N ANTISERA TO HUMAN CERULOPLASMIN

K053074 · Dade Behring, Inc. · DDB · Mar 16, 2006 · Immunology

Device Facts

• Record ID: K053074
• Device Name: N ANTISERA TO HUMAN CERULOPLASMIN
• Applicant: Dade Behring, Inc.
• Product Code: DDB · Immunology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5210
• Device Class: Class 2

Indications for Use

In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of ceruloplasmin aids in the diagnosis of copper metabolism disorders.

Device Story

In vitro diagnostic reagents; N antiserum to human ceruloplasmin or hemopexin. Used on BNII, BN 100, and BN Prospec analyzers. Principle: immunonephelometry; proteins in sample react with specific antibodies to form complexes; complexes scatter light beam; scattered light intensity proportional to protein concentration. Output: quantitative protein concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing copper metabolism disorders.

Clinical Evidence

Bench testing only. Method comparison study performed to demonstrate equivalence between serum and heparinized plasma samples. Reported correlation coefficient of 0.99.

Technological Characteristics

Quantitative immunonephelometry assay. Reagents consist of rabbit anti-human ceruloplasmin or hemopexin polyclonal antibodies. Instrumentation: BNII, BN 100, and BN Prospec analyzers. Analyte detection based on light scattering intensity proportional to protein concentration.

Indications for Use

Indicated for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma to aid in the diagnosis of copper metabolism disorders. For prescription use only.

Regulatory Classification

Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

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 § 866.9.

Predicate Devices

• N Antisera to Human Ceruloplasmin (K860894)

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k053074

B. Purpose for Submission:
Device modification. Addition of heparinized plasma as sample matrix for both human ceruloplasmin and hemopexin (note: hemopexin is Class II exempt)

C. Measurand:
Human ceruloplasmin and human hemopexin

D. Type of Test:
Quantitative immunonephelometry

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
N Antisera to Human Ceruloplasmin, Ceruloplasmin immunological test system
N Antisera to Human Hemopexin, Hemopexin immunological test system

G. Regulatory Information:
1. Regulation section:
21 CFR 866.5210, Ceruloplasmin immunological test system
21 CFR 866.5490, Hemopexin immunological test system
2. Classification:
Class II (Ceruloplasmin)
Class II (Hemopexin)
3. Product code:
DDB, Ceruloplasmin, antigen, antiserum, control
CZX, Hemopexin, antigen, antiserum, control
4. Panel:
Immunology 82

H. Intended Use:
1. Intended use(s):
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma by means of immunonephelometry on the BN™ systems.
2. Indication(s) for use:
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma by means of immunonephelometry on the BN™ systems. Measurement of ceruloplasmin aids in the diagnosis of copper metabolism disorders.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
For use on the Dade Behring BNII, BN 100, and BN Prospec analyzers, previously cleared under k860894.

{1}

2

I. Device Description:
The device consists of one vial containing 2 ml of N antiserum to human ceruloplasmin or hemopexin.

J. Substantial Equivalence Information:
1. Predicate device name(s):
N Antisera to Human Ceruloplasmin
2. Predicate 510(k) number(s):
K860894
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometry on the BNTM Systems. | In Vitro diagnostic reagents for the quantitative determination of ceruloplasmin in serum and heparinized plasma by means of immunonephelometry on the BNTM Systems. |
| Antibody | Rabbit anti-Human ceruloplasmin (polyclonal) | Same |
| Instrumentation | BNTM Systems | Same |
| Assay Format | Quantitative nephelometry | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample | Serum and heparinized plasma | Serum |

K. Standard/Guidance Document Referenced (if applicable):
None

L. Test Principle:
Proteins contained in human body fluids form immunochemical reaction with specific antibodies. These complexes scatter a beam o flight passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
No change.
b. Linearity/assay reportable range:
No change.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
No change.
d. Detection limit:

{2}

No change.

e. Analytical specificity:

Interference by endogenous substances:

Ceruloplasmin: Normal serum samples (0.175-0.43 g/L) were spiked with increasing concentrations of bilirubin, hemoglobin, and triglycerides. The percent recovery was determined for each sample relative to a reference sample (± 20%). No interference was seen up to: 0.6 g/L bilirubin, 10 g/L hemoglobin, and 2.4 g/L triglycerides. Normal serum samples (0.258-0.466 g/L) were compared to sera spiked with 5% of lithium, sodium, or ammonium heparin to determine potential interference by heparin anticoagulants for plasma samples. No interference was seen. Percent deviation (± 7%) between the mean recoveries of the heparin types was (-)0.305 to (+)0.386%.

Hemopexin: No data was provided for interference from bilirubin, hemoglobin, or triglycerides. Normal serum samples (0.82-1.22 g/L) were compared to sera spiked with 5% of lithium, sodium, or ammonium heparin to determine potential interference by heparin anticoagulants for plasma samples. No interference was seen. Percent deviation (± 7%) between the mean recoveries of the heparin types was (-)2.301 to (-)0.907%.

f. Assay cut-off:

No change.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable.

b. Matrix comparison:

Matrix comparison: Fresh and frozen serum and heparinized plasma samples covering the reportable range (1:20 dilutions, Ceruloplasmin: 0.07-2.2 g/L; Hemopexin: 0.2-6.4 g/L) were compared to determine if any significant bias between matrices. The heparin samples were a mixture of heparin types, however since the percent deviation between the heparin types (see Interference studies above) was low, this was deemed acceptable.

| | N (pooled) | Regression equation | R² | 95% Confidence intervals (slope) |
| --- | --- | --- | --- | --- |
| Ceruloplasmin Heparin | 111 | y = 1.0057x - 0.0043 | 0.9971 | 0.9910, 1.0208 |
| Hemopexin Heparin | 84 | y = 0.9949x - 0.0140 | 0.9944 | 0.9759, 1.0183 |

3. Clinical studies:

a. Clinical Sensitivity:

No change.

b. Clinical specificity:

No change.

4. Clinical cut-off:

No change.

5. Expected values/Reference range:

{3}

No change.

**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.

4