The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.

Device Description

Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.

AI/ML Overview

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

Acceptance Criteria and Device Performance Study for Randox Aldolase Control Level 2 and Level 3

This device is a quality control material, and its performance is evaluated based on its stability and the accuracy and precision of its assigned values when used with specific clinical chemistry analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Open Vial Stability	Aldolase must be stable for 5 days when stored at +2°C to +8°C after reconstitution, if kept capped and free from contamination.	Reconstituted Aldolase in Aldolase Controls (Level 2 and 3) was stable for 5 days when stored at +2°C to +8°C, kept capped in the original container and free from contamination. This was determined by reconstituting vials and storing them for 5 days at this temperature range. (The text only states it "was determined by" this method, implying successful stability within the specified period.)
Unopened Shelf Life	Aldolase Controls must be stable for 24 months when stored at +2°C to +8°C.	The Aldolase Controls (Level 2 and 3) have an assigned shelf life of 24 months. This was tested using real-time studies where three batches were stored at +2°C to +8°C for at least 24 months, and all three batches "passed real time stability testing."
Value Assignment - Precision (CV%)	For Aldolase concentration ≥ 10%, the CV% should be ≤ 3%. For Aldolase concentration < 10%, the CV% should be ≤ 6%. (This is explicitly stated as the acceptance criteria for precision in the value assignment process.)	RX Daytona: - Level 2: CV% = 4.3 (Target Value 7.67 IU/L, System Specific Value 7.53 IU/L). This level has a target value <10 IU/L, so the ≤6% criteria applies, and 4.3% meets this. - Level 3: CV% = 2.9 (Target Value 18.3 IU/L, System Specific Value 18.1 IU/L). This level has a target value >10 IU/L, so the ≤3% criteria applies, and 2.9% meets this. Beckman Coulter AU640: - Level 2: CV% = 3.1 (Target Value 7.67 IU/L, System Specific Value 7.79 IU/L). This level has a target value <10 IU/L, so the ≤6% applies, and 3.1% meets this. - Level 3: CV% = 1.8 (Target Value 18.3 IU/L, System Specific Value 18.4 IU/L). This level has a target value >10 IU/L, so the ≤3% applies, and 1.8% meets this.
Value Assignment - Range	A range is provided by taking +/- 25% of the assigned system-specific values and the consensus mean. (This describes the method for generating the range, implying that this method itself is part of the acceptance criteria for how values are presented).	The document states, "A range is also provided by taking +/- 25% of the assigned system specific values and the consensus mean," indicating this process is followed. No raw data for specific ranges is provided, but the method is stated to be used.

2. Sample Size and Data Provenance

Open Vial Stability Test Set: The sample size is not explicitly stated in terms of the number of vials used, but it involved "reconstituting vials of Aldolase Controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective study assessing stability over time.
Unopened Shelf Life Test Set: The sample size referred to is "three batches of the Aldolase controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective (real-time) study assessing stability over 24 months.
Value Assignment Test Set: For each level (2 and 3) on each analyzer (RX Daytona and Beckman Coulter AU640), the sample size (N) was 10 replicates. The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. This appears to be a prospective study during the value assignment process.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" and their qualifications for establishing ground truth isn't directly applicable for a quality control material where the "ground truth" is typically a target concentration derived through a stringent, standardized "nest testing" process.

For the value assignment:

The process involves "nest testing," where a new lot is assessed against a "master lot of controls or calibrators." While experts might oversee this, the ground truth is established through a defined analytical comparison process rather than subjective expert consensus. The "master lot" serves as the reference for truth.
No specific number or qualification of experts is mentioned for the generation of the "master lot" or its ground truth.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where subjective interpretation is involved. For this device (an assayed quality control material), the "ground truth" is established through quantitative measurement and comparison to a master lot. Therefore, no multi-reader adjudication method is mentioned or relevant.

The process for value assignment involves:

Assessment of new lots against a master lot.
Ten replicates measured on two or more systems.
Mean and CV calculated.
Recovery of the master lot also measured.

This is a quantitative comparison against a known standard (the master lot/calibrator) rather than an interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices that assist human readers in interpreting clinical data (e.g., medical images). The Randox Aldolase Control is a quality control material used to monitor the performance of analytical instruments; it does not involve human readers making diagnostic interpretations.

6. Standalone (Algorithm Only) Performance

This device is not an algorithm or software-only device. It is a physical assayed quality control material. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable. Its performance is measured by its inherent stability and its ability to yield consistent and accurate measurements (based on its assigned values) when run on clinical chemistry analyzers.

7. Type of Ground Truth Used

The ground truth for the Aldolase Controls' values is established by comparison to a master lot of controls or calibrators. This is a reference standard or traceability approach, where the "truth" is derived from established, well-characterized reference materials. The document explicitly states "Nest testing involves assessment of the new lot of controls against a master lot of controls or calibrators."

8. Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI models, as this device is a chemical reagent control, not an AI or software device. If "training set" is interpreted as the data used to establish the master lot's values, that information is not provided. The data provided pertains to the verification of new lots against an already established "master lot."

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

As noted above, there is no explicit "training set" in the AI/ML sense. For the master lot itself, the general industry practice for establishing the ground truth (assigned values) for such master calibrators or controls involves:

Using highly accurate reference methods.
Traceability to international reference standards (if available).
Rigorous inter-laboratory studies and consensus values.
Multiple measurements by highly skilled personnel using validated methods.

However, the provided 510(k) summary does not detail how the ground truth for the master lot itself was established, focusing instead on how new lots of the Randox Aldolase Control are assigned values relative to that master lot.

Summary

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510(k) Summary

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

JUL 1 8 2013

Name: Dr. Clodagh Finnegan clodagh.finnegan@randox.com

Address: Randox Laboratories Limited 55 Diamond Road, Crumlin County Antrim BT294OY. United Kingdom

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

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

510k Number: K131776

Device Proprietary Name: Adolase Control Level 2 and Adolase Control Level 3

ﺮ ﺩ

Common Name: Aldolase Controls

Purpose for Submission: New Device

Regulatory Classification: Single Specified Analyte Controls, (assayed and unassayed); Class I, reserved

Panel: Clinical Chemistry

Product Code: JJX

21 CFR Number: 21 CFR 862.1660

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

BIO-RAD OCS Assayed Control 510(k) Number: K000875

5. INTENDED USE

6. DEVICE DISCRIPTION

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7. PREDICATE DEVICE COMPARISON TABLE

Comparison of Randox Aldolase Controls Level 2 and 3 with the Predicate Device

Similarities and Differences
CHARACTERISTICS	RANDOX ALDOLASE CONTROLS LEVEL 2 AND 3(New Device)	BIO-RADQCS Assayed Control (K000875)(Predicate Device)
INTENDED USE	The Randox Aldolase Control Level 2 andAldolase Control Level 3 are intended for invitro diagnostic use as assayed quality controlmaterials for the quantitative determinationof aldolase on the clinical chemistry analyzersindicated in the package insert. This device isfor prescription use only.	An assayed quality control serum to monitorthe precision of laboratory testing proceduresfor the numerous analytes listed in thepackage insert
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	5 days when stored at 2 to 8 °C afterreconstitution	Analyze Aldolase as soon as possible afterreconstitution due to rapid decrease in activitywith time
SIZE	1ml	5ml
Shelf life	24 months when stored at 2 to 8°C	48 months when stored at 2 to 8°C

8. SUMMARY OF STABILTY STUDIES

Opened: Store refrigerated (+2℃ to +8℃), Reconstituted Aldolase is stable for 5 days at +2℃ to +8℃

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if kept capped in the original container and free from contamination. Only the required amount of product should be removed. After use, any residual product should not be returned to the original vial.

The reconstituted stability of Aldolase was determined by reconstituting vials of Aldolase Controls and storing them at +20C to +80C for 5 days.

Unopened: Store refrigerated (+2℃ to +8℃). Stable to the expiration date printed on individual vials. The Aldolase Controls have been assigned a shelf life of 24 months. This has been tested using real time studies, three batches of the Aldolase controls have been stored at +2℃ to +8℃ for a period of at least 24 months and all three batches have passed real time stability testing.

9. SUMMARY OF VALUE ASSIGNMENT

An assigned value is calculated for each new batch of Randox Aldolase Controls by nest testing. Nest testing involves assessment of the new lot of controls against a master lot of controls or calibrators. Ten replicates of the test controls are assessed on two or more systems and the mean and CV calculated. The recovery of the master lot is also measured. In the instructions for use there are system specific values quoted and a consensus mean. A range is also provided by taking +/- 25% of the assigned system specific values and the consensus mean. The acceptance criteria states the precision measured by the CV should be less than or equal to 3%, unless the concentration of aldolase in <10% then precision should be less than or equal to 6%.

RX Daytona

Aldolase ControlLevel	Target Value(IU/L)	N	System SpecificValue (IU/L)	CV%
2	7.67	10	7.53	4.3
3	18.3	10	18.1	2.9

Beckman Coulter AU640

Aldolase ControlLevel	Target Value(IU/L)	N	System SpecificValue (IU/L)	CV%
2	7.67	10	7.79	3.1
3	18.3	10	18.4	1.8

10. TRACEABILITY

Analyte	Supplier	ProductNumber	Origin	Source
Aldolase	Sigma	A2714	RabbitMuscle	CommercialSource, added volumetrically

11. 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/3/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 an abstract human figure or a caduceus, rendered in black.

Public Health Service

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

Randox Laboratories C/O Pauline Armstrong 55 Diamond Rd. Crumlin, County Antrim, BT2940 Y United Kingdom (UK)

July 18, 2013

Re: K131776

Trade/Device Name: Aldolase Control Level 2 and Aldolase Control Level 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Single (Specified) Analyte Controls Regulatory Class: I, reserved Product Code: JJX Dated: June 10, 2013 Received: June 17, 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 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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Page 2-Ms. Armstrong

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/Industry/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Yung-W.Chan-S 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): K131776

Device Name: Aldolase Control Level 2 and Aldolase Control Level 3

Indication for Use:

The Randox Aldolase Controls Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of Aldolase on the clinical chemistry analysers indicated in the package insert. This device is for prescription use only.

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

Prescription Use And/Or (21 CFR Part 801 Subpart D)

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)

Ruth A. Chesler -S

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

K131776 510(k)_

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.