MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE 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 cardiac marker determinations. Include CardioImmune® TL 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.

The MAS® CardioImmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® proBNP 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.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a Class I quality control material. Typically, for this type of device, substantial equivalence is established by demonstrating that the device has the same intended use and similar technological characteristics as a predicate device, and does not raise different questions of safety and effectiveness.

The provided document (K032335) does not contain the information requested regarding acceptance criteria studies, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These types of detailed performance studies are generally not required for Class I quality control materials where the regulatory path focuses on substantial equivalence to existing devices.

The letter explicitly states: "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..." This confirms the basis of the clearance.

Therefore, I cannot provide the requested information from the given text.

Summary of what can be inferred or is missing:

Table of acceptance criteria and reported device performance: Not provided. The document is a clearance letter, not a study report.
Sample size used for the test set and data provenance: No test set information is provided as this is not a study report.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided.
Adjudication method for the test set: Not applicable/Not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted/Not reported for this type of device.
Standalone performance study: Not reported. The clearance is based on substantial equivalence, not a detailed performance study like what would be seen for a diagnostic algorithm.
Type of ground truth used: Not applicable/Not provided. For quality control materials, "ground truth" often refers to assigned values established by reference methods or validated consensus processes, but details are not in this document.
Sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML algorithm device.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

AUG 1 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K032335

Trade/Device Name: MAS® CardioImmune® TL MAS® CardioImmune® proBNP Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 28, 2003 Received: July 30, 2003

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).

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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,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM

510(k) Number (if known): K032335

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MAS® CardioImmune® TL Device Name: MAS® CardioImmune® proBNP

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
	OR Over-The-Counter
(Per 21 CFR 801.109)1-2-96)	(Optional Format

Carol Benson for Jean Cooper, DVM

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety (Optional Format 3-10-98)

510(k)	K032335
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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.