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 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.

AI/ML Overview

The provided text describes the Randox Maternal Controls Levels 1, 2 and 3 device and its substantial equivalence to a predicate device, focusing on its intended use as quality control material.

However, the provided text does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical study would for a diagnostic device. Instead, it describes the product's characteristics and the basis for its 510(k) clearance, which is primarily demonstrating substantial equivalence to an already legally marketed predicate device.

The "acceptance criteria" for a control material typically relate to its stability and performance characteristics, but the document doesn't explicitly list numerical target values for these. The closest information related to this is the stability testing methodology.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability: Percentage deviation between stressed and routine control samples should be below 10% for a given shelf-life prediction.	"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." (This describes the methodology for determining stability-based shelf life, rather than reporting specific performance values for the Randox Maternal Controls).
Clinical Relevance of Analyte Concentrations: Analyte concentrations across the three levels are chosen to span a range including chemically significant or medical decision levels.	"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."

Acceptance Criteria

Reported Device Performance

Stability: Percentage deviation between stressed and routine control samples should be below 10% for a given shelf-life prediction.

"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." (This describes the methodology for determining stability-based shelf life, rather than reporting specific performance values for the Randox Maternal Controls).

Clinical Relevance of Analyte Concentrations: Analyte concentrations across the three levels are chosen to span a range including chemically significant or medical decision levels.

"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."

Study Proving Device Meets Acceptance Criteria:

The provided document describes a stability study to determine the shelf-life of the controls. This is the primary "study" detailed in the submission.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Stability Test: Not explicitly stated in terms of number of individual control units tested. It refers to "a control stored at 37°C" and "the control stored at routine temperature," implying at least one sample was subjected to each condition.
Data Provenance: Not specified, but the manufacturer is Randox Laboratories Limited, based in the United Kingdom. Given the context of a 510(k) submission, the data would have been generated as part of the device's development and testing by the manufacturer. It is a prospective study for the purpose of demonstrating stability characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated, but referred to as "a panel of experts."
Qualifications of Experts: The document states they reviewed analyte concentrations "to ensure that the concentrations are clinically relevant." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided; however, based on the context of clinical chemistry controls, these would likely be clinical chemists, laboratory directors, or medical professionals with expertise in maternal serum screening.

4. Adjudication Method for the Test Set

For the stability testing, the "adjudication method" is the comparison of percentage deviation against a 10% threshold. There's no human adjudication process described for the quantitative results of the stability test itself beyond this pre-defined criterion.
For the clinical relevance of analyte concentrations, a "panel of experts" reviewed the concentrations, implying a consensus-based or expert opinion adjudication process, though the specific method (e.g., informal agreement, structured voting) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. This device is a quality control material for laboratory tests, not an imaging or interpretive diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the conventional sense. This device is a "control material," not an algorithm or an AI system. Its performance is evaluated biochemically/chemically, not through an algorithm's standalone interpretative capabilities. The "performance" relates to its stability and the accuracy of its assigned values for the analytes.

7. The Type of Ground Truth Used

For Analyte Concentrations: Expert consensus/review regarding clinical relevance.
For Stability: The "ground truth" for stability testing is the pre-defined target threshold of <10% deviation from a routinely stored control. The values of the analytes within the controls serve as the reference for precision and accuracy measurements, where the assigned values for the analytes themselves (provided in the product insert, though not detailed here) are the 'ground truth' or target values.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this type of device.

Summary

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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: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: marketing@randox.com

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

Intended Use

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-5680 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:

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

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.