← Product Code [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ) · K963080 # TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080) _Bayer Corp. · CDZ · Sep 27, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K963080 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [CDZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ.md) - **Decision Date:** Sep 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1680 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use This in vitro method is intended to quantitatively measure testosterone in human serum on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. ## Device Story The Immuno 1 Testosterone method is an in vitro diagnostic assay for the Technicon Immuno 1 system. It measures testosterone levels in human serum samples. The system processes samples to provide quantitative results, which clinicians use to diagnose and manage hormonal sexual disorders. The device operates in a clinical laboratory setting, managed by laboratory technicians or medical professionals. The output is a numerical concentration value (ng/mL), which informs clinical decision-making regarding patient hormonal status and treatment efficacy. ## Clinical Evidence Bench testing only. Performance compared to DPC Coat-a-Count RIA kit using 335 serum samples. Correlation: y=0.98x + 0.01, r=0.990, Syx=0.41 ng/mL. Precision (between-run) reported at three concentration levels (0.86, 3.13, 8.58 ng/mL) with CVs ranging from 2.2% to 6.3%. Specificity evaluated against various cross-reactants. ## Technological Characteristics In vitro diagnostic immunoassay reagents and calibrators for use on the Technicon Immuno 1 system. Quantitative measurement principle. Minimum detectable concentration 0.04 ng/mL. ## 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 Coat-a-Count Total Testosterone RIA kit (TKTT1) ## 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} SEP 20 '96 10:45AM CLIN MED & REG AF Enclosure 1 P.4/10 # SUMMARY OF SAFETY AND EFFECTIVENESS K-963080 # Testosterone Method for the Bayer Immuno 1® System SEP 27 1996 Listed below is a comparison of the performance between the Immuno 1 Testosterone method and a similar device that was granted clearance of substantial equivalence (DPC Coat-a-Count® Total Testosterone RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Testosterone method sheet and the DPC Total Testosterone method sheet. # INTENDED USE This in vitro method is intended to quantitatively measure testosterone in human serum on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. | METHOD | Immuno 1 Testosterone | DPC (predicate Device) | | --- | --- | --- | | Part No. | Reagents T01-3694-51 Calibrators T03-3695-01 | TKTT1 (100 tubes) | | Minimum Det. Conc. | 0.04 ng/mL | 0.04 ng/mL | | Precision (Between-Run) | 0.86 ng/mL 6.3% 3.13 ng/mL 3.5% 8.58 ng/mL 2.2% | 0.93 ng/mL 12% 2.64 ng/mL 6.4% 6.72 ng/mL 6.0% | | Correlation | y=0.98x + 0.01 where y=Immuno 1 Total Testosterone method x=DPC Total Testosterone method n=335 r=0.990 S_{yx}=0.41 ng/mL | | Gabe Muraca Bayer Corporation 511 Benedict Ave Tarrytown, NY 10591 Rev. Date: 09/16/96 {1} SEP 20 '96 10:45AM CLIN MEI . REG AF P.5/10 # Specificity | Crossreactant | Immuno 1 % Crossreactivity | DPC Coat-a-Count % Crossreactivity | | --- | --- | --- | | Aldosterone | ND | 0 | | 5β-Androstan-3α,17β-diol | 0.3 | 0.4 | | Androstenedione | 0.4 | 0.5 | | 5α-Androstan-3β,17β-diol | 1.2 | 0.04 | | 5-Androsten-3β,17β-diol | 0.8 | 0.2 | | 5α-Androstan-3,17-dione | ND | 0.05 | | Androsterone | ND | 0 | | Corticosterone | ND | 0 | | Cortisol | ND | 0 | | Cortisone | ND | 0 | | Danazol | ND | 0.09 | | 11-Deoxycortisol | ND | 0 | | Dexamethasone | ND | 0 | | DHEA | ND | 0 | | DHEA-Sulfate | ND | 0.01 | | 5α-Dihydrotestosterone | 4.7 | 3.3 | | Estradiol | 0.1 | 0.02 | | 5(10)-Estren-17α-ethynyl-17β-ol-3-0ne | ND | 0.2 | | 4-Estren-7α-methyl-17β-ol-one | ND | 1.1 | | 19-Nortestosterone | 7.6 | 20 | | Estrone | ND | 0.01 | | Ethisterone | 0.5 | 0.7 | | Fluoxymesterone | ND | 0.01 | | 19-Hydroxyandrostenedione | ND | 2 | | 11-Ketotestosterone | -1.2 | 16 | | 11β-Hydroxy testosterone | 14.2 | 0.8 | | Methyltestosterone | 2.2 | 1.7 | | Norethindrone | 0.1 | 0.1 | | Prednisone | ND | 0 | | Progesterone | ND | 0 | | Spironolactone | ND | 0 | | Triamicinolone | -0.1 | 0.2 | | 5α-Androstan-3α-,17β-diol | 0.2 | NR | | Desoxycortisone | ND | NR | | Estriol | ND | NR | | 11β-Hydroxyandrostenedione | ND | NR | | 11β-Hydroxyandrostenedione | ND | NR | | 17-Hydroxyprogesterone | ND | NR | NR= None reported ND=None detected Gabe Muraca Bayer Corporation 511 Benedict Ave Tarrytown, NY 10591 Rev. Date: 09/16/96 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K963080](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDZ/K963080) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com