(37 days)
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology enzyme Immunoassay (EIA) screening procedures.
Liquichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek Urine Toxicology Control (Levels S1S and S2S):
The provided document is a 510(k) summary for a medical device (quality control material for toxicology testing). It claims substantial equivalence to a predicate device and does not detail a study conducted to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study comparing it to an external reference standard. Instead, the "study" referenced focuses on stability testing to support product claims.
Therefore, many of the requested fields cannot be directly extracted from this document as they pertain to a type of performance study that was not conducted or reported here.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Implied from predicate comparison and claims) | Reported Device Performance |
|---|---|
| Intended Use: Quality control to monitor performance of laboratory urine toxicology EIA screening procedures. | Matches intended use of predicate device. |
| Form: Liquid | Liquid |
| Matrix: Urine | Urine |
| Storage (Unopened): 2-8°C until expiration date | 2-8°C until expiration date |
| Open Vial Stability: 30 days at 2-8°C | Claimed: 30 days at 2-8°C (supported by stability studies) |
| Shelf Life: (Not explicitly stated as an initial acceptance criteria, but a claim to be supported) | Claimed: Three years stored at 2-8 °C (supported by ongoing real-time studies for future validation) |
| Drug Content: Specific panel of drugs. | The new device contains a modified panel of drugs compared to the predicate, with MDMA added and several others removed. This is a difference, not a direct performance measure against a criterion. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for a clinical performance test. The "performance data" section only references "stability studies."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of study (stability) does not typically involve expert review for ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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:
- No. This is a quality control material, not an AI-powered diagnostic device. An MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a quality control material.
7. The type of ground truth used:
- For the stability studies, the "ground truth" would be the known concentration of the spiked drugs in the control material, measured by a reference method over time.
8. The sample size for the training set:
- Not applicable. This device is a quality control material, not an algorithm that requires training 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.