(28 days)
J&S Medical Associates Sentry dipstick urine controls are intended to be used by laboratory technicians in order to verify the performance of various urine dipsticks as a part of the laboratory's quality control practices.
The three Sentry controls are prepared with human and animal proteins and with various chemical additives. These chemicals interact with the dipstick reactant pads to produce specific color changes that mimic actual normal and/or abnormal urine samples.
Here's an analysis of the provided text regarding the acceptance criteria and study for the J&S Medical Sentry Urine Dipstick Control:
The provided document is a 510(k) Summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical trial for efficacy. Therefore, much of the requested information (like specific acceptance criteria for a diagnostic performance metric, MRMC studies, or training set details) is not present. The "study" described is primarily a stability evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly related to the stability of the controls – that they continue to react "within specifications" and produce "positive" or expected results with dipsticks over time, mimicking actual urine samples. The reported device performance is that it met these stability specifications.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain performance within specifications for 65 days at 4°C, ambient, 25°C, and 37°C when tested with Quidel and Bayer dipsticks. | All controls performed "within specifications" after 65 days incubation at 37°C. |
| Maintain hCG positive response for 120 days at 4°C, 25°C, and 37°C when tested with Quidel QuickVue One-Step hCG Combo. | A positive response for hCG was detected after 120 days. |
| Maintain performance within specifications for 65 days at ambient temperature (open vial) when tested with Quidel and Bayer dipsticks. | Controls reacted "within specifications" at day 65. |
| Shelf life of two years. | Indicated a shelf life of two years for all three controls based on the 65-day 37°C stability data. |
| Open vial shelf life of at least two months. | Indicated open vial shelf life of at least two months based on 65-day ambient stability data. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: Samples of the three Sentry controls (Level 1, Level 2, and Level 3).
- Sample Size for Stability Testing: Not explicitly stated as a number of distinct "samples" or replicates beyond "Samples of the three controls." The focus is on the long-term observation of these control solutions.
- Data Provenance: The study was conducted by J&S Medical Associates. The country of origin of the data is not specified but is presumably the USA, where the company is based. The study is prospective in nature, as it involves incubating the controls and testing them at future intervals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a urine dipstick control is its known chemical composition and intended reactivity profile. The evaluation involves comparing the control's observed reactions to these known profiles, not to an expert's diagnosis. The testing involved visual comparison to color charts and instrument readings, which are objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" (expected results for the controls) is inherent in their formulation. The stability assessment involves direct measurement and comparison to predefined specifications (visual color chart matching or instrument readings), not expert adjudication of subjective findings.
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
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore, an MRMC study or AI-related effectiveness analysis is entirely outside the scope of this submission. The device is intended to verify the performance of existing urine dipsticks, which include both visual and instrument-read types.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As a urine dipstick control, this device is not an algorithm. Its performance is assessed by its chemical reactivity, not by an algorithm's output.
7. The Type of Ground Truth Used
The ground truth used is the known chemical composition and expected reactivity profile of the control solutions. These controls are manufactured to elicit specific reactions on urine dipsticks. Their performance is verified by ensuring they consistently produce these expected results over time under various conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical control, not a machine learning algorithm, and thus does not have a "training set" in the computational sense. The "training" in manufacturing would relate to process control and formulation development, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.