DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

K122126 · Randox Laboratories Limited · JIS · Aug 14, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122126
• Device Name: DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
• Applicant: Randox Laboratories Limited
• Product Code: JIS · Clinical Chemistry
• Decision Date: Aug 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Device Story

Randox Direct LDL/HDL Cholesterol Calibrator is a lyophilized human serum-based calibrator containing LDL and HDL lipoproteins. Used in clinical laboratories by professionals to calibrate Randox HDL and LDL cholesterol assay methods. The calibrator is supplied in 3x1ml vials; requires reconstitution before use. Assigned values are established on multiple analyzers (e.g., Abbott Architect, Beckman Coulter AU, Hitachi, Randox RX series, Siemens Advia) relative to a master lot. Provides standardized reference points for clinical chemistry analyzers to ensure accurate patient sample quantification. Benefits patient care by ensuring the accuracy and reliability of cholesterol testing, which is critical for lipid profile assessment and cardiovascular risk management.

Clinical Evidence

Bench testing only. Stability studies confirmed performance of the calibrator under specified storage conditions (unopened at 2-8°C; reconstituted at 2-8°C for 5 days or -20°C for 1 month). Value assignment was validated across multiple clinical analyzer platforms.

Technological Characteristics

Lyophilized human serum matrix containing LDL and HDL lipoproteins. Form factor: 3x1ml vials. Storage: 2-8°C. Stability: 5 days post-reconstitution at 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by professionals in clinical settings to calibrate Randox HDL and LDL cholesterol diagnostic methods. No specific patient population or disease state contraindications provided.

Regulatory Classification

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.)

Special Controls

*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.

Submission Summary (Full Text)

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K1221266

AUG 1 4 2012

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### 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: Randox Laboratories Limited

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

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

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

510k No: k122126

Device Proprietary Name: Randox Direct LDL/HDL Cholesterol Calibrator

Common Name: Direct LDL/HDL Cholesterol Calibrator

Purpose for Submission: New Device

Regulatory Classification: Primary Calibrator Class II

Panel: Clinical Chemistry

Product Code: JIS

21 CFR Number: 21 CFR 862.1150

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

Predicate Device Proprietary Name: Teco Diagnostics Direct HDL/LDL Cholesterol Calibrator

### 510 (k) Number: k050823

### 5. INTENDED USE

The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

### 6. DEVICE DESCRIPTION

The Randox Direct LDL/HDL Cholesterol Calibrator is supplied in a kit containing 3x1mls vials. The calibrator contains the analytes LDL and HDL.

The base matrix used for the manufacture of Randox Direct LDL/HDL Cholesterol Calibrator is Human Serum. The calibrator contains lipoproteins from the various lipoprotein classes including high density lipoproteins.

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#### PREDICATE DEVICE COMPARISON TABLE 7.

| CHARACTERISTICS | RANDOX DIRECT LDL/HDL<br>CHOLESTEROL CALIBRATOR | TECO DIAGNOSTICS DIRECT<br>HDL/LDL CHOLESTEROL<br>CALIBRATOR |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Randox Direct LDL/HDL Cholesterol<br>Calibrator is intended for in vitro<br>diagnostic use in the calibration of<br>Randox HDL and LDL Cholesterol<br>methods.<br>This in vitro diagnostic device is intended<br>for prescription use only and can only be<br>used by professionals. | The Teco Diagnostics Direct HDL/LDL<br>Cholesterol Calibrator is intended for the<br>calibration of Teco Diagnostics' direct<br>HDL and LDL Cholesterol Reagent set in<br>serum or plasma.<br>For in vitro diagnostic use only. |
| SIZE | Randox Direct LDL/HDL Cholesterol<br>calibrator 3x1ml | Teco Diagnostics Direct HDL/LDL<br>Cholesterol Calibrator 3mls |
| FORMAT | Lyophilized serum calibrator | Lyophilized serum calibrator |
| MATRIX | Human Serum. The calibrator contains<br>lipoproteins from the various lipoprotein<br>classes including high density lipoproteins | Human Serum. The calibrator contains<br>lipoproteins from the various lipoprotein<br>classes including high density lipoproteins |
| STORAGE<br>(unopened) | Stable to the expiry date printed on the<br>product label when stored between +2°C<br>and +8°C | Stable to the expiry date printed on<br>the product label when stored<br>between +2°C and +8°C |
| STORAGE<br>(Opened) | Once reconstituted, the components in<br>the calibrator are stable for 5 days at<br>+2°C to +8°C | Once reconstituted, the components in<br>the calibrator are stable for 21 days at<br>+2°C to +8°C |
| ANALYTES | Direct LDL<br>Direct HDL | Direct LDL<br>Direct HDL |

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## 8. SUMMARY OF STABILITY STUDIES

Unopened Calibrator is stable until the expiry date printed on the product label when stored between +2℃ and +8℃. Once reconstituted the components are stable for 5 days at +2℃ and +8℃ and 1 month at -20℃ when frozen once. After use, any residual product should NOT be returned to the original vial.

### 9. SUMMARY OF VALUE ASSIGNMENT

The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot.

| Analyte | System | Target | |
|------------|------------------------|--------------------|-------|
| | | mmol/l | mg/dl |
| | Abbott Architect c8000 | 1.77 | 68.3 |
| | Beckman Coulter AU640 | 1.73 | 66.8 |
| | Hitachi 717 | 1.67 | 64.5 |
| | Hitachi 911 | 1.65 | 63.7 |
| | Randox RX Daytona | 1.73 | 66.8 |
| | Randox Rx Imola | 1.65 | 63.7 |
| Direct HDL | Siemens Advia 1650 | 1.7 | 65.6 |
| | Beckman Coulter AU640 | 3.16 | 122 |
| | Hitachi 717 | 3.01 | 116 |
| | Hitachi 911 | 3.03 | 117 |
| | Randox RX Daytona | 3.11 | 120 |
| | Randox Rx Imola | 3.12 | 120 |
| | Direct LDL | Siemens Advia 1650 | 3.09 |

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# 10. TRACEABILITY

| ANALYTE | SUPPLIER | PRODUCT<br>NUMBER | ORIGIN | SOURCE |
|------------|---------------|-------------------|--------|--------|
| Direct HDL | Creative Labs | 361-10 | Human | Plasma |
| Direct LDL | Creative Labs | 360-10 | Human | Plasma |

# 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/5/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, representing the department's mission related to health and well-being.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 1 4 2012

Randox Laboratories Ltd. c/o Pauline Armstrong 55 Diamond Road Crumlin, County Antrim BT29 4QY United Kingdom

Re: k122126

Trade Name: Randox Direct LDL/HDL Cholesterol Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIS Dated: July 18, 2012 Received: July 18, 2012

Dear Ms. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the davice 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 the Federal I 60d, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classinod (oos as othional controls. Existing major regulations affecting. (I MA), it may be subject to sach actively of Federal Regulations (CFR), Parts 800 to 895. 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 modi that I DX mas mace a deceminations administered by other Federal agencies. of the Act of ally I oderal statutes and vuirements, including, but not limited to: registration 1 ou inust compty what any; labeling (21 CFR Parts 801 and 809); medical device and fisting (21 OF N Furt 607), nevelse elated adverse events) (21 CFR 803); and good reporting (reporting of medical device s set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

signature

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k122126

Device Name: Direct LDL/HDL Cholesterol Calibrator

Indication for Use:

ﺎ

The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods.

This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

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

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 Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K12212