Free testosterone test is 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 female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Device Description

The radioimmunoassay of free testosterone is a competitive assay. The procedure follows the basic principle of radioimmunoassay where there is competition between a radioactive and a non-radioactive antigen for a mixed number of antibody binding sites. The amount of [125]]-labeled testosterone analog bound to the antibody is inversely proportional to the concentration of unlabeled free testosterone present. The separation of the free and bound antigen is achieved by decanting or aspirating the antibody-coated tubes. A standard curve is constructed and unknown free testosterone values are obtained from the curve by interpolation.

Kit Content:
Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use)
125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use)
Calibrators: one 1.0 mL vial labeled 0, and seven 0.5 mL vials labeled 1-7 (ready-to-use)
Controls: two 0.5 mL vials labeled 1, 2 (ready-to-use)

AI/ML Overview

The provided text describes the Immunotech ACTIV\u00AE Free Testosterone RIA device, a radioimmunoassay for the quantitative measurement of free testosterone in human serum. This is an in vitro diagnostic device and the information provided is a 510(k) summary, which is typically for demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for overall device performance in the form of pass/fail thresholds for clinical utility. Instead, it provides a summary of the analytical performance characteristics and reference ranges, which are the results of validation studies conducted to support the device's claims and demonstrate its performance.

Performance Characteristic	Acceptance Criteria (Implicit from CLSI guidelines and typical IVD requirements)	Reported Device Performance
Sensitivity	- Limit of Blank (LoB) < 0.1 pg/mL (typical for low-end sensitivity) - Limit of Detection (LoD) < 0.2 pg/mL (typical) - Limit of Quantitation (LoQ) < 0.5 pg/mL (typical)	LoB: 0.05 pg/mL LoD: 0.13 pg/mL LoQ: 0.37 pg/mL
Specificity	High specificity for free testosterone, low cross-reactivity with related molecules.	Antibody highly specific for free testosterone. Low cross-reactivity (< 0.1% for most, up to 0.116% for 19-Nortestosterone in depleted serum) for various related compounds.
Precision (Repeatability)	Coefficient of Variation (CV) <= 15% (typical for IVDs, especially at lower concentrations)	<= 13.2% for serum samples
Precision (Within-Laboratory)	Coefficient of Variation (CV) <= 20% (typical for IVDs)	<= 19.3% for serum samples
Measurement Range	Range should cover clinically relevant concentrations.	0.37 pg/mL (LoQ) to ~100 pg/mL (highest calibrator)
Interference	Minimal interference from common endogenous substances and medications at specified concentrations.	Tested against various substances (e.g., hemoglobin, bilirubin, biotin, ibuprofen, cholesterol, certain hormones) at specified concentrations, implying no significant interference.
Linearity	Linear response across the entire measuring range.	Linear throughout the measuring range of the kit (0.30 \u2013 114.11 pg/mL).
Cross-reactivity	Low cross-reactivity to structurally similar compounds.	Very low cross-reactivity (often ND or < 0.1%) for a panel of 20+ compounds in pooled normal serum and pooled depleted serum. Specific percentages are provided.
Method Comparison	Good agreement/correlation with the predicate device (e.g., slope close to 1, intercept close to 0, high R-value).	n=278; Range: 0.26 \u2013 101.21 pg/mL; Slope: 1.0078; Intercept: 0.0759; R: 0.9956 (indicating very good agreement with the predicate)
Expected Values/Reference Ranges	Established stratification for different populations (age, sex, physiological state).	Comprehensive tables for Men (by age group), Women (by cycle phase, menopausal status, and contraceptives), Boys (by age group), and Girls (by age group).

2. Sample Size Used for the Test Set and Data Provenance

The document describes specific sample sizes for different analyses:

Method Comparison: N = 278 samples were used to compare the proposed device with the predicate. The dataProvenance is implicitly retrospective as it compares results from two versions of a device, likely using banked samples or samples run consecutively.
Expected Values/Reference Ranges:
- Men: N = 120 (30 per age group: 20-29, 30-39, 40-49, 50+).
- Women: N = 120 (32 follicular, 32 luteal, 21 preovulatory peak, 13 postmenopausal, 19 contraceptives \u2013 totaling 117 individual samples given in the subcategories, implying some overlap or missing a few for the total of 120 "Random Women").
- Boys: N = 114 (18 infant, 48 child, 30 adolescent in one grouping; 36 6m-9y, 20 10-11y, 20 12-13y in another grouping - these age ranges seem to be different categorizations of the same underlying data or separate cohorts).
- Girls: N = 119 (34 infant, 55 child, 30 adolescent in one grouping; 69 6m-9y, 20 10-12y, 20 13-16y in another grouping - similar to boys, likely different categorizations or cohorts).

The data provenance is not explicitly stated (e.g., country of origin). Given the manufacturer is based in the Czech Republic, the samples could be from Europe, but this is not confirmed. The nature of these studies (establishing reference ranges) suggests they are prospective or retrospective collections specific for this type of validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device and study. The device, Immunotech ACTIV\u00AE Free Testosterone RIA, is an in vitro diagnostic (IVD) test that measures a quantitative biomarker concentration (free testosterone in serum). The "ground truth" for such a device is established through:

Reference measurement procedures (RMPs) or reference methods, which are highly accurate and precise analytical techniques.
Certified reference materials (CRMs) with known concentrations.
Comparisons to a legally marketed predicate device (as is the case here).

Experts, clinical consensus, or pathology are typical for image-based diagnostic AI, not for quantitative chemical assays.

4. Adjudication Method for the Test Set

This section is not applicable for this type of in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiology for AI interpretation) to establish a consensus ground truth. For an IVD, the measurement itself using a validated method is the "truth," or the comparison is made against a validated predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating devices (often AI-powered) that assist human readers (e.g., radiologists, pathologists) in making diagnoses. This device is a quantitative immunoassay, not a reader-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance characteristics provided (sensitivity, specificity, precision, measurement range, interference, linearity, cross-reactivity, method comparison) represent the standalone performance of the assay itself, as an in vitro diagnostic test. There is no human intervention in the result generation beyond operating the instrument and following the assay procedure.

7. The Type of Ground Truth Used

The ground truth for evaluating the analytical performance of the device is established using:

Internal standards for calibrator values.
Reference materials/samples with known concentrations for sensitivity, linearity, and interference studies (though not explicitly detailed, this is standard practice for CLSI guidelines).
Comparison to a legally marketed predicate device (ACTIV\u00AE Free Testosterone RIA, K952281) for method comparison, which serves as a high-quality comparator given its prior FDA clearance.
Clinically characterized samples (e.g., from different age groups, sexes, and physiological states) to establish expected values/reference ranges.

The document implicitly uses these standard analytical validation approaches rather than, for instance, pathology or outcomes data (which would be for clinical utility, not analytical performance).

8. The Sample Size for the Training Set

This document only details validation and verification activities, not the development or "training" of the assay. For a traditional immunoassay like this RIA, there isn't a "training set" in the context of machine learning or AI. The assay's "design" is based on biochemical principles (antibody-antigen binding) rather than statistical learning from a dataset. The formulation of reagents, selection of antibody, and optimization of the protocol would involve internal R&D, but not a formally defined "training set" with ground truth in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As stated above, this is not applicable for a traditional immunoassay. The concept of a "training set" and "ground truth" establishment in the context of AI does not directly translate to the development process of this type of diagnostic kit.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

December 20, 2019

Immunotech s.r.o. Vit Oburka Ouality and Regulatory Affairs Manager Radiova 1 Prague, 102 27 Cz

Re: K191350

Trade/Device Name: ACTIVE® Free Testosterone RIA Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: November 25, 2019 Received: November 25, 2019

Dear Vit Oburka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191350

Device Name ACTIVE® Free Testosterone RIA

Indications for Use (Describe)

Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left and the word "IMMUNOTECH" in blue bold letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller letters.

510k Summary ACTIVE® Free Testosterone RIA

1. Submitted by:

Vit Oburka Quality and Regulatory Affairs Manager IMMUNOTECH s.r.o. Radiova 1, 102 27 Prague Czech Republic Tel.: +420 272 017 368 Email: voburka@beckman.com

2. Date of preparation:

October 19, 2019

3. Device Identification

Proprietary Name:	ACTIVE® Free Testosterone RIA
Common Name:	Free Testosterone
Classification:	Class I, reserved
Product Codes:	CDZ
Regulation Number:	21 CFR 862.1680

4. Predicate Device

Proposed Device	Predicate	Manufacturer	LicenseNumber
ACTIVE® FreeTestosterone RIA	ACTIVE® FreeTestosterone RIA	IMMUNOTECH s.r.o.	K952281

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Description 5.

Kit Content:

Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use)

Plastic tubes with rabbit anti-testosterone immunoglobulin immobilized to the inside wall of each tube.

125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use)

At the time of manufacture, the vial contains 185 kBq, (<5 µCi), of 120-labeled testosterone analog in buffer with proteins (BSA), sodium azide (<0.1%) and a dye.

Calibrators: one 1.0 mL vial labeled 0, and seven 0.5 mL vials labeled 1-7 (ready-touse)

The calibrator vials contain from 0 to approximately 100 pg/mL (0 to approximately 346.7 pmol/L) of free testosterone in human serum with sodium azide (< 0.1%). The exact concentration is indicated on each vial label. Once opened, store at 2-8°C for up to 3 weeks, or at < -20°C until expiration date of kit. The calibrator values were established using an internal standard.

Controls: two 0.5 mL vials labeled 1, 2 (ready-to-use)

The vials contain free testosterone in human serum with sodium azide (<0.1%). The expected values are in the concentration range indicated in a supplement found in the kit. Once opened, store at 2-8°C for up to 3 weeks, or at < -20°C until expiration date of kit.

Principle

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Image /page/5/Picture/0 description: The image shows the Immunotech logo. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller, non-bold letters.

6. Intended use:

Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.

Clinical Significance:

Free Testosterone is often measured in conjunction with other androgens (DHEA/DHEA-S, androstenedione, 17α-hydroxyprogesterone), SHBG and gonadotropins (LH and FSH) to evaluate reproductive abnormalities in children, men and women.

7. Comparison to Predicate(s):

The following tables shows similarities and differences between the predicate identified in Section 4. of this summary.

Similarities between the Predicate Device and the Proposed Device:

	Predicate	Proposed Device
Proprietary andEstablishedNames	ACTIVE® Free TestosteroneRIA	ACTIVE ® Free TestosteroneRIA
Antibody	Polyclonal RabbitTestosterone Antiserum,A140, DSL	Polyclonal RabbitTestosterone Antibody, 20-TR05T, Fitzgerald
Intended use	SameRadioimmunoassay for thequantitative measurement offree testosterone in humanserum. This assay is intendedfor in vitro diagnostic use.	SameRadioimmunoassay for thequantitative measurement offree testosterone in humanserum. This assay is intendedfor in vitro diagnostic use.
PrincipalWarning andPrecautions		Same
MaterialsProvided		Same
Materialsrequired, but notprovided		Same
Specimencollection,processing,		Same

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Image /page/6/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, it says "A BECKMAN COULTER COMPANY" in smaller, black letters.

storage anddilution
Procedure	Same
Quality Control	Same
Packaging	Same
Stability	Same

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Image /page/7/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, it says "A BECKMAN COULTER COMPANY" in smaller, regular font.

These are the study results from the validation and verification activities conducted to support the change in polyclonal antibody.

Information describing new proposed assay:

IFU Claim	Proposed Device
ExpectedValuesClaimexpansionthroughstratification	Each laboratory should establish its own reference ranges.
Men (age in years)	n	Median(pg/mL)	Min(pg/mL)	Max(pg/mL)	2.5thPercentile(pg/mL)	97.5thPercentile(pg/mL)
20-29	30	15.40	7.54	27.79	8.68	25.09
30-39	30	14.94	6.77	22.36	8.85	21.40
40-49	30	11.48	7.37	20.47	7.56	18.64
50 andabove	30	9.05	4.52	15.05	5.72	14.21
All	120	12.35	4.52	27.79	6.76	22.76
Women	n	Median(pg/mL)	Min(pg/mL)	Max(pg/mL)	2.5thPercentilee (pg/mL)	97.5thPercentile(pg/mL)
FollicularPhase	32	1.48	0.59	4.28	0.64	3.41
LutealPhase	32	1.44	0.59	3.31	0.60	2.95
Preovulatory Peak	21	1.51	0.81	3.79	0.90	3.79
Postmenopausal	13	1.17	0.33	1.97	0.36	1.85
Contraceptives	19	1.45	0.49	2.81	0.57	2.70
Random Women	n	Median(pg/mL)	Min(pg/mL)	Max(pg/mL)	2.5thPercentilee (pg/mL)	97.5thPercentile(pg/mL)
All	120	1.29	0.33	4.28	0.49	2.87
Boys	n	Median(pg/mL)	Min(pg/mL)	Max(pg/mL)	2.5thPercentilee (pg/mL)	97.5thPercentile(pg/mL)
	Infant	18	< 0.13	< 0.13	0.31	< 0.13	0.28
	Child	48	0.56	0.13	12.79	0.16	12.65
	Adolescent	30	15.10	1.71	32.09	1.88	28.55
	Boys	N	Median (pg/mL)	Minimum (pg/mL)	Maximum (pg/mL)	2.5th Percentile (pg/mL)	97.5th Percentile (pg/mL)
	6 months-9 years	36	0.20	<0.13	0.62	<0.13	0.54
	10-11 years	20	0.67	0.41	5.11	0.42	5.00
	12-13 years	20	6.21	0.60	27.21	0.63	23.27
	Girls	n	Median (pg/mL)	Min (pg/mL)	Max (pg/mL)	2.5th Percentile (pg/mL)	97.5th Percentile (pg/mL)
	Infant	34	< 0.13	< 0.13	0.42	< 0.13	0.33
	Child	55	0.46	< 0.13	2.53	< 0.13	1.90
	Adolescent	30	1.37	0.57	3.27	0.64	3.23
	Girls	N	Median (pg/mL)	Minimum (pg/mL)	Maximum (pg/mL)	2.5th Percentile (pg/mL)	97.5th Percentile (pg/mL)
	6 months-9 years	69	0.24	<0.13	0.86	<0.13	0.57
	10-12 years	20	0.88	0.37	2.53	0.41	2.25
	13-16 years	20	1.42	0.57	3.27	0.65	3.24
Performance characteristicMeasuredaccording toCLSIguidelines	SensitivityLimit of Blank (LoB) of 0.05 pg/mL.Limit of detection (LoD): 0.13 pg/mLLimit of Quantitation (LoQ): 0.37 pg/mLSpecificityThe antibody used in the immunoassay is highly specific for free testosterone.Low cross reactivities were obtained against several related molecules.

IMMUNOTECH s.r.o. Radiová 1, 102 27 Praha 10 tel.: +420 272 017 011 tel.: +420 272 017 200 E-mail: office.iot@beckman.com www.immunotech.cz

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Image /page/8/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller letters.

tel.: +420 272 017 011
tel.: +420 272 017 200

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Image /page/9/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller black letters. The logo is clean and professional, and the colors are consistent.

	PrecisionRepeatability and within-laboratory precisionFor repeatability the coefficients of variation werefound below or equal to 13.2% for serum samples. For within laboratoryprecision the coefficients of variation were found below or equal to 19.3% for serum samples.
Measurement range	Measurement range (from LoQ to the highest calibrator): 0.37 pg/mL to approximately 100 pg/mL
InterferenceNew data CLSIguidelines	Substance Interferent concentration Hemoglobin 641 µg/mL Conjugated bilirubin 199 µg/mL Unconjugated bilirubin 92.7 µg/mL Biotin 1,020 ng/mL Ascorbic acid 40.5 µg/mL Ibuprofen 122 µg/mL Cholesterol 0.75 mg/mL Heparin 7,248 ng/mL Prednisone 384 ng/mL Prednisolone 1,294 ng/mL Protein (γ-globulin) 49.5 mg/mL Rheumatoid factor 3.45 IU/mL Acetylsalicylic acid 24.2 µg/mL Triglycerides 3.35 mg/mL
Linearity	Criterion Result Linear throughout the measuring range of the kit (from LoQ to the highest calibrator) Linear within 0.30 – 114.11 pg/mL
Cross-reactivityDifferent methodologyof cross-reactivitytesting	Pooled normal serum Compound Cross-reactant conc. (ng/mL) Cross reactivity (%) 19-Nortestosterone 8.62 0.068 11-Ketotestosterone 102 0.020 11beta-Hydroxytestosterone 14.1 0.029 Androstenediol 14.8 0.010 Methyltestosterone 96.5 0.017 Androstenedione 92.4 0.006 Norethindrone 1,056 0.001 5α-Androstane-3α,17β-diol 1,076 0.002 5β-Androstane-3,17-dione 1011 ND 5α-Androstane-3,17-dione 846 0.001 Danazol 921 0.001 Estradiol 946 0.001 Progesterone 956 0.001 Deoxycorticosterone 911 ND

tel.: +420 272 017 011
tel.: +420 272 017 200

E-mail: office.iot@beckman.com
www.immunotech.cz

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Image /page/10/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, the text "A BECKMAN COULTER COMPANY" is written in a smaller, sans-serif font.

Androsterone	1.002	ND
Epiandosterone	943	ND
DHEA	896	ND
Estriol	882	ND
Estrone	913	ND
Corticosterone	951	ND
Cortisol	857	ND
Pregnenolone	944	ND
DHT	168	0.020
Androstanediol Glucuronide	1,031	ND
DHEA-S	922	ND
5α -Androstan-3β, 17β diol	98.0	0.005
rhSHBG	10,407	ND
ND = Non-Detectable (< 0.1%)
	Pooled depleted serum
Compound		Cross
	Crossreactant conc.	reactivity
	(ng/ml)	(%)
19-Nortestosterone	43.6	0.116
11-Ketotestosterone	6.59	0.026
11beta-Hydroxytestosterone	2.62	0.029
Androstenediol	91.6	0.024
Methyltestosterone	11.1	0.005
		0.004
Androstenedione	10.5
Norethindrone	40.0	0.002
5α -Androstane-3α,17β -diol	749	ND
5ß -Androstane-3,17-dione	746	ND
5a -Androstane-3,17-dione	747	ND
Danazol	79.2	0.001
Estradiol	820	ND
Progesterone	8,330	ND
Deoxycorticosterone	7,681	ND
Androsterone	8,280	ND
Epiandosterone	7,634	ND
DHEA	8,362	ND
Estriol	8,981	ND
	8,442	ND
Estrone
Corticosterone	7,197	ND
Cortisol	79,944	ND
Pregnenolone	83,919	ND
DHT	96.1	0.013
Androstanediol Glucuronide	8,111	ND
DHEA-S	89,418	ND
5α -Androstan-3β, 17β diolrhSHBG	43.110,407	0.001ND

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Image /page/11/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract symbol on the left and the word "IMMUNOTECH" in blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller, black letters.

Methodcomparison	The current version Active® Free Testosterone RIA (Method A) was compared to previous version Active® Free Testosterone RIA (Method B):
	n	Range (pg/mL)	Slope	Intercept	R
	278	0.26 – 101.21	1.0078	0.0759	0.9956

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Image /page/12/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, resembling interconnected bars. To the right of the symbol is the word "IMMUNOTECH" in bold, blue letters. Below "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in a smaller, non-bold font.

8. Performance Characteristics - Analytical Performance

Performance characteristics were measured to align product with current industry standards (data measured according to CLSI guidelines).

9. Conclusion:

The conclusions drawn from the non-clinical testing (discussed above) supports a substantial equivalence decision.

Verification of the changes does not raise any new items of safety and effectiveness.

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.