(154 days)
The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
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Here's an analysis of the acceptance criteria and study information for the Uric Acid (AOX) device based on the provided 510(k) summary:
This device is an IVD (In Vitro Diagnostic) and the criteria and performance metrics are related to analytical performance, not clinical performance metrics typical of AI/ML devices for diagnostic imaging studies. Therefore, many of the requested fields for AI/ML studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K991576) | Reported Device Performance (Uric Acid (AOX)) |
|---|---|---|
| Measuring Range | Serum: 0 - 20 mg/dL | Serum: 0.2 - 20.0 mg/dl (10 - 1200 µmol/l) |
| Urine: 0 - 180 mg/dL | Not applicable (device does not test urine) | |
| Precision | Within Run: | Within Run: |
| Level 3.9 mg/dL: CV(%) = 1.1 | Level 1.2 mg/dL: CV(%) = 0.8 | |
| Level 8.6 mg/dL: CV(%) = 1.1 | Level 2.3 mg/dL: CV(%) = 0.7 | |
| Level 10.0 mg/dL: CV(%) = 0.6 | Level 4.4 mg/dL: CV(%) = 0.7 | |
| Level 8.9 mg/dL: CV(%) = 0.5 | ||
| Total Precision: | Between Run: | |
| Level 3.9 mg/dL: CV(%) = 1.9 | Level 1.2 mg/dL: CV(%) = 1.3 | |
| Level 8.6 mg/dL: CV(%) = 1.6 | Level 2.3 mg/dL: CV(%) = 0.9 | |
| Level 10.0 mg/dL: CV(%) = 2.3 | Level 4.4 mg/dL: CV(%) = 0.7 | |
| Level 8.9 mg/dL: CV(%) = 0.4 | ||
| Total Precision: | ||
| Level 1.2 mg/dL: CV(%) = 2.3 | ||
| Level 2.3 mg/dL: CV(%) = 1.7 | ||
| Level 4.4 mg/dL: CV(%) = 2.8 | ||
| Level 8.9 mg/dL: CV(%) = 1.1 | ||
| Method Comparison | Comparison to Technicon DAX: r = 0.994 | Comparison to Bayer ADVIA 2400: R = 0.999 |
| Range: 0.2 - 18.0 mg/dL | Range: 0.3 to 12.6 mg/dL | |
| N = 154 | N = 105 | |
| Comparison to Reference Method: r = 0.999 | ||
| Range: 1.7 - 19.5 mg/dL | ||
| N = 49 | ||
| Limitations | Hemolysate: No significant interference up | Lipemia: No interference up to 900 mg/dl |
| to 525 mg/dl of hemoglobin | Hemolysate: No interference up to 1000 mg/dl of hemoglobin | |
| Bilirubin: No significant interference up | Bilirubin conjugated: No interference up | |
| to 30 mg/dl | to 11 mg/dl | |
| Triglycerides: Effect measured | Bilirubin total: No interference up to | |
| 14 mg/dl |
Note: The acceptance criteria for the new device are implicitly demonstrated by showing comparable or better performance relative to the predicate device across the various analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" but rather presents a comparison to the predicate, implying that performance similar to or better than the predicate is considered acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison (Linearity/Correlation): N = 105 human serum/plasma samples (range 0.3 to 12.6 mg/dL).
- Precision: Not explicitly stated as "sample size" but rather "levels" tested (e.g., Level 1.2 mg/dL, 2.3 mg/dL, 4.4 mg/dL, 8.9 mg/dL) with corresponding SD and CV values. Typically, precision studies involve multiple replicates of control or patient samples.
- Limitations (Interference): Specific concentrations of interfering substances (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested. The number of samples for each interference test is not explicitly stated.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human serum or plasma" samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for an in vitro diagnostic (IVD) device that quantifies a biomarker (uric acid) using chemical reactions on an instrument. The "ground truth" for the test set is established by comparative measurements against a legally marketed predicate device (Bayer ADVIA 2400) and/or reference methods, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic decisions (e.g., in medical imaging).
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
- No. This is an IVD device for quantitative measurement, not a diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, effectively. The performance data presented (measuring range, precision, method comparison, limitations) are measurements of the device's analytical performance on its own (algorithm/reagent/instrument combination) without human qualitative interpretation being a variable. The device provides a quantitative measurement, and its accuracy and precision are assessed directly.
7. The Type of Ground Truth Used
- Comparative Measurement to a Predicate Device and Traceability to a Primary Reference (NIST SRM 909b).
- Method Comparison: The device's results were compared to the Bayer ADVIA 2400 Chemistry System, which serves as a widely accepted "ground truth" for method comparison in IVD submissions.
- Traceability/Standardization: The value of Uric Acid (AOX) is stated to be assigned using NIST SRM 909b as a primary reference. The predicate device also establishes traceability to the CDC candidate reference method, which uses NIST reference materials. This indicates a strong chain of traceability to established analytical standards for ground truth.
8. The Sample Size for the Training Set
- Not explicitly stated/applicable in the context of this traditional IVD. Traditional IVDs like this do not typically use "training sets" in the same way machine learning algorithms do. The development process involves optimizing the reagent formulation and instrument parameters, which is an iterative process, but not framed as "training" with a specific data set.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated/applicable. As mentioned above, the concept of a "training set" and establishing ground truth for it is not directly transferable to the development of this type of IVD device. The development relies on principles of analytical chemistry, reagent formulation, and instrument engineering to achieve accurate and precise measurements traceable to established standards.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.