← Product Code [DEB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB) · K053073

# N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (K053073)

_Dade Behring, Inc. · DEB · Mar 28, 2006 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K053073

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DEB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB.md)
- **Decision Date:** Mar 28, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5620
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

In vitro diagnostic reagents for the quantitative determination of α2-macroglobulin in human serum and heparinized plasma by means of immunonephelometry on the BN™ systems. For prescription use only.

## Device Story

In vitro diagnostic reagent kit for quantitative measurement of a2-macroglobulin in human serum and heparinized plasma. Operates via immunonephelometry on BN™ Systems; specific antibodies form immune complexes with target proteins in patient samples. These complexes scatter light; intensity of scattered light is proportional to protein concentration. Results are calculated by comparing sample light scatter against a standard of known concentration. Used in clinical laboratory settings by trained personnel. Output aids clinicians in diagnosing blood clotting or clot lysis disorders.

## Clinical Evidence

Bench testing only. Method comparison study performed to validate the use of heparinized plasma alongside serum. Results demonstrated equivalent performance with a correlation coefficient of 0.98.

## Technological Characteristics

Quantitative immunonephelometry assay. Reagent: Rabbit anti-human α2-macroglobulin (polyclonal). Instrumentation: BN™ Systems (BNII, BN 100, BN Prospec). Sensing principle: Light scattering intensity proportional to antigen-antibody complex concentration. Sample matrices: Serum and heparinized plasma.

## Regulatory Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis 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 a2-Macroglobulin ([K860894](/device/K860894.md))

## Submission Summary (Full Text)

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>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k053073

B. Purpose for Submission:
Device modification. Addition of heparinized plasma as sample matrix for human alpha 2-macroglobulin

C. Measurand:
Human alpha2-macroglobulin

D. Type of Test:
Quantitative immunonephelometry

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
N Antisera to Human $\alpha_{2}$-Macroglobulin test system
Alpha 2-Macroglobulin Immunological test system

G. Regulatory Information:
1. Regulation section:
21 CFR 866.5620, Alpha-2-Macroglobulin Immunological Test System
2. Classification:
Class II
3. Product code:
DEB, Alpha-2-Macroglobulin, Antigen, Antiserum, Control
4. Panel:
Immunology 82

H. Intended Use:
1. Intended use(s):
In vitro diagnostic reagents for the quantitative determination of $\alpha_{2}$-macroglobulin 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 $\alpha_{2}$-macroglobulin in human serum and heparinized plasma by means of immunonephelometry on the BN™ systems. Measurement of $\alpha_{2}$-macroglobulin may aid in the diagnosis of blood clotting or clot lysis 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.

I. Device Description:
The device consists of one vial of $2\mathrm{ml}$ or $5\mathrm{ml}$ of N antiserum to human $\alpha_{2}$-macroglobulin.

J. Substantial Equivalence Information:

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1. Predicate device name(s):
N Antisera to Human $\alpha_{2}$-Macroglobulin.
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 $\alpha_{2}$-macroglobulin in serum and heparinized plasma by means of immunonephelometry on the BN™ Systems. | In Vitro diagnostic reagents for the quantitative determination of $\alpha_{2}$-macroglobulin in serum by means of immunonephelometry on the BN™ Systems.  |
|  Antibody | Rabbit anti-Human $\alpha_{2}$-macroglobulin (polyclonal) | Same  |
|  Instrumentation | BN™ 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 provided.

L. Test Principle:
Proteins contained in human body fluids form immunochemical reaction with specific antibodies. These complexes scatter a beam of 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:
Precision Study
The N Antisera to Human $\alpha_{2}$-Macroglobulin assay was used to measure $\alpha_{2}$-Macroglobulin concentrations ranging from 1.06 to $5.13\mathrm{g/L}$ in N/T Protein Control SL-L/M/H, a low serum pool, and a high serum pool. Four determinations per day over 10 days ($n=40$) were performed using a BN™ System. A summary of the precision data is presented in the Table below.

Precision Data Summary

|   | Mean value (g/L) | Run-to-Run (% CV) | Within Run (% CV) | Total (% CV)  |
| --- | --- | --- | --- | --- |
|  N/T Protein Control SL - L | 1.06 | 1.4 | 1.9 | 2.2  |

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b. Linearity/assay reportable range:
No change.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
No change.

d. Detection limit:
No change.

e. Analytical specificity:
Potentially interfering endogenous substances
Interference testing was performed to determine the effect of icterus, lipemia, and hemolysis, on the N Antisera to Human $\alpha_{2}$-Macroglobulin assay. Normal serum samples preparations (1.70-2.06 g/L) were spiked with increased concentrations of bilirubin, hemoglobin, and triglycerides. For each spiked sample, the % recovery was determined [% Recovery = (Test result/Baseline) x 100]. The acceptance criterion was $\pm 20$ relative deviation from the base pool. No interference was seen up to: $0.6\mathrm{g / L}$ bilirubin, $10\mathrm{g / L}$ hemoglobin, and $5.7\mathrm{g / L}$ triglycerides.

Normal serum samples (1.41-2.21 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 between the mean recoveries of
Lithium/Sodium/Ammonium Heparin was $\pm 7\%$. (Lithium vs. Sodium: -2.81%, Lithium vs. Ammonium: -6.13% and Ammonium vs. Sodium: 4.21%)

f. Assay cut-off:
No change.

2. Comparison studies:

a. Method comparison with predicate device:
Not applicable.

b. Matrix comparison:
Fresh and frozen serum and heparinized plasma samples covering the reportable range (1:20 dilutions, $\alpha_{2}$-Macroglobulin: 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 was low, this was acceptable.

|  N | Regression equation | R² | 95% CI (slope) | 95% CI (intercept)  |
| --- | --- | --- | --- | --- |
|  82 | y = 0.9836x - 0.0066 | 0.9929 | 0.9669, 0.9994 | -0.0281,00153  |

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3. Clinical studies:
a. Clinical Sensitivity: No change.
b. Clinical specificity: No change.

4. Clinical cut-off: No change.

5. Expected values/Reference range: 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/DEB/K053073](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K053073)

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