2, HCV, and HBsAg.

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J. Substantial Equivalence Information:

1. Predicate device name(s): Bio-Rad Liquichek Lipids Control, Level 1 and 2
2. Predicate 510(k) number(s): k012513
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device: MSC Lipid Control | Predicate: Bio-Rad Liquichek Lipids Control |
| Intended Use | Assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol | Assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert |
| Levels | Two | Two |
| Matrix | Human serum based liquid | Human serum based liquid |
| Differences | | |
| Number of Constituents | Four | Eight |
| Constituents | Cholesterol
Triglycerides
HDL Cholesterol
LDL Cholesterol | Cholesterol
Triglycerides
HDL Cholesterol
LDL Cholesterol
Apolipoprotein A-1
Apolipoprotein B
C-Reactive Protein
Lipoprotein Lp(a) |
| Target Range | Different assigned values | Different assigned values |

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

- ISO 14971:2000, Medical Devices – Application of risk management to medical devices.
- FDA Guidance: Format for Traditional and Abbreviated 510(k)s (2005).
- FDA Guidance: Points to Consider for Review of Calibration and Quality Control Labeling for in vitro Diagnostic Devices (1996).
- CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition.
- CLSI C24-A3: Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions: Approved Guideline – Third Edition.
- CDRH: Guidance for Industry and FDA Staff – Assayed and Unassayed Quality Control Material (2007).

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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, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Values assigned to the assayed controls are traceable to the reference standards used by the assay manufacturer to establish instrument response in their assays.

Stability:
Stability and acceptance criteria were reviewed and the stability claims for the MSC Lipid Control are as follows. Unopened – stable until expiration date at -10° to -20°C, Opened – stable for 30 days at 2° to 8°C. The device is under continuing real-stability testing, but current data is supportive of the aforementioned claims.

Value Assignment:
The two level MSC Lipid Control was tested at independent laboratories using different clinical systems. Twenty runs were performed in singlet at each location. The analytes were tested on the following platforms: Roche Hitachi 911, Roche Hitachi ModP, Roche Hitachi 917 (the Roche Hitachi 917 laboratory does not run LDL Cholesterol), Dade Dimension Expand and the Beckman Coulter LX. Data for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol were collected, statistically analyzed, and the range calculated for each clinical platform (n = 20 per platform).

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

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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.