VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

K042303 · Ortho-Clinical Diagnostics · JJX · Sep 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042303
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

Device Story

VITROS Immunodiagnostic Products Anti-HBs Controls consist of three levels of freeze-dried human serum-based controls (one negative, two positive) containing antimicrobial agents. Used in clinical laboratory settings to monitor performance of VITROS Immunodiagnostic System during quantitative anti-HBs testing. Controls are processed alongside patient samples; healthcare providers compare observed system results against assigned lot-specific mean values and standard deviations to verify assay accuracy and precision. Benefits include ensuring reliability of diagnostic results for Hepatitis B surface antigen antibodies.

Clinical Evidence

No clinical data. Bench testing only; performance established via assignment of mean values and standard deviations derived from a minimum of 10 assays across multiple laboratories using different reagent batches.

Technological Characteristics

Matrix: human serum with added constituents and antimicrobial agents. Three-level control set (negative and two positive). Traceability: WHO 1st International Reference Preparation (1977). Intended for use on VITROS ECi/ECiQ Immunodiagnostic System.

Indications for Use

Indicated for monitoring the performance of the VITROS Immunodiagnostic System during quantitative in vitro determination of total anti-HBs antibodies in human serum. For professional in vitro diagnostic use.

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.

Predicate Devices

• VITROS Immunodiagnostic Products Anti-HBs Controls (k003112)

Submission Summary (Full Text)

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

A. 510(k) Number:
k042303

B. Purpose for Submission:
Assayed quality control material

C. Measurand:
Anti-HBs

D. Type of Test:
NA

E. Applicant:
Ortho-Clinical Diagnostics, Inc.

F. Proprietary and Established Names:
VITROS Immunodiagnostic Products Anti-HBs Controls

G. Regulatory Information:
1. Regulation section:
21 CFR section 862.1660, Quality control material, assayed and unassayed.
2. Classification:
I
3. Product code:
JJX
4. Panel:
Microbiology (83)

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H. Intended Use:

1. Intended use(s):

For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

2. Indication(s) for use:

For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.

3. Special conditions for use statement(s):

Prescription Use

4. Special instrument requirements:

VITROS ECi/ECiQ Immunodiagnostic System

I. Device Description:

The device is quality control material containing a measured amount of anti- HBs as determined by testing against a secondary standard calibrated against the World Health Organization's 1st International Reference Preparation, 1977. The device contains three levels of controls; nominally < 0.75 mIU/mL, 19 mIU/mL, and 289 mIU/mL.

J. Substantial Equivalence Information:

1. Predicate device name(s):

VITROS Immunodiagnostic Products Anti-HBs Controls

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

k003112

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix of controls | Human serum with added constituents of human origin and antimicrobial agents | Human serum with added constituents of human origin and antimicrobial agents |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays. | For use in monitoring the performance of the VITROS Immunodiagnostic System when used for the qualitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Reagent Pack on the VITROS ECi Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays. |
| Control levels | 2 positive and 1 negative | 1 positive and 1 negative |
| Expected values | Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations of each control in a number of different laboratories | Control is only positive or negative, no assigned values. |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | using different reagent lots. Values are lot specific. | |

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

Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft, 1999

L. Test Principle:

NA

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

NA

b. Linearity/assay reportable range:

NA

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

World Health Organization’s 1st International Reference Preparation for anti-hepatitis B surface antigen, 1977.

d. Detection limit:

NA

e. Analytical specificity:

NA

f. Assay cut-off:

NA

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2. Comparison studies:

a. Method comparison with predicate device:

NA

b. Matrix comparison:

NA

3. Clinical studies:

a. Clinical Sensitivity:

NA

b. Clinical specificity:

NA

c. Other clinical supportive data (when a. and b. are not applicable):

NA

4. Clinical cut-off:

NA

5. Expected values/Reference range:

Manufacturer’s product release criteria:

| Control C1 | ≤0.75 mIU/mL |
| --- | --- |
| Control C2 | 19-32 mIU/mL |
| Control C3 | 289-479 mIU/mL |

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.