(27 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Randox Direct LDL/HDL Cholesterol Calibrator:
Acceptance Criteria and Device Performance Study for Randox Direct LDL/HDL Cholesterol Calibrator
Based on the provided K1221266 document, the device described is a calibrator, not a diagnostic device that measures patient samples directly. Therefore, the "acceptance criteria" and "device performance" are focused on its role as a calibration standard and its ability to maintain stability and assignable values. The document primarily describes the characteristics of the calibrator and how its values are assigned, rather than presenting a traditional clinical study with outcome-based performance metrics like sensitivity, specificity, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical sense for a diagnostic device (e.g., meeting a certain accuracy threshold against a reference standard). Instead, the performance is demonstrated through its stability and the value assignment process, ensuring it reliably provides known concentrations of analytes for instrument calibration.
Acceptance Criteria (Implied from the document's content):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Calibration of Randox HDL and LDL Cholesterol methods. | The device is supplied as a calibrator for this purpose. The value assignment process demonstrates its ability to reliably provide known values for these analytes across multiple analyzer systems. |
| Composition: Contains analytes LDL and HDL in a human serum matrix, with lipoproteins from various classes. | The device description confirms this composition. |
| Stability (unopened): Stable between +2°C and +8°C until the expiry date. | "Unopened Calibrator is stable until the expiry date printed on the product label when stored between +2℃ and +8℃." |
| Stability (reconstituted): Stable for 5 days at +2°C to +8°C and 1 month at -20°C (frozen once). | "Once reconstituted the components are stable for 5 days at +2℃ and +8℃ and 1 month at -20℃ when frozen once." |
| Value Assignment: Assignable target values for Direct LDL and Direct HDL across a range of common clinical chemistry analyzers. | A table is provided showing target values (mmol/l and mg/dl) for both Direct LDL and Direct HDL on 6 different analyzer systems (Abbott Architect c8000, Beckman Coulter AU640, Hitachi 717, Hitachi 911, Randox RX Daytona, Randox Rx Imola, Siemens Advia 1650). |
| Traceability: Analytes are traceable to specific human plasma products. | Traceability information for Direct HDL (Creative Labs 361-10) and Direct LDL (Creative Labs 360-10) from human plasma is provided. |
| Substantial Equivalence: Demonstrated to be substantially equivalent to the predicate device (Teco Diagnostics Direct HDL/LDL Cholesterol Calibrator). | The "CONCLUSION" explicitly states: "Testing results indicate that the proposed device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
For a calibrator, a "test set" in the traditional sense of patient samples is not applicable. The "test set" for this device would refer to the samples used during the value assignment process.
- Sample Size: The document does not specify a distinct "sample size" of individual samples used to determine the values. Instead, it refers to "multiple analysers with reference to a master lot." This implies the calibrator was run numerous times on various instruments. The explicit number of replicates or individual calibrator vials tested for value assignment is not stated.
- Data Provenance: Not explicitly stated, but given Randox Laboratories is a UK-based company and the predicate device comparison table includes international analyzer brands, the testing likely occurred in a controlled laboratory setting (likely in the UK or a partner lab). The data is inherent to the manufacturing and quality control process of the calibrator itself, rather than external patient data. It is a prospective study in the sense that the testing was performed to assign values to the newly manufactured calibrator lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a calibrator, the "ground truth" is established through a hierarchical metrological process, not typically by "experts" reviewing results in the way a radiologist reviews images.
- Number of Experts: Not applicable. The "ground truth" (assigned values) is traceable to established reference materials and methods, often from organizations like the CDC or a certified reference material producer. The document states values are established "with reference to a master lot," which would have its own established traceable values.
- Qualifications of Experts: Not specified or applicable in the context of expert review. The "experts" would be the metrologists and analytical chemists involved in establishing the master lot's values and performing the value assignment on specific instruments, ensuring adherence to rigorous analytical standards.
4. Adjudication Method for the Test Set
Not applicable. As discussed above, the "test set" refers to the value assignment process, which relies on analytical measurements and metrological traceability, not consensus-based adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a calibrator, an in-vitro diagnostic reagent, so an MRMC study is not appropriate or presented.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable to a calibrator. A calibrator does not have an "algorithm" in the sense of an AI or software processing data. Its function is to provide known concentrations for instrument calibration. The "performance" is its ability to consistently deliver these known concentrations and be stable over time.
7. The Type of Ground Truth Used
The "ground truth" for the calibrator's values is established by metrological traceability to a master lot, which in turn is traceable to higher order reference materials and methods. The document explicitly mentions "The assigned values for the direct LDL/HDL Cholesterol Calibrator are established on multiple analysers with reference to a master lot." And the "Traceability" section identifies the specific human plasma products (Creative Labs) as the origin for the analytes.
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator, not an algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this type of device.
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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
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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/HDLCHOLESTEROL CALIBRATOR | TECO DIAGNOSTICS DIRECTHDL/LDL CHOLESTEROLCALIBRATOR |
|---|---|---|
| INTENDED USE | The Randox Direct LDL/HDL CholesterolCalibrator is intended for in vitrodiagnostic use in the calibration ofRandox HDL and LDL Cholesterolmethods.This in vitro diagnostic device is intendedfor prescription use only and can only beused by professionals. | The Teco Diagnostics Direct HDL/LDLCholesterol Calibrator is intended for thecalibration of Teco Diagnostics' directHDL and LDL Cholesterol Reagent set inserum or plasma.For in vitro diagnostic use only. |
| SIZE | Randox Direct LDL/HDL Cholesterolcalibrator 3x1ml | Teco Diagnostics Direct HDL/LDLCholesterol Calibrator 3mls |
| FORMAT | Lyophilized serum calibrator | Lyophilized serum calibrator |
| MATRIX | Human Serum. The calibrator containslipoproteins from the various lipoproteinclasses including high density lipoproteins | Human Serum. The calibrator containslipoproteins from the various lipoproteinclasses including high density lipoproteins |
| STORAGE(unopened) | Stable to the expiry date printed on theproduct label when stored between +2°Cand +8°C | Stable to the expiry date printed onthe product label when storedbetween +2°C and +8°C |
| STORAGE(Opened) | Once reconstituted, the components inthe calibrator are stable for 5 days at+2°C to +8°C | Once reconstituted, the components inthe calibrator are stable for 21 days at+2°C to +8°C |
| ANALYTES | Direct LDLDirect HDL | Direct LDLDirect 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 | PRODUCTNUMBER | 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 (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
§ 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.