(114 days)
Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Liquichek Opiate Control is prepared from human urine with added drugs of abuse, metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
This submission from Bio-Rad Laboratories is for a Liquichek Opiate Control, which is a quality control material for urine toxicology testing. The documentation does not describe a study involving a medical device with a "device performance" in the typical sense of diagnostic accuracy (sensitivity, specificity, AUC) or an AI algorithm. Instead, it details a 510(k) premarket notification for an in vitro diagnostic (IVD) control material. The "performance data" refers to the stability of the control material itself, not the performance of a diagnostic device it would be used with.
Therefore, many of the requested elements of your query (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training set, training set size, and how training ground truth was established) are not applicable to this type of submission.
Here's an adaptation of the requested table and information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the control material) | Reported Device Performance (Characteristics of the control material) |
|---|---|
| Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2 to 8°C after thawing. | All analytes are stable for 30 days when stored tightly capped at 2 to 8°C. (This is a claim based on completed stability studies, implying the data met the criteria). |
| Shelf Life Stability: Stable for a specified duration (e.g., 3 years) when stored at -20 to -70°C. | Three years when stored at -20 to -70°C. (This is a claim based on initial studies, with real-time studies described as "ongoing" to further support this claim, implying initial data met the criteria). |
| Substantial Equivalence to Predicate Device (for characteristics and intended use) | The device is substantially equivalent to the predicate device (Liquichek Urine Toxicology Control, K022707) in intended use, form (liquid), matrix (urine), and open vial stability. Differences exist in storage (unopened), fill volume, and specific analytes claimed, but these differences did not raise new questions of safety or effectiveness. |
| Intended Use Fulfilment | Intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. (The FDA's 510(k) clearance confirms this intended use as acceptable). |
| Composition and Preparation | Prepared from human urine with added drugs of abuse, metabolites, preservatives, stabilizers, and animal origin constituents. (This describes the material as submitted and found acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
As this document describes the stability and characteristics of a quality control material, rather than a diagnostic device's performance on patient data, the concept of a "test set" in the context of diagnostic accuracy is not directly applicable.
The performance data refers to:
- Stability Studies: These involve testing the control material over time under specified conditions. The sample size would be related to the number of vials/batches tested at various time points. This specific number is not provided in the summary.
- Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin for the data is implicitly the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve monitoring the product's characteristics over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the sense of expert consensus on patient cases is not relevant for the stability testing of a quality control material. The 'ground truth' for the stability studies would be the scientifically established chemical stability of the analytes, measured directly in the control material using validated analytical methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among experts on patient diagnoses. This is not a diagnostic device study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with and without AI assistance, in diagnostic tasks. This submission is for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an algorithm or AI device. The "device" is a physical control material.
7. The Type of Ground Truth Used
The "ground truth" for the stability data supporting the claims would be based on analytical measurements (e.g., using validated laboratory assays) of the analyte concentrations within the control material over time and under various storage conditions. This is a direct measurement of the control material's properties, not an expert panel diagnosis or pathology.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained in this context. The "training set" concept is not relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.