CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E

K052679 · Cliniqa Corporation · JJX · Nov 18, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052679
• Device Name: CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E
• Applicant: Cliniqa Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the performance of clinical methods for Total and Direct Bilirubin. Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Total and Direct Bilirubin.

Device Story

Cliniqa Liquid QC Bilirubin Controls and LiniCAL Bilirubin Calibration Verifiers are human serum-based products used in clinical laboratories to monitor performance, verify calibration, and assess linearity of automated chemistry analyzers (specifically Olympus AU systems for verifiers). Controls are provided at three levels; calibration verifiers are provided at five levels across the reportable range. Products are prepared from human serum with added preservatives and stabilizers. Healthcare providers use these products to validate the accuracy of patient bilirubin testing. By ensuring analyzer performance, the device helps maintain the reliability of clinical diagnostic results for bilirubin levels.

Clinical Evidence

No clinical data; bench testing only. The device is an in vitro diagnostic quality control material; performance is established through analytical verification of assay values and stability testing.

Technological Characteristics

Liquid, assayed quality control material. Formulated for use with Olympus AU Systems™. Provides multiple concentration levels (3 for controls, 5 for verifiers) for Total and Direct Bilirubin. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as quality control products to evaluate performance of clinical methods for Total and Direct Bilirubin in clinical laboratory settings. 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:
k052679

B. Purpose for Submission:
New Device

C. Measurand:
Bilirubin

D. Type of Test:
N/A

E. Applicant:
Cliniqa Corporation

F. Proprietary and Established Names:
- Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3
- Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660
2. Classification:
Class I
3. Product code:
JJX, single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the performance of clinical methods for Total and Direct Bilirubin.
Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Total and Direct Bilirubin.
2. Indication(s) for use:
See Intended Use section above
3. Special conditions for use statement(s):
Prescription Use Only

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3. Special instrument requirements:

The calibration verifiers are to be used with the Olympus AU systems only. The liquid QC controls may be used with a number of automated chemistry analyzers.

I. Device Description:

Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 are prepared from human serum and purified chemicals. Preservatives and stabilizers are added to maintain product integrity. Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems are human-serum based, containing constituents of human origin and are used in the clinical laboratory to verify calibration and/or assess linearity of the Olympus AU Systems. Five assayed levels of Bilirubin are provided to allow monitoring of the reportable range.

Each serum 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 ntibody to HIV-1/2 and found non-reactive using FDA accepted test methods.

Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 are 0.30, 7.76, and 22.6 mg/dL for total bilirubin respectively and 0.10, 3.20, and 8.07 mg/dL for direct bilirubin respectively.

The Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems have a series of analyte concentrations ranging from 0.30 mg/dL to 32 mg/dL for total bilirubin and 0.10 mg/dL to 10.6 mg/dL for direct bilirubin.

J. Substantial Equivalence Information:

1. Predicate device name(s): MAS Bilirubin Control and LiniCAL Chemistry Calibration Verifiers Levels A - E for Olympus AU Systems
2. Predicate 510(k) number(s): k031890 and k033162
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Bilirubin Control/Calibrator Verifier | Bilirubin Control/Multi-analyte Calibrator Verifier |
| Origin | Human serum | Human serum - Calibrator |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Control: Bilirubin Calibrator Verifier: Bilirubin | Control: Bilirubin Calibrator Verifier: N/A |
| Origin | Human serum | Bovine serum – Control |
| Stability | Both: Open vial at 2-8°C = 30 days | Both: Open vial at 2-8°C = 14 days |

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

L. Test Principle: N/A

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability
The Olympus instrument, reagents and calibrators are standardized to the NIST Standard Reference Material (SRM) 916a.

Stability
Stability characteristics of the Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 and the of Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems were determined using the Arrhenius model of accelerated elevated temperature studies to predict estimated storage stability at 2 – 8 °C. Open vial stability was determined in a real time on board stability study at 2-8 °C on an Olympus AU 400 chemistry analyzer.

Expected Values
Expected values presented in each lot-specific insert of Cliniqa Liquid QC Bilirubin Controls Levels 1, 2, & 3 will be generated on the Olympus AU System.

Expected values presented in each lot-specific insert of Cliniqa LiniCAL Bilirubin Calibration Verifiers Levels A - E for Olympus AU Systems will be generated on the Olympus AU Systems.

Data points will be obtained from replicate assays obtained by multiple laboratories. At least two sets of data and a minimum of 12 data points will be used to determine the mean. Within and between assay Standard Deviations and Coefficient of Variations will be calculated for each set of data.

d. Detection limit: N/A

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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): N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

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.