(76 days)
The Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
The Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are prepared from simulated human urine with purified chemicals, constituents of animal origin, preservatives and stabilizers. The controls are available in two levels, ready to use liquid format packaged in dropper bottles under the brand name Mission Liquid Urine Control and in diptube containers under the brand name Mission Liquid Diptube Urine Control. The results of the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers.
The Mission Dry Strip Urine Control are firm plastic strips onto which reagent areas are affixed. The negative level strips have five reagent areas containing one or more synthetic ingredients. When placed in a measured quantity of distilled or deionized water, the ingredients dissolve out of the reagent areas to produce a Level 1 Control Solution. The Level 2 strips have six reagent areas affixed. The ingredients on the positive level strips dissolve out to produce a Level 2 Control Solution. The results of the Mission Dry Strip Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers
The provided 510(k) summary (K103387) describes the "Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, and Mission Dry Strip Urine Control" devices. However, it does not explicitly state specific, quantifiable acceptance criteria or provide a detailed study that proves the device meets such criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Discussion of Non-Clinical Tests Performed" section broadly lists types of evaluations conducted (matrix effects, control value assignment, temperature flexibility, humidity effect, lighting effect, number of dip times, incubation time, and shelf life and stability), but it does not present the results of these tests in a way that allows for the extraction of acceptance criteria or performance metrics directly from this document.
The "Conclusion" states: "The laboratory testing demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are safe, accurate and easy-to-use. It also demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are substantially equivalent to the Bio-Rad Laboratories Liquicheck Urinalysis Control and Siemens Healthcare Diagnostics Inc. Chek-Stix Positive and Negative Control Strips for Urine Chemistry, currently sold on the U.S. market."
Based on the provided text, the specific information requested cannot be fully extracted in the format desired for acceptance criteria and a performance study. Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully provided as specific, quantifiable acceptance criteria and performance data are not detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general statements about testing.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|
| Intended Use: For use as an assayed quality control urine to monitor the precision of urinalysis test procedures for listed analytes. | Met, as the intended use is "Same" as predicate devices. |
| Form: Liquid (for Liquid/Diptube), Dry strip (for Dry Strip). | Met, as the form is "Same" as predicate devices. |
| Levels: 2 | Met, as the number of levels is "Same" as predicate devices. |
| Storage Temperature: 2-8°C (Liquid/Diptube), 2-30°C (Dry Strip). | Met, though with slight differences in range for Dry Strip compared to predicate (2-30°C vs. 15-30°C), considered substantially equivalent. |
| Shelf Life: 24 months (Liquid/Diptube & Dry Strip). | Met, though with slight differences compared to predicates (24 months vs. 30 months for Liquid, 24 months vs. 18 months for Dry Strip), considered substantially equivalent. |
| Open Stability: Varies by device type and temperature. | Met, though with differences in duration and temperature compared to predicates, considered substantially equivalent. |
| Analytes Covered: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes, Ascorbic Acid. | Met, as listed analytes are "Same" as predicate for Dry Strip, and largely similar for Liquid (predicate has more). |
| Maximum Tests per Unit: 20 (diptube), 12 (dry strip). | Met, as listed. For Dry Strip, "Same" as predicate. |
| Preservatives: 0.02% Proclin | Met, as listed. |
| Temperature Flexibility: Demonstrated through testing. | Not specified quantitatively. |
| Humidity Effect: Demonstrated through testing. | Not specified quantitatively. |
| Lighting Effect: Demonstrated through testing. | Not specified quantitatively. |
| Number of Dip Times (diptube and dry strip only): Demonstrated through testing. | Not specified quantitatively. |
| Incubation Time (dry strip only): Demonstrated through testing (30 minutes). | Met, as listed. "Same" as predicate. |
| Shelf Life and Stability: Demonstrated through testing. | Not specified quantitatively beyond stated shelf life values. |
| Matrix Effects: Demonstrated through testing. | Not specified quantitatively. |
| Control Value Assignment: Demonstrated through testing. | Not specified quantitatively. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The text only refers to "Laboratory Testing" and "studies" without detailing the number of units or measurements included in these evaluations.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable based on the provided document. The device is a quality control material intended for validating the precision of urinalysis instruments and visual reading. The "ground truth" for such controls typically involves precisely manufactured solutions with known concentrations of analytes, not expert interpretation of results. The document states "control value assignment" was evaluated through laboratory testing, implying these values are determined analytically rather than by expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for this type of device is likely based on precise chemical formulation and analytical validation, not expert adjudication of subjective assessments.
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 for urinalysis, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device type.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a quality control material, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of its function.
7. The Type of Ground Truth Used
The ground truth for this type of device (urinalysis control) would be based on known, precisely manufactured concentrations of analytes within the control solutions. The document mentions "control value assignment" was evaluated, which supports this. It is a "manufacturer-assigned value" (also often referred to as an "assayed control").
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not an AI model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.