(229 days)
No
The device description details a radioimmunoassay based on competitive binding principles and gamma counting. There is no mention of AI or ML in the device description, intended use, performance studies, or key metrics. The analysis relies on comparing measured values to a standard curve and reference ranges, which is a traditional analytical method.
No
This device is for in vitro diagnostic use, intended for the quantitative determination of testosterone levels to aid in diagnosis, not for direct treatment or therapy.
Yes
The intended use explicitly states, "The device is intended to be used for the diagnosis of elevated or depressed levels of testosterone."
No
The device is an in vitro diagnostic (IVD) kit that utilizes radioimmunoassay principles and includes physical reagents and components (e.g., labeled antigen, antibody, magnetic particles) that are essential for its function. It also requires a gamma counter, which is a hardware device, to measure the results. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- Intended Use / Indications for Use: "It is FOR IN VITRO DIAGNOSTIC USE ONLY."
- Intended User / Care Setting: "FOR IN VITRO DIAGNOSTIC USE ONLY."
These statements clearly indicate that the device is intended for use in vitro (outside of a living organism) for diagnostic purposes. The description of the device and its intended use (measuring testosterone in human serum or plasma for the diagnosis of elevated or depressed levels) further supports this classification.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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 125I ("testosterone - 125I") (labeled antigen) for a limited number of testosterone antibody sites. The amount of testosterone - 125I 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 125I.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Males: 18 to 71 years old
Females: Not specified, but samples tested
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Intra-Assay Precision: Three different assays were conducted on Serotest S-18, three commercially-available Lyphocheck controls, and three patient pool controls (each with 20 replicates). The data indicated a high degree of precision within assays.
- Inter-Assay Precision Study: Different operators conducted ten separate assays on seven controls. The data indicated a high degree of precision between assays.
- Recovery Studies: Three patient plasma pools were spiked with increasing levels of testosterone antigen and assayed. The data indicated satisfactory accuracy over the range of 1.25 to 10.00 ng/mL of testosterone.
- Dilution Studies: Three patient samples were serially diluted up to a factor of 32 with a low (0.70 ng/mL) testosterone standard and then assayed. The data indicated that dilution using the low testosterone concentration standard is acceptable.
- Sensitivity Study: Sensitivity (Minimum Detection Limit - MDL) was evaluated using a standard curve, 20 replicates of the zero standard, and three replicates of the first standard (0.25 ng/mL). The mean detection limit was found to be 0.064 ng/mL.
- Specificity Study: The specificity was evaluated by measuring the apparent response to eight potentially cross-reactive analytes. The data indicated no significant cross-reaction with testosterone.
- Sex Hormone Binding Globulin Interference Study: Five serum pools were heated at 60° C for 32 minutes, and testosterone and SHBG concentrations were measured at various time points using the new and old kits. The data indicated that SHBG Concentration does not significantly affect the measurement of testosterone in the assay.
- Variation of Recommended Assay Procedures: Three controls and three pools of sera were run with the recommended incubation time (60 minutes) varied by plus or minus 15 minutes (45 and 75 minutes). The data indicated that this variation does not significantly affect control and sample values.
- Gas Chromatography Mass Spectroscopy Tested Samples: Several control sera previously checked by Gas Chromatography Mass Spectroscopy in Germany were tested. The mean percentage recovery was 75.69%, and all data fell within the GCMS results range.
- Correlation Studies:
- 120 male samples were tested with DPC Testosterone Kit, old Testosterone Maia Kit, and new Biodata Testosterone Maia Kit. High correlation was shown between the new kit and DPC kit (R = 0.8700) and between the new kit and old kit (R = 0.8769).
- 63 female samples were tested with DPC Testosterone Kit, old Testosterone Maia Kit, and new Biodata Testosterone Maia Kit. Satisfactory correlation was shown between the new kit and DPC kit (R = 0.7598) and high correlation between the new kit and old kit (R = 0.9322).
- 60 pre-puberal children samples were assayed using DPC Testosterone Kit, old Testosterone Maia Kit, and new Biodata Testosterone Maia Kit. The correlation was satisfactory.
- Expected Values Study:
- 659 serum samples from males (18-71 years old) were assayed. Mean was 6.0 ng/mL, 5-95 percentile was 2.8 - 9.7 ng/mL.
- 300 serum samples from females were assayed. Mean was 0.65 ng/mL, 95 percentile was
§ 862.1680 Testosterone test system.
(a)
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.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the text "JUN 24" in bold, black font. The text appears to be part of a larger document or label. The letters are uniformly sized and spaced, creating a clear and legible message. The background is plain and white.
510(K) SUMMARY FOR THE BIODATA TESTOSTERONE MAIA KIT
- Submitter's Name, Address, Telephone Number, and Contact I. Person
Biodata S.p.A. Via Luigi Einaudi 7. 00012 Guidonia Montecelio, Rome. Italy
Laurence A. Potter Contact: BioChem ImmunoSystems (U.S.), Inc. Allentown, PA
Telephone: (610) 266-4315 Facsimile: (610) 266-0184
I. DESCRIPTION OF THE DEVICE
A. Intended Use
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.
1
B. Radioimmunoassay Protocol
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.
\\DC - 64050/1 - 0065061.01
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
2
II. PREDICATE DEVICE
The Biodata Testosterone Maia Kit is substantially equivalent to Diagnostic Products Corporation's ("DPC") Coat-A-Count Testosterone Assay (K831342). Biodata also manufactured this device without U.S. commercialization.
III. PERFORMANCE DATA
Substantial equivalence to the Serono Immunoassay is demonstrated by the following performance data.
A. Intra-Assay Precision
Three different assays were conducted on the following controls: (1) Serotest S-18; (2) three commercially-available Lyphocheck controls; and (3) three patient pool controls, each of which had 20 replicates. The data is summarized in Table 1. The data indicates that the Biodata Testosterone Maia Kit has a high degree of precision within assays.
| SAMPLE | MEAN | S.D. | % CV |
|---|---|---|---|
| (ng/mL) | |||
| SEROTEST S-18 | 1.78 | 0.125 | 7.01 |
| LYPHOCHECK 90001 | 0.25 | 0.019 | 7.55 |
| LYPHOCHECK 90002 | 3.57 | 0.154 | 4.31 |
| LYPHOCHECK 90003 | 9.05 | 0.428 | 4.72 |
| PATIENT POOL L | 0.46 | 0.036 | 7.70 |
| PATIENT POOL M | 0.82 | 0.041 | 5.02 |
| PATIENT POOL H | 8.89 | 0.312 | 3.51 |
Table 1 Summary of Intra-Assay Data
3
2. Inter-Assay Precision Study
Different operators conducted ten separate assays on seven controls.
The inter-assay data is summarized in Table 2. The data indicates that the Biodata
Testosterone Maia assay has a high degree of precision between assays.
| SAMPLE | MEAN
(ng/mL) | S.D. | % CV |
|------------------|-----------------|-------|------|
| SEROTEST S-18 | 1.96 | 0.185 | 9.43 |
| LYPHOCHECK 90001 | 0.23 | 0.02 | 7.45 |
| LYPHOCHECK 90002 | 3.43 | 0.19 | 5.41 |
| LYPHOCHECK 90003 | 8.87 | 0.25 | 2.77 |
| PATIENT POOL L | 0.43 | 0.024 | 5.58 |
| PATIENT POOL M | 0.83 | 0.044 | 5.30 |
| PATIENT POOL H | 8.36 | 0.265 | 3.17 |
Table 2 Summary of Inter-Assay Data
C. Recovery Studies
Three patient plasma pools were made from randomly selected patient samples that had assayed values that were not greater than 7.89 ng/mL. Increasing levels of testosterone antigen were prepared in bovine serum and then were calibrated with the Biodata Testosterone Maia Kit. Aliquots of 950 µl of each pool were spiked with 50 ul of bovine serum or 50 ul of testosterone solution in bovine serum. All spiked samples were then assayed with the Biodata Testosterone Maia Kit. The recovery data is summarized in Table 3. The data indicates that the
4
accuracy of the Biodata Testosterone Maia Kit is satisfactory over the range of 1.25 to 10.00 ng/mL of testosterone is satisfactory.
| SPIKE VALUE
NG/ML | % RECOVERY (MEAN $\pm$ 1 S.D.) n = 3
BATCH 1 REAGENTS | | |
|----------------------|----------------------------------------------------------|-------|------|
| 10.00 | 108.5 | $\pm$ | 3.90 |
| 5.00 | 109.3 | $\pm$ | 1.03 |
| 2.50 | 104.1 | $\pm$ | 4.89 |
| 1.25 | 97.6 | $\pm$ | 9.73 |
Table 3 Summary of Recovery Data
4. Dilution Studies
Three patient samples were serially diluted up to a dilution factor of 32 with a low (0.70 ng/mL) testosterone standard and then assayed. The dilution data is summarized in Table 4. The data indicates that dilution using the low testosterone concentration standard is acceptable.
| DILUTION FACTOR | % RECOVERY | ± 1 S.D. |
|---|---|---|
| 1 | 100.00 | -- |
| 2 | 94.05 | 2.52 |
| 4 | 90.64 | 0.76 |
| 8 | 93.85 | 2.10 |
| 16 | 96.98 | 5.52 |
| 32 | 104.29 | 3.88 |
Table 4 Summary of Dilution Data
5
E. Sensitivity Study
Sensitivity is the smallest quantity of testosterone that can be differentiated from zero and corresponds to the count that is two standard deviations from the mean count of the zero standard. Sensitivity was evaluated by using a standard curve plus 20 further replicates of the zero standard and three replicates of first standard (0.25 ng/mL). The Minimum Detection Limit ("MDL") was calculated by linear regression. The sensitivity data is presented in Table 5. The mean detection limit for the Biodata Testosterone Maia assay was found to be 0.064 ng/mL.
| RESULTS | |
|---|---|
| BATCH 1 REAGENTS | |
| STANDARD "ZERO" cpm | STANDARD 1 (0.25 ng/mL) cpm |
| 1) 67782 | 1) 57961 |
| 2) 68153 | 2) 55969 |
| 3) 66001 | 3) 55961 |
| 4) 65197 | |
| 5) 65095 | |
| 6) 65088 | |
| 7) 64605 | |
| 8) 65525 | |
| 9) 64041 | |
| 10) 65757 | |
| 11) 64819 | |
| 12) 65551 | |
| 13) 64792 | |
| 14) 65596 | |
| 15) 65190 | |
| 16) 66322 | |
| 17) 67674 | |
| 18) 67712 | |
| 19) 67139 | |
| 20) 66088 | |
| X = 65906 | X = 56630 |
| S.D. = 1192 | S.D. = 1152 |
| CV% = 1.8 | CV% = 2.0 |
Table 5 Sensitivity of the Biodata Testosterone Maia Kit
6
F. Specificity Study
The specificity of the Biodata Testosterone Maia Kit was evaluated by measuring the apparent response of the assay to eight potentially cross-reactive analytes. The percentage of interference was calculated according to Abraham (x/y x 100) where x and y are respectively the weight of the testosterone and the interference compound that cause a 50% decrease in binding. The specificity data is presented in Table 6. The data indicates no significant cross-reaction with testosterone.
| ANTIGEN | 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 |
Table 6 Specificity of Biodata Testosterone MAIA Kit
G. Sex Hormone Binding Globulin Interference Study
Sex-hormone binding globulin ("SHBG") is the major serum binding
protein of testosterone. Five serum pools were heated at 60° C for 32 minutes.
Testosterone and SHBG concentrations were measured at zero, two, four, eight,
sixteen, and thirty-two minutes using the Biodata Testosterone Maia Kit that is the
7
subject of this submission ("the new Biodata Testosterone Maia Kit") and an earlier version of the Testosterone Maia Kit ("the old Testosterone Maia Kit"). The percent change in testosterone concentration from time zero was then calculated. The data for the Biodata Testosterone Maia Kit is presented is summarized in Table 7. The data for the old Testosterone Maia Kit is summarized in Table 8. Most of the SHBG was denatured after 32 minutes. The data indicates that the SHBG Concentration does not significantly affect the measurement of testosterone in the assay.
Table '7 Summary of Sex Hormone Binding Globulis Interference Study - New Kit
% CHANGE TESTOSTERONE CONCENTRATION (MEAN +/- 1 S.D.) (n = 5)
| MINUTES | AVERAGE % | ± 1 S.D. |
|---|---|---|
| 2 | 99.33 | 5.08 |
| 4 | 103.12 | 0.99 |
| 8 | 104.58 | 2.40 |
| 16 | 105.49 | 4.22 |
| 32 | 103.06 | 6.37 |
Table 8 Summary of Sex Hormone Binding Globulis Interface Study - Old Kit
% CHANGE TESTOSTERONE CONCENTRATION (MEAN +/- 1 S.D.) (n = 5)
| MINUTES | AVERAGE % | ± 1 S.D. |
|---|---|---|
| 2 | 95.64 | 6.04 |
| 4 | 99.21 | 4.31 |
| 8 | 99.71 | 3.64 |
| 16 | 98.97 | 3.75 |
| 32 | 100.65 | 6.52 |
)
8
H. Variation of Recommended Assay Procedures
Three controls and three pools of sera were run in the assay with the recommended incubation time of 60 minutes varied by plus or minus 15 minutes, i.e., 45 minutes and 75 minutes. The data for controls is presented in Table 9. The data for sera is presented in Table 10. The data indicates that a variation in the incubation time for the immunological reaction of plus or minus 15 minutes does not significantly affect the control and sample values.
| SAMPLE | 45' INCUB. TIME | | REFERENCE
INCUB. TIME 60' | 75' INCUB. TIME | |
|------------------|-----------------|-------|------------------------------|-----------------|-------|
| | ng/mL | %REC | ng/mL | ng/mL | %REC |
| SEROTEST S-18 | 1.85 | 94.4 | 1.96 | 1.82 | 92.9 |
| LYPHOCHECK 90001 |