CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

K070741 · Cliniqa Corporation · JJY · May 4, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070741
• Device Name: CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CLINIQA® Liquid QC™ Assayed is intended for use as an assayed quality control material for the constituents listed in this package insert.

Device Story

CLINIQA Liquid QC Assayed General Chemistry Control is a ready-to-use liquid control material prepared from human serum, purified extracts of human and animal origin, chemicals, and drugs. It is used in clinical laboratories to monitor the performance of various clinical chemistry assays. The product is provided in three levels to cover different concentration ranges. Healthcare professionals use the control by running it alongside patient samples on clinical chemistry analyzers. The output is a measured value for specific analytes, which the laboratory compares against the provided target values to verify the accuracy and precision of their testing systems. This process helps ensure the reliability of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Serum-based control material containing human/animal extracts, chemicals, and drugs. Ready-to-use liquid form; no reconstitution required. Includes preservatives and stabilizers. Storage requirements: -20°C unopened; 2-8°C once opened. Standard: CLSI EP6-P (linearity evaluation).

Indications for Use

Indicated for use as an assayed quality control material for general chemistry constituents in clinical laboratory settings.

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:
k070741

B. Purpose for Submission:
New Device

C. Measurand:
Multi constituents listed in the package insert

D. Type of Test:
N/A

E. Applicant:
CLINIQA Corporation

F. Proprietary and Established Names:
CLINIQA Liquid QC Assayed and Unassayed General Chemistry Control 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™ Assayed is intended for use as an assayed quality control material for the constituents listed in this package insert.

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

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

4. Special instrument requirements:
None

I. Device Description:
CLINIQA Liquid QC Assayed General Chemistry Control is prepared from human serum with purified extracts of human and animal origin, chemicals, and drugs.

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Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Liquid QC Assayed General Chemistry Control is a ready-to-use liquid control requiring no reconstitution.

Each serum/plasma donor unit used in the manufacture of this product has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. While these methods are highly accurate, they do not guarantee that all infected units will be detected. Because no known test method can offer complete assurance the hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) or other infectious agents are absent, all products containing human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.

The analyte constituents are as follows:

| Constituent | Constituent |
| --- | --- |
| Acetaminophen | Haptoglobin |
| Acid Phosphatase | β hCG, total |
| Alanine Amonitransferase | IgA |
| Albumin | IgG |
| Alkaline Phosphatase | IgM |
| Alpha-1-Antitrypsin | Iron |
| Amikacin | Iron Binding Capacity, Unsaturated |
| Amylase | Lactate |
| Amylase Pancreatic | Lactate Dehydrogenase |
| Apolipoprotein A1 | Lipase |
| Apolipoprotein B | Lithium |
| Aspartate Aminotransferase | Magnesium |
| Bicarbonate | Osmolality |
| Bilirubin Direct | Phenobarbital |
| Bilirubin Total | Phenytoin |
| C3 | Phosphorous |
| C4 | Potassium |
| Calcium | Prealbumin |
| Carbamazepine | Protein Total |
| Carbon Dioxide | Salicylate |
| Ceruloplasmin | Salicylate |
| Chloride | Sodium |
| Cholesterol, HDL | T3 Uptake |
| Cholesterol, LDL | T3 Free |
| Cholesterol Total | T3 Total |
| Cholinesterase | T4 Free |

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| Constituent | Constituent |
| --- | --- |
| Cortisol | T4 Total |
| Creatine Kinase | Theophylline |
| Creatine Kinase MB | Thyroid Stimulating Hormone |
| Creatinine | Tobramycin |
| Digoxin | Transferrin |
| Ethanol | Triglycerides |
| Constituent | Urea |
| Ferritin | Uric Acid |
| Gamma Glutamyl Transferase | Valproic Acid |
| Gentamicin | Vitamin B12 |
| Glucose | |

J. Substantial Equivalence Information:
1. Predicate device name(s): Liquid Assayed Multiqual Control
2. Predicate 510(k) number(s): k043208
3. Comparison with predicate:
Both devices are serum-based products manufactured using the same processes.
The difference is the constituents and their target concentrations.

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP6-P, Evaluation of the Linearity of Quantitative Analytical Methods

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):
The Arhenius model of accelerated elevated temperature studies were used to support CLINIQA Liquid QC™ Assayed General Chemistry Control Levels 1, 2, & 3 storage stability claims at 2-8°C. Vials of CLINIQA Liquid QC Assayed General Chemistry Control Levels 1, 2, & 3 have been on real time stability for over 10 months and demonstrate recovery consistent with the predicated stability claim. CLINIQA Liquid QC Assayed General Chemistry Control is stable until the expiration date on the vial label when stored unopened at or below -20°C. Once opened, CLINIQA Liquid QC Assayed General Chemistry Control is stable for 15 days when stored tightly capped at

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2-8°C except Acid Phosphatase and Total and Direct Bilirubin are stable for 5 days.

Target values are provided to assist the laboratory until it has established its own mean and standard deviation. The values are usually method dependent. Variations can occur over time and between laboratories. These variations may be attributed to differences in laboratory technique, instrumentation, reagent lot, method modifications, and other systematic errors including random errors.

The expected values printed in the package insert were derived from replicate analyses of representative samples of the product and are specific to this lot of CLINIQA Liquid QC™ General Chemistry Control, Levels 1, 2 & 3. Consensus testing data used to establish the expected values were derived from multiple laboratories. All values have been assigned with the instrument manufacturer's reagents available at the time of assay.

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

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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.

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