(114 days)
Immunoassay for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
A device for the measurement of human SHBG in serum or plasma.
Here's a breakdown of the acceptance criteria and study information for the Elecsys SHBG Immunoassay System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys SHBG Assay, K031717) rather than setting distinct acceptance criteria for the new device. Therefore, the "acceptance criteria" are implicitly "same as predicate" or "comparable to predicate" for most features.
| Feature | Implicit Acceptance Criteria (based on Predicate) | Reported Device Performance (Elecsys SHBG Assay in K102814) |
|---|---|---|
| Intended Use/Indications | Immunoassay for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma, for use on Elecsys and cobas e immunoassay analyzers. (Same as predicate) | Same |
| Assay Protocol | Sandwich assay (Same as predicate) | Same |
| Detection Protocol | Electrochemiluminescent Immunoassay (Same as predicate) | Same |
| Application | 18 Minute (Same as predicate) | Same |
| Instrument Platform | Roche Elecsys 1010, 2010/cobas e 411 and MODULAR ANALYTICS E170/cobas e 601 (Predicate) | Same, with the exception of the removal of the Elecsys 1010 analyzer. |
| Sample Volume | 10 µL (Same as predicate) | Same |
| Sample Type | Human serum and plasma treated with lithium heparin. (Same as predicate) | Same |
| Traceability | Standardized against the 1st International Standard for SHBG, NIBSC code 95/560. (Same as predicate) | Same |
| Calibrator | Elecsys SHBG CalSet (Same as predicate) | Same Sae |
| Calibration Interval | Once per reagent lot (with specific recommendations for renewed calibration based on instrument and time). (Predicate) | Same, with the exception of the removal of the Elecsys 1010 analyzer. |
| Controls | Elecsys PreciControl Universal 1 and 2 (Same as predicate) | Same |
| Reagent Stability/Storage | Specific conditions and durations (e.g., unopened, after opening, on analyzer). (Predicate) | Same, with the exception of the removal of the Elecsys 1010 analyzer. |
| Measuring Range | 0.350-200 nmol/L (Predicate) | 0.800 -200 nmol/L (Note: The lower limit has changed from the predicate. This is a key difference and implies an acceptance criterion for the new range.) |
| Expected Values | Reference ranges for various demographics (Males, Females). (Predicate) | Reference ranges for the SHBG (nmol/L): Males 20-49 years: N=136, Median=33.5, 5th Perc=16.5, 95th perc=55.9; Males ≥ 50 years: N=78, Median=40.8, 5th Perc=19.3, 95th perc=76.4; Females 21-49 years: N=89, Median=64.3, 5th Perc=24.6, 95th perc=122; Females ≥ 50 years: N=71, Median=57.4, 5th Perc=17.3, 95th perc=125. (Includes specific N, Median, 5th Perc, 95th perc for each group). |
| Precision | E1010/2010/411: Within Run 2.1 – 2.7 % CV, Total 2.6 – 5.6% CV. E170/e601: Within run 1.1 – 1.7% CV, Total 1.8 – 4.0% CV. (Predicate) | Same, with the exception of the removal of the Elecsys 1010 analyzer. |
| Analytical Sensitivity | Limit Detection Level (LDL): 0.35 nmol/L (Predicate) | Limit of Blank (LoB): 0.500 nmol/L; Limit of Detection (LoD): 0.800 nmol/L; Limit of Quantitation (LoQ): 2.00 nmol/L (Note: These are different specific metrics and values compared to the predicate's LDL. This implies an acceptance criterion for these new metrics.) |
| Hook Effect | No high-dose hook effect up to 1000 nmol/L. (Same as predicate) | Same |
| Limitations | Unaffected by certain levels of hemoglobin, bilirubin, intralipid, biotin, rheumatoid factors; no interference from 16 common pharmaceuticals; stated caveats about mouse antibodies and other interferences. (Same as predicate) | Same |
| Method Comparison | Correlation with a commercially available SHBG assay (y) vs (x) with specific statistical parameters (Slope, Intercept, Tau/r). (Predicate) | Passing/Bablok: Slope = 1.17, Intercept = -3.26; Linear Regression: Slope = 1.15, Intercept = -1.82; Tau / r = 0.909 / 0.981. (These reported values are for the new device as compared to the predicate or another commercial assay, implying that these statistics met an internal threshold for comparability to demonstrate substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document provides specific sample sizes for particular aspects of the performance evaluation:
- Expected Values (Reference Ranges for SHBG):
- Males 20-49 years: N = 136
- Males ≥ 50 years: N = 78
- Females 21-49 years: N = 89
- Females ≥ 50 years: N = 71
- Method Comparison: n = 109 clinical samples.
The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. The evaluations appear to be analytical performance studies of an immunoassay, typically relying on reference methods and statistical comparisons rather than expert consensus on diagnostic images or interpretations.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the studies described are analytical performance studies of a quantitative immunoassay, not clinical studies requiring adjudication of diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device is an in vitro diagnostic immunoassay, not an AI-powered diagnostic imaging tool or a device that involves human interpretation of results requiring MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Elecsys SHBG Immunoassay is a laboratory test, where the "algorithm" is the immunoassay procedure itself and the detection system on the analyzer. Its performance is by definition "standalone" in that it produces a quantitative result without human subjective interpretation of the raw signal to get that result. Human "in-the-loop" performance would relate to the interpretation of the numerical SHBG value in a clinical context, which is beyond the scope of the device's standalone performance.
7. The Type of Ground Truth Used
For the analytical performance characteristics:
- Traceability: The assay is standardized against the 1st International Standard for SHBG, NIBSC code 95/560. This serves as the ultimate "ground truth" for SHBG concentration.
- Expected Values (Reference Ranges): These are established through studies on healthy populations, deriving typical ranges.
- Method Comparison: The "ground truth" for the method comparison was a "commercially available SHBG assay (x)." This means the new device's performance was compared against an existing, likely validated, commercial assay.
8. The Sample Size for the Training Set
This information is not provided. The Elecsys SHBG Immunoassay System is a laboratory test, not a machine learning model that typically involves a distinct "training set." Its development would involve extensive R&D, assay optimization, and calibration, but the term "training set" doesn't directly apply in the same way it would for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the context of an immunoassay is different from AI/ML. The "ground truth" for optimizing such an assay would involve:
- Reference materials: Use of the International Standard for SHBG (NIBSC code 95/560) and other characterized control materials with known SHBG concentrations.
- Clinical samples: Testing of a broad range of patient samples (potentially used for method development and validation, which might be analogous to "training") with a reference method or validated predicate device to ensure accurate and reliable measurements across the measuring range.
The document implies this through the statements on traceability and method comparison, but does not explicitly detail the "training" process.
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.