(20 days)
The Randox Cystatin C Controls Level 2 and Level 3 are intended for use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Randox Cystatin C Controls are manufactured at two levels, Level 2 and Level 3. They are single analyte controls derived from human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
The provided text describes a 510(k) summary for the 'Randox Cystatin C Level 2 and Randox Cystatin C Level 3' controls. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.
Therefore, many of the requested criteria for a device-proving study, such as specific performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, are not applicable to this type of submission. The 'device' here is a quality control material, not a diagnostic test providing patient results.
However, based on the information provided, here's an attempt to address the applicable points:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define acceptance criteria as a new diagnostic device would (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated by establishing its characteristics as a quality control material and showing its "similarities" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Characteristics) |
|---|---|
| Bi-level material | Manufactured at two levels (Level 2 and Level 3) |
| Intended for in vitro diagnostic use | Yes, for monitoring precision and accuracy of human Cystatin C immunoturbidimetric assays |
| Human serum matrix | Derived from human serum |
| Preserved with sodium azide | Yes, preserved with sodium azide |
| Liquid form, ready to use | Yes, provided in liquid form and ready-to-use |
| Stable up to expiry date when capped & stored at +2 to +8°C (unopened) | Stable up to expiry date when capped and stored at +2 to +8°C in the absence of contamination |
| Stable for specified period when opened | Stable for 30 days when capped in the original container at +2 to +8°C in the absence of contamination |
| Analyte concentrations clinically relevant | Analyte concentrations reviewed by a panel of experts to ensure clinical relevance |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The submission focuses on the characteristics of the control material (stability, matrix, preservation, etc.) rather than a performance study on a 'test set' of patient samples. Any "testing results" mentioned are implicitly related to characterizing the control material itself, not its performance against a ground truth on patient samples.
- Data Provenance: Not specified, but likely refers to internal testing and characterization conducted by Randox Laboratories Limited in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: A "panel of experts" reviewed the analyte concentrations to ensure clinical relevance. The exact number is not specified.
- Qualifications of experts: Not specified beyond being "experts."
4. Adjudication method for the test set
- Not applicable. There isn't a "test set" of patient cases requiring adjudication as would be found in a diagnostic performance study. The expert panel's role was to review the concentrations within the control material, not to adjudicate patient results.
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
- Not applicable. This is a quality control material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
- For the analyte concentrations within the control, the "ground truth" was established by a panel of experts confirming their clinical relevance. This is specific to the characteristics of the control material itself.
- For the overall device, the "ground truth" for substantial equivalence is derived from comparison to the DakoCytomation Cystatin C Control Set (K041627), the predicate device.
8. The sample size for the training set
- Not applicable. This is a quality control material, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a quality control material, not a machine learning algorithm.
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JUN 20 2012
1715
510(k) Summary
Safety and Effectiveness as Required by 21 CFR 807.92
Manufacturer and Submitter
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
Device Name
Trade Names: Randox Cystatin C Level 2 and Randox Cystatin C Level 3.
Common Names: Cystatin C Level 2 and Randox Cystatin C Level 3.
Classification: Single (Specified) Analyte Controls (Assayed and Unassayed)
Product Code: JJX
Date of Summary Preparation
11™ May 2012
Predicate Devices
DakoCytomation Cystatin C Control Set, K041627
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Device Description ·
Randox Cystatin C Controls are manufactured at two levels, Level 2 and Level 3. They are single analyte controls derived from human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Intended Use
Randox Cystatin C Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.
Similarities to the Predicate Device
- The Randox Cystatin C Controls are bi-level materials intended for in vitro diagnostic use in quality control.
- They have a human serum matrix and are preserved with sodium azide
- They are provided in liquid form and are ready to use
- They are stable up to the expiry date when capped and stored at +2 to +8℃.
Stability
OPENED: The Cystatin C Controls are stable for 30 days when capped in the original container at +2 to +8°C in the absence of contamination.
UNOPENED: The Cystatin C Controls are supplied ready to use and are stable up to the expiry date when capped and stored at +2 to +8°C in the absence of contamination.
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/2/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 a stylized image of an eagle with its wings spread, facing to the right.
10903 New Hampshire Avenue Silver Spring, MD 20993
JUN 2002012
Randox Laboratories Limited c/o Pauline Armstrong 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
K121588 Re:
Trade Name: Cystatin C Control Level 2 and Cystatin C Control Level 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: May 31, 2012 Received: May 31, 2012
Dear Ms. 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 approvisions of the Act. The general controls provisions of the Act include controls providents or annual 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may of sachest to Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device our of to to to to ther announcements concerning your device in the Eederal 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 modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I ederal startists and squirements, including, but not limited to: registration 1 ou maxe compt) ; labeling (21 CFR Parts 801 and 809); medical device and fisting (21 OF N 1 art 007), device-related adverse events) (21 CFR 803); and good reporting (reporting of measur nents as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Steven H. Lein, Ph.D.
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
5 10(k) Number (if known):
Device Name: Cystatin C Controls Levels 2 and 3
Indication for Use:
The Randox Cystatin C Controls Level 2 and Level 3 are intended for use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.
N for a more and read the comments of the state of the state of the
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Prescription Use > (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) K|2/.58
§ 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.