(111 days)
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
This document is a 510(k) premarket notification letter from the FDA to Randox Laboratories Ltd. for their "Tri-Level Cardiac Control" device. It confirms that the device is substantially equivalent to a legally marketed predicate device.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically expected for a medical device's performance evaluation (e.g., sensitivity, specificity, accuracy, clinical trial results). This document is a regulatory approval letter, not a device performance study report.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, or training set details based on the provided text.
The information present in the document is:
- Device Name: Tri-Level Cardiac Control
- Manufacturer: Randox Laboratories Ltd.
- Regulation Number: 21 CFR 862.1660
- Regulation Name: Quality control material (assayed and unassayed)
- Regulatory Class: Class I
- Product Code: JJY
- Indications For Use: "The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume."
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 9 2004
Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY
Re: K041361
Trade/Device Name: Tri- Level Cardiac Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 31, 2004 Received: September 2, 2004
Dear Dr. 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.
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 your device can be found in Title 21, Code 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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)
Device Name: Tri-Level Cardiac Control
Indications For Use:
The Randox Laboratories Ltd. Tri-Level Cardiac Control (Level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.
The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Carol Benson
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041361
§ 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.