CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM

K041898 · Cliniqa Corporation · JJX · Aug 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041898
• Device Name: CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
• Applicant: Cliniqa Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Cliniqa Liquid QCᵗʰ TDM Controls Level 1, 2, & 3 are intended for use as an assayed quality control material. Three assayed levels of Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, and Vancomycin are provided. Cliniqa LiniCALᵗʰ TDM Calibration Verifiers Levels A – E for Olympus AU Systemsᵗʰ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Acetaminophen, Amikacin, Caffeine, Carbamazepine, Digoxin, Disopyramide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, primidone, Procainamide, Quinidine, Theophylline, Tobramycin, Valproic Acid, and Vancomycin at five useful concentrations.

Device Story

Liquid quality control materials and calibration verifiers; serum-based matrix; used in clinical laboratories to monitor accuracy and precision of therapeutic drug monitoring (TDM) assays. Controls provided in three levels; calibration verifiers provided in five concentrations. Used on Olympus AU Systems to evaluate assay performance. Stability determined via Arrhenius model of accelerated elevated temperature studies; open-vial stability validated via real-time on-board testing. Provides objective verification of clinical method performance.

Clinical Evidence

No clinical data. Bench testing only. Stability characteristics determined using Arrhenius model of accelerated elevated temperature studies. Open vial stability determined via real-time on-board study on Olympus AU 400 chemistry analyzer.

Technological Characteristics

Serum-based liquid quality control material. Stability testing via Arrhenius model. Designed for use on Olympus AU Systems. No specific software algorithm or electronic connectivity described.

Indications for Use

Indicated for use as assayed quality control materials and calibration verifiers for monitoring therapeutic drug levels (TDM) on Olympus AU Systems. Intended for prescription use in clinical laboratory settings to evaluate assay performance and accuracy.

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
DEVICE ONLY TEMPLATE

510(k) Number: K041898

Purpose for Submission: Notification of intent to manufacture and market the device: Liquid TDM Controls (Three Levels)

Analyte: TDM – Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, and Vancomycin.

Calibration Verifiers – Acetaminophen, Amikacin, Caffeine, Carbamazepine, Digoxin, Disopyramide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Theophylline, Tobramycin, Valproic Acid, and Vancomycin.

A. Type of Test: n/a
B. Applicant: Cliniqa Corporation
C. Proprietary and Established Names: Proprietary - Cliniqa Liquid QCᵗʰ TDM Controls Level 1, 2, & 3 – Cliniqa LiniCALᵗʰ TDM Calibration Verifiers Levels A – E for Olympus Systemsᵗʰ Established – Quality Control Material

Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

D. Intended Use:
1. Intended use(s): Cliniqa Liquid QCᵗʰ TDM Controls Level 1, 2, & 3 are intended for use as an assayed quality control material. Three assayed levels of Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, and Vancomycin are provided.

Cliniqa LiniCALᵗʰ TDM Calibration Verifiers Levels A – E for Olympus AU Systemsᵗʰ are assayed, liquid, quality control products which may be used to

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evaluate the performance of the Olympus AU Systems™ for Acetaminophen, Amikacin, Caffeine, Carbamazepine, Digoxin, Disopyramide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, primidone, Procainamide, Quinidine, Theophylline, Tobramycin, Valproic Acid, and Vancomycin at five useful concentrations.

2. **Indication(s) for use**: These products can aid clinical laboratory personnel to objectively monitor the accuracy and precision of clinical methods.

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

4. **Special instrument Requirements**: Cliniqa LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are designed for use on the Olympus AU Systems™.

E. **Device Description**: Quality Control Material (Assayed)

**Substantial Equivalence Information**:

1. **Predicate device name(s)**: Cliniqa Liquid QC™ TDM Controls Level 1, 2, & 3 are substantially equivalent to MAS PAR Brand TDM Liquid Assayed Therapeutic Drug Monitoring Controls Levels 1, 2, & 3. Cliniqa LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are substantially equivalent to LiniCAL™ Clinical Chemistry Verifiers Levels A – E for the Beckman Coulter Synchron Systems.

2. **Predicate K number(s)**: MAS PAR Brand TDM Liquid Assayed Therapeutic Drug Monitoring Controls Levels 1, 2, & 3– k032826 & LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ – k031921.

3. **Comparison with predicate**:

| Cliniqa Liquid QC™ TDM Controls Level 1, 2, & 3 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed quality control material | Assayed quality control material |
| Matrix | Serum based liquid | Serum based liquid |
| Constituents | Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, | Acetaminophen, Amikacin, Amitriptyline, Caffeine, Carbamazepine, Chloramphenicol, Cocaine, Cyclosporine, Desipramine, Digoxin, |

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| Cliniqa Liquid QC^{tm} TDM Controls Level 1, 2, & 3 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Target range | Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, and Vancomycin | Disopyramide, Estriol, Ethanol, Ethosuximide, Gentamicin, Imipramine, Lidocaine, Lithium, Methotrexate, N-Acetylprocainamide, Netilmicin, Nortriptyline, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Total T3-Triidothyronine, Total T4, Tricyclic Antidepressants, TSH, Valporic Acid, and Vancomycin.
Assigned values differ |
| | Assigned values differ | |
| Cliniqa LiniCAL^{tm} TDM Calibration Verifiers Levels A – E for Olympus AU Systems^{tm} | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed quality control material | Assayed quality control material |
| Matrix | Serum based liquid | Serum based liquid |
| Constituents | Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, | Albumin, BUN, calcium, creatinine, lactate, magnesium, phosphorus, total protein, triglycerides, glucose, iron, sodium, potassium, chloride. |

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| Cliniqa LiniCAL^{tm} TDM Calibration Verifiers Levels A – E for Olympus AU Systems^{tm} | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Valproic Acid, and Vancomycin | |

F. Standard/Guidance Document Referenced (if applicable): Arrhenius model of accelerated elevated temperature studies.

G. Test Principle: N/A

Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method): “Expected Values” presented in each lot-specific insert of CLINIQA Liquid QC TDM Controls Levels 1, 2 & 3 will be generated on the Roche Integra and the Olympus AU Systems. Expected values presented in each lot-specific insert of LiniCAL TDM Calibration Verifiers Levels A – E will be generated on the Olympus AU Systems. Data points will be obtained from replicate assays obtained by multiple laboratories. 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. Stability characteristics of the CLINIQA Liquid QC TDM Controls Levels 1, 2 & 3 and the of LiniCAL TDM Calibration Verifiers Levels A – E 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.
d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A

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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

H. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.