MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL by MEDICAL ANALYSIS SYSTEMS, INC.

The MAS™ Lipid Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS™ Lipid Control 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 DADE® Lipid Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include DADE® Lipid Control 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

The provided document is a 510(k) premarket notification letter from the FDA for a quality control material (MAS™ Lipid Control and DADE® Lipid Control). This type of regulatory submission is for an in-vitro diagnostic device and does not involve studies related to AI algorithms, image analysis, or human-in-the-loop performance. Therefore, most of the requested information (acceptance criteria for device performance studies, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

The document primarily focuses on the substantial equivalence determination for a quality control material, which means it compares the device to a legally marketed predicate device to ensure it performs as intended for monitoring assay conditions in lipid determinations.

Let's address what information can be gleaned from the document based on the context of a quality control material:

A table of acceptance criteria and the reported device performance:
- This document is "Indications for Use" form, which states the intended use of the device. It does not provide specific acceptance criteria or performance data for the device itself. For quality control materials, acceptance criteria would typically involve demonstrating consistency and stability of the control material over its shelf life, and its ability to produce expected results when run on specified assay systems within predefined ranges. However, these specific criteria and their demonstration are not detailed in this public 510(k) summary letter. The letter only states that the device is intended "for monitoring assay conditions" and that "assay values are provided for the specific systems listed" (though not listed in this document). The "user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable to this document. The 510(k) letter does not describe a clinical study or a test set in the context of an AI device. For quality control materials, the "test set" would be the internal testing done by the manufacturer to establish the stability and assigned values of the control material, typically not disclosed in this level of detail in a 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is not an AI or image-based diagnostic device where expert ground truth as described would be established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a quality control material.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a quality control material, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document pertains to a physical quality control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a quality control material, the "ground truth" would be the assigned lot values for various analytes, established through extensive testing by the manufacturer using reference methods or established clinical analyzers. This process is not detailed in the provided document.
The sample size for the training set:
- Not applicable to this document, as it is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document is a regulatory approval letter for a quality control material, and as such, it does not contain the information requested in your prompt, which is tailored for AI-based diagnostic devices.

Summary

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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 emblem 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 an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 0 7 2001 Ms. Penny M. Layman Regulatory Affairs Manager Medical Analysis Systems Inc. 5300 Adolfo Road Camarillo, CA 93012

Re: K013734

Trade/Device Name: MAS™ Lipid Control Levels 1 and 2 and DADE® Lipid Control Levels 1 and 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: November 9, 2001 Received: November 13, 2001

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 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 notification. The I Dr Intellig ssification 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 CFF Part 801 and 1 IT you desire spocitie actives from tic devices), please contact the Office of Compliance at additionally 807.10 for mi viao allestions on the promotion and advertising of your device, (201) 594-4560. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Universe 2011 mormation on your responsional 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 Butman

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): KO13734

Device Name:

The MAS™ Lipid Control Liquid Assayed Lipid Control Level 1 and 2

DADE® Lipid Control, Level 1and 2 Liquid Assayed Lipid Control Level 1 and 2

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)

(División Sign-Off)
Division of Clinical Laborat
510(k) Number 1373,4

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Prescription use

(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.