CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

K083554 · Cliniqa Corporation · JJY · Apr 21, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083554
• Device Name: CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the performance of clinical methods for immunoassay analytes listed in the product insert.

Device Story

CLINIQA® Liquid QC™ ImmunoAssay Controls are serum-based, multi-analyte quality control products provided at three levels. Used in clinical laboratories to monitor analytical system performance within the clinical range. Controls contain human source material tested for HBsAg, HIV-1 antigen, HCV antibody, and HIV-1/2 antibody. Product is supplied in 5 mL vials. Healthcare providers use the controls to verify assay performance; results are compared against lot-specific expected ranges provided in the package insert to ensure analytical accuracy and reliability.

Clinical Evidence

No clinical data. Bench testing only. Stability protocols reviewed and found adequate. Accelerated stability data supports unopened vial storage of 3.0 years at -20°C and open vial stability of 30 days at 2-8°C (with exceptions for free PSA [7 days], insulin [15 days], and folate [15 days]).

Technological Characteristics

Serum-based liquid control material containing human source constituents. Provided in three levels. Stability established via accelerated testing. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as an assayed, liquid quality control product to evaluate the performance of clinical laboratory assays for specific analytes listed in the product insert. For prescription use only.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k083554

B. Purpose for Submission:
New Device

C. Measurand:
Quality control materials for multiple constituents listed in the package insert

D. Type of Test:
N/A

E. Applicant:
CLINIQA Corporation

F. Proprietary and Established Names:
CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3

G. Regulatory Information:

1. Regulation section:
21 CFR § 862.1660 Quality control material (assayed and unassayed).

2. Classification:
Class I (Reserved)

3. Product code:
JJY, Multi-Analyte controls (assayed and unassayed)

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the performance of clinical methods for immunoassay analytes listed in the product insert.

2. Indication(s) for use:
See Intended Use section above

3. Special conditions for use statement(s):
For prescription use
For In Vitro Diagnostic Use

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4. Special instrument requirements:
Specific instruments and methodologies are listed in the package insert

I. Device Description:
CLINIQA® Liquid QCTM ImmunoAssay Controls, Levels 1, 2, & 3 are provided at three levels to assist in the monitoring of analytical systems within the clinical range. The three levels of control materials which contain human source material and added constituents are provided in two vials (5 mL each).

Each human donor unit used to manufacture this product was tested for Hepatitis B Surface Antigen (HBsAg), HIV-1 antigen, antibody to Hepatitis C Virus (HCV), and antibody to HIV-1/2 and found non-reactive using FDA approved test methods.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Liquimmune® ImmunoAssay Controls Levels 1-3
2. Predicate 510(k) number(s):
k011731
3. Comparison with predicate:
The subject and predicate devices are serum-based products manufactured using the same processes. The difference between the products is the constituents and their target concentrations, which have been optimized for each test system.

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

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):
No traceability was provided.

The protocols for establishing stability were reviewed and found to be adequate. Open-vial stability testing was performed. The accelerated stability data generated substantiate the proposed stability claims for CLINIQA® Liquid QCTM ImmunoAssay Controls, Levels 1, 2, & 3. Data supports the

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sponsors proposed stability claims of unopened vial storage stability at -20°C of 3.0 years and open vial stability at 2-8°C of 30 days, with the following exceptions: free PSA of 7 days, insulin of 15 days and folate of 15 days.

Assignment of values is performed using the reagents, calibrators, and controls available at the time of assay by the manufacturer. The raw data obtained for each method are averaged to obtain the mean. The standard deviations (SD) and coefficient of variations (CV) are calculated for each set of data and an expected range is calculated for each analyte in the control material. Some analytes in this control product are endogenous. The mean and expected range for each analyte are presented in the lot-specific insert. The manufacturer recommends that each laboratory establish their own control ranges.

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
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 table in the package insert lists the expected values for each analyte.

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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.

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