(63 days)
Immunoassay for the in vitro quantitative determination 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 including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.
A device for the measurement of human SHBG in serum or plasma.
This document is a 510(k) summary for the Elecsys® SHBG Immunoassay by Roche Diagnostics Corporation, submitted to the FDA in 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device, the DPC Immulite SHBG. The information provided is characteristic of a medical device submission rather than a clinical study evaluating AI performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a modern AI-driven device are not present in this document. This submission is for an in-vitro diagnostic immunoassay, not an AI device.
Here's an analysis of the provided text based on your request, with a clear distinction for information that is not available from this document given its nature:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the way one might for an AI device. Instead, it presents performance characteristics of the Elecsys SHBG Immunoassay and compares them to a predicate device to demonstrate substantial equivalence. The "reported device performance" refers to the characteristics of the Elecsys SHBG Immunoassay.
| Feature | Elecsys SHBG Immunoassay Performance | DPC Immulite SHBG (predicate) Performance (for comparison) |
|---|---|---|
| Calibration Interval (E170/E2010) | After 1 month (same lot), After 7 days (same kit) | 2 weeks |
| Calibration Interval (E1010) | With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C) | 2 weeks |
| Sample Type | Human serum and Li-heparin plasma | Human serum |
| Reagent Stability (Unopened) | Up to stated expiration date at 2-8°C | 7 days at 2-8°C; 2 months at -20°C |
| Reagent Stability (Opened) | 12 weeks at 2-8°C (7 weeks on E170/2010, 4 weeks on E1010, up to 20 hours opened in total at 20-25° ambient temp) | 7 days at 2-8°C; 2 months at -20°C |
| Expected Values (Males) | 10-80 nmol/L | Central 95% 13-71 nmol/L; Median 32 nmol/L |
| Expected Values (Females) | 20-130 nmol/L | Central 95% 18-114 nmol/L; Median 51 nmol/L |
| Measuring Range | 0.350-200 nmol/L | 0.2-180 nmol/L |
| Precision (E170, Within-run) | 1.1-1.7 %CV from 14.9-219 nmol/L | 4.1-7.7 %CV from 4.5-121 nmol/L |
| Precision (E170, Total) | 1.8-4.0 %CV from 14.9-219 nmol/L | 5.8-13 %CV from 6.0-105 nmol/L |
| Precision (E1010/2010, Within-run) | 2.1-2.7 %CV from 14.1-204 nmol/L | (Not specified for predicate by instrument type) |
| Precision (E1010/2010, Total) | 2.6-5.6 %CV from 14.1-204 nmol/L | (Not specified for predicate by instrument type) |
| Hook Effect | No high dose hook effect up to 1000 nmol/L | No high-dose hook effect up to 11,000 nmol/L |
| Analytical sensitivity (LDL) | 0.35 nmol/L | 0.2 nmol/L |
| Interference (Bilirubin) | No interference up to 60 mg/dL | No interference up to 200mg/L |
| Interference (Hemoglobin) | No interference up to 2.9 g/dL | No interference up to 10000 mg/dL |
| Interference (Intralipid) | No interference up to 2700 mg/dL | (Not specified for predicate) |
| Interference (Biotin) | No interference up to 60 ng/mL (warning for >5 mg/dL) | (Not specified for predicate) |
| Interference (Rheumatoid factor) | No interference up to 1160 IU/mL | (Not specified for predicate) |
| Interference (Pharmaceuticals) | No interference from 16 commonly used pharmaceuticals | (Not specified for predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. A 510(k) summary typically doesn't detail the specific sample sizes used for each performance characteristic study (e.g., precision, interference) or the demographic/provenance of the samples. These details would be in the full submission, but not summarized here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is an immunoassay measuring a biochemical marker, not an AI device interpreting images or other data requiring expert human-established ground truth. The "ground truth" for an immunoassay is typically established by comparing its measurements to a reference method or validated standard, not by expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for an immunoassay. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging with multiple readers.
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
This is not applicable. This document describes an immunoassay, not an AI system. Therefore, no MRMC study involving human readers and AI assistance would have been performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the immunoassay device itself. The listed performance characteristics (precision, measuring range, analytical sensitivity, hook effect, interference) reflect the standalone performance of the Elecsys SHBG Immunoassay system (reagents + analyzer) as it would be used in a laboratory setting. Human intervention is involved in operating the analyzer and interpreting the quantitative results, but the "algorithm" equivalent is the chemical reaction and detection method within the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an immunoassay, the "ground truth" for accuracy and calibration is typically established using:
- Reference materials/standards: The document states "1st International Standard for SHBG NIBSC code 95/560" for traceability/standardization. This is the primary "ground truth" for ensuring the assay accurately measures SHBG.
- Known concentrations: For studies like precision, known concentrations of SHBG are used.
- Comparison to established/predicate methods: The entire 510(k) process is about demonstrating equivalence to an already legally marketed device (predicate), implying that the predicate's measurements serve as a comparative "truth"
- Clinical correlation: The "Intended Use" and "Indications for Use" connect the measured SHBG levels to clinical conditions, but the direct ground truth for the measurement itself comes from reference standards.
8. The sample size for the training set
This information is not available as the concept of a "training set" in the context of machine learning/AI does not apply to this immunoassay. The development of an immunoassay involves optimization and validation using various samples, but these are not referred to as a "training set" in the AI sense.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.