(32 days)
Cardiolmmune®XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Not Found
This is a 510(k) premarket notification for a cardiac marker control device, not an AI or medical imaging device. Therefore, the questions about acceptance criteria, study design, ground truth, experts, and sample sizes that are typically relevant for AI/imaging devices are not applicable here.
The document states:
- Device Name: CardioImmune® XL Cardiac Marker Control
- Regulation Number: 21 CFR § 862.1660
- Regulation Name: Quality control material (assayed and unassayed)
- Regulatory Class: Class I
- Product Code: JJY
- Indications For Use: "CardioImmune®XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations."
For a Class I quality control material, the "acceptance criteria" generally refer to the performance specifications of the control material itself (e.g., target values, acceptable ranges, stability) and its ability to monitor the performance of assays. The "study" would typically involve demonstrating that the control material provides consistent and reliable results within its defined ranges and is stable over time, as well as showing substantial equivalence to existing predicate devices.
However, the provided text does not contain the specific performance data, study results, or detailed acceptance criteria for this particular device. It is a regulatory clearance letter rather than a performance study report.
Therefore, I cannot populate the table or answer the specific questions as they pertain to aspects that are either not present in this document or are not relevant to this type of device and regulatory submission.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a stylized representation of human figures.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scott Huntsman RAC Manager, Regulatory Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538
MAY 3 U 2006
Re: K061196
Trade/Device Name: CardioImmune® XL Cardiac Marker Control Regulation Number: 21 CFR& 862,1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: April 17, 2006 Received: May 8, 2006
Dear Mr. Huntsman :
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).
{1}------------------------------------------------
Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
CardioImmune®XL Cardiac Marker Control
Indications For Use:
Cardiolmmune®XL Cardiac Marker Control is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Prescription Use XX (Part 21 CFR 801 Subpart D)
Evaluation and Safety
- 10/k
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ce of CBRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Page 1 of Office of In Vito Diagnostic Device
§ 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.