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.
Device Story
Elecsys SHBG Immunoassay is an in vitro diagnostic test for quantitative measurement of SHBG in human serum or plasma. It utilizes electrochemiluminescence immunoassay (ECLIA) technology on Roche Elecsys family analyzers (1010, 2010, E170). The assay measures SHBG levels to assist clinicians in diagnosing androgen-related disorders and interpreting sex hormone concentrations. The device is intended for professional use in clinical laboratory settings. Results are provided to physicians to aid in clinical decision-making regarding endocrine health and hormone balance. The assay offers improved precision and a wider measuring range compared to the predicate device.
Clinical Evidence
No clinical studies performed. Evidence based on analytical bench testing: precision (within-run CV ≤2.7%, total CV ≤4.0%), linearity (85-115% recovery), and analytical specificity (no cross-reactivity with common hormones/proteins). Method comparison with predicate (n=109) showed linear regression y = 1.15x – 1.82, r = 0.981. Matrix comparison (n=44) between serum and Li-heparin plasma showed r = 0.998.
Technological Characteristics
Electrochemiluminescent sandwich immunoassay. Reagents: streptavidin-coated microparticles, biotinylated mouse monoclonal anti-SHBG, ruthenium-labeled mouse monoclonal anti-SHBG. Measuring range: 0.350–200 nmol/L. Standardized against NIBSC 95/560. Analyzers: Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170. Calibrators: equine serum matrix and human SHBG in human serum matrix.
Indications for Use
Indicated for patients requiring quantitative determination of sex hormone binding globulin (SHBG) as an aid in diagnosing androgen disorders (hirsutism, virilization, PCOS, adrenogenital syndrome, hyperandrogenism), interpreting testosterone/estradiol levels, investigating androgen-estrogen balance in gonadal/sexual dysfunction, and assessing peripheral hormone effects.
Regulatory Classification
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.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K031717
B. Analyte:
Sex hormone binding globulin
Calibrator
Quality control material
C. Type of Test:
Quantitative; electrochemiluminescent immunoassay
D. Applicant:
Roche Diagnostics Corporation
E. Proprietary and Established Names:
Elecsys® SHBG Immunoassay System
Elecsys® SHBG CalSet
Elecsys® PreciControl Universal
F. Regulatory Information:
1. Regulation section:
21 CFR 862.1680 (reagent)
21 CFR 862.1150 (calibrator)
21 CFR 862.1660 (control)
2. Classification:
Class I (reagent)
Class II (calibrator)
Class I (control)
3. Product Code:
CDZ – Radioimmunoassay, testosterones and dihydrotestosterone
JIS – Primary calibrator
JJY – Multi-analyte controls, all kinds (assayed and unassayed)
4. Panel:
75
G. Intended Use:
1. Intended use(s):
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Elecsys® SHBG Immunoassay is for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Elecsys® SHBG CalSet is used for calibrating the quantitative Elecsys SHBG assay on Elecsys immunoassay systems.
PreciControl Universal is used for quality control of Elecsys immunoassay systems.
2. Indication(s) for use:
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 including hirsuitism, virilization, polycystic ovarian syndrome, andrenogenital 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.
3. Special condition for use statement(s):
Not applicable
4. Special instrument Requirements:
Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers
H. Device Description:
The Elecsys® SHBG Immunoassay kit contains reagents sufficient for 100 tests. The reagents are as follows: 1 bottle containing streptavidin-coated microparticles and preservative; 1 bottle containing biotinylated monoclonal anti-SHBG antibody (mouse), buffer, and preservative; and 1 bottle of monoclonal anti-SHBG antibody (mouse) labeled with ruthenium complex, buffer, and preservative.
The Elecsys® SHBG CalSet kit, sold separately, contains the following: lyophilized calibrators, barcode card, calibrator barcode sheet, 4 labeled empty snap-cap bottles, and 2 x 6 bottle labels. Calibrator 1 contains approximately 0 nmol/L SHBG in equine serum, and calibrator 2 contains approximately 40 nmol/L human SHBG in human serum matrix. Each calibrator is supplied in two bottles, each for 1 mL of calibrator.
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The PreciControl Universal, sold separately, contains the following: lyophilized controls, two barcode cards, control barcode sheet, $2 \times 2$ labeled empty snap-cap bottles, and $2 \times 6$ bottle labels. The control serum is based on human serum in two concentration ranges. The two controls are supplied in two bottles, each for $3 \mathrm{~mL}$ of control.
# I. Substantial Equivalence Information:
1. Predicate device name(s): DPC Immulite SHBG
2. Predicate K number(s): K941797
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of sex hormone-binding globulin in serum, for professional use | Quantitative determination of sex hormone-binding globulin in serum, for professional use |
| Principle | Immunoassay | Immunoassay |
| Differences | | |
| Item | Device | Predicate |
| IU/Specimen | Serum and Li-heparain plasma | Serum only |
| Instrument(s) | Elecsys 1010/2010 and MODULAR ANALYTICS E170 | Immulite |
| Reagents | Streptavidin-coated microparticles, biotinylated mouse monoclonal anti-SHBG, mouse monoclonal anti-SHBG labeled with ruthenium complex | Monoclonal murine anti-SHBG coated beads, alkaline phosphatase conjugated to polyclonal rabbit anti-SHBG |
| | Calibrators – equine serum matrix and SHBG in human serum matrix Controls – SHBG in human serum | Adjustors and controls – SHBG in nonhuman protein/buffer matrix |
| Reportable Range | 0.350 – 200 nmol/L | 0.2 - 180 nmol/L |
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J. Standard/Guidance Document Referenced (if applicable):
Not applicable
K. Test Principle:
The Elecsys® SHBG Immunoassay is an electrochemiluminescent, sandwich based assay.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility was determined using Elecsys reagents, pooled human serum and controls in a modified protocol (EP5-A) of the National Committee for Clinical Laboratory Standards (NCCLS). In one study n = 60 and in another, n = 21. Within-run precision results were 2.7% CV and below. Total precision results were 4.0% CV and below.
b. Linearity/assay reportable range:
Linearity was evaluated by diluting three patient samples with varying amounts of the low-analyte human serum. In order to demonstrate linearity at the lower end of measuring range, a patient sample was diluted with varying amounts of horse serum, as analyte-free human serum is difficult to obtain.
The expected values were generated using the concentrations measured in the diluent and the undiluted patient sample and then applying the dilution factors. The % recovery was determined by dividing the measured concentration with the expected concentration. Linearity was defined as 85-115% recovery.
The measuring range is 0.350-200 nmol/L (defined by the lower detection limit and the maximum of the master curve). Values below the detection limit are reported as <0.350 nmol/L. Values above the measuring range are reported as >200 nmol/L.
c. Traceability (controls, calibrators, or method):
The assay has been standardized against the 1st International Standard for SHBG from the National Institute for Biological Standards and Controls (NIBSC) code 95/560. The CalSet is traceable to NIBSC’s 1st International Standard for SHBG.
d. Detection limit:
The detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying
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two standard deviations above that of the lowest standard (master calibrator, within-run precision, n = 21).
e. Analytical specificity:
The specificity of the Elecsys® SHBG was determined using human serum samples spiked with potential cross-reactant compounds and non-spiked human serum samples. The spiked and non-spiked samples were tested in duplicate. Non detectable cross reactivities were found for AFP, CBG, DHT, estradiol, fibrinogen, human IgA, human IgG, plasminogen, TBG, testosterone, Tg, transferring, and TSH.
Endogenous interferences were evaluated by using natural and spiked samples. The assay was unaffected by icterus (bilirubin < 1026 μmol/L or < 60 mg/dL), hemolysis (Hb < 1.8 mmol/L or < 2.9 g/dL), lipemia (Intralipid < 2700 mg/dL), and biotin < 60 ng/mL. The criterion was recovery within +/- 10% of initial value. Additionally, no interference was observed from rheumatoid factors up to 1160 U/mL.
f. Assay cut-off:
See Detection limit above.
2. Comparison studies:
a. Method comparison with predicate device:
The Elecsys® SHBG Immunoassay was compared with a commercially available SHBG assay using 109 clinical samples. Each sample was tested in singleton. SHBG values ranged from 11.2 – 155 nmol/L. The following linear regression resulted: y = 1.15x – 1.82, r = 0.981.
b. Matrix comparison:
A comparison of values obtained from samples drawn into serum and Li heparin plasma vacutainer tubes was conducted. Forty four samples were analyzed and included concentrations ranging from 18-244 nmol/L. The following linear regression resulted: y = 0.99x – 0.39, r = 0.998.
3. Clinical studies:
a. Clinical sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a and b are not applicable):
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Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The following expected values are from published literature:
Males 10-80 nmol/L
Females 20-130 nmol/L
M. Conclusion:
Descriptive characteristics and performance data above demonstrate that the new device is similar to the DPC Immulite SHBG and other commercially available assays of this type. Additionally, the labeling is adequate and conforms to 21 CFR 809.10. Therefore, I recommend a substantial equivalence determination for the Elecsys® SHBG Immunoassay System, Elecsys® SHBG CalSet, and PreciControl Universal (as modified).
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
