Dade® Moni-Trol® Control is intended for use as an unassayed quality control material in quantitative clinical chemistry control programs.
Dade® Moni-Trol® Control is intended to assist in the control of accuracy and precision of clinical chemistry quality control programs.
Dade® Moni-Trol® Calibrator is intended for use as a calibrator in the quantitative determination of clinical assays.

Device Description

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AI/ML Overview

This document describes the Dade Moni-Trol® Chemistry Control and Calibrator devices, which are unassayed quality control materials and calibrators for quantitative clinical chemistry programs. The information provided is a Summary of Safety and Effectiveness for a 510(k) premarket notification (K960103) from April 26, 1996.

This is a regulatory submission for a quality control material/calibrator, not a diagnostic device that interprets patient data. Therefore, the traditional metrics of acceptance criteria (e.g., sensitivity, specificity, AUC) and study designs (e.g., test sets, ground truth establishment, expert adjudication, MRMC studies) typically applied to image-based AI or clinical diagnostic devices do not apply in this context.

Instead, the performance data for these devices focuses on characteristics relevant to their function as controls and calibrators, such as:

Typical analyte values: Ensuring the control material contains analytes at expected levels.
Shelf-life: Demonstrating the stability of the product over its intended storage duration.
Reconstituted stability: Demonstrating the stability of the product once prepared for use.

The document states: "Performance data: Non-clinical tests for typical analyte values, shelf-life and reconstituted stability submitted in the premarket notification support the conclusion that the candidate device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary."

Given the nature of the device and the provided document, I cannot provide the specific information requested in the format of a diagnostic device study. However, I can infer the acceptance criteria relate to the stability and integrity of the control material over time and its ability to provide consistent "typical analyte values." The "study" mentioned would be a series of non-clinical, analytical tests performed by Dade International Inc. to demonstrate this stability and value consistency.

Here's an attempt to answer the questions based on the closest relevant information, with the understanding that many requested fields are not applicable:

A table of acceptance criteria and the reported device performance

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Typical analyte values	Demonstrated to be "as safe and effective, and performs as well as or better than legally marketed devices."
Shelf-life stability	Demonstrated through non-clinical tests.
Reconstituted stability	Demonstrated through non-clinical tests.

Explanation: The document does not provide specific numerical acceptance criteria (e.g., "% deviation within a certain range") nor the exact measurements. It only states that "non-clinical tests" were performed and the results "support the conclusion that the candidate device is as safe and effective, and performs as well as or better than the legally marketed devices."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of clinical patient data. For analytical studies, it would refer to the number of lots, replicates, or time points tested. This information is not provided in the summary.
- Data Provenance: The studies were "non-clinical tests" conducted by Dade International Inc., likely at their facilities (Miami, FL, USA). The data would be internally generated without patient data. This is an analytical validation, not a clinical trial.
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. Ground truth for a quality control material is established by analytical methods and reference standards, not by expert interpretation of patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of patient data.
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 a diagnostic AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a quality control material would be established through analytical reference methods and certified reference materials to determine the precise concentration or activity of analytes within the control. This would be a chemical/analytical ground truth.
The sample size for the training set
- Not applicable. Quality control materials do not have "training sets" in the AI or machine learning sense. The manufacturing process of a control material is established through process validation, not data training.
How the ground truth for the training set was established
- Not applicable as there is no "training set." The performance of the control material is validated against established analytical methods and reference standards in controlled laboratory settings.

Summary

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DADE

APR 26 1996
K960103
DADE INTERNATIONAL

Dade International Inc. P.O. Box 520672 Miami, FL 33152-0672

East: 305.633.6461 Fax: 305.637.6802

West: 305.592.2311 Fax: 305.591.5552

Darnell Center: 305.222.6200 Fax: 305.222.6222

X. Summary of Safety and Effectiveness

Submitter: Marian Harding Cochran, J.D., Regulatory Affairs Manager Dade International Inc., Miami FL. 33172

Date: January 5, 1996

Device Names:

Moni-Trol® Level 1 Chemistry Control and Carbonate Diluent 1, Moni-Trol® Level ● 2 Chemistry Control and Carbonate Diluent 2
Moni-Trol® Level 1 Chemistry Control, Moni-Trol® Level 2 Chemistry Control and . Moni-Trol® Level 3 Chemistry Control
. Moni-Trol® Level 1X Chemistry Control and Carbonate Diluent 1, Moni-Trol® Level 2X Chemistry Control and Carbonate Diluent 2
Moni-Trol® Level 1X Chemistry Control, Moni-Trol® Level 2X Chemistry Control ● and Moni-Trol® Level 3X Chemistry Control
Moni-Trol® Calibrator A and Carbonate Diluent 1, Moni-Trol® Calibrator B and ● Carbonate Diluent 2
Moni-Trol® Calibrator A, Moni-Trol® Calibrator B and Moni-Trol® Calibrator C ●

Predicate Devices:

. Dade® Moni-Trol® Chemistry Control / Calibrator (K871977); Moni-Trol® and Other Brand names Chemistry Control / Calibrator, (K891929/A); Dade® Urine Chemistry Control; Dade@Immunoassay Control; Dade®Anemia/Hemochromatosis Control; Dade® CK/LD Control
. BIO-RAD Lyophochek®Chemistry Control, Liquichek™ Immunology Control, Liquichek™ Rheumatoid Factor Control
CIBA-CORNING QCS® Control Serum ●
Boehringer Mannheim Precical®
Beckman CAL 1 .

Intended Uses:

. Dade® Moni-Trol® Control is intended for use as an unassayed quality control material in quantitative clinical chemistry control programs.
. Dade® Moni-Trol® Control is intended to assist in the control of accuracy and precision of clinical chemistry quality control programs.
Dade® Moni-Trol® Calibrator is intended for use as a calibrator in the quantitative . determination of clinical assays.

Comparison of the candidate device to the predicate devices: Comparison of intended uses, base material and constituents supports the determination of substantial equivalence.

Performance data: Non-clinical tests for typical analyte values, shelf-life and reconstituted stability submitted in the premarket notification support the conclusion that the candidate device is as safe and effective, and performs as well as or better of minereled page than the legally marketed devices identified in this summary.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.