HUMAN CAERULOPLASMIN KIT

K122965 · The Binding Site Group , Ltd. · DDB · Jun 3, 2013 · Immunology

Device Facts

• Record ID: K122965
• Device Name: HUMAN CAERULOPLASMIN KIT
• Applicant: The Binding Site Group , Ltd.
• Product Code: DDB · Immunology
• Decision Date: Jun 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5210
• Device Class: Class 2

Intended Use

The Human Ceruloplasmin Kit for use on SPA_PLUS is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPA_PLUS turbidimetric analyzer. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.

Device Story

The Human Ceruloplasmin Kit is an in vitro diagnostic reagent system designed for use on the SPAPLUS turbidimetric analyzer. It measures human ceruloplasmin levels in serum samples. The device utilizes turbidimetric immunoassay technology to quantify ceruloplasmin concentration. It is intended for use in clinical laboratory settings by trained personnel. The output provides quantitative results that assist clinicians in diagnosing copper metabolism disorders when interpreted alongside other clinical and laboratory findings.

Clinical Evidence

Bench testing only. Performance evaluation included analytical sensitivity, precision, linearity, and method comparison studies against the predicate device. No clinical prospective or retrospective studies were required for this 510(k) submission.

Technological Characteristics

Turbidimetric immunoassay. Reagents: sheep anti-human ceruloplasmin antiserum, reaction buffer, lyophilized calibrators/controls. Measuring range: 0.03–0.82 g/L (1/10 dilution) or 0.06–1.64 g/L (1/20 dilution). Instrument: SPA_PLUS analyzer. Calibration traceable to Siemens N Protein Standard. Stability: 12 months closed vial, 2 months open vial, 30 days on-board. Standards: CLSI EP05-A2, EP06-A, EP7-A2, EP17-A, C28-A3.

Indications for Use

Indicated for the quantitative in vitro measurement of human ceruloplasmin in serum to aid in the diagnosis of copper metabolism disorders. For use by clinical laboratory professionals.

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 and Hemopexin (k053074)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2013

THE BINDING SITE GROUP LTD C/O DR. JILL CONSTANTINE, REGULATORY SCIENTIST 8 CALTHORPE ROAD EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM

Re: K122965

Trade/Device Name: Human Ceruloplasmin Kit for use on SPAPLUS Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: II Product Code: DDB Dated: May 16, 2013 Received: May 16, 2013

Dear Dr. Constantine:

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-Gosmetic-Act-(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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2-Dr. Jill Constantine

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.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k122965

Device Name: Human Ceruloplasmin Kit for use on SPAPLUS

Indications For Use: The Human Ceruloplasmin Kit for use on SPAPLus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

MariaM. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): k122965