The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.

Device Description

The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of lyophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.

The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.

Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.

However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

AI/ML Overview

The provided document describes the Randox Aldolase Calibration Serum. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Open Vial Stability	Percentage deviation of reconstituted to fresh should be ≤5%.	Current open vial studies support a reconstituted claim of 5 days when stored at +2°C to +8°C.
Real Time Testing (Shelf Life)	Calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range.	Current Real Time studies support a 2-year shelf life.
Value Assignment (Precision)	Precision measured by the CV should be less than or equal to 3%.	RX Daytona: CV = 2.2% Beckman Coulter AU640: CV = 1.8%

2. Sample size used for the test set and the data provenance

Open Vial Stability: The document states "Samples were reconstituted and stored...and tested for Aldolase." It does not specify the exact number of samples (vials) used, but it implies a sufficient number for testing the 7-day stability.
Real Time Testing: The document refers to "routinely stored calibrators are compared to the ultra frozen calibrators at various time points." It doesn't specify the exact sample size or number of comparisons.
Value Assignment: For the precision study, N=10 replicates were performed for each instrument (RX Daytona and Beckman Coulter AU640).
Data Provenance: The studies were conducted by Randox Laboratories, Ltd., which is based in the United Kingdom. The studies appear to be prospective as they are verifying and validating the performance characteristics of the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a calibration serum, not a diagnostic imaging or AI-driven interpretative device that requires expert review for ground truth. The "ground truth" here is the assigned value of the calibrator, derived from established reference calibrators or consensus values.

4. Adjudication method for the test set

This section is not applicable for the reasons stated above. Adjudication is not relevant for the performance evaluation of a calibration serum.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers, which is not the nature of this calibration serum.

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

This section is not applicable. The device is a calibration serum used in conjunction with analytical instruments (Randox RX Daytona and Beckman Coulter AU640) for calibrating aldolase assays. It is not an algorithm or AI system. Its performance is demonstrated through its ability to provide stable and precise values according to established measurement principles, not as a standalone interpretive algorithm.

7. The type of ground truth used

The ground truth for the Randox Aldolase Calibration Serum values is based on:

Nested testing against a master lot calibrator: The master lot's value assignment was derived using a Randox calibrator with established consensus values or an International Reference Preparation (IRP) where available and applicable. This implies traceability to primary or secondary reference materials.
For the precision study, the "ground truth" (or target value) for the Aldolase concentration is established through this hierarchical value assignment process.

8. The sample size for the training set

This section is not applicable. This is a calibration serum, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable as there is no training set for this device.

Summary

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

September 18, 2014

RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND ROAD ARDMORE, CRUMLIN, COUNTY ANTRIM, BT29 40Y UNITED KINGDOM

Re: K142181

Trade/Device Name: Randox Aldolase Calibration Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: II Product Code: JIT Dated: August 6, 2014 Received: August 8, 2014

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

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney

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)

K142181 Device Name Randox Aldolase Calibration Serum

Indications for Use (Describe)

The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems.

This device is intended for prescription use only.

Type of Use (Select one or both, as applicable)

V Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY,RANDOX ALDOLASE CALIBRATION SERUM

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

Submitter: Randox Laboratories Limited

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

Contact: Dr. Pauline Armstrong Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com

Date of Summary Preparation: September 11, 2014

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

510k No: K142181

Device Proprietary Name: Randox Aldolase Calibration Serum

Common Name: Aldolase Calibration Serum

Purpose for Submission: New Device

Requlatory Classification: Calibrator,Secondary

Classification: Class II

Panel: Clinical Chemistry (75)

Product Code: JIT (Calibrator, Secondary) 21 CFR Number: 21 CFR 862.1150.

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

Predicate Device : Randox Calibration Serum Levels 2 and 3

510 (k) Numbers: K053153

5. INTENDED USE

6. DEVICE DESCRIPTION

The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of Ivophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.

The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.

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7. PREDICATE DEVICE COMPARISON TABLE

TABLE 1: COMPARISON OF RANDOX ALDOLASE CALIBRATION SERUM WITH THE PREDICATE DEVICE

CHARACTERISTICS	ALDOLASE CALIBRATION SERUM(New Device)	RANDOX CALIBRATIONSERUMLEVELS 2 AND 3K053153(Predicate Device)
INTENDED USE	The Aldolase Calibration Serum isintended for in vitro diagnostic use inthe calibration of Aldolase on theRandox RX Daytona and BeckmanCoulter AU640 systems. This device isfor prescription use only.	For use as a Calibrator in clinicalchemistry assays. RandoxCalibration Sera are based onlyophilised human serum. Theconcentrations and activities aresuitable for calibration of clinicalchemistry assays on a wide rangeof automatic analysers.
FORMAT	Lyophilised	Same
MATRIX	Human Serum	Same
ANALYTES	1 analyte, Aldolase	43 analytes including Aldolase
STORAGE(Unopened)	2 to 8 °CUntil expiration date	Same
OPEN VIAL CLAIM	Reconstituted serum is stable for 5 daysat +2°C to +8°C.	Reconstituted serum is stable for 7 daysat +2°C to +8°C, 1 month frozen once at20°C and 8 hours at +25°C.
SIZE	3 x 1ml	20 x 5ml
SHELF LIFE	24 months	36 months

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8. SUMMARY OF STABILITY STUDIES

Open vial stabiltiy

Open vial stability of the Aldolase Calibration Serum was assessed by reconstituting the material according to the package insert. Samples were reconstituted and stored at +2 to +8°C for 7 days and tested for Aldolase.

The acceptance criteria state the percentage deviation of reconstituted to fresh should be ≤5%.

Current open vial studies support a reconstituted claim of 5 days when stored at +2°C to +8°C.

Real Time Testing

This study was designed to verify and validate the predicted or desirable shelf life of the Aldolase Calibration Serum. Real Time studies are carried out using procedure RRD-1359. Controls are stored at the routinely stored temperature of +2 - +8°C and at ultra-frozen conditions -75 to -90°C. For real time assessment the routinely stored calibrators are compared to the ultra frozen calibrators at various time points.

The acceptance criteria states that the calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range. Current Real Time studies support a 2 year shelf life.

9. SUMMARY OF VALUE ASSIGNMENT

A mean value for new lots of the Aldolase calibrator are established by performing nested testing of the new calibrator lot against a master lot. The value assignment of the master lot calibrator was derived by nest testing on a suitable clinical Chemistry/Immunoassay Analyzer using a Randox calibrator with established consensus values or an International reference preparation (IRP) where available and applicable. The master lot values must fall within the predetermined acceptance criteria.
The value assignment was determined by analyzing ten replicates of the test calibrator on two or more systems and the mean, SD and CV calculated for each lot before release to the user. The acceptance criteria states the precision measured by the CV should be less than or equal to 3%.

AldolaseCalibration Serum	N	Mean (U/L)	System SpecificValue (U/L)	CV %
RX Daytona	10	18.4	18.7	2.2
Beckman CoulterAU640	10	19	18.7	1.8

10. TRACEABILITY

ANALYTE	SUPPLIER	PRODUCTNUMBER	ORIGIN	SOURCE
Aldolase	Sigma	A2714	Rabbit Muscle	Commercial Source,added volumetrically

11. CONCLUSION

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

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.