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Lyphochek REMEDi Control is intended for use as a quality control urine for the REMEDi HS Drug Profiling System.

Lyphochek REMEDi Control is prepared from human urine with added therapeutic drugs and drugs of abuse. The control is provided in lyophilized form for increased stability.

This document, K972174, is a 510(k) premarket notification for a medical device called "Lyphochek REMEDi Control." This device is a quality control urine for the REMEDi HS Drug Profiling System. The document focuses on establishing substantial equivalence to a predicate device, "Lyphochek Urine Toxicology Control (K881989)", rather than detailing specific performance studies with acceptance criteria for a new clinical efficacy claim. Therefore, many of the requested categories about acceptance criteria, study design, and performance metrics for a diagnostic device algorithm are not directly applicable or available in this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission is for a quality control material, not a diagnostic device or algorithm with performance metrics like sensitivity, specificity, accuracy, etc. The document asserts "substantial equivalence" based on similar technological characteristics and intended use, rather than demonstrating clinical performance against predefined acceptance criteria for a specific outcome.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) focuses on the chemical composition and intended use of a quality control material and its similarity to a predicate device. It does not describe a test set or data provenance for evaluating device performance as a diagnostic tool.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth establishment for a diagnostic test set is not relevant to this submission for a quality control material.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in clinical studies to establish ground truth for test sets, which is not described in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a diagnostic device or AI on human reader performance, which is not the purpose of this 510(k) for a quality control material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone performance study was not done. This submission is for a quality control material, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. Ground truth, in the context of clinical diagnostic performance, is not discussed in this submission. The "truth" for this device revolves around its chemical composition and stability as a control material, which is implied by its manufacturing process rather than a specific ground truth study.

8. The Sample Size for the Training Set

Not applicable. This submission is about a quality control material and does not involve machine learning algorithms requiring training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth establishment for it.

Summary of the Study and Substantial Equivalence:

The document describes the Lyphochek REMEDi Control as a quality control urine prepared from human urine with added therapeutic drugs and drugs of abuse, provided in lyophilized form.

The study that "proves" the device meets acceptance criteria is fundamentally a comparison to a predicate device to establish substantial equivalence, rather than a performance study with explicit acceptance criteria for diagnostic accuracy.

The comparison is presented in a table (refer to section {1} of the input) highlighting the similarities between the Lyphochek REMEDi Control and the predicate device, Lyphochek Urine Toxicology Control (K881989).

Key comparative characteristics for establishing substantial equivalence were:

• Intended Use: Both are intended for use as quality control urine. The submitted device specifies for the REMEDi HS Drug Profiling System, while the predicate is for broad-screen testing of drugs of abuse in urine. The FDA determined this was substantially equivalent.
• Levels: The submitted device has two levels, while the predicate has one. This difference was accepted.
• Form: Both are lyophilized.
• Open Vial Stability: The submitted device has 30 days at 2-8°C, while the predicate has 10 days at 2-8°C. This difference was accepted.
• Matrix: Both use human urine.
• Storage: Both require 2-8°C.

The FDA's decision (section {2} and {3} of the input) indicates that they reviewed the 510(k) notification and determined the device is "substantially equivalent ... to devices marketed in interstate commerce prior to May 28, 1976." This determination, based on the comparative information provided by Bio-Rad, served as the "proof" for market clearance rather than a separate clinical performance study with predefined acceptance criteria.

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