← Product Code [DDB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB) · K053074

# N ANTISERA TO HUMAN CERULOPLASMIN (K053074)

_Dade Behring, Inc. · DDB · Mar 16, 2006 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K053074

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DDB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB.md)
- **Decision Date:** Mar 16, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5210
- **Device Class:** Class 2
- **Review Panel:** Immunology

## 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.

## Regulatory 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](/device/K860894.md))

## Submission Summary (Full Text)

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# 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.

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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:

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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:

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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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K053074](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K053074)

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