(52 days)
The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.
Not Found
This is a 510(k) premarket notification for a Class I quality control material (Orion Diagnostica QuikRead® CRP Verification Set). The provided document is an FDA clearance letter and the "Indications for Use" statement. It does not contain a study or data proving the device meets acceptance criteria.
The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. For Class I devices like this, detailed performance studies with acceptance criteria are typically not required as part of the 510(k) submission itself, as these are often well-established technologies. The focus is on demonstrating that the new device is substantially equivalent to an existing one.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present.
- Adjudication method: Not applicable/present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a verification set, not an algorithm.
- The type of ground truth used: Not applicable/present.
- The sample size for the training set: Not applicable/present.
- How the ground truth for the training set was established: Not applicable/present.
Summary based on the provided document:
The provided document is an FDA clearance letter for a Class I quality control material. It confirms that the Orion Diagnostica QuikRead® CRP Verification Set is substantially equivalent to predicate devices for its intended use of "verification of calibration and method validation of the QuikRead CRP System." However, the document does not include any performance study data, acceptance criteria, or details of ground truth establishment. For Class I devices, the 510(k) process primarily focuses on demonstrating substantial equivalence, rather than requiring extensive clinical performance studies that would typically involve acceptance criteria and ground truth validation as described in your request.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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NOV 1 8 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annikka Rantama Assistant Vice President Quality Assurance and Regulatory Affairs Orion Diagnostica Oy Koivumankkaan Tie 6 Espoo, Finland 02200
Re: K042625
Trade/Device Name: Orion Diagnostica QuikRead® CRP Verification Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 25, 2004 Received: October 27, 2004
Dear Ms. Rantama:
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. Iisting 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,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA 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
510(k) Number (if known): K042625
Device Name: Orion Diagnostica QuikRead® CRP Verification Set
The Orion Diagnostica QuikRead CRP Verification Set is intended for Indications For Use: verification of calibration and method validation of the QuikRead CRP System.
For in vitro diagnostic use.
Prescription Use X (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)
Albert Sat
Office of In Vitro Diagnostic Device Evaluation
510(k) K042625
§ 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.