(27 days)
Not Found
No
The document describes a calibrator for cholesterol tests, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an in vitro diagnostic calibrator, used to ensure the accuracy of other diagnostic methods, not to directly treat or diagnose a patient's condition.
No
This device is a calibrator, used to calibrate other diagnostic devices, not to diagnose patients itself. The "Intended Use" explicitly states it's for "in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods," making it an accessory to a diagnostic device rather than a diagnostic device itself.
No
The device description clearly states it is a "Calibrator" supplied in "vials" containing "Human Serum," indicating a physical, in vitro diagnostic product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 statement clearly identifies the device's purpose as being used outside of the body to diagnose or aid in the diagnosis of conditions, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use only and can only be used by professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
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K1221266
AUG 1 4 2012
r i
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: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: marketing@randox.com
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
1
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.
2
PREDICATE DEVICE COMPARISON TABLE 7.
| CHARACTERISTICS | RANDOX DIRECT LDL/HDL
CHOLESTEROL CALIBRATOR | TECO DIAGNOSTICS DIRECT
HDL/LDL CHOLESTEROL
CALIBRATOR |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Teco Diagnostics Direct HDL/LDL
Cholesterol Calibrator is intended for the
calibration of Teco Diagnostics' direct
HDL and LDL Cholesterol Reagent set in
serum or plasma.
For in vitro diagnostic use only. |
| SIZE | Randox Direct LDL/HDL Cholesterol
calibrator 3x1ml | Teco Diagnostics Direct HDL/LDL
Cholesterol Calibrator 3mls |
| FORMAT | Lyophilized serum calibrator | Lyophilized serum calibrator |
| MATRIX | Human Serum. The calibrator contains
lipoproteins from the various lipoprotein
classes including high density lipoproteins | Human Serum. The calibrator contains
lipoproteins from the various lipoprotein
classes including high density lipoproteins |
| STORAGE
(unopened) | Stable to the expiry date printed on the
product label when stored between +2°C
and +8°C | Stable to the expiry date printed on
the product label when stored
between +2°C and +8°C |
| STORAGE
(Opened) | Once reconstituted, the components in
the calibrator are stable for 5 days at
+2°C to +8°C | Once reconstituted, the components in
the calibrator are stable for 21 days at
+2°C to +8°C |
| ANALYTES | Direct LDL
Direct HDL | Direct LDL
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
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
・
5
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).
6
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 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