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 <1.0 ng/mL (Mean 0.65 ng/mL).

Details of the Studies:

2. Sample sizes used for the test set and the data provenance

Intra-Assay Precision:
- Test Set Sample Size: 3 controls (Serotest S-18, 3 Lyphocheck controls, 3 patient pools) with 20 replicates each. Total: 7 samples * 20 replicates = 140 measurements.
- Data Provenance: Not explicitly stated, but derived from "commercially-available Lyphocheck controls" and "patient pool controls" which suggests laboratory-generated data, likely in a controlled setting.
Inter-Assay Precision:
- Test Set Sample Size: 7 controls (Serotest S-18, 3 Lyphocheck controls, 3 patient pools) tested across 10 separate assays.
- Data Provenance: Not explicitly stated, but results from "different operators" conducting assays, indicating laboratory-generated data.
Recovery Studies:
- Test Set Sample Size: 3 patient plasma pools, each spiked with 50 ul of bovine serum or 50 ul of testosterone solution at 4 different concentrations. The number of replicates for each spike value is n=3.
- Data Provenance: "randomly selected patient samples" and laboratory-prepared solutions.
Dilution Studies:
- Test Set Sample Size: 3 patient samples, serially diluted up to a factor of 32.
- Data Provenance: "patient samples" and a "low (0.70 ng/mL) testosterone standard," suggesting laboratory-generated data.
Sensitivity Study:
- Test Set Sample Size: 20 replicates of the zero standard and 3 replicates of the first standard (0.25 ng/mL).
- Data Provenance: Laboratory-generated data ("BATCH 1 REAGENTS").
Specificity Study:
- Test Set Sample Size: 8 potentially cross-reactive analytes.
- Data Provenance: Laboratory-generated data (measuring apparent response to specific analytes).
Sex Hormone Binding Globulin Interference Study:
- Test Set Sample Size: 5 serum pools, measured at 6 time points (0, 2, 4, 8, 16, and 32 minutes) after heating. (n=5 for calculating mean +/- 1 S.D.).
- Data Provenance: "Five serum pools," likely from patient samples, and laboratory-induced conditions (heating).
Variation of Recommended Assay Procedures Study:
- Test Set Sample Size: 3 controls and 3 pools of sera.
- Data Provenance: Controls and "pools of sera" (likely patient samples), tested under varied laboratory conditions.
Gas Chromatography Mass Spectroscopy Tested Samples Comparison:
- Test Set Sample Size: 13 control sera samples (some with A/B identifiers).
- Data Provenance: "Several control sera previously checked by Gas Chromatography Mass Spectroscopy in Germany." This indicates retrospective use of samples with a highly reliable reference method.
Correlation Studies:
- Test Set Sample Size:
  - 120 samples from males.
  - 63 samples from females.
  - 60 samples from pre-puberal children.
- Data Provenance: "samples from males," "samples from females," "samples from pre-puberal children." Specific country of origin is not stated, but compared against DPC Testosterone Kit and an "old Testosterone Maia Kit," which are commercial products. This suggests retrospective or prospective testing of patient samples.
Expected Values Study (Reference Range):
- Test Set Sample Size:
  - 659 serum samples from males (aged 18 to 71 years).
  - 300 serum samples from females.
- Data Provenance: "serum samples from males," "serum samples from females." Country of origin not stated, but these are patient samples used to establish population-based reference ranges.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document describes in vitro diagnostic device performance studies, not clinical decision-making based on image interpretation or complex diagnoses where expert consensus is typically used for ground truth. The "ground truth" here is the actual concentration of testosterone or the known properties of the samples/analytes.

For precision, recovery, dilution, sensitivity, specificity, and assay variation studies, the ground truth is established by the analytical methods themselves, known concentrations of standards, or the chemical properties of the substances. No human experts are involved in establishing this ground truth beyond setting up the experiment and analyzing the results according to established protocols.
For the Gas Chromatography Mass Spectroscopy (GCMS) Tested Samples Comparison, GCMS itself serves as the "gold standard" or highly reliable ground truth method. No specific number or qualification of human experts involved in the GCMS analysis is provided, but GCMS is an instrumental analytical technique.
For the Correlation Studies, the ground truth is essentially the results obtained by the predicate device (DPC Testosterone Kit) and the previous version of the device (old Testosterone Maia Kit), which are established diagnostic assays. There's no mention of human experts defining the "truth" for these comparative analyses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since this is an in vitro diagnostic device for quantitative measurement of testosterone, the concepts of "adjudication" by multiple human experts (e.g., 2+1, 3+1) typically used in medical image analysis or complex clinical diagnosis studies do not apply. The performance is assessed by comparing quantitative results against reference methods, known concentrations, or established statistical metrics (e.g., CV%, recovery %, correlation coefficients).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating diagnostic aids where human readers interpret medical images or data, and an AI system might assist them. The Biodata Testosterone Maia Kit is an in vitro diagnostic assay that produces a quantitative measurement, not an AI-powered interpretive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies presented are all standalone performance evaluations of the Biodata Testosterone Maia Kit. The device (a radioimmunoassay kit) operates as an "algorithm only" in the sense that it performs a chemical reaction and measurement process to yield a numerical result. Human involvement is in operating the laboratory equipment and analyzing the raw count data, but the performance metrics (precision, accuracy, sensitivity, specificity, correlation) are inherent to the assay's chemical and measurement characteristics, not to human interpretation of its output in a "human-in-the-loop" clinical decision-making context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used varied by study type:

Known concentrations/values: For precision, sensitivity, recovery, dilution, and specificity studies, the ground truth was based on analytically prepared standards with known concentrations of testosterone or other analytes.
Gold Standard Analytical Method: For the Gas Chromatography Mass Spectroscopy Tested Samples Comparison, the results from GCMS were considered the ground truth.
Predicate Device/Reference Method: For the Correlation Studies, the results from the DPC Testosterone Kit (the predicate device) and the old Testosterone Maia Kit served as the reference for comparison.
Biological Samples: For studies establishing reference ranges (Expected Values Study) and those using "patient pools" or "patient samples," the ground truth was the actual presence and concentration of testosterone as measured by the device itself, validated through other performance metrics and comparison to a predicate.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device. Therefore, there is no AI training set as such. The "training" of the assay refers to its development and optimization based on chemical principles and experimental results. The samples used for various performance evaluations (precision, recovery, etc.) could be considered as part of the overall development and validation, but not a distinct "training set" like in AI/ML.

9. How the ground truth for the training set was established

As there is no "training set" in the AI/ML sense, this question is not directly applicable. For a traditional diagnostic kit, the "ground truth" for its development is based on established biochemical principles, known concentrations of calibrators, and reference methods to ensure the assay accurately measures the target analyte (testosterone).

Summary

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K955102

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

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B. Radioimmunoassay Protocol

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ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

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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

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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

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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 VALUENG/ML	% RECOVERY (MEAN $\pm$ 1 S.D.) n = 3BATCH 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

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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

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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

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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

)

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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		REFERENCEINCUB. 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	<0.25	--	<0.25	<0.25	--
LYPHOCHECK 90002	2.86	95.3	3.00	2.83	94.3
LYPHOCHECK 90003	8.19	104.9	7.81	7.88	100.9
POOL OF SERA 1	0.49	104.2	0.47	0.47	100.0
POOL OF SERA 2	0.77	93.9	0.82	0.77	93.9
POOL OF SERA 3	7.01	101.9	6.88	7.43	108.0
AVERAGE %		99.1			98.3
RECOVERY

Table 9 Variation of Recommend Assay Procedures - Sample

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STANDARD	45'STD CURVE		REFERENCESTANDARD CURVE		75'STD CURVE
	%B/B₀	%B/T	%B/B₀	%B/T	%B/B₀	%B/T
1 0.25 ng/mL	85.4	67.0	84.6	67.8	86.0	68.2
2 1.00 ng/mL	62.9	49.7	62.9	50.7	63.8	51.0
3 3.00 ng/mL	48.1	38.4	48.3	39.2	48.7	39.2
4 8.00 ng/mL	32.6	26.4	32.0	26.3	34.0	27.8
5 20.00 ng/mL	19.6	16.4	19.7	16.6	20.7	17.9
NSB		1.4		1.0		1.3
B₀		76.9		78.9		77.7
TOTAL Cpm		81373		81373		81373

Table 10 Variation of Recommended Assay Procedures - Standard

I. Gas Chromatography Mass Spectroscopy Tested Samples

Several control sera previously checked by Gas Chromatography Mass Spectroscopy in Germany were tested by the Biodata Testosterone Maia Kit. The data is presented in Table 11. The mean percentage recovery was found to be 75.69%. Thus, all the data fell within the range of the gas chromatography mass spectroscopy results.

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		GCMS TARGETVALUES	GCMSRANGE	OBTAINEDVALUES	RECOVERY
		ng/mL	ng/mL	ng/mL	%
CONTROL SERUM
HM1/91	A	4.15	2.28 - 6.02	3.40	81.93
HM1/91	B	10.00	5.47 - 14.52	10.17	101.70
HM2/91	A	2.15	1.18 - 3.14	1.66	77.21
HM2/91	B	2.87	1.58 - 4.18	2.11	73.52
HM3/91	B	6.86	3.75 - 10.49	4.88	71.13
HM4/90	A	5.70	3.40 - 8.01	3.68	64.56
HM1/92	A	2.15	0.86 - 3.46	1.59	73.95
HM1/92	B	5.70	3.40 - 8.01	4.09	71.75
HM2/92	A	6.86	3.08 - 10.63	4.38	63.85
HM2/92	B	4.15	2.57 - 5.73	3.40	81.93
HM3/92	B	2.15	0.86 - 3.46	1.50	69.77
HM1/93	A	3.60	2.16 - 5.04	3.83	106.39
HM1/93	B	1.47	0.58 - 2.35	0.68	46.25
AVERAGE %					75.69

Table 11 Gas Chromatography Mass Spectroscopy Tested Samples Comparison

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J. Correlation Studies

In the first correlation study, 120 samples from males were tested with the DPC Testosterone Kit, the old Testosterone Maia Kit, and the new Biodata Testosterone Maia Kit. The data comparing the DPC Testosterone Kit and the new Biodata Testosterone Maia Kit is summarized in Table 12. The data comparing the old Testosterone Maia Kit and the new Biodata Testosterone Maia Kit is summarized in Table 13. The data indicates a high degree of correlation between the new Biodata Testosterone Maia Kit and the DPC Testosterone Kit and the new Biodata Testosterone Maia Kit and the old Testosterone Maia Kit.

Table 12 Summary of Correlation Study - 120 Male Samples

TESTOSTERONE DPC (x)

TESTOSTERONE MAIA NEW (y)

	N. 120 MALE SAMPLES
LINEAR REGRESSION	Y = 1.0895 X - 1.034
CORRELATION COEFFICIENT	R = 0.8700
AVERAGE X	6.47 ng/mL
AVERAGE Y	6.02 ng/mL
OVER-UNDER ESTIMATION	- 7.99%

Table 13
Summary of Correlation Study - 120 Male Samples

TESTOSTERONE MAIA OLD (x)

TESTOSTERONE MAIA NEW (y)

	N. 120 MALE SAMPLES
LINEAR REGRESSION	$Y = 0.4667 X + 1.407$
CORRELATION COEFFICIENT	$R = 0.8769$
AVERAGE X	9.88 ng/mL
AVERAGE Y	6.02 ng/mL
OVER-UNDER ESTIMATION	- 36.43%

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In the second correlation study, 63 samples from females were tested with the Testosterone DPC Kit, the old Testosterone Maia Kit, and the new Biodata Testosterone Maia Kit. The data comparing the DPC Testosterone Kit and the new Biodata Testosterone Maia Kit is summarized in Table 14. The data comparing the old Testosterone Maia and the new Biodata Testosterone Maia Kits is summarized in Table 15. The data indicates a satisfactory correlation between the new Biodata Testosterone Maia Kit and the DPC Testosterone Kit and a high degree of correlation between the new Biodata Testosterone Maia Kit and the old Testosterone Maia Kit.

Table 14 Summary of Correlation Study - 63 Female Samples

TESTOSTERONE DPC (x)

TESTOSTERONE MAIA NEW (v)

	N. 63 FEMALE SAMPLES
LINEAR REGRESSION	Y = 0.6061 X + 0.2471
CORRELATION COEFFICIENT	R = 0.7598
AVERAGE X	0.67 ng/mL
AVERAGE Y	0.66 ng/mL
OVER-UNDER ESTIMATION	+ 5.37%

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Table 15 Summary of Correlation Study - 63 Female Samples

TESTOSTERONE MAIA OLD (x)

TESTOSTERONE MAIA NEW (y)

	N. 63 FEMALE SAMPLES
LINEAR REGRESSION	$Y = 0.8036 X + 0.145$
CORRELATION COEFFICIENT	$R = 0.9322$
AVERAGE X	0.64 ng/mL
AVERAGE Y	0.67 ng/mL
OVER-UNDER ESTIMATION	+ 5.66%

In the third part of the correlation study, 60 samples from pre-puberal children were assayed using the DPC Testosterone Kit, the old Testosterone Maia Kit, and the new Biodata Testosterone Maia Kit. The data is summarized in Table 16. The data indicates that the correlation between the new Biodata Testosterone Maia Kit and those devices is satisfactory.

Table 16 Summary of Correlation Study - 60 Pre-Puberal Children

KIT	NR	95 PERCENTILE(ng/mL)
NEW TESTOSTERONE MAIA	60	<0.60
OLD TESTOSTERONE MAIA	60	<0.60
TESTOSTERONE D.P.C.	60	<0.40

K. Expected Values Study

In the first part of the reference range study, 659 serum samples from males were assayed using the Biodata Testosterone Maia Kit. The males ranged in

{14}------------------------------------------------

age from 18 to 71 years old; the mean age was 25. The data is summarized in Table 17.

Table 17 Summary of Reference Range - 659 Male Serum Sample

N.	MEAN(ng/mL)	5-95 PERCENTILE(ng/mL)
MAN (18 TO 71 YEARS)	659	6.0	2.8 - 9.7

In the second part of the study 300 serum samples from females were

assayed using the Biodata Testosterone Maia Kit. The data is summarized in Table

Table 18 Summary of Reference Range - 300 Female Serum Sample

	N.	MEAN(ng/mL)	95 PERCENTILE(ng/mL)
WOMAN	300	0.65	<1.0

Regulation Number and Section

§ 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.