← Product Code [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ) · K031717 # ELECSYS SHBG IMMUNOASSAY (K031717) _Roche Diagnostics Corp. · CDZ · Aug 5, 2003 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K031717 ## Device Facts - **Applicant:** Roche Diagnostics Corp. - **Product Code:** [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ.md) - **Decision Date:** Aug 5, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1680 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use 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. ## Regulatory 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. ## Predicate Devices - DPC Immulite SHBG ([K941797](/device/K941797.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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): {1} Page 2 of 6 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. {2} 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 | {3} Page 4 of 6 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 {4} Page 5 of 6 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): {5} Page 6 of 6 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). --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K031717](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K031717) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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