MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL by MEDICAL ANALYSIS SYSTEMS, INC.

The MAS™ CardioImmune TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assayed control bornmontions. Include MAS™ Cardiolmmune TL with patient cardrac mance delemination for any of the listed constituents. Assay values scrant specific the specific systems listed. The user can compare observations are provided for the eas a means of assuring consistent performance of reagent and instrument.

The DADE® Cardiac TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assured oonly of our an of any and e DADE® Cardiac TL with patient serum carolac manel determinations: "In of the listed constituents. Assay values are Specifichs when assuring for any any any can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter from the FDA for MAS™ CardioImmune TL Level 1, 2 and 3 and DADE® Cardiac TL Level 1, 2, and 3. These devices are classified as Quality Control Material (Assayed and Unassayed).

The document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the same performance and safety standards as existing devices on the market, usually demonstrated through comparison with those predicates rather than entirely new studies with specific acceptance criteria and detailed performance reporting as requested.

Therefore, I cannot provide the requested information based on the given text.

Summary

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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" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

DEC 21 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Penny M. Layman Regulatory Affairs Manager Medical Analysis Systems Inc. 5300 Adolfo Road Camarillo, CA 93012

K013995 Re:

R013995
Trade/Device Name: MAS™ CardioImmune TL Level 1, 2 and 3 and DADE® Cardiac TL Level 1, 2, and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: November 30, 2001 Received: December 4, 2001

Dear Ms. Layman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM

Page 1 of 1

510(k) Number (if known): KO13995

Devicc Namc:

MAS™ CardioImmune TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3

DADE® Cardiac TL, Level 1and 2 Liquid Assayed Cardiac Marker Control Level 1, 2 and 3

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory 510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 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.