MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL by MEDICAL ANALYSIS SYSTEMS, INC.

The MAS® chemTRAK® · H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II 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 us a means of assuring consistent performance of reagent and instrument.

The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H 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 OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. 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) clearance letter from the FDA for several chemistry control materials (MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control). This type of device is a "Quality control material (assayed and unassayed)" and is classified as Class I.

The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or diagnostic performance in the way a medical diagnostic AI might. Therefore, the questions related to acceptance criteria for diagnostic performance, study design with test sets, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable in the context of this specific regulatory document.

Here's how to address the questions based on the provided FDA letter:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission of a Class I quality control material is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. For quality control materials, this would involve comparing their physical and chemical properties, stability, and control ranges to that of established controls. The specific quantitative acceptance criteria (e.g., within certain percentage of known values, specific coefficient of variation) are not detailed in this FDA letter but would have been part of the 510(k) submission.
Reported Device Performance: The FDA letter 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...". This is the reported "performance" in the context of regulatory clearance – the device met the criteria for substantial equivalence to a predicate. The specific performance data (e.g., assay values, stability data, precision data) for these specific controls are not detailed in the public FDA letter but would be in the confidential 510(k) submission. The "Indications for Use" section mentions that "Assay values are provided for the specific systems listed" and that users can "compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." This implies that the controls provide known, consistent values.

2. Sample size used for the test set and the data provenance

Not applicable in this document. A "test set" in the context of diagnostic AI algorithms is for evaluating performance on unseen data. For a Class I quality control material seeking 510(k) clearance for substantial equivalence, the "testing" involves demonstrating the product's consistency, stability, and ability to provide known control values. The document does not specify sample sizes for such internal validation studies for these control materials. Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in this document. "Ground truth" in the context of a diagnostic algorithm refers to a definitive diagnosis or finding. For a quality control material, the "ground truth" or "known concentration" is established through analytical methods and manufacturing processes, not typically by expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable in this document. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies for establishing ground truth for diagnostic devices, especially those involving image interpretation. This is not relevant for the clearance of liquid chemistry control materials.

5. 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. MRMC studies are used to evaluate the impact of a diagnostic tool (like AI) on human reader performance. This device is a quality control material, not a diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a chemical control; it's not an algorithm, so "standalone performance" of an algorithm is not relevant.

7. The type of ground truth used

For quality control materials, the "ground truth" refers to the assigned values or expected ranges for various analytes (e.g., glucose, cholesterol) within the control material. These values are established through rigorous analytical testing and calibration processes during the manufacturing and initial validation of the control material, often against reference methods or certified reference materials. It's not "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. The sample size for the training set

Not applicable. "Training set" is a concept for machine learning models. This device is a manufactured chemical product, not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. As explained in point 8, there is no "training set" in the context of these quality control materials. The establishing of "known concentrations" for the control materials themselves is through analytical validation, as described in point 7.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

APR 2 8 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: K030942

Trade/Device Name: MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 24, 2003 Received: March 26, 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 net 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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Page _ 1 of _l _

510(k) Number (if known): Ko30942

Device Name:

MAS® chemTRAK® · H Liquid Assayed Chemistry Control

DADE® Moni-Trol® · H Liquid Assayed Chemistry Control

OLYMPUS Chemistry Control Liquid Assayed Chemistry Control

Indications for Use:

The MAS® chemTRAKE.• H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II 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 us a means of assuring consistent performance of reagent and instrument.

coopes

(Division Sign-Off)
Division of Clinical Laboratory Levice.
510(k) Number K030947

510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)

(ODE)	Concurrence of CDRH, Office of Device Evaluation
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Prescription Use 1 Use

Over-The-Counter

(Per 21 CFR 801.109) 1-2-96)

(Optional Format

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.