Randox Immunoassay Speciality Control (I) is manufactured at three levels, Level 1. Level 2 and Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x2ml vials and require reconstitution with 2ml of distilled water. 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 Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 is a quality control material intended to monitor the precision of laboratory testing procedures for a specific panel of analytes. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list "acceptance criteria" for the performance of the Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 in the way one might expect for a diagnostic test with specific sensitivity/specificity targets. Instead, the "performance" is implicitly demonstrated through substantial equivalence to a predicate device. The primary characteristics compared are functional and compositional.

Characteristic	Acceptance Criterion (Implied by Predicate Equivalence)	Reported Device Performance (Randox Immunoassay Speciality Control (I))
Intended Use	For in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for listed analytes.	The Randox Immunoassay Speciality Control (I) is intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Matrix	Human Serum	Human Serum
Analytes	Comparable set of analytes in the predicate device	1-25 OH Vitamin D, 25 OH Vitamin D, Anti TG, Anti TPO, C-Peptide, Insulin Like Growth Factor (IGF 1), Osteocalcin, Parathyroid Hormone (PTH), Insulin, Procalcitonin
Stability (Unopened)	Comparable to predicate device (-20 to -70°C, until expiration date)	2 to 8 °C, Until expiration date (Note: Different storage temp. but deemed equivalent for QC material functionality)
Stability (Opened)	Comparable to predicate device (e.g., 30 days at 2-8°C for most analytes)	Reconstituted serum stable for 5 days at +2 to 8°C (capped) or 4 weeks frozen at -20°C. Specific analyte stabilities vary (e.g., Anti-TG for 3 days, C-Peptide, IGF-I, Procalcitonin for 1 day, Osteocalcin for 4 hours, PTH for 4 hours at 2-8°C or 2 weeks frozen).
Value Assignment	Reliable and traceable method for assigning values	Values assigned from a consensus of results obtained by reference laboratories using a unique statistical analysis.
Traceability	Source materials for analytes are known and appropriate	Suppliers and origins for each analyte are listed (e.g., synthetic, human plasma, human peptide, recombinant)

Note: The differences in "SIZE," "FORMAT," "STORAGE (Unopened)," and "SHIPPING TEMPERATURE" are noted in the comparison table but are implicitly deemed acceptable as they do not hinder the fundamental function of the device as a quality control material. The key is that it functions as intended to monitor precision.

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

The document does not detail a "test set" in the context of clinical or performance data for a diagnostic test. For a quality control material, the performance is primarily demonstrated through stability studies and value assignment reproducibility.

Stability Studies: The summary provides stability claims (e.g., "5 days at +2°C to +8°C" reconstituted) but does not specify the sample size (number of vials, number of runs, etc.) or detailed methodology used to determine these stability periods.
Value Assignment: It states that "Each batch of Immunoassay Speciality Control is submitted to a number of reference laboratories." The exact number of laboratories or the number of measurements taken for value assignment per batch are not specified.
Data Provenance: The device is manufactured by Randox Laboratories Limited in the United Kingdom. Therefore, the internal studies for stability and value assignment would originate from the UK. The document does not specify if external data (e.g., from different countries) were used for these evaluations. These are inherent development and validation activities for the product, not typically "retrospective or prospective" studies on patient data.

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

For this device:

Ground Truth for Value Assignment: The document states, "Each batch of Immunoassay Speciality Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis." While these laboratories are "reference laboratories," the specific number of individual experts or their qualifications (e.g., years of experience, specific certifications) are not provided.
Clinical Relevance of Concentrations: "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." The number and qualifications of these "panel of experts" are not specified.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for this type of device. There isn't a "test set" of patient cases requiring adjudication. For value assignment, a "consensus of results" from reference laboratories is used, implying an analytical agreement process rather than a clinical adjudication of a diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a quality control material, not a diagnostic imaging or AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical quality control material, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this quality control device is established through:

Analytical Consensus: For the assigned values of the analytes within the control material, "values are assigned from a consensus of results obtained by these (reference) laboratories using a unique statistical analysis." This relies on the analytical accuracy and precision of multiple expert reference laboratories.
Material Composition/Concentration: The "ground truth" of what the control is (e.g., 25 OH Vitamin D from a synthetic source) is given by its manufacturing specifications and traceability data.

No pathology or outcomes data are involved as this device does not diagnose disease; it monitors the performance of other diagnostic tests.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a "training set."

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

Not applicable, as it's not an AI/ML device.

Summary

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K130337

JUN 1 9 2013

Participant

510(k) Summary

Date of Preparation: 22nd January 2013

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

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

2. SUBMITTER NAME AND ADDRESS

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

3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER

510k No: Not known

Device Proprietary Name: Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3

Common Name: Immunoassay Speciality Control (I) Levels 1, 2 and 3

Purpose for Submission: New Device

Regulatory Classification: Multi-analyte Controls, All kinds (Assayed and Unassayed)

Panel: Clinical Chemistry

Product Code: JJY

21 CFR Number: 21 CFR 862.1660

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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS

Predicate Device Proprietary Name:

BIO-RAD Liquichek 110 Speciality Immunoassay Control Levels LTA Levels 1, 2 and 3.

510 (k) Number: K043108

5. INTENDED USE

6. DEVICE DESCRIPTION

Randox Immunoassay Speciality Control (I) is manufactured at three levels, Level 1. Level 2 and Level 3.

Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x2ml vials and require reconstitution with 2ml of distilled water.

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.

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7. PREDICATE DEVICE COMPARISON TABLE

CHARACTERISTICS	RANDOX SPECIALITYIMMUNOASSAY CONTROL (I)LEVELS 1, 2 AND 3	BIO-RADLIQUICHEK TMSPECIALTY IMMUNOASSAYCONTROL LTA LEVELS 1, 2 & 3K043108
INTENDED USE	The Randox Immunoassay SpecialityControl (I), levels 1, 2 & 3 are intended forin vitro diagnostic use as assayed qualitycontrol material to monitor the precision oflaboratory testing procedures for theanalytes listed in the package insert.	For use as a quality control serum tomonitor the precision of laboratory testingprocedures listed in the package insert
SIZE	2ml	5ml
FORMAT	Lyophilised	Liquid
MATRIX	Human Serum	Human Serum
STORAGE(Unopened)	2 to 8 °CUntil expiration date	-20 to -70°CUntil expiration date
OPEN VIAL CLAIM	Store refrigerated +2 to 8°CReconstituted serum is stable for 5days at+2 to 8°C if kept capped in originalcontainer or 4weeks frozen once at -20°C.Anti-TG is stable for 3days at +2 to 8°C.C-Peptide, IGF-I and Procalcitonin arestable for 1day at +2 to 8°C. Osteocalcinis stable for 4hours at +2 to 8°C andParathyroid hormone should be testedwithin 4hours of reconstitution whenstored at +2 to 8°C or within 2weeks whenstored below -20°C.	Once the product is thawed and opened,all analytes will be stable for 30days whenstored tightly capped at 2-8°C with theexception of PTH which will be stable for23days.PTH, Anti-TG and Anti TPO will be stablefor 30 days when stored in tightly cappedaliquot vials at -20°C to -70°C.
SHIPPINGTEMPERATURE	+2 to 8°C	-20 to -70°C
ANALYTES	1-25 OH Vitamin D, 25 OH Vitamin D,Anti TG, Anti TPO, C-Peptide, Insulin LikeGrowth Factor (IGF 1), Osteocalcin,Parathyroid Hormone (PTH)Insulin	Anti-Thyroglobulin (Anti-TG)Anti-Thyroperoxidase (Anti-TPO)C-PeptideInsulin Like Growth Factor I (IGF-I)Intact Parathyroid Hormone(Intact-PTH)25-OH Vitamin DOsteocalcin

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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8. SUMMARY OF STABILITY STUDIES

Opened: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 5 days at +2°C to +8°C if kept capped in the original container and free from contamination or 4 weeks frozen once at -20℃. Anti-TG is stable for 3days at +2°C to +8°C. C-Peptide, IGF-I and Procalcitonin are stable for 1day at +2°C to +8°C. Osteocalcin is stable for 4 hours at +2°C to +4°C. Parathyroid hormone (PTH) should be tested within 4hours of reconstitution when stored at +2℃ to +8°C, or within 2 weeks when stored below -20°C. Only the required amount of product should be removed. After use, any residual product should not be returned to the original vial.

Unopened: Store refrigerated (+2℃ to +8℃), Stable to the expiration date printed on individual vials.

9. SUMMARY OF VALUE ASSIGNMENT

Each batch of Immunoassay Speciality | Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis. With each batch a control range is provided for individual parameters and each parameter method. Average values should normally fall within the listed range for analytes specified in the product insert. However, variations may be caused by instrument, reagent, and laboratory technique. Therefore ranged provided here in should only be considered as a reference and it is recommended that each laboratory establish its not ranges.

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10. TRACEABILITY

ANALYTE	SUPPLIER	PRODUCTNUMBER	ORIGIN	SOURCE
1-25 OH Vitamin D	Sigma	D-1530	SyntheticAnalytical Gradechemical	Commercial source, addedvolumetrically
25-OH Vitamin D	Sigma	H-4014	SyntheticAnalytical Gradechemical	Commercial source, addedvolumetrically
Anti TG	Access Biologicals	Receivedunder lotnumber	Human Plasma	Commercial source, addedvolumetrically
Anti TPO	Access Biologicals	Receivedunder lotnumber	Human Plasma	Commercial source, addedvolumetrically
C-Peptide	Sigma	C-4999	Human Peptide	Commercial source, addedvolumetrically
IGF 1	Scipac	P264-0	Expressed inE.coli	Commercial source, addedvolumetrically
Insulin	Sigma	1-0259/1-2643	Humanrecombinant	Commercial source, addedvolumetrically
Osteocalcin	Anaspec/Sigma	22831/0-5761	Human Bone	Commercial source, addedvolumetrically
Procalcitonin	Randox	RCP9522	Extracted andpurified fromE.coli	Commercial source, addedvolumetrically
Parathyroid Hormone(PTH)	Sigma	P-7036	Human Thyroid	Commercial source, addedvolumetrically

11. CONCLUSION

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 a stylized symbol that resembles three overlapping, curved lines, which is the department's official emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2013 ·

RANDOX LABORATORIES LTD. C/O Ms. PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN CO ANTRIM BT29 4QY UNITED KINGDOM

Re: K130337

Trade/Device Name: Immunoassay Speciality Control (I) levels 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: April 12, 2013 Received: May 20, 2013

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 controls provisions of the Act. The general-controls-provisions-of-the-Act-include-requirements-for-annual-registration-listing-ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR. Part 820); and if applicable, the

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Page 2-Ms. Pauline Armstrong

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Maria M. @han -S

Maria M. Chan, Ph. D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological -- Health

Center for Devices and Radiological Health

Enclosure

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Indications for Use

·510(k) Number (if known): K130337

Immunoassay Speciality Control (I) Levels 1, 2 and 3 Device Name:

Indications For Use:

The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)2 Vitamin D), 25 Hydroxy Vitamin D (25 OH Vitamin D), Anti-Thyroglobulin (Anti TG), Anti-Thyroid Peroxidase (Anti TPO), C-Peptide, Insulin Like Growth Factor (IGF 1), Parathyroid Hormone (PTH), Procalcitonin and Insulin.

This device is for prescription use only.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Maria M.Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): K130337

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.