RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

K121746 · Randox Laboratories, Ltd. · JJX · Jul 11, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121746
• Device Name: RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Randox Microalbumin controls are designed for in vitro diagnostic use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Device Story

Randox Microalbumin Control Level 1 and Level 2 are liquid, human serum-based quality control materials; used in clinical laboratories to monitor the precision of quantitative albumin determination in human urine. Controls are supplied in two levels with target values of 30 mg/L and 150 mg/L. Laboratory professionals use these controls to validate analytical runs on clinical chemistry analyzers (e.g., Hitachi 717, Cobas Mira, RX Daytona, Dimension). By comparing measured values against assigned target ranges, clinicians ensure the accuracy and reliability of patient urine albumin testing. This process supports the clinical decision-making related to renal function monitoring and disease management.

Clinical Evidence

Bench testing only. Value assignment was performed by running 10 replicates on four different analyzer platforms (Hitachi 717, Cobas Mira, RX Daytona, and Dimension). Target values were established based on the average of results across these platforms, with an acceptable manufacturing range of +/- 20%. Performance metrics included CV% ≤ 5% and % recovery error ≤ 5%.

Technological Characteristics

Liquid, human serum-based control material. Analyte: Microalbumin. Supplied in 6x1ml vials. Storage: +2°C to +8°C. Stability: 28 days opened (refrigerated), stable to expiry unopened. No electronic or software components.

Indications for Use

Indicated for use as assayed quality control materials for the quantitative determination of albumin in human urine by professional laboratory personnel in a clinical setting.

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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# 1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.

JUL 1 1 2012

#### 2. SUBMITTER NAME AND ADDRESS

Name: Randox Laboratories Limited

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

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

# 3. DEVICE PROPRIETARY NAME, COMMON NAME, PRODUCT CODE CLASSIFICATION AND 21 CFR NUMBER

Device Proprietary Name: Randox Microalbumin Control Level 1 and Level 2 (Liquid)

Common Names: Microalbumin Control Level 1 and Level 2

Product Code: JJX

Classification: Single (Specified) Analyte Controls (Assayed and Unassayed) Class I. reserved

21 CFR Number: 21 CRF 862.1660

#### 4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER

Predicate Device Proprietary Name: LIQUICHEK™ Microalbumin Control Levels 1 and 2

510 (k) Number: K072835

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### 5. INTENDED USE

The Randox Microalbumin controls are designed for in vitro diagnostic use as assayed quality control materials for the quantitative determination of albumin in human urine.

# 6. DEVICE DESCRIPTION

Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level They are single analyte controls made with human serum. The analyte 2. 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.

#### PREDICATE DEVICE COMPARISON TABLE 7.

| CHARACTERISTICS | RANDOX MICROALBUMIN<br>CONTROL LEVEL 1 AND<br>CONTROL LEVEL 2 | LIQUICHEK™ MICROALBUMIN<br>CONTROL LEVELS 1 AND 2<br>K072835 | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| INTENDED USE | Randox Microalbumin Control Levels 1<br>and 2 are designed for in vitro diagnostic<br>use as assayed quality control materials<br>for the guantitative determination of<br>albumin in human urine. | Liquichek Microalbumin Control is<br>intended for use as assayed quality<br>control urine to monitor the precision of<br>laboratory testing procedures for the<br>analytes Microalbumin and Creatinine. | |
| SIZE | Microalbumin Liquid Controls<br>6x1mls | Level 1 12x10mls<br>Level 2 12x10mls<br>Bilevel Mini Pak 2x10mls | |
| FORMAT | Liquid | Liquid | |
| MATRIX | Prepared from Human Serum | · Prepared from Human Urine | |
| STORAGE<br>(Unopened) | The Microalbumin Liquid Controls are<br>supplied ready for use and are stable up<br>to the expiry date when capped and<br>stored at +2 to +8°C. | The Liquichek Microalbumin controls<br>are supplied ready for use and are<br>stable up to the expiry date when<br>capped and stored at +2 to +8°C. | |
| ANALYTES | Microalbumin | Microalbumin | |
| | | Creatinine | |

3

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#### 8. SUMMARY OF STABILITY STUDIES

OPENED: Store refrigerated (+2°C to +8°C). Microalbumin is stable for 28days if kept capped in the original container and free from contamination. Only the required amount of product should be removed.

UNOPENED: Store refrigerated (2°C to +8°C). Stable to the expiration date printed on the individual vials.

# 9. SUMMARY OF VALUE ASSIGNMENT

10 reps were run on the following analysers, Hitachi 717, Cobas Mira, RX Daytona and Dimension. One lot of previous control material was assessed to validate the run. A target was assigned based on the average of all the results from the various analysers and a range of +/- 20% was applied.

The CV% and % recovery error result should fall within the range shown below.

| PRODUCT<br>NUMBER(S) | TARGET VALUE | ACCEPTABLE<br>MANUFACTURING<br>RANGE | %CV | % RECOVERY ERROR |
|----------------------|--------------|--------------------------------------|-----|------------------|
| MA041 (Level 1) | 30 mg/L | 20 - 40 mg/L | ≤ 5 | ≤ 5 |
| MA042 (Level 2) | 150 mg/L | 130 – 170 mg/L | ≤ 5 | ≤ 5 |

#### 10. TRACEABILITY

| ANALYTE | SUPPLIER | PRODUCT<br>NUMBER | ORIGIN | SOURCE |
|--------------|----------|-------------------|--------|-------------|
| Microalbumin | Sigma | A-8763 | Human | Human Serum |

### 11. 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/3/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUL 1 1 2012

k121746 Re:

K121740
Trade Name: Randox Microalbumin Control Level 1 and Level 2 (Liquid) Regulation Number: 21 CFR §862.1660 Regulation Name: Single (Specified) Analyte Controls (Assayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: June 14, 2012 Received: June 14, 2012

Dear Ms. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your Section 310(4) procession is substantially equivalent (for the referenced above and have determined the device to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collinered prof to thay 20, 1978, and sized in accordance with the provisions of Amendments, of to Gevices that have book formsther do not require approval of a premarket the Federal Food, Drug, and Cosment . Fer (recre, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Act. The gentiral 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 If your device is classified (sec adove) into controls. Existing major regulations affecting (PMA), it may of Subject to Such additional Connects ------------------------------------------------------------------------------------------------------------------------your device can be found in Title 21, Code of Peacharter (1 - 1)
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 Please be advised that FDA S Issualice of a substantes with other requirements
mean that FDA has made a determination that your device Fodorol ageacies mean that FDA Illas made a decemination hatt 700atministered by other Federal agencies.
of the Act or any Federal statutes and regulations and mot limited to: registration of the Act of any rederal stants and roginatents, including, but not limited to: registration
You must comply with all the Act of a created and 800; medical device You must comply with an the Act Siequationship.
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and oc and listing (21 CFR Fall 807), labeling (27 OF R-10 (21 CFR 803); and good
reporting (reporting of medical device-related adverse (QS) requation reporting (reporting of medical device-related daverse oversion (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you deen o openio an Noro 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 CI K Fat 607.97). Por queetions rogas (08 p ) Division of Postmarket Surveillance at (301) 01160 of Bur remains and regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

OFF : art 009), preace aroblem/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 Tou may other baner gefarers, International and Consumer Assistance at its to!!-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

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

510(k) Number (if known):

Device Name: Randox Microalbumin Control Level 1-and Control Level 2

Indication for Use:

The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine.

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

V 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)

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

510(k) 1411746