HUMAN ALBUMIN CSF KIT

K121045 · The Binding Site Group , Ltd. · DCF · Jun 19, 2013 · Immunology

Device Facts

• Record ID: K121045
• Device Name: HUMAN ALBUMIN CSF KIT
• Applicant: The Binding Site Group , Ltd.
• Product Code: DCF · Immunology
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

Human Albumin CSF Kit for use on SPA_PLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPA_PLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.

Device Story

Turbidometric assay for human albumin quantification in serum and CSF. Device uses SPA_PLUS analyzer to measure light transmission through a suspension of albumin-antiserum complexes. Input: patient serum or CSF samples; Output: albumin concentration (mg/L or g/L) calculated via instrument-stored calibration curves. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing kidney and intestinal diseases by comparing results against reference ranges.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (total CV <10%). Linearity evaluated per CLSI EP6-A. Interference testing (hemoglobin, bilirubin, acetaminophen, aspirin) showed <10% interference. Method comparison performed on 85 serum samples and 67 CSF samples using Passing-Bablok regression; results showed statistical equivalence to the predicate device. No clinical studies on patient populations were performed.

Technological Characteristics

Turbidometric assay; sheep anti-human albumin antibody; liquid reagents containing sodium azide, EACA, and benzamidine. Measuring range: CSF 170-2700 mg/L; Serum 5.1-81 g/L. Instrument: SPA_PLUS analyzer (k040958). Calibration: 6-level human serum-based calibrators standardized to ERM-DA470k. Stability: 3 months open vial, 30 days on-board.

Indications for Use

Indicated for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) to aid in the diagnosis of kidney and intestinal diseases. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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 § 866.9.

Predicate Devices

• The Binding Site Human Albumin Kit (K042636)

Submission Summary (Full Text)

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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 19, 2013

## THE BINDING SITE GROUP LTD. C/O MS. SUZANNE HORNE REGULATORY AFFAIRS MANAGER 8 CALTHORPE ROAD EDGBASTON, BIRMINGHAM, B15 IQT UNITED KINGDOM

Re: K121045

Trade/Device Name: The Binding Site Human Albumin CSF kit for use on SPAplus Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: II Product Code: DCF Dated: May 13, 2013 Received: May 15, 2013

Dear Ms. Horne:

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. 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 as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Ms. Suzanne Horne

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/Safety/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):_k121045

Device Name: Human Albumin CSF Kit for use on SPAPLUS

Indications For Use:

Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

## Maria M. Chan -S

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

510(k): k121045