CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

K060140 · Diagnostic Chemicals , Ltd. · JIT · Apr 24, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060140
• Device Name: CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum. The CRP-ADVANCE Multi-Calibrator Set, Cat. No SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be used with the DCL CRP-ADVANCE Assay.

Device Story

CRP-ADVANCE Multi-Calibrator Set (Model SE-250) consists of 5 levels of human C-reactive protein standards (3.0–362 mg/L). Used as calibrators for DCL CRP-ADVANCE immuno-agglutination assays on clinical chemistry analyzers (e.g., Hitachi 911). Liquid, ready-to-use serum matrix. Donor units tested non-reactive for HBsAg, HCV, and HIV-1/2. Used by laboratory professionals to establish calibration curves for quantitative CRP measurement, ensuring accuracy of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human C-reactive protein standards in serum matrix. 5 levels (3.0-362 mg/L). Packaged in 2 mL vials. Ready-to-use liquid. Traceable to ERM 470. Compatible with Hitachi 911 or equivalent analyzers. Storage at 2-8°C.

Indications for Use

Indicated for in vitro diagnostic use as calibrators for the DCL CRP-ADVANCE Assay to quantify C-reactive protein in human serum.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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

A. 510(k) Number:
k060140

B. Purpose for Submission:
New Submission

C. Measurand:
Calibrator materials for C-Reactive Protein

D. Type of Test:
Not applicable

E. Applicant:
Diagnostic Chemicals LTD.

F. Proprietary and Established Names:
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

G. Regulatory Information:

1. Regulation section:
21CFR Sec.- 862.1150-Calibrator

2. Classification:
Class 2

3. Product code:
JIT - Calibrator, Secondary

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum.

The CRP-ADVANCE Multi-Calibrator Set, Cat. No SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be used with the DCL CRP-ADVANCE Assay.

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3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
The Hitachi 911 or any analyzer with assay compatible specifications

I. Device Description:

The calibrators included are C-reactive protein standards containing known quantities of human C-reactive protein. These calibrators are to be used with the DCL CRP-ADVANCE Assay. There are 5 levels of calibrators ranging from 3.0 mg/L to 362 mg/L. They are packaged ready to use in 2 mL vials.

Each serum donor unit used in the preparation of this product has been tested by an FDA approved method and found non-reactive for the presence of HBsAg, HCV, and antibody to HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Equal Diagnostics', CRP Ultra Wide Range Calibrator Set B manufactured by Denka Seiken Co., Ltd.

2. Predicate 510(k) number(s):
k030546

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Intended to calibrate
Quantitative C-Reactive
Protein Assay | Intended to calibrate
Quantitative C-Reactive
Protein Assay |
| Sample | Serum | Serum |
| Matrix | Liquid ready to use | Liquid ready to use |

K. Standard/Guidance Document Referenced (if applicable):
CLSI - Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline - EP06
CLSI - Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition - EP09

L. Test Principle:
Calibrator for Quantitative immuno-agglutination assay

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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 calibrator is traceable to European Reference Materials (ERM) 470 and the assigned values of 3.0, 6.1, 30.0, 181.0 and 362.0 mg/L have been validated by calibrator comparison studies on the Hitachi 911 yielding results of 2.98, 6.12, 30.18, 184.71 and 358.75 mg/L respectively.
Stability studies include accelerated and ongoing real time studies for unopened shelf life when stored at 2-8°C and real time studies for opened calibrators when stored at 2-8°C at 30 days.
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:

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Not Applicable

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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