The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.

Device Description

The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C. Each level is supplied in a 12 by 5ml vials.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) premarket notification for a medical device called "Liquid Assayed Chemistry Control Premium Plus Level 1, 2 and 3". It describes the device, its intended use, compares it to a predicate device, and includes summaries of stability studies (thawed open vial stability and shelf-life study) and value assignment.

Here's what I can extract, focusing on "acceptance criteria" as applied in the context of the control material stability studies:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Summary)
Thawed Open Vial Stability	All acceptance criteria for all analytes	All acceptance criteria were met for all analytes.
Shelf-life Study (Real Time Testing)	All acceptance criteria for all analytes	All acceptance criteria were met for all analytes.

Important Note: The document states that "All acceptance criteria were met for all the analytes" for both stability studies, but it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only mentions that the percentage deviation was calculated for the shelf-life study.

Regarding the other requested information, there is no data in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the stability studies or value assignment process.
It does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a quality control material, not an AI or diagnostic imaging device that requires interpretation by experts for ground truth establishment in a test set.
For value assignment, it mentions "a number of external laboratories" and "in-house testing," but does not specify the number or qualifications of personnel involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective data, which is not the primary focus of testing a quality control material.

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

This information is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the stability studies, the "ground truth" or reference is assumed to be the established values or expected performance of the control material under specific conditions, compared to its performance over time. The document mentions "statistical analysis including the mean, SD and % CV were calculated" and that "an assigned value is calculated from the target mean specific value." This implies a reference standard derived from analytical measurements rather than expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as the device is a quality control material, not an AI model requiring a training set.

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

This information is not applicable.

Summary

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Image /page/0/Picture/1 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 entwined with a serpent, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

December 8, 2014

RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG, QA/REGULATORY AFFAIRS MANAGER 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY UNITED KINGDOM

Re: K140971

Trade/Device Name: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class 1, Reserved Product Code: JJY Dated: October 31, 2014 Received: October 31, 2014

Dear Dr. Pauline 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,

Katherine Serrano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140971

Device Name

Liguid Assayed Chemistry Control Premium Plus Level 1, Level 2 and Level 3

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

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510(K) SUMMARY, LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVELS 1, 2 AND 3

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: December 5, 2014

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

510k No: K140971

Device Proprietary Name: Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 & 3

Common Name: Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 & 3

Purpose for Submission: New Device

Requlatory 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 Laboratories, Liquid Assayed Multiqual Premium

510 (k) Number: K130162

5. INTENDED USE

6. DEVICE DESCRIPTION

Each level is supplied in a 12 by 5ml vials.

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.

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7. PREDICATE DEVICE COMPARISON TABLE

COMPARISON OF LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVELS 1, 2 AND 3 WITH THE PREDICATE DEVICE

CHARACTERISTICS	LIQUID ASSAYED CHEMISTRYCONTROLPREMIUM PLUS LEVELS 1, 2AND 3(New Device)	BIO-RAD LABORATORIESLIQUID ASSAYED MULTIQUALPREMIUM K130162(Predicate Device)
Differences
ANALYTES	Total: 98 AnalytesAlpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Total Acid Phosphatase, Albumin,Alkaline Phosphatase, alpha-HBDH, ALT,Amikacin, Amylase Pancreatic, AmylaseTotal, APO A-1, APO B, AST, Beta-2-microglobulin, Bicarbonate, Bile Acids,Bilirubin Direct, Bilirubin Total, C3, C4,Caffeine, Calcium, Carbamazepine,Ceruloplasmin, Chloride, Cholesterol,Cholinesterase, CK Total, Copper, Cortisol,Creatinine, CRP, DHEA-S, D-3-Hydroxybutyate, Digoxin, Electrophoresis(albumin, alpha-1-globulin, alpha-2-globulin,beta-globulin, gamma-globulin), Ethanol,Ferritin, Folate, Free T3, Free T4, FSH,Gamma-GT, Gentamicin, GLDH, Glucose,Haptoglobin, HDL, Immunoglobulin A,Immunoglobulin E, Immunoglobulin G,Immunoglobulin M, Iron, Lactate, LAP, LDH,LDL, LH, Lipase, Lp(a), Lithium, Magnesium,Myoglobin, Osmolality, Paracetamol,Phenobarbital, Phenytoin, PhosphateInorganic, Potassium, Prealbumin,Progesterone, Prolactin, Protein Total, PSATotal, Salicylate, Sodium, Testosterone,Theophylline, Total beta hCG Total T3, TotalT4, TSH, TIBC, Transferrin, Triglycerides,Troponin T, T uptake, Urea, Uric Acid,Valproic acid, Vancomycin, Vitamin B12, Zinc.	Total: 78 AnalytesAlpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Albumin, AlkalinePhosphatase, alpha-HBDH, ALT,Amikacin, Amylase Pancreatic, AmylaseTotal, ASO, AST, Beta-2-microglobulin,Bicarbonate, Bilirubin Direct, BilirubinTotal, C3, C4, Caffeine, Calcium,Carbamazepine, Ceruloplasmin, Chloride,Cholesterol, Cholinesterase, CK Total,Copper, Cortisol, Creatinine, CRP,Cystatin C, Ethanol, Ferritin, , Free T3,Free T4, Gamma-GT,Gentamicin, Glucose, Haptoglobin, HDL,Immunoglobulin A, Immunoglobulin G,Immunoglobulin M, Iron, Lactate, LDH,LDL, Lipase, Lithium, Lidocaine,Magnesium, Methotrexate, NAPA,Osmolality, Paracetamol, Phenobarbital,Phenytoin, Phosphate Inorganic,Potassium, Prealbumin, Procainamide,Protein Total, Quinidine, Salicylate,Sodium, Theophylline, Tobramycin, TotalT3, Total T4, TSH, TIBC, Transferrin,Triglycerides, T uptake, Urea, Uric Acid,Valproic acid, Vancomycin, Vitamin B12.
OPEN VIAL CLAIM	Store refrigerated at +2 to +8°C. Thawedserum is stable for 7 days with the followingexceptions: Troponin T is stable for 3 days at+2 to +8°C.	Once the control material is thawed andopened, all analytes will be stable for 14days when stored tightly capped at 2 to8°C, with the following exceptions: DirectBilirubin will be stable for 11 days,Triglycerides, HDL, Cholinesterase andPhosphorous will be stable for 7 days.
SIZE	12 x 5ml	6 x 5ml
Similarities
INTENDED USE	The Liquid Assayed Chemistry ControlPremium Plus Levels 1, 2 and 3 are assayedquality control materials intended for in vitrodiagnostic use in the quality control ofdiagnostic assays. This material can be usedto monitor the accuracy or reproducibility ofanalytes listed in the package insert. Thisdevice is for prescription use only.	Liquid assayed Multiqual Premium isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for theanalytes listed in the package insert.
FORMAT	Liquid	Liquid
MATRIX	Human Serum	Human Serum
STORAGE(Unopened)	Until expiration date at -20 to -70°C	Until expiration date at -20 to -70°C

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8. SUMMARY OF STABILITY STUDIES

Thawed Open vial stability

Thawed Open vial stability of the Liquid Assayed Chemistry Control Premium Plus levels 1, 2 & 3 was assessed by removing the product from the routine storage temperature of -18 to -24°C, thawed at +15 to 25°C and stored at +2 to 8°C for 3 and 8 days.

All acceptance criteria were met for all the analytes

The data demonstrates that the Liquid Assayed Chemistry Control Premium Plus Control levels 1, 2 & 3 are stable for 7 days when thawed and stored + 2 to 8°C. Troponin T is stable for 3 days when thawed and stored at +2℃ to +8℃.

Shelf-life Study

Real Time Testing

The Liquid Assayed Chemistry Control Premium Plus 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 alongside control material stored unopened at the routine storage temperature of -18°C to -24°C at various time points and the percentage deviation is calculated.

All acceptance criteria were met for all the analytes

Current Real Time studies support an 18 month shelf life.

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9. SUMMARY OF VALUE ASSIGNMENT

Each batch of Liquid Assayed Chemistry Control Premium Plus is submitted to a number of external laboratories and values are assigned from results obtained by these laboratories and/or by in-house testing. Statistical analysis including the mean, SD and % CV were calculated. With each batch, an assigned value is calculated from the target mean specific value and an analyte specific fixed percentage range is applied. Average values should normally fall within the listed range. However, variations may be caused by instrument, reagent, and laboratory technique. Therefore the range provided should only be considered as a reference and it is recommended that each laboratory establish its own ranges. All the assigned values for all the specific analyzers tested are printed in the package insert.

10. TRACEABILITY

Randox Liquid Assayed Chemistry Controls Premium Plus Levels 1, 2, and 3 were obtained from commercially available sources. Control solutions are derived from gravimetrically prepared stock solutions and analyzed in-house

11. CONCLUSION

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

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.