IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS

K123763 · Immunodiagnostic Systems , Ltd. · CIB · Dec 24, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123763
• Device Name: IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: CIB · Clinical Chemistry
• Decision Date: Dec 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1085
• Device Class: Class 2

Intended Use

The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension. The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.

Device Story

The IDS-iSYS Direct Renin assay is an in vitro diagnostic test performed on the IDS-iSYS Multi-Discipline Automated System. It measures Direct Renin levels in human EDTA plasma samples. The system automates the assay process, providing quantitative results that clinicians use to assist in the diagnosis and management of hypertension. The device includes associated control sets and calibration verifiers to ensure analytical performance and accuracy. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical diagnostic studies performed. Analytical performance established via bench testing: precision (total CV 6.2-9.0%), linearity (r²=1.00, range 2.0-256 pg/mL), LoD (1.63 pg/mL), and LoQ (2.0 pg/mL). Method comparison with predicate (n=139) showed high correlation (r=0.992). Interference testing confirmed no significant impact from common substances (e.g., triglycerides, hemoglobin, bilirubin, biotin, various antihypertensives). Reference ranges established using 245 healthy donors.

Technological Characteristics

Chemiluminescent immunoassay; sandwich principle. Reagents: biotin-labeled and acridinium-labeled mouse anti-renin monoclonal antibodies, streptavidin-coated magnetic particles. Energy source: photomultiplier for light detection. Connectivity: integrated with IDS-iSYS Multi-Discipline Automated System. Calibration: 2-point. Stability: 6 months at 2-8°C (accelerated).

Indications for Use

Indicated for quantitative determination of Direct Renin in human EDTA plasma to aid in diagnosis and treatment of hypertension. For prescription use only.

Regulatory Classification

Identification

An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

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

December 24, 2013

IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON GLOBAL RA MANAGER 10 DIDCOT WAY BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD UK

Re: K123763 Trade/Device Name: IDS iSYS Direct Renin Assay, IDS iSYS Direct Renin Control Set, and IDS iSYS Direct Renin Calibration Verifiers Regulation Number: 21 CFR 862.1085 Regulation Name: Angiotensin I and renin test system Regulatory Class: II Product Code: CIB Dated: November 28, 2013 Received: December 2, 2013

Dear Mr. Fenton:

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. Ilsting 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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- 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Carol C. Benson -S

for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

k123763

Device Name

IDS iSYS Direct Renin Assay, IDS-iSYS Direct Renin Control Set, and IDS-iSYS Direct Renin Calibration Verifiers

## Indications for Use (Describe)

The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension.

The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.

Type of Use (Select one or both; as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.