In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.
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 cooply of metabolism disorders.

Device Description

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light 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.

AI/ML Overview

This document describes the 510(k) summary for the "N Antisera to Human Ceruloplasmin" device, which is an in vitro diagnostic reagent used for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma. The submission claims substantial equivalence to a legally marketed predicate device (K860894).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific performance metrics like accuracy, precision, or detection limits. Instead, it focuses on demonstrating equivalence to a predicate device.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Method Equivalence	Substantially equivalent to predicate device (K860894)	Demonstrated equivalent performance to the predicate device.
Serum vs. Heparinized Plasma Measurement	Method comparison should show high correlation	0.99 correlation coefficient between serum and heparinized plasma measurements.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document mentions "a method comparison was performed" but does not give the number of samples or subjects used in this comparison.
Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable as this is an in vitro diagnostic reagent claiming equivalence, not a medical imaging or clinical diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable for a chemistry assay where the "ground truth" is typically established by reference methods or comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not performed. This type of study is relevant for devices involving human interpretation of medical images or data. This device is an automated in vitro diagnostic reagent.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, this device operates as a standalone diagnostic reagent on the BN™ Systems. Its performance is evaluated based on its ability to quantitatively determine ceruloplasmin and hemopexin levels, without requiring human interpretation of results beyond reading the quantitative output. The "method comparison" study conducted is essentially a standalone performance evaluation against a comparable method.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is established through comparison to a legally marketed predicate device (K860894), and by demonstrating correlation between different sample types (serum and heparinized plasma). The predicate device itself would have been validated against established reference methods or clinical outcomes.

8. The Sample Size for the Training Set:

Not applicable. This device is an in vitro diagnostic reagent, not an AI/ML algorithm that undergoes a "training" phase with a dataset. Its development likely involved R&D, formulation, and analytical validation.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of this traditional in vitro diagnostic reagent.

Summary

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510(k) Summary for N Antisera to Human Ceruloplasmin

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: ___

K053074

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date:

February 17, 2006

1. Device Name/ Classification: N Antisera to Human Ceruloplasmin Class: Ceruloplasmin Immunological Test System, Class II, 21 CFR 866.5210 Panel: Immunology Product Code: DDB

3. Identification of the Legally Marketed Device:

N Antisera to Human Ceruloplasmin- K860894

4. Device Description:

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5. Device Intended Use:

In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.

ର, Medical device to which equivalence is claimed and comparison information:

The modified N Antisera to Human Ceruloplasmin assay is substantially equivalent to the N Antisera to Human Ceruloplasmin currently marketed (K860894). The modified N Antisera to Human Ceruloplasmin assay, like the current N Antisera to Human Ceruloplasmin assay, is intended for the carrent in Yrintsera to Hulfall means of immunonephelometry on the BN™ Systems.

7. Device Performance Characteristics:

To demonstrate equivalence in measurement between serum and heparinized plasma, a method comparison was performed. This study demonstrates equivalent performance with a correlation coefficient of 0.99

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

MAR 16 2006

Dade Behring, Inc. c/o Ms. Kathleen A Dray-Lyons Glasgow Site P.O. Box 6101 Newark, DE 19714

Re: K053074

Trade/Device Name: N Antisera to Human Ceruloplasmin Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin immunological test system Regulatory Class: Class II Product Code: DDB Dated: October 28, 2005 Received: November 1, 2005

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Becker/

Robert L. Becker, Jr., M.D., Ph.p. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications Statement

Device Name: N Antisera to Human Ceruloplasmin Assay

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 cooply of metabolism disorders.

X Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use_ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Mana Chan

The of In Vitro Diagnostic Device Safen and Safety

K053074

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Regulation Number and Section

§ 866.5210 Ceruloplasmin immunological test system.

(a)
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.(b)
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.