LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

K140971 · Randox Laboratories Limited · JJY · Dec 8, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140971
• Device Name: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 Story

Randox Liquid Assayed Chemistry Control Premium Plus (Levels 1, 2, 3) consists of human serum-based quality control materials containing biochemicals, chemicals, drugs, preservatives, and stabilizers. Used in clinical laboratories to monitor accuracy and reproducibility of diagnostic assays across various instrument systems (e.g., Beckman Coulter AU, Hitachi Modular, Siemens Advia, Roche Cobas, Randox RX). Supplied as frozen liquid in 12 x 5ml vials; requires thawing before use. Healthcare providers use the control material to verify instrument performance; results are compared against assigned values provided in the package insert. Benefits include ensuring diagnostic assay reliability and consistency in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time) confirmed shelf life of 18 months at -20°C to -70°C and open-vial stability of 7 days (3 days for Troponin T) at 2-8°C. Value assignment performed via replicate in-house analysis and confirmation by external laboratories.

Technological Characteristics

Human serum matrix with added biochemicals, chemicals, drugs, preservatives, and stabilizers. Supplied as frozen liquid (12 x 5ml vials). Analyte values assigned via gravimetric preparation and multi-instrument analysis. Storage: -20°C to -70°C. Open-vial stability: 7 days at 2-8°C (3 days for Troponin T).

Indications for Use

Indicated for use as an assayed quality control material to monitor the accuracy or reproducibility of diagnostic assays in a clinical laboratory setting. No specific patient population is targeted as the device is used for instrument quality control.

Regulatory Classification

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.

Predicate Devices

• Bio-rad Laboratories, Liquid Assayed Multiqual Premium (K130162)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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: [phone] Fax: [phone] E-mail: [e-mail]

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

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.

# 6. 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.

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