The Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.

Device Description

Randox Immunoassay Speciality Control (II) 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 5x1ml vials and require reconstitution with 1ml 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

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3), the primary "performance" is its stability and its ability to provide consistent "value assignments" for the analytes it controls. The acceptance criteria relate to the consistency of these assigned values.

Acceptance Criteria	Reported Device Performance/Method
Value Assignment Precision: % Coefficient of Variation (CV) for analyte value assignment	Achieved: % CV ≤ 15% for the mean value generated from 20 replicates (5 replicates per vial, 2 vials, over 2 days of analysis). This criterion ensures the consistency of the assigned values for Calcitonin, Gastrin, and Procalcitonin.
Open Vial Stability (Refrigerated): Procalcitonin stability	Achieved: Stable for 1 day at +2°C to +8°C if kept capped and free from contamination. This demonstrates the product's practical usability for a typical daily laboratory workflow.
Open Vial Stability (Refrigerated): Gastrin and Calcitonin stability	Achieved: Stable for 8 hours at +2°C to +8°C if kept capped and free from contamination. Similar to Procalcitonin, this ensures practical usability for a single work shift.
Open Vial Stability (Frozen): All analytes	Achieved: Stable if frozen once for 28 days at -20°C. This provides extended stability for laboratories that may need to store reconstituted controls for longer periods, reducing waste.
Unopened Vial Stability (Refrigerated): All analytes	Achieved: Stable to the expiration date printed on individual vials when stored at +2°C to +8°C. This is a fundamental requirement for the shelf-life of the product as a quality control material.
Clinical Relevance of Analyte Concentrations	Achieved: "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." This ensures the control material is useful for monitoring clinically important ranges.
Substantial Equivalence to Predicate Device	Achieved: The general conclusion of the 510(k) submission is that "Testing results indicate that the proposed device is substantially equivalent to the predicate devices." This implies that the device performs comparably to an already legally marketed device (Biorad Lyphochek Immunoassay plus Control Levels 1, 2 and 3) in terms of its intended use, format, matrix, storage, and relevant analytes (Gastrin and Calcitonin, in particular, were compared directly). While not a direct numerical criterion, it's a key regulatory acceptance.

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

Test Set Description: The "test set" in this context refers to the samples used for the value assignment study, which establishes the expected concentrations and ranges for the control material.
Sample Size: For each analyte (Calcitonin, Gastrin, Procalcitonin), two vials of the control material were used. From these two vials, a total of 20 replicates were analyzed (5 replicates per vial, over 2 days).
Data Provenance: The study was conducted at Randox Laboratories. The nature of the study (analyzing their own manufactured control material to establish values) implies it is an internal, prospective study aimed at characterizing the product. No specific country of origin for the underlying human serum in the control is stated beyond "human serum with added constituents of human origin." The added analytes (Calcitonin, Gastrin, Procalcitonin) have commercial origins as specified in the "Traceability" section (Sigma and Randox itself).

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

Number of Experts: "A panel of experts" was used. The exact number is not explicitly stated, but the plural "experts" indicates more than one.
Qualifications of Experts: The document states that these experts were involved in ensuring "the concentrations are clinically relevant for use in routine hospital laboratories." This implies they are likely clinical laboratory professionals, physicians, or scientists with expertise in immunoassay testing and clinical interpretation of analyte levels. Specific qualifications (e.g., years of experience, certifications) are not provided in the text.

4. Adjudication Method for the Test Set

For Value Assignment: No explicit adjudication method (like 2+1 or 3+1 consensus) is described for the numerical value assignment. The assigned value is derived statistically as the mean of 20 replicates. The acceptance criterion for this is simply a %CV ≤ 15%.
For Clinical Relevance: A "panel of experts" reviewed the analyte concentrations for clinical relevance. This implies a form of consensus-based "adjudication" for the appropriateness of the chosen concentration ranges, though the specific process (e.g., majority vote, discussion until agreement) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a quality control material, not a diagnostic device that humans interpret. Therefore, concepts like "human readers improving with AI vs. without AI assistance" are not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was implicitly done for the value assignment. The "device" in this context is the control material itself, and its performance (assigned values and stability) was determined using laboratory analyzers and protocols as described. There isn't an "algorithm" in the typical sense for this type of device; rather, it's about the analytical performance and characteristics of the control material when measured by standard laboratory equipment. The criteria (e.g., %CV) are quantitative measures of its performance.

7. Type of Ground Truth Used

For Value Assignment: The "ground truth" for the analyte concentrations (Calcitonin, Gastrin, Procalcitonin) is established by replication and averaging on selected analyzers according to a defined protocol, meeting a specific precision criterion (%CV ≤ 15%). This is an analytical ground truth based on repeated measurements.
For Clinical Relevance: The "ground truth" for the appropriateness of concentration ranges for clinical use is based on expert consensus (review by a panel of experts).

8. Sample Size for the Training Set

This information is not explicitly provided. For a quality control material, there isn't a "training set" in the sense of machine learning. The focus is on characterizing the manufactured product. The "development" or "formulation" of the control material would involve a different set of experiments, but those aren't detailed here as a "training set." The materials used for value assignment (2 vials, 20 replicates) constitute the test set for its performance characteristics.

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

As there isn't a "training set" described for this type of device, this question is not fully applicable. However, for the development of the control material itself (if we interpret "training set" loosely as the development phase leading up to the final product), the ground truth for its formulation and stability would have been established through a series of internal R&D experiments and analytical testing, likely guided by industry standards and regulatory expectations for control materials. The text only describes the validation/characterization of the final product.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string is "K121603". The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the handwritten string.

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: K121603

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

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

Purpose for Submission: New Device

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

Panel: Clinical Chemistry

Product Code: JJY

21 CFR Number: 21 CFR 862.1660

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

Predicate Device Proprietary Name:

Biorad Lyphochek Immunoassay plus Control Levels 1, 2 and 3

510 (k) Numbers: K981532

5. INTENDED USE

The Randox Immunoassay Speciality Control (II), Level 1, Level 2, Level 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin. Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.

6. DEVICE DESCRIPTION

Randox Immunoassay Speciality Control (II) 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 5x1ml vials and require reconstitution with 1ml 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 (II)LEVELS 1, 2 AND 3	BIO-RADLYPHOCHEKRIMMUNOASSAY PLUSCONTROL LEVELS 1, 2 & 3K981532
INTENDED USE	The Randox Immunoassay SpecialityControl (II), Level 1, Level 2, Level 3 areintended for in vitro diagnostic use asassayed quality control material forCalcitonin, Gastrin, and Procalcitonin tomonitor the precision of the laboratorytesting systems listed in the packageinsert. This device is for prescription useonly.	For use as an assayed quality controlserum to monitor the precision oflaboratory testing procedures listed in thepackage insert
SIZE	1ml	5ml
FORMAT	Lyophilised	Lyophilised
MATRIX	Human Serum	Human Serum
STORAGE(Unopened)	2 to 8 °CUntil expiration date	2 to 8 °CUntil expiration date
OPEN VIAL CLAIM	Store refrigerated +2 to 8°CIn reconstituted serum Procalcitonin isstable for 1day, Gastrin and Calcitonin arestable for 8hours at +2 to 8°C if keptcapped in original container and free fromcontamination. The control is stable iffrozen once for 28days at -20°C.	Once the control is reconstituted allanalytes will be stable for 7days whenstored tightly capped at +2 to 8°C with theexceptions of Calcitonin and Gastrin,which should be assayed immediatelyafter reconstitution. After reconstitutingand freezing the control, all analytes arestable for 20days when stored tightlycapped at -10°C to -20°C with theexception of Calcitonin as there is nofrozen stability claim supplied.
SHIPPINGTEMPERATURE	+2 to 8°C	+2 to 8°C
ANALYTES	Procalcitonin, Gastrin and Calcitonin.	There are a total of 92 analytes listed inthe package insert. However onlyGastrin and Calcitonin are applicable tothis comparison.

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8. SUMMARY OF STABILITY STUDIES

Opened: Store refrigerated (+2°C to +8°C). In reconstituted serum, Procalcitonin is stable for 1 dav. Gastrin and Calcitonin are stable for 8 hours at +2℃ to +8℃ if kept capped in original container and free from contamination. The control is stable of frozen once for 28 days at -20°C. Only the required amount of the product should be removed. After use, any residual product should not be returned to the original vial.

Unopened: Store refrigerated (+20C to +80C). Stable to the expiration date printed on individual vials.

9. SUMMARY OF VALUE ASSIGNMENT

The value assignment for Calcitonin and Gastrin is performed at Randox Laboratories. The analysis is carried out on selected analysers. Two vials of sample are analyzed by running five replicates of each vial over the course of 2 days using the normal procedures for calibration on each day.

The mean value generated from the 20 replicates is used as the assigned value and ranges are set as +/- 25% of the assigned value.

The acceptance criteria for data is % coefficient of variation ≤ 15%.

ANALYTE	SUPPLIER	PRODUCTNUMBER	ORIGIN	SOURCE
Calcitonin	Sigma	T-3525	SyntheticAnalyticalGradeChemical	Commercial source, addedvolumetrically
Gastrin	Sigma	G-9020	Human Gastrin	Commercial source, addedvolumetrically
Procalcitonin	Randox	RCP9522	Extracted andpurified fromE.coli	Commercial source, addedvolumetrically

10. TRACEABILITY

11. CONCLUSION

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

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2012

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

Re: K121603

Trade/Device Name: Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved . Product Code: JJY Dated: October 11, 2012 Received: October 15, 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 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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Pauline Armstrong

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

for

Courtney H. Lias, Ph.D. Director

Division of Chemistry and Toxicology 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): K121603

Device Name: Randox Immunoassay Speciality Control (II) Levels 1, 2 and 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 Diagnostics and Radiological Health (OIR)

Yung Chan

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

510(k) K121603

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.