(23 days)
The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a cardiac marker control device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets performance criteria in the way a diagnostic or AI-driven device would. The device, "MAS® CardioImmune® TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3," is a quality control material intended for use in clinical laboratories to monitor assay conditions for cardiac marker determinations.
Therefore, I cannot provide the requested information for acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is not typically part of a 510(k) clearance letter for a quality control material.
The letter primarily focuses on:
- Substantial equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
- Device classification: Class I.
- Intended Use: "intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations."
The clearance process for a quality control material like this primarily involves demonstrating that it performs as intended for quality control without significant safety or effectiveness concerns, often through comparisons to existing, similar products rather than extensive clinical efficacy trials as you would see for a diagnostic test.
{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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 8 2004
Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012
Rc: K040880
Trade/Device Name: MAS® CardioImmune® TL
Liquid Assayed Cardiac Maker Control Level 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY, JJX Dated: April 2, 2004 Received: April 5, 2004
Dear Ms. Layman:
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 (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.
Jean 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
{2}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K040880
MAS® Cardiolmmune® TL Device Name: Liquid Assayed Cardiac Marker Control Level 1, 2 and 3
Indications for Usc:
The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
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 CDRII, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page | of 1_
510(k) K040880
§ 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.