SENTINEL PLASMAPROTEINS CAL 3X

K081533 · SENTINEL CH. SpA · JIX · Jun 25, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081533
• Device Name: SENTINEL PLASMAPROTEINS CAL 3X
• Applicant: SENTINEL CH. SpA
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.

Device Story

Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator derived from human serum; contains specific plasmaproteins (Ceruloplasmin, Kappa/Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, IgA, IgG, IgM). Used in clinical laboratories to calibrate immunoturbidimetric assays on automated analyzers (e.g., Roche Hitachi 911, Abbott c8000 ARCHITECT). Traceable to CRM 470/ERM-DA 470. Clinicians use the resulting assay values to aid in patient diagnosis and monitoring. The calibrator ensures measurement accuracy by establishing reference points for the analytical system.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time) confirmed 24-month shelf life (unopened) and 6-week stability (opened) at 2-8°C. Traceability established to ERM-DA 470 (CRM-470).

Technological Characteristics

Liquid, ready-to-use human serum-based matrix. Contains Ceruloplasmin, Kappa/Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, IgA, IgG, and IgM. Traceable to ERM-DA 470. Used for immunoturbidimetric assay calibration on automated clinical chemistry analyzers.

Indications for Use

Indicated for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays to establish reference points for human serum and plasma measurements.

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.

Predicate Devices

• Sentinel Plasmaproteins 3x (K051457)
• Roche Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226)

Submission Summary (Full Text)

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

A. 510(k) Number:
k081533

B. Purpose for Submission:
New device

C. Measurand:
Plasmaproteins - Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M

D. Type of Test:
Calibrator, Multi-Analyte

E. Applicant:
SENTINEL CH. SPA

F. Proprietary and Established Names:
Sentinel Plasmaproteins Cal 3x

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIX -Calibrator | Class II | 862.1150 | 75, Chemistry |

H. Intended Use:

1. Intended use(s):
Sentinel Plasmaproteins Cal 3x must only be used for the calibration of plasmaprotein tests with the immunoturbidimetric methods.

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2. Indication(s) for use:

Clinical Chemistry – The Sentinel Plasaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.

3. Special conditions for use statement(s):

For Prescription Use Only

4. Special instrument requirements:

Automated, semi-automated and manual clinical chemistry systems using immunoturbidimetric methods.

I. Device Description:

The Sentinel Plasmaprotein Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum matrix.

Human source material was tested and found negative for HIV 1 and 2, HBV and HCV using FDA approved methods.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Calibrator for Automated Systems (C.f.a.s.) Proteins, Roche Diagnostics Corp. Plasmaproteins Cal 3x, SENTINEL CH. SPA

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

k011226 and k051457 respectively

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3. Comparison with predicate:

| Similarities/Differences | | | |
| --- | --- | --- | --- |
| Item | Roche k011226 | Plasmaprotein Cal 3x k051457 | Device |
| Intended use | Must be used only for the calibration of plasmaprotein tests with immunoturbidimetric methods. | Same | Same |
| Storage | 2-8° C | Same | Same |
| Standardization | ERM-DA 470 (CRM-470) | Same | Same |
| Matrix | Liquid- ready-to-use | Same | Same |
| Constituents | Ceruloplasmin, C-Reative Protein, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M, Transferrin, Haptoglobin, Alpha 1-Antitrypsin, C3c, C4, Prealbumin and Ferritin | Ceruloplasmin, Kappa light chains and Lambda light chains | Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M |

K. Standard/Guidance Document Referenced (if applicable):

Guidance for Industry – Abbreviated 510(k) Submissions for In Vitro Calibrators, dated February 22, 1999

The New Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. Dated March 20, 1998

L. Test Principle:

Not applicable

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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):
Traceability:
The calibrator is traceable to CRM 470 (Certified Reference Material) renamed ERM-DA 470 (European Reference Material).

Stability:
Real time stability studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following:

Un-open calibrator has an expiration date of 24 months when stored at 2-8° C.

Open calibrator has an expiration date of 6 weeks when stored at 2-8° C.

Value Assignment:
The value assigned to each plasmaprotein is specific for each lot and is determined by calculating the mean of the results obtained in multiple determinations for multiple instruments.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

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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

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.