(56 days)
Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Not Found
The provided text describes a 510(k) premarket notification for "Data-Trol A Abnormal Control Serum" and "Data-Trol N Normal Control Serum." This document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices.
However, the document is a regulatory approval notice and does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in points 1-9 of your prompt.
The FDA 510(k) process for these types of Class I devices often relies on demonstrating substantial equivalence to existing devices through comparative data (e.g., performance characteristics like accuracy and precision compared to a predicate) rather than requiring a detailed clinical study with the specifics you're asking for. For a quality control material, the "performance" typically refers to its ability to serve as a stable, known sample for monitoring laboratory test procedures.
To address your request, I would need a different type of document, such as a study report, validation protocol, or a more detailed technical submission from the manufacturer.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Re:
Public Health Service
SEP 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Melita Lambiris Quality Assurance Manger Thermo Electron Corporation 189-199 Browns Road Noble Park, Victoria 3174 Australia
K052056 Trade/Device Name: Data-Trol A Abnormal Control Serum Data-Trol N Normal Control Serum Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 8, 2005 Received: September 12, 2005
Dear Ms. Lambiris:
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) I ms letter will anow you to oegn marketing of substantial equivalence of your device to a legally promatics nonifeation: "The PDF 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, If you desire specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Villo Diagnostic Device Drana.com and sees to premarket notification" (21CFR Part 807.97). It guilation chitica, "Whisording of roien on your responsibilities under the Act from the You may offail bunci general mormational 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting 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 STATEMENT
| 510(k) Number (if known): | K052056 |
|---|---|
| Device Name: | Data-Trol A Abnormal Control SerumData-Trol N Normal Control Serum |
| Indications For Use: | Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only. |
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 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)
Division Sign-Off
Office of In Vitre Diagnostic Device Evaluation and Safety
510(k) K052056
§ 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.