QUIKREAD CRP CALIBRATOR SET

K042625 · Orion Diagnostica, OY · JJY · Nov 18, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042625
• Device Name: QUIKREAD CRP CALIBRATOR SET
• Applicant: Orion Diagnostica, OY
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.

Device Story

The Orion Diagnostica QuikRead CRP Verification Set consists of three levels of human-serum-based control materials (low, medium, high) used to verify calibration and validate methods for the QuikRead CRP System. The device is used by laboratory personnel in a clinical setting. The user processes the verification material in the same manner as a clinical whole blood specimen according to the QuikRead CRP test procedure. The resulting values are compared against lot-specific expected values provided on the vial labels to ensure system accuracy and performance. This process supports compliance with CLIA regulations regarding method validation and calibration verification.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Quality control material for in vitro diagnostic use. Formulated for verification of calibration and method validation of the QuikRead CRP System. Class I device under 21 CFR 862.1660.

Indications for Use

Indicated for verification of calibration and method validation of the QuikRead CRP System in a clinical laboratory setting.

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

A. 510(k) Number: k042625
B. Purpose for Submission: Notification of intent to manufacture and market the device: QuikRead CRP Verification Set
C. Analyte: CRP
D. Type of Test: N/A
E. Applicant: Orion Diagnostica
F. Proprietary and Established Names: Proprietary - Orion Diagnostica QuikRead CRP Verification Set Established – Quality Control Material

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1660 Quality control material (assayed and unassayed)
2. Classification: Class I
3. Product Code: JJY
4. Panel: 75

H. Intended Use:
1. Intended use(s): The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation for the QuikRead CRP System.
2. Indication(s) for use: The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation for the QuikRead CRP System.
3. Special condition for use statement(s): For prescription use only
4. Special instrument Requirements: N/A

I. Device Description: The Orion Diagnostica QuikRead CRP Verification Set contains three controls with different levels of CRP. The controls are human based materials. Each human donor unit and collected human pleural fluid, has been tested by an FDA approved method and found to be non Reactive

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for HIV-1 & 2 Antibody, Serologic Test for Syphilis and Hepatitis Surface B antigen.

# J. Substantial Equivalence Information:

1. Predicate device name(s): Orion QuikRead CRP Control Set
2. Predicate K number(s): k042442
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Orion Diagnostica QuikRead CRP Verification Set | Orion Diagnostica QuikRead CRP Control Set |
| Intended use | Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use. | QuikRead CRP Control Set is intended for quality control of the QuikRead CRP assay by the QuikRead 101 Instrument. For in vitro diagnostic use. |
| Levels | 3 levels covering the whole measurement range (low, medium and high) to support the implementation of CLIA regulations (method validation and verification of calibration). Levels are appr. 5, 90, and 180 mg/l. The values have been derived from replicate analyses on the QuikRead system and are lot specific. Expected values are printed on the vial labels. | 2 levels for daily quality control. Levels are appr. 50 mg/l and 120 mg/l. The values have been derived from replicate analyses on the QuikRead system and are lot specific. Expected values are printed on the vial labels. |
| Matrix | Human Serum | Human Serum |
| Form | Liquid, ready to use | Liquid, ready to use |
| Way of use | Use in the same way as unknown whole blood specimen would be used, following the instructions for the QuikRead CRP test procedure. | Use in the same way as unknown whole blood specimen would be used, following the instructions for the QuikRead CRP test procedure. |
| Packaging | 1 ml of each level | 1 ml of each level |
| Stability | 24 months at 2-8 °C | 36 months at 2-8 °C |

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K. Standard/Guidance Document Referenced (if applicable): Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material – FOD# 2231; NCCLS EP5-A Vol 19 Nov 2, 1999 Evaluation of a Precision Performance of Clinical Chemistry Devices.

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 (controls, calibrators, or method): The Orion Diagnostica QuikRead CRP Verification Set is derived from Normal Human Serum that has been lipid stripped and Human C-Reactive Protein from human pleural fluid, certified by Scipac. Normal human serum is used as a diluent with the Scipac CRP protein to prepare control stock. CRP control is then prepared by diluting control stock with normal human serum that has been lipid stripped. Quality Control on bulk solutions. Assayed values are then printed on the control bottle label.

Stability testing of the CRP control was performed at three levels (7, 102, and 151 mg/l) for 0 – 25 months stored at 2 – 8 °C. Absorbance values were stable throughout the testing time indicating an unopened shelf life of 24 months.

Stability testing of opened CRP control stored at 2 – 8 °C at three levels (7, 102, and 151 mg/l) for 14 days. Smaller amounts of sample were used as opposed to normal clinical testing. As a result values are lower than expected. The CRP expected concentrations were within the target limit indicating an open vial stability of 14 days.

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
b. Matrix comparison: N/A

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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.