(28 days)
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. The control is provided in lyophilized form for increased stability.
This document describes the Lyphochek Urine Metals Control, a quality control urine product. It is intended to monitor the precision of laboratory testing procedures for certain analytes. The provided text is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for a diagnostic or therapeutic medical device.
The document essentially establishes "substantial equivalence" of the new Lyphochek Urine Metals Control to a previously marketed version (K891691/A). This type of submission generally doesn't require performance studies against specific acceptance criteria for safety and effectiveness in the same way a novel device would. Instead, it relies on demonstrating that the new device is as safe and effective as the predicate device.
However, I can extract the relevant information based on the typical requirements implied by your request, even if the specific details are not fully present for each point.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for a quality control product like this primarily revolves around demonstrating that it performs its intended function (monitoring precision) comparably to an existing, cleared product. Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implied to be at least as good as the predicate device, particularly for stability and intended use.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | To function as an assayed quality control urine to monitor precision of laboratory testing procedures. | "An assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." (Matches predicate device) |
| Form | Lyophilized. | Lyophilized (Matches predicate device) |
| Matrix | Human urine. | Human urine (Matches predicate device) |
| Storage | 2-8°C. | 2-8°C (Matches predicate device) |
| Open Vial Claim | 5 days when stored tightly capped at 2-8°C. | 5 days when stored tightly capped at 2-8°C (Matches predicate device) |
| Additional Analytes | Function as a quality control for new analytes (Hippuric Acid, Mandelic Acid, Pentachlorophenol, Phenol, Phenylglyoxylic Acid, and Trichloroacetic Acid) effectively. | The new submission claims these additional analytes. The implicit "performance" is that it adequately serves as a control for these analytes. No specific performance data for these analytes is provided in this summary, but would have been part of the full 510(k) submission to justify the claim of substantial equivalence for these additions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes or data provenance in the way a clinical trial for a diagnostic device would. For substantial equivalence of a quality control product, the "test set" would primarily involve demonstrating that the new product, including its new analytes, is stable and performs as expected with laboratory instruments. This information is typically proprietary to the manufacturer and not detailed in the public 510(k) summary.
The comparison table indicates the device claims are based on combining "Domestic and International products" and adding new analytes. This suggests internal data collection for these modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the 510(k) submission of a quality control product. Ground truth, in the context of a quality control, refers to the accurately known concentrations of the analytes within the control material. This is established by the manufacturer through rigorous analytical methods and reference standards, not typically by "experts" in the sense of clinical decision-makers.
4. Adjudication Method for the Test Set
Not applicable for a quality control product.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are typically for imaging or diagnostic devices where human interpretation plays a role. This is a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical quality control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for a quality control product is the assigned value (concentration) of each analyte in the control material, established through certified reference materials or highly accurate analytical methods during manufacturing. The document doesn't explicitly state "certified reference materials" but that is the standard practice for assigning values to quality controls.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured quality control product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.