VITAL SERUM CONTROLS

K111063 · Vital Diagnostics (Manufacturing) Ptyltd · JJY · Jun 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111063
• Device Name: VITAL SERUM CONTROLS
• Applicant: Vital Diagnostics (Manufacturing) Ptyltd
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.

Device Story

Vital Diagnostics Serum Controls are lyophilized human serum-based quality control materials; supplemented with human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Used in clinical chemistry laboratories to monitor test system precision and detect systematic analytical deviations caused by reagent or instrument variation. Provided in two levels per analyte; packaged in 5 mL glass amber bottles. Operators (laboratory technicians/clinicians) use the controls within an analytical test system; results are compared against assigned values provided in labeling to verify instrument performance. Benefits include ensuring accuracy and reliability of diagnostic assay results for patient testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time) support a 4-year shelf life at 2-8°C and open-vial stability of 7 days at 2-8°C or 31 days at -20°C. Traceability established via NIST SRMs and recognized reference methods.

Technological Characteristics

Lyophilized human serum matrix; contains human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Two levels provided. Storage at 2-8°C. Traceable to NIST SRMs and established reference methods (e.g., CDC HDL-C reference method). Compatible with ATAC 8000 and ENVOY 500 analyzers (with specific TIBC exclusion for ENVOY 500).

Indications for Use

Indicated for use as an assayed multi-analyte quality control material in clinical laboratory test systems to estimate test precision and detect systematic analytical deviations arising from reagent or instrument variation. May be used for proficiency testing in inter-laboratory surveys.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 2 8 2011

Vital Diagnostics (Manufacturing) Pty. Ltd. c/o Ms. Melita Lambiris Technical and Regulatory Affairs, Manager 189-190 Browns Road Noble Park. Victoria 3174 Australia

Re: k111063 Trade Name: Vital Diagnostics Serum Controls Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material Regulatory Class: Class I reserved Product Codes: JJY Dated: May 26, 2011 Received: June 20, 2011

Dear Ms. Lambiris

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viiro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K111063

Device Name:

Vital Diagnostics Serum Controls

Indications for Use:

Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.

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

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

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

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

Carol C. Bensen

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k///063

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