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510(k) Data Aggregation
(79 days)
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur® Testosterone II (TSTI) assav is for in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.
Measurements 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) due to tumors, polycystic ovaries, and adrenogenital syndromes.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.
The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The re-standardized ADVIA Centaur® Testosterone II (TSTII) and the ADVIA Centaur® SHBG are in vitro diagnostic immunoassays for use on the ADVIA Centaur® XP system. The ADVIA Centaur® Testosterone II (TSTII) assay quantitatively determines total testosterone in human serum and plasma. The ADVIA Centaur® SHBG assay quantitatively determines sex hormone-binding globulin (SHBG) in human serum and plasma. The submission includes details on the ingredients of the reagents for both assays.
Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur® Testosterone II (TSTII) and ADVIA Centaur® SHBG based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (ADVIA Centaur® Testosterone II (TSTII)) | Reported Device Performance (ADVIA Centaur® Testosterone II (TSTII)) | Acceptance Criteria (ADVIA Centaur® SHBG) | Reported Device Performance (ADVIA Centaur® SHBG) |
|---|---|---|---|---|
| Detection Limits | ||||
| Limit of Blank (LoB) | (Implicitly good performance relative to predicate) | 2.50 ng/dL | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Limit of Detection (LoD) | (Implicitly good performance relative to predicate) | 5.00 ng/dL (95% probability) | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Limit of Quantitation (LoQ) | (Total CV of 20%) | 7.00 ng/dL (at 20% CV) | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Precision | (Implicitly good performance relative to predicate) | See table below for detailed CVs across various samples and concentrations. Generally, Within-Run CVs are lower than Within-Lab CVs. | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Linearity | Bias from linear fit estimate < 10% | Bias from the linear fit estimate was <10% for all 9 samples. | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Method Comparison | Acceptable correlation with predicate device and reference method | Vs ID-LC-MS/MS: y = 0.97(x) - 0.22 ng/dL (r = 0.98) Vs Predicate ADVIA Centaur TSTII: y = 1.04(x) - 4.14 ng/dL (r = 1.00) Vs Dimension Vista LOCI Total Testosterone (Adult & Pediatric): y = 1.01(x) - 3.32 ng/dL (r = 0.99) Vs Dimension Vista LOCI Total Testosterone (Pediatric only): y = 1.01(x) - 4.74 ng/dL (r = 1.00) | (Implicitly good agreement with predicate with new reference intervals not affecting analytical performance) | (Previously established, see K151986 & K091867; this submission focused solely on new reference intervals) |
| Reference Intervals | Established in accordance with CLSI guideline EP28-A3c | New reference intervals established and provided in detail for adult and pediatric populations, stratified by age and Tanner stage. | Established in accordance with CLSI guideline EP28-A3c | New reference intervals established for adult male and female populations. |
| Biotin Interference | No significant effect on the assay at 30 ng/mL | % Bias ranged from 2% to 6% for 30 ng/mL biotin at various analyte concentrations. Higher biotin levels (e.g., 250, 500 ng/mL) showed significant bias. | Less than or equal to 10% change in results at 300 ng/mL | % Bias ranged from -3% to -9% at 300 ng/mL biotin for various analyte concentrations. Higher biotin levels (e.g., 600, 1200 ng/mL) showed greater bias. |
ADVIA Centaur® Testosterone II (TSTII) Precision Results:
| Sample | n | Mean (ng/dL) | SD (Repeatability) | CV (Repeatability) | SD (Within-Lab) | CV (Within-Lab) |
|---|---|---|---|---|---|---|
| Control 1 | 80 | 257.38 | 9.06 | 3.5 | 14.38 | 5.6 |
| Control 2 | 80 | 636.57 | 45.14 | 7.1 | 53.12 | 8.3 |
| Control 3 | 80 | 1021.93 | 62.28 | 6.1 | 81.02 | 7.9 |
| MDP1 | 80 | 20.92 | 1.3 | 6.2 | 1.86 | 8.9 |
| MDP2 | 80 | 73.57 | 3.54 | 4.8 | 5.24 | 7.1 |
| MDP3 | 80 | 312.81 | 13.4 | 4.3 | 23.99 | 7.7 |
| MDP4 | 80 | 776.64 | 42.59 | 5.5 | 58.26 | 7.5 |
| MDP5 | 80 | 1123.83 | 59.22 | 5.3 | 109.57 | 9.7 |
| Female Patient Serum Pool | 80 | 15.86 | 1.84 | 11.6 | 2.39 | 15.1 |
2. Sample sizes used for the test set and the data provenance:
-
ADVIA Centaur® Testosterone II (TSTII):
- Precision: 80 replicates per sample, totaling 9 samples (3 controls, 5 medical decision pools, 1 female patient serum pool). Data provenance not explicitly stated, but typically internal lab data.
- Linearity: 9 serially diluted samples. Data provenance not explicitly stated.
- Method Comparison:
- Vs ID-LC-MS/MS: 108 adult male and female serum samples (7.27-1394.00 ng/dL). Data provenance not explicitly stated, but implied to be patient samples.
- Vs Predicate ADVIA Centaur TSTII: 108 individual male and female adult serum samples (10.93-1439.77 ng/dL). Data provenance not explicitly stated.
- Vs Dimension Vista LOCI Total Testosterone: 124 serum samples (79 adult, 45 pediatric). Data provenance not explicitly stated.
- Pediatric: 45 samples (31 females, ages 7-18; 14 males, ages 22 months-18 years).
- Reference Intervals: Samples from apparently healthy, normal adult females and males, and pediatric populations. Collected prospectively.
- Adult Male (Under 50): 250 samples
- Adult Male (50 and Over): 135 samples
- Adult Female (Under 50): 224 samples
- Adult Female (50 and Over): 151 samples
- Pediatric Male (by Tanner Stage): 101-129 samples per stage
- Pediatric Male (by Age): 27-149 samples per age group
- Pediatric Female (by Tanner Stage): 49-138 samples per stage
- Pediatric Female (by Age): 145-174 samples per age group
- Biotin Interference: Not explicitly stated, but typically in-house spiked samples.
-
ADVIA Centaur® SHBG:
- Reference Intervals: Samples from apparently healthy, normal adult females and males. (Presumably collected prospectively, similar to TSTII).
- Adult Male (Under 50): 250 samples
- Adult Male (50 and Over): 135 samples
- Adult Female (Under 50): 224 samples
- Adult Female (50 and Over): 151 samples
- Biotin Interference: Not explicitly stated, but typically in-house spiked samples.
- Reference Intervals: Samples from apparently healthy, normal adult females and males. (Presumably collected prospectively, similar to TSTII).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For both devices: The ground truth for the ADVIA Centaur® Testosterone II (TSTII) method comparison was established using ID-LC-MS/MS (Isotope Dilution Liquid Chromatography-Mass Spectrometry/Mass Spectrometry), with samples assigned concentrations by the CDC HoSt RMP ID-LC/MS/MS. This is an analytical reference method, not expert human readers.
- For the ADVIA Centaur® SHBG, the ground truth for traceability/standardization is stated as WHO 2nd International Standard (08/226), an internationally recognized analytical standard.
No human experts were used to establish the ground truth for the test set in the traditional sense of image or clinical interpretation. The methods employed are laboratory analytical techniques. When discussing reference intervals for pediatric subjects, it mentions that "Samples were also clinically characterized according to Tanner Stage," which would implicitly involve clinical experts (pediatricians or endocrinologists) for classification, but the number and qualifications are not specified in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. The ground truth was established by objective analytical reference methods (ID-LC-MS/MS) and international standards (WHO).
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 document describes laboratory diagnostic devices (immunoassays) for quantitative determination of biomarkers, not AI-assisted image analysis or clinical decision support tools that involve human readers/interpreters in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this describes standalone performance. The ADVIA Centaur® Testosterone II (TSTII) and ADVIA Centaur® SHBG are automated in-vitro diagnostic assays. The performance metrics (precision, linearity, method comparison, detection limits, etc.) represent the performance of the algorithm/instrument itself without human intervention in the measurement process, beyond sample loading and general operation according to the Instructions for Use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Analytical Reference Methods and International Standards:
- For the ADVIA Centaur® Testosterone II (TSTII), the primary ground truth for method comparison was ID-LC-MS/MS (specifically, CDC HoSt RMP ID-LC/MS/MS).
- For the ADVIA Centaur® SHBG, the primary ground truth for traceability/standardization is the WHO 2nd International Standard (08/226).
- For reference intervals, apparently healthy individuals were identified, and for pediatric subjects, Tanner Stage classification was used, which is a clinical assessment.
8. The sample size for the training set:
- Not explicitly stated in this document. The document discusses the performance of a re-standardized assay (ADVIA Centaur® Testosterone II (TSTII)) and new reference intervals for another (ADVIA Centaur® SHBG). It does not detail the development or "training" process of the original assays or any underlying algorithms, which would typically involve a separate, often larger, dataset. The studies described are primarily for validation of the modified device and new reference intervals.
9. How the ground truth for the training set was established:
- Not explicitly stated in this document. As mentioned above, this document focuses on validation studies of a modified/re-standardized device and new reference intervals for an existing device, rather than the initial development and "training" of the assays. The original development would have involved similar analytical ground truth methods, but the specifics are not provided here.
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