The Randox Ammonia Ethanol Control Levels 1, 2 & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only.

Device Description

The Randox Ammonia Ethanol Controls are liquid and supplied at levels 1, 2 and level 3. The base matrix used for the manufacture of Randox Ammonia Ethanol Controls Levels 1, 2 & 3 is saturated benzoic acid with added chemicals. Each level of control is supplied in liquid form in 6 x 2ml vials and is ready for use. Only the required amount of product should be removed from the vial. After use, any residual product should not be returned to the original vial.

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

1. Table of Acceptance Criteria and Reported Device Performance

Device Type: Randox Ammonia Ethanol Control Levels 1, 2 & 3 (Multi-analyte Controls, Assayed)

Study Focus: Open Vial Stability and Real-Time Shelf-Life Stability

Criteria Category	Acceptance Criteria	Reported Device Performance (Open Vial Stability - Day 30)	Reported Device Performance (Real-Time Shelf-Life)
Open Vial Stability (Percentage Deviation)	≤ 5%	Ammonia (ADVIA 1650):- Level 1: 0.7%- Level 2: -0.9%- Level 3: -2.0%Ethanol (RX Daytona):- Level 1: 4.7%- Level 2: 1.2%- Level 3: 1.3%	Not explicitly given for individual analytes at specific time points, but states "Current Real Time studies support an 18 month shelf life."
Real Time Shelf-Life (Percentage Deviation to routine temp. controls)	≤ 5%	N/A (Applies to comparison against routine temp. controls, not open vial test)	"Current Real Time studies support an 18 month shelf life."
Value Assignment Precision (CV)	≤ 10% for Control Level 1≤ 7.5% for Control Levels 2 and 3	Not explicitly stated in the results section, only the criteria.	N/A
Value Assignment Recovery Error (Master Lot)	≤ 7.5% for all control levels	Not explicitly stated in the results section, only the criteria.	N/A

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

Sample Size: The text does not explicitly state the number of vials or how many test runs were conducted for the open vial stability study. It mentions testing "a set of Randox Ammonia Ethanol Control levels 1, 2 & 3." For real-time testing, it mentions "the controls were then tested." The exact number of replicates or distinct samples per time point is not provided.
Data Provenance: The study was conducted by Randox Laboratories Limited, located in Crumlin, County Antrim, BT29 4QY, United Kingdom. The data is prospective as it involves testing materials over time under specific conditions to assess stability.

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

This information is not applicable to this device and study. The "device" is a quality control material, not a diagnostic tool that provides a result that requires human interpretation or expert ground truth. The "ground truth" in this context is the measured concentration of Ammonia and Ethanol by the specified analytical instruments (ADVIA 1650 for Ammonia and RX Daytona for Ethanol) and comparison to a fresh control or a defined target value.

4. Adjudication Method for the Test Set

This information is not applicable as the study does not involve subjective human interpretation that would require adjudication. The results are quantitative measurements from analytical instruments.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where reader performance is a key metric. This submission is for a quality control material where the performance is assessed through analytical precision and stability.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done. The device itself is a control material, and its performance (stability, value assignment) is evaluated independently using established laboratory methods and instruments (ADVIA 1650 and RX Daytona). There is no "human-in-the-loop" interaction for the functioning or assessment of the control material itself in these studies.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

Analytical Measurement: The measured concentrations of ammonia and ethanol obtained from established and calibrated clinical chemistry systems (ADVIA 1650 for Ammonia, RX Daytona for Ethanol).
Comparison to Fresh Material: For open vial stability, the "fresh result" serves as the reference point (ground truth) for calculating percentage difference.
Comparison to Routine Temperature Controls: For real-time testing, the "control material stored unopened at the routine storage temperature of +2 to +8°C" serves as the reference.
Master Lot Concept: For value assignment, a "master lot" is used as a reference to assign values to new lots.

Essentially, the ground truth is derived from objective analytical measurements and comparisons to reference materials/conditions rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. The concept of a "training set" is generally associated with machine learning or artificial intelligence models. This submission is for a quality control material, which does not involve such a training process.

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

Not applicable. As the device is a quality control material and not an AI/ML diagnostic model, there is no "training set" or "ground truth for the training set" in the context typically described for such technologies.

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

Name: Dr Pauline Armstrong

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

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

Date of Summary Preparation: March 19, 2014

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

510k No: K140393

Device Proprietary Name: Randox Ammonia Ethanol Control Levels 1. 2 & 3

Common Name: Randox Ammonia Ethanol Control Levels 1, 2 & 3

Purpose for Submission: New Device

Requiatory 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: Liquichek Ethanol/ Ammonia Control

510 (k) Number: K123198

5. INTENDED USE

6. DEVICE DESCRIPTION

Each level of control is supplied in liquid form in 6 x 2ml vials and is ready for use. Only the required amount of product should be removed from the vial. After use, any residual product should not be returned to the original vial.

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7. PREDICATE DEVICE COMPARISON TABLE

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COMPARISON OF RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND 3 WITH THE PREDICATE DEVICE

CHARACTERISTICS	RANDOX ETHANOL CONTROLLEVELS 1, 2 AND 3(New Device)	BIO-RAD LABORATORIESLIQUICHEKETHANOL/AMMONIA CONTROLK123198(Predicate Device)
SIMILARITIES
INTENDED USE	The Randox Ammonia Ethanol ControlLevels 1, 2 & 3 are intended for in vitrodiagnostic use in the quality control ofAmmonia and Alcohol Assays to monitorprecision and to detect systematicanalytical deviations on clinical chemistrysystems. This device is for prescriptionuse only.	Liqichek Ethanol/Ammonia Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures forAmmonia and Alcohol assays.
FORMAT	Liquid	Liquid
STORAGE(Unopened)	2 to 8 °CUntil expiration date	2 to 8 °CUntil expiration date
DIFFERENCES
MATRIX	Saturated Benzoic acid with addedchemicals.	Bovine serum albumin with addedchemicals, stabilisers and preservatives.
OPEN VIAL CLAIM	30 days at +2 to 8°C.	20 days at +2 to 8°C on board SiemensDimension Vista instrument.
SIZE	2ml	2.5ml
SHELF LIFE	18 months	24 months

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8. SUMMARY OF STABILITY STUDIES

Open vial stabiltiy

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Open vial stability of the Randox Ammonia Ethanol Control Levels 1, 2 & 3 was assessed by opening a set of Randox Ammonia Ethanol Control levels 1, 2 & 3 and handling them according to the package insert. Vials were stored at +2 to +8°C for 7, 14, 21 and 30 days and tested on the ADVIA 1650 for Ammonia and RX Daytona for Ethanol.

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

The table below shows the summary of the open vial stability at Day 30.

Results

Open Vial Stability Day 30

Ammonia Analyte onthe ADVIA 1650	Open VialResult (umol/l)	Fresh Result(umol/l)	% Difference
Level 1	55.19	54.79	0.7%
Level 2	151.24	152.60	-0.9%
Level 3	284.35	290.27	-2.0%

Ethanol Analyte onthe RX Daytona	Open VialResult (mg/dl)	Fresh Result(mg/dl)	% Difference
Level 1	51.83	49.50	4.7%
Level 2	165.04	163.16	1.2%
Level 3	292.18	387.22	1.3%

The data demonstrates that the Randox Ammonia Ethanol Control levels 1, 2 & 3 are stable for 30 days at + 2 to 8°C.

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Real Time Testing

The Randox Ammonia Ethanol Control levels 1, 2 & 3 were stored at ultra frozen conditions -75 to -90°C. Following storage at the ultra frozen temperature, the controls were then tested and on the ADVIA 1650 for Ammonia and RX Davtona for Ethanol alongside control material stored unopened at the routine storage temperature of +2 to +8°C at various timepoints and the percentage deviation is calculated.

The acceptance criteria state the percentage deviation to controls stored at the routine temperature should be ≤5%.

Current Real Time studies support a 18 month shelf life.

9. SUMMARY OF VALUE ASSIGNMENT

Value assignment is used to calculate an assigned value for the Randox Ammonia Ethanol Control Levels 1, 2 & 3. The value assignment process for the Randox Ammonia Ethanol controls is based on the master lot concept. The value is assigned by performing nested testing of the new lot of control against the master lot on a clinical chemistry analyser (ADVIA 1650 for Ammonia. RXDaytona for Ethanol). Multiple replicates of the test calibrator and controls are assessed on the clinical chemistry analyser and the mean and CV calculated. The recovery of the master lot is also measured.

The acceptance criteria states the precision measured by the CV should be less than or equal to 10% for Control Level 1 and less than or equal to 7.5% for Control Levels 2 and Level 3. The recovery error of the master lot is also measured and should be ≤ 7.5% for all control levels. An assigned value is calculated and a +/-20% range applied.

Control ranges stated in the package insert are summarized in the tables below.

LEVEL I
ANALYTE	SYSTEM	METHOD	TARGET	RANGE
AMMONIA (μmol/l)	ADVIA 1650	Enzymatic (UV)	55	44 - 66
ETHANOL (g/l)	RX Daytona	Enzymatic (UV)	0.51	0.41 - 0.61
ETHANOL (mg/dl)	RX Daytona	Enzymatic (UV)	51	41 - 61

LEVEL 2
ANALYTE	SYSTEM	METHOD	TARGET	RANGE
AMMONIA (µmol/l)	ADVIA 1650	Enzymatic (UV)	141	113 - 169

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ETHANOL (g/l)	RX Daytona	Enzymatic (UV)	1.47	1.18 - 1.76
ETHANOL (mg/dl)	RX Daytona	Enzymatic (UV)	147	118 - 176

LEVEL 3
ANALYTE	SYSTEM	METHOD	TARGET	RANGE
AMMONIA (µmol/l)	ADVIA 1650	Enzymatic (UV)	297	238 - 356
ETHANOL (g/l)	RX Daytona	Enzymatic (UV)	3.76	3.01 - 4.51
ETHANOL (mg/dl)	RX Daytona	Enzymatic (UV)	376	301 - 451

10. CONCLUSION

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 25, 2014

RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY UK

Re: K140393

Trade/Device Name: Randox Ammonia Ethanol Control Levels 1, 2 and Level 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: 1, Reserved Product Code: JJY Dated: February 11, 2014 Received: February 21, 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 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-Dr. 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/Resources/orYou/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/ReportalProblem/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.

Courtney H. Lias -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) k 140393

Device Name

Randox Ammonia Ethanol Controls Levels 1, 2, & 3

Indications for Use (Describe)

The Randox Ammonia Ethanol Controls Levels 1, 2, & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

L 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)

Yung W. Chan -S

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.