RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

K121588 · Randox Laboratories, Ltd. · JJX · Jun 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121588
• Device Name: RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Randox Cystatin C Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.

Device Story

Randox Cystatin C Controls (Levels 2 and 3) are human serum-derived, single-analyte quality control materials. Used in clinical laboratory settings by professionals to monitor the precision and accuracy of immunoturbidimetric assays for human Cystatin C. Provided in liquid, ready-to-use form. Healthcare providers use the control results to verify the performance of their diagnostic testing systems, ensuring reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Human serum matrix; preserved with sodium azide; liquid form; ready-to-use; stable at 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as assayed quality control material for monitoring precision and accuracy of quantitative human Cystatin C immunoturbidimetric assays. Intended for professional, prescription use only.

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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JUN 20 2012

1715

# 510(k) Summary

Safety and Effectiveness as Required by 21 CFR 807.92

Manufacturer and Submitter

Name: Randox Laboratories Limited

Address: 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.

Telephone: [phone] Fax: [phone] E-mail: [e-mail]

### Device Name

Trade Names: Randox Cystatin C Level 2 and Randox Cystatin C Level 3.

Common Names: Cystatin C Level 2 and Randox Cystatin C Level 3.

Classification: Single (Specified) Analyte Controls (Assayed and Unassayed)

Product Code: JJX

### Date of Summary Preparation

11™ May 2012

## Predicate Devices

DakoCytomation Cystatin C Control Set, K041627

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## Device Description ·

Randox Cystatin C Controls are manufactured at two levels, Level 2 and Level 3. They are single analyte controls derived from human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

#### Intended Use

Randox Cystatin C Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.

#### Similarities to the Predicate Device

- The Randox Cystatin C Controls are bi-level materials intended for in vitro diagnostic use in quality control.
- They have a human serum matrix and are preserved with sodium azide
- They are provided in liquid form and are ready to use
- They are stable up to the expiry date when capped and stored at +2 to +8℃.

#### Stability

OPENED: The Cystatin C Controls are stable for 30 days when capped in the original container at +2 to +8°C in the absence of contamination.

UNOPENED: The Cystatin C Controls are supplied ready to use and are stable up to the expiry date when capped and stored at +2 to +8°C in the absence of contamination.

#### Conclusion

Testing results indicate that the proposed device is substantially equivalent to the predicate device.

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

10903 New Hampshire Avenue Silver Spring, MD 20993

## JUN 2002012

Randox Laboratories Limited c/o Pauline Armstrong 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom

k121588 Re:

Trade Name: Cystatin C Control Level 2 and Cystatin C Control Level 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: May 31, 2012 Received: May 31, 2012

Dear Ms. Armstrong:

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 approvisions of the Act. The general controls provisions of the Act include controls providents or 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 (1 Mrs), it may of sachest to Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device our of to to to to ther announcements concerning your device in the Eederal 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 modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I ederal startists and squirements, including, but not limited to: registration 1 ou maxe compt) ; labeling (21 CFR Parts 801 and 809); medical device and fisting (21 OF N 1 art 007), device-related adverse events) (21 CFR 803); and good reporting (reporting of measur nents as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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,

signature

Steven H. Lein, Ph.D.

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

Enclosure

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## Indications for Use

5 10(k) Number (if known):

Device Name: Cystatin C Controls Levels 2 and 3

Indication for Use:

The Randox Cystatin C Controls Level 2 and Level 3 are intended for use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.

N for a more and read the comments of the state of the state of the

This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Prescription Use > (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 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)

signature

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

510(k) K|2/.58