← Product Code [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ) · K964889 # ELECSYS TESTOSTERONE ASSAY (K964889) _Boehringer Mannheim Corp. · CDZ · Mar 18, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K964889 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ.md) - **Decision Date:** Mar 18, 1997 - **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 of testosterone in serum and plasma. ## Device Story Elecsys® Testosterone Assay is an in vitro diagnostic immunoassay for quantitative testosterone measurement in serum and plasma. It utilizes an electrochemiluminescence (ECL) competition principle. Sample is incubated with biotinylated testosterone-specific antibody and ruthenium-labeled testosterone derivative; immunocomplexes form. Streptavidin-coated microparticles bind the complex via biotin-streptavidin interaction. Microparticles are magnetically captured on an electrode in the Elecsys® 2010 instrument. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated via a 2-point calibration curve and master curve provided by reagent bar code. The assay provides clinicians with quantitative testosterone levels to aid in the diagnosis and monitoring of testosterone-related conditions. ## Clinical Evidence Bench testing only. Performance compared to RIA predicate (N=71). Precision (within-run and total) reported across low, mid, and high levels. Lower detection limit 0.02 ng/mL. Linearity 0.02-15.00 ng/mL. Method comparison (Passing/Bablok) yielded y = 1.02x - 0.108, r = 0.963. Interference testing performed for bilirubin, hemoglobin, lipemia, and biotin. Specificity evaluated via cross-reactivity testing against various steroids. ## Technological Characteristics Electrochemiluminescence immunoassay. Uses biotinylated testosterone-specific antibody and ruthenium-labeled testosterone derivative. Solid-phase: streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescence induced by electrode voltage. Instrument: Elecsys® 2010. Calibration: 2-point, master curve via reagent bar code. Connectivity: instrument-specific. ## 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 - Coat-A-Count® Total Testosterone Assay (K81340) - [K844423](/device/K844423.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} MAR 18 1997 K964889 510(k) Summary BEEFERIEGER MANNHEIM CORPORATION ## Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ### 1. Submitter name, address, contact Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, CA 94524-4117 (510) 674 - 0690 extension 8413 FAX 510 687 - 1850 Contact Person: Yvette Lloyd Date Prepared: December 5, 1996 ### 2. Device name Proprietary name: Elecsys® Testosterone Assay Common name: Electrochemiluminescence assay for the determination of testosterone. Classification name: System, Test, Testosterone ### 3. Predicate device We claim substantial equivalence to the Coat-A-Count® Total Testosterone Assay (K81340). (K84423) Continued on next page page 27 {1} 510(k) Summary, Continued 4. Device Description Competition principle. Total duration of assay: 18 minutes. - 1st incubation (9 min.): 50 µL of sample is incubated with a testosterone-specific biotinylated antibody (55 µL) and a testosterone derivative labeled with a ruthenium complex (55 µL).** The binding sites of the labeled antibody become occupied partly by the sample analyte (depending on its concentration) and partly by the ruthenium-labeled hapten to form the respective immunocomplexes. - 2nd incubation (9 min.): After addition of streptavidin-coated microparticles (40 µL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin. - The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). - Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)²⁺) 5. Intended use Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma. 6. Comparison to predicate device The Boehringer Mannheim Elecsys® Testosterone Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Coat-A-Count® Total Testosterone Assay (K81340). K844423 Continued on next page {2} 510(k) Summary, Continued 6. Comparison to predicate device, cont. The following table compares the Elecsys® Testosterone Assay with the predicate device, Coat-A-Count® Total Testosterone Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6. Similarities: - Intended Use: Immunoassay for the in vitro quantitative determination of testosterone - Sample type: Serum and plasma Differences: | Feature | Elecsys® Testosterone | Coat-A-Count® Total Testosterone | | --- | --- | --- | | Solid-Phase Binding Principal | Streptavidin/Biotin | Antibody-coated tubes | | Reaction test principle | Electrochemiluminescence | Radioimmunoassay (RIA) | | Instrument required | Elecsys® 2010 | Gamma counter | | Calibration Stability | A calibration is recommended every 7 days if kit is not consumed; 4 weeks with same reagent lot if reagent is consumed within 7 days. | Calibration required every run | Continued on next page {3} 510(k) Summary, Continued 6. Comparison to predicate device, cont. Performance Characteristics: | Feature | Elecsys® Testosterone | | | Coat-A-Count® Total Testosterone | | | | --- | --- | --- | --- | --- | --- | --- | | Precision | Modified NCCLS (ng/mL): | | | Modified NCCLS (ng/mL): | | | | Level | Low | Mid | High | Low | Mid | High | | Within-Run: N | | | | | | | | Mean | 60 | 60 | 60 | -- | -- | -- | | %CV | 0.24 | 2.75 | 7.01 | -- | -- | -- | | Total: N | 4.62 | 1.39 | 1.09 | -- | -- | -- | | Mean | 60 | 60 | 60 | 20 | 20 | 20 | | %CV | 0.24 | 2.75 | 7.01 | 0.76 | 2.64 | 6.72 | | | 7.41 | 2.21 | 1.68 | 11.0 | 6.4 | 6.0 | | Lower Detection Limit | 0.02 ng/mL | | | 0.04 ng/mL | | | | Linearity | 0.02-15.00 ng/mL (with a deviation from a linear line of ±10%) | | | 0.04-16.00 ng/mL (with a deviation from a linear line of ±10%) | | | | Method Comparison | Vs RIA for Testosterone Least Squares y = 0.956x + 0.049 r = 0.963 SEE = 0.459 N = 71 Passing/Bablok y = 1.02 x - 0.108 r = 0.963 SEE = 0.349 N = 71 | | | Vs RIA for Testosterone Least Squares y = 1.23x + 0.16 r = 0.987 SEE = --- N = 83 | | | Continued on next page {4} Premarket Notification, 510(k) for Elecsys® Testosterone, Continued F. Substantial equivalence, cont. Performance Characteristics, cont: | Feature | Elecsys® Testosterone | | Coat-A-Count® Total Testosterone | | | --- | --- | --- | --- | --- | | Interfering substances | No interference at: | | No interference at: | | | Bilirubin | 25 mg/dL | | Not listed | | | Hemoglobin | 1.0 g/dL | | Not listed | | | Lipemia | 1500 mg/dL | | Not listed | | | Biotin | 30 ng/mL | | Not listed | | | Specificity | Level tested (ng/mL) | %Cross-reactivity | Level tested (ng/mL) | %Cross-reactivity | | 5-α-Dihydrotestosterone | 40 | 1.89 | 50 | 3.3 | | 11-Ketotestosterone | 40 | 10.4 | 1.3 | 16 | | 11-β-Hydroxytestosterone | 40 | 8.34 | 2000 | 0.8 | | Ethisterone | 40 | 0.02 | 50 | 0.7 | | 5-Androstene-3β,17β-diol | 40 | 0.30 | 250 | 0.2 | | Androstenedione | 40 | 0.91 | --- | --- | | 5-α-Androstan-3β,17β-diol | 40 | 0.51 | 1000 | 0.04 | | Danazol | 40 | 0.00 | 200 | 0.09 | | Norgestrel | 40 | 0.00 | --- | --- | | Estradiol | 40 | 0.00 | 1000 | 0.02 | --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K964889](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K964889) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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