RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

K113720 · Randox Laboratories, Ltd. · JJY · Sep 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113720
• Device Name: RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Maternal Controls are multi-analyte quality control materials provided in three levels (Level 1, 2, 3) to monitor clinical chemistry assay performance. Derived from human serum, the controls contain Unconjugated Estriol and Total β-Human Chorionic Gonadotrophin (Beta hCG). The product is supplied in a lyophilized format requiring reconstitution. Used in routine hospital laboratories, the controls are processed on clinical chemistry analyzers alongside patient samples. Healthcare providers compare the analyzer's measured values for the controls against target ranges provided in lot-specific inserts to verify assay accuracy and precision. This monitoring ensures the reliability of maternal screening test results, aiding in clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically accelerated stress testing to establish shelf-life stability. Stability was confirmed by comparing recovery of controls stored at 37°C against those stored at 2-8°C, with a passing criterion of <10% deviation.

Technological Characteristics

Lyophilized human serum-based multianalyte controls. Provided in three levels to span clinically significant decision ranges. Designed for use on clinical chemistry systems. Stability established via accelerated stress testing at 37°C.

Indications for Use

Indicated for quality control of Unconjugated Estriol and Total ß-Human Chorionic Gonadotrophin assays on clinical chemistry systems. Intended for prescription use in laboratory settings.

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.

Predicate Devices

• Bio-Rad Lyphochek Maternal Serum Controls Levels 1, 2 and 3

Submission Summary (Full Text)

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K113720

SEP 20 2012

# 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 Name: Randox Maternal Controls Levels 1, 2 and 3

Common Name: Maternal Controls Levels 1, 2 and 3

Classification: Multianalyte Controls, All kinds (Assayed and Unassayed)

Product Code: JJY

# Date of Summary Preparation 28th August 2012

## Predicate Devices

Bio-Rad Lyphochek Maternal Serum Controls Levels 1, 2 and 3

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## Device Description

Randox Maternal Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

#### Intended Use

The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems.

#### Similarity to Predicate Device

- Both are assayed quality control serums. .
- . Both are intended to monitor the precision of laboratory testing procedures for the analytes named in the product insert.
- Both are in vitro diagnostic devices. .
- Both devices are in Ivophilised format and manufactured from human . serum.

#### Stability

Accelerated stress tests have been used to predict shelf life for controls stored routinely at +2 - +8°C. A control stored at 37°C for 1 week is tested against the control stored at routine temperature and recovery assessed. If a percentage deviation between stressed and routine is below 10% then a 1 year shelf life would be assigned to the control. For every week stressed at 37°C that passed these criteria then 1 year shelf life would be added.

i.e. Controls stored for 3 weeks at 37°C which passed criteria would be given 3 years of shelf life.

### 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 representation of an eagle or other bird, with three curved lines forming the body and wings.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

Re: k113720

> Trade Name: Randox Maternal Controls Level 1, Level 2 and Level 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 7, 2012 Received: September 10, 2012

Dear Dr. 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 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).

SEP 20 2012

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad view 101 your evaluation and Safety at [phone]. Also, comation the Office of in Viro Dieganding by reference to premarket notification" (21 productions increading postmarket surveillance, "Milliance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of but vinance and 220ling 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 Tou may of amall 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

Courney 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): K113720

Device Name: Randox Maternal Controls Level 1, Level 2 and Level 3

Indication for Use:

The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems.

This in vitro diagnostic device is intended for prescription use only.

> 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)

Rute Charlie

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

510(k) 卡川3720