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The Biodata Testosterone Maia Kit is a radioimmunoassay for the quantitative determination of testosterone in human serum or plasma. The device is intended to be used for the diagnosis of elevated or depressed levels of testosterone. It is FOR IN VITRO DIAGNOSTIC USE ONLY.

Neoplasms of the testes and adrenal cortex and hyperthyroidism may result in elevated levels of testosterone in the male. Elevated testosterone levels are observed in females with endometrial carcinoma, hirsutism, neoplasms of the ovaries, and Cushing syndrome. Patients with hypogonadism of pituitary origin, anorchia, gonadel dysgenesis, Klinefelter syndrome, and pseudohermaphroditism have decreased testosterone levels.

Device Description

The Biodata Testosterone Maia kit is based on the competitive binding principles of radioimmunoassay. Testosterone (unlabeled antigen) in samples, standards, or controls competes with testosterone labeled with radioactive 1251 ("testosterone - 1251") (labeled antigen) for a limited number of testosterone antibody sites. The amount of testosterone - 1251 bound by the antibody is inversely proportional to the amount of testosterone present in the sample, standard, or control. Testosterone Maia Separation Reagent (an antibody covalently bound to a magnetic particle capable of binding the testosterone antibody) is added to the reaction mixture to facilitate the separation of the bound and free fractions of labeled testosterone. The bound fraction of each standard, sample and control is sedimented in a magnetic separator. Each bound fraction is then counted in a gamma counter calibrated to detect 125].

The concentration of testosterone in the samples can be determined by comparing the relative percent binding of the standards with known concentrates of testosterone on the standard curve. The testosterone concentration in the sample is then compared to the reference range of testosterone concentrations established by each laboratory or the expected volumes listed in the package insert.

AI/ML Overview

The provided text describes several studies related to the performance of the Biodata Testosterone Maia Kit, but it does not explicitly state pre-defined acceptance criteria for each study. Instead, it presents the results and concludes that the performance is "satisfactory," "high degree of precision," "acceptable," "no significant cross-reaction," or "does not significantly affect."

Therefore, I will create a table with the study type, the reported device performance, and then explain the details of each study as they relate to the requested information.

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit "acceptance criteria" are stated in the document, the table will reflect the reported findings/conclusions for each performance study, indicating whether the device met the implied performance standards.

Study Type	Implied/Observed Acceptance Criteria (based on text)	Reported Device Performance
Intra-Assay Precision	High degree of precision within assays	CV% for all samples (Serotest S-18, Lyphocheck controls, Patient Pools) ranged from 3.51% to 7.70%. Conclusion: "high degree of precision within assays."
Inter-Assay Precision	High degree of precision between assays	CV% for all samples (Serotest S-18, Lyphocheck controls, Patient Pools) ranged from 2.77% to 9.43%. Conclusion: "high degree of precision between assays."
Recovery Studies	Satisfactory accuracy over the specified range	% Recovery (Mean ± 1 S.D.) for spike values from 1.25 to 10.00 ng/mL ranged from 97.6% (± 9.73) to 109.3% (± 1.03). Conclusion: "accuracy... is satisfactory over the range of 1.25 to 10.00 ng/mL."
Dilution Studies	Acceptable dilution performance with low standard	For various dilution factors (1 to 32), % recovery ranged from 90.64% to 104.29%. Conclusion: "dilution using the low testosterone concentration standard is acceptable."
Sensitivity Study	Ability to differentiate from zero (low MDL)	Mean Detection Limit (MDL) was 0.064 ng/mL.
Specificity Study	No significant cross-reaction with other analytes	Cross-reactivity: Testosterone 100%, DHT 15.0%, Estradiol 0.007%, Progesterone 0.01%, Estrone 0.001%, Estriol 0.0005%, Cortisol 0.002%, DHEA-S 0.006%. Conclusion: "no significant cross-reaction with testosterone."
SHBG Interference Study	SHBG concentration not to significantly affect measurement	Average % Change in Testosterone Concentration over time (2 to 32 minutes) ranged from 99.33% to 105.49% for the new kit. Conclusion: "the SHBG Concentration does not significantly affect the measurement of testosterone."
Variation of Assay Procedures	Variation in incubation time not to significantly affect values	Average % Recovery for controls and sera with incubation times of 45' and 75' (vs. 60' reference) were 99.1% and 98.3% respectively. Conclusion: "variation in the incubation time... does not significantly affect the control and sample values."
GCMS Tested Samples Comparison	Results to fall within GCMS range	Mean percentage recovery was 75.69%, with individual sample recoveries ranging from 46.25% to 106.39%. Conclusion: "all the data fell within the range of the gas chromatography mass spectroscopy results."
Correlation Studies (vs DPC)	High/Satisfactory correlation with predicate device	Males (120 samples): R = 0.8700 (vs DPC), Y = 1.0895 X - 1.034. Females (63 samples): R = 0.7598 (vs DPC), Y = 0.6061 X + 0.2471. Pre-puberal children (60 samples): satisfactory correlation (no R value given for DPC comparison).
Correlation Studies (vs Old Maia Kit)	High/Satisfactory correlation with old version	Males (120 samples): R = 0.8769 (vs Old Maia), Y = 0.4667 X + 1.407. Females (63 samples): R = 0.9322 (vs Old Maia), Y = 0.8036 X + 0.145. Pre-puberal children (60 samples): satisfactory correlation.
Expected Values Study	Establishment of reference ranges	Males: 5-95 percentile 2.8 - 9.7 ng/mL (Mean 6.0 ng/mL). Females: 95 percentile

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