Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies detail a standard Enzyme Immunoassay (EIA) kit for measuring testosterone levels. There is no mention of AI, ML, or any computational analysis beyond standard data processing for calculating results from optical density readings.

Therapeutic

No
This device is an in vitro diagnostic (IVD) test kit used to measure testosterone levels, which aids in the diagnosis and treatment of disorders. It does not directly treat or prevent a disease or condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones".

SaMD (Software as a Medical Device)

No

The device is a laboratory kit consisting of reagents, a microplate, and a sample collection device, all of which are physical components. The description details a chemical reaction and optical density measurement, not software processing of data.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states "for the quantitative measurement of testosterone in human saliva... used in the diagnosis and treatment of disorders involving the male sex hormones". This clearly indicates a diagnostic purpose performed outside of the body (in vitro).
Device Description: The description details a laboratory-based assay (Enzyme Immunoassay) using biological samples (saliva) and reagents to measure an analyte (testosterone). This is characteristic of an in vitro diagnostic device.
Performance Studies: The performance studies describe analytical performance characteristics like precision, linearity, recovery, and detection limits, which are standard evaluations for IVD devices.
Predicate Device: The mention of a predicate device (K033786; Testosterone Luminescence Immunoassay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and andrenogential syndromes.

Product codes (comma separated list FDA assigned to the subject device)

JKA, CDZ

Device Description

The Pantex Salivary Direct Testosterone EIA kit, Cat # 635 is based on the competition principal and microplate separation. Testosterone calibrators of known concentration, unknown amounts of testosterone in saliva samples and a fixed amount of testosterone (analog) conjugated to horse radish peroxidase (Testosterone-HRP) compete for binding sites with a rabbit monoclonal antiserum bound to GARGG (goat anti-rabbit gamma globulin) coated wells of a microplate. After incubation, unbound components are washed away, enzyme substrate solution is added and a blue color formed. This reaction is stopped with an acid solution to produce a yellow color. The optical density is then read at 450 nm. The amount of Testosterone-HRP detected is inversely proportional to the amount of testosterone in a sample.

The Pantex collection device is a 10 mL, non-sterile, plain polypropylene tube with a screw cap. It is provided as 50 units per package. The expiration date of the Pantex Sample Collection Device is 48 months from the day of manufacture.

The kit consists of a 96 well GARGG (goat anti-rabbit gamma globulin) coated microplate (12x8 breakable strip wells), one concentrated stock testosterone calibrator (62,500 pg/ml), one stock testosterone control (40,000 pg/ml), both traceable to the USP, Anti-Testosterone (rabbit monoclonal), 20X concentrated testosterone-peroxidase (analog), substrate solution, stop reaction solution and 10X concentrated wash solution.

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

Not Found

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)

Precision/Reproducibility:

Intra-assay precision: Determined from 20 replicates of low, medium, and high saliva pools.
- Low: Mean 21.0 pg/mL, SD 1.063 pg/mL, %CV 5.1
- Medium: Mean 174.7 pg/mL, SD 3.641 pg/mL, %CV 2.1
- High: Mean 318.7 pg/mL, SD 13.517 pg/mL, %CV 4.2
Inter-assay precision: Determined from the mean of the average of duplicates for 12 separate assays with low, medium, and high saliva pools.
- Low: Mean 19.1 pg/mL, SD 1.232 pg/mL, %CV 6.4
- Medium: Mean 155.6 pg/mL, SD 7.106 pg/mL, %CV 4.6
- High: Mean 285.5 pg/mL, SD 8.847 pg/mL, %CV 3.1
Inter-lot precision: Duplicate measurements of 5 saliva samples and 2 spiked controls using 3 different reagent lots. %CV

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 19, 2014

BIO-ANALYSIS, INC. C/O REGINA O'MEARA PRINCIPAL 27735 TAMARA DRIVE YORBA LINDA CA 92887

Re: K133303 Trade/Device Name: Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: II Product Code: JKA, CDZ Dated: November 17, 2014 Received: November 19, 2014

Dear Ms. Regina O'Meara:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K133303

Device Name Pantex Salivary Direct Testosterone EIA Kit Pantex Sample Collection Device

Indications for Use (Describe)

The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and andrenogential syndromes.

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

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

510(k) Summary Pantex Salivary Direct Testosterone EIA Kit

| Submitted by: | Pantex, Division of Bio-Analysis, Inc.
1701 Berkeley Street
Santa Monica, CA 90404
USA
(310) 828-7423 |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Romulo Garza, Ph.D., President & Senior Scientist |
| Date: | 10/27/14 |
| Trade Name:
Common Name:
Regulation Number and Panel:
Classification Product Code:
Classification: | Pantex Sample Collection Device
Blood Specimen Collection Device
862.1675 / Clinical Chemistry (75)
JKA
Class II |
| Trade Name:
Common Name:
Regulation Number and Panel:
Classification Product Code:
Classification: | Pantex Salivary Direct Testosterone EIA Kit
Enzyme immunoassay, Testosterone, salivary
862.1608 / Clinical Chemistry (75)
CDZ
Class I, Reserved |

Predicate Device:

Device Name: Company: 510(k) Reference:

Testosterone Luminescence Immunoassay IBL International GMBH K033786

1. Device Description:

a. Test principle

The Pantex Salivary Direct Testosterone EIA kit, Cat # 635 is based on the competition principal and microplate separation. Testosterone calibrators of known concentration, unknown amounts of testosterone in saliva samples and a fixed amount of testosterone (analog) conjugated to horse radish peroxidase (Testosterone-HRP) compete for binding sites with a rabbit monoclonal antiserum bound to GARGG (goat anti-rabbit gamma globulin) coated wells of a microplate. After incubation, unbound components are washed away, enzyme substrate solution is added and a blue color formed. This reaction is stopped with an acid solution to produce a yellow color. The optical density is then read at 450 nm. The amount of Testosterone-HRP detected is inversely proportional to the amount of testosterone in a sample.

4

b. Pantex Sample Collection Device

The Pantex collection device is a 10 mL, non-sterile, plain polypropylene tube with a screw cap. It is provided as 50 units per package. The expiration date of the Pantex Sample Collection Device is 48 months from the day of manufacture.

Kit Contents ﻦ

The kit consists of a 96 well GARGG (goat anti-rabbit gamma globulin) coated microplate (12x8 breakable strip wells), one concentrated stock testosterone calibrator (62,500 pg/ml), one stock testosterone control (40,000 pg/ml), both traceable to the USP, Anti-Testosterone (rabbit monoclonal), 20X concentrated testosterone-peroxidase (analog), substrate solution, stop reaction solution and 10X concentrated wash solution.

d. Intended Use

The Pantex Salivary Direct Testosterone ELA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males, and females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and andrenogential syndromes.

	Predicate Device:	New Device:
	IBL Testosterone LIA
(K033786)	Pantex Salivary Direct Testosterone EIA Kit
(K133303)
Indications
for use	Luminescence Immunoassay (LIA) for the in-vitro diagnostic quantitative measurement of testosterone in saliva.
Measurement of testosterone (a male sex hormone) is used in the diagnosis of treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.	The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.
Analyte	Free Testosterone	Free Testosterone
Sample
Type	Saliva	Saliva
Method	Luminescence Immunoassay	Enzyme Immunoassay

2. Technology Comparison

5

| Detection

Method	Microplate Luminometer reader	Microplate Colormetric reader
Test
Principle	Luminescence immunoassays (LIA) are based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells of a microplate. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution, the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.	Enzyme Immunoassays (EIA) are based on the competition principle. An unknown amount of antigen in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of antibodies coated onto a GARGG coated microplate. After incubation, the microplate is washed to stop the competition reaction and remove unbound components. After addition of the enzyme substrate (TMB) solution, color is formed and the optical density read. The intensity of the color measured is inversely proportional to the amount of the antigen present in the sample. Results of samples can be determined directly using the standard curve.
Calculations	Quantitative determination with standard curve	Quantitative determination with standard curve
Quality
Control	Use of reference controls is recommended	Use of reference controls is recommended
Analytical
Measuring
Range
(AMR)	2.0 pg/mL – 500 pg/mL	6.4 pg/mL – 500 pg/mL
Expected
Values
(Normal
range)	Female Age Median Range
5-95% N 20-29 19.0 5.5-49.0 40 30-39 17.3 5.2-49.0 39 40-49 13.8 4.5-49.0 47 50-59 13.2 3.6-49.0 53 60-69 15.8 2.9-38.8 33 Male 20-29 78.8 41.4-
142.5 55 30-39 58.8 31.8-
100.4 35 40-49 54.4 30.1-97.8 48 50-59 54.8 30.0-92.0 64 60-69 42.9 23.2-86.9 63			Female Age Median
(pg/mL) 95% ref.
limits 90% CI
(pg/mL) N 20-49 17.20 3.91-40.9 3.70-50.0 120 50-70 14.75 4.51-34.17 4.2-35.1 120 Male 20-49 86.6 41.12-
142.16 33.6-
157.9 120 50-70 60.15 24.03-
119.52 22.0-
131.9 120
	Limits of
Detection	Analytical Sensitivity = 1.8 pg/mL	Limit of Blank (LoB)
1.8 pg/mL
Limit of Detection (LoD)
2.1 pg/mL
Limit of Quantitation (LoQ)
3.9 pg/mL
	Saliva
Collection
Device	IBL Saliva Sampling Set (conical polypropylene tubes with 2.0 mL capacity).	Pantex sample collection device, Cat # PCD602. The Pantex collection device is a 10 mL, non-sterile, plain polypropylene tube with a screw cap. The expiration date of the device is 48 months from the day of

6

		manufacture.
Interference	Did not test for interferences in
salivary testosterone measurement
when testing with caffeine, food,
nicotine, alcohol. or chewing gum.	An in-vivo study with caffeine, food,
nicotine, alcohol and chewing gum
not reveal significant interference in the
measurement of testosterone in saliva
using the Pantex Salivary Direct
Testosterone EIA Kit, Cat #635.
Table Continues
Stability and
Storage of
Kit reagents	Stated as stable at 2-8°C until kits
expiration date	4 months at 2-8°C. The stability study is
still on-going.

7

3. Test Summary

Performance Characteristics

The performance characteristics of the Pantex Salivary Direct Testosterone EIA Kit were based on evaluations by the following analytical performance tests. All saliva samples used in the performance testing were collected and processed through the Pantex Sample Collection Device (Cat # PCD602).

a. Precision/Reproducibility

The intra-assay precision was determined from 20 replicates of low, medium and high saliva pools.

| Sample | N | Mean (pg/mL) | Standard
Deviation
(pg/mL) | %CV |
|--------|----|--------------|----------------------------------|-----|
| Low | 20 | 21.0 | 1.063 | 5.1 |
| Medium | 20 | 174.7 | 3.641 | 2.1 |
| High | 20 | 318.7 | 13.517 | 4.2 |

The inter-assay precision was determined from the mean of the average of duplicates for 12 separate assays with low, medium and high saliva pools.

| Sample | N | Mean (pg/mL) | Standard
Deviation
(pg/mL) | %CV |
|--------|----|--------------|----------------------------------|-----|
| Low | 12 | 19.1 | 1.232 | 6.4 |
| Medium | 12 | 155.6 | 7.106 | 4.6 |
| High | 12 | 285.5 | 8.847 | 3.1 |

The inter-lot precision was determined by duplicate measurements of five (5) saliva samples and two levels of one (1) spiked control in saliva like matrix, using three (3) different reagent lots. The results of intra-assay, inter-assay and inter-lot variation concluded a %CV of ≤10% for each sample tested.

| Saliva
Samples
ID | Lot # 007
mean
(pg/ml) | Lot # 008
mean
(pg/ml) | Lot # 009
mean
(pg/ml) | Inter-lot
mean
(pg/ml) | Inter-lot
Std. Dev.
(pg/ml) | Inter-lot
%CV
(pg/ml) |
|-------------------------|------------------------------|------------------------------|------------------------------|------------------------------|-----------------------------------|-----------------------------|
| 1 | 314.6 | 324.0 | 320.1 | 319.6 | 4.723 | 1.5 |
| 2 | 101.8 | 97.4 | 99.3 | 99.5 | 2.207 | 2.2 |
| 3 | 69.2 | 69.4 | 61.0 | 66.5 | 4.793 | 7.2 |
| 4 | 8.8 | 9.7 | 9.9 | 9.5 | 0.586 | 6.2 |
| 5 | 23.8 | 21.7 | 21.3 | 22.3 | 1.343 | 6.0 |
| C1 | 21.1 | 19.5 | 20.5 | 20.4 | 0.808 | 4.0 |
| C2 | 210.2 | 196.3 | 212.2 | 206.2 | 8.660 | 4.2 |

8

Repeatability

This study was conducted during 5 days of a familiarization period and 20 days of testing. Two assays were performed daily with a minimum of 1 hour between assays. Three (3) different reagents lots and three (3) saliva pools were used for the study (low, medium and high concentration). The pools were aliquoted and frozen until the day of assay.

| Sample
Concentration | N | Mean
(pg/mL) | Repeatability | | Total Precision | |
|-------------------------|-----|-----------------|---------------|-----|-----------------|-----|
| Low | 100 | 19.4 | 0.8 | 3.8 | 1.1 | 5.6 |
| Medium | 100 | 155.3 | 3.7 | 2.5 | 7.9 | 5.3 |
| High | 100 | 275.6 | 7.4 | 2.5 | 11.9 | 4.0 |
| Control 1 | 100 | 19.3 | 0.9 | 4.6 | 1.2 | 5.8 |
| Control 2 | 100 | 201.4 | 3.8 | 1.8 | 8.2 | 4.0 |

Precision Study Data Summary

b. Linearity

Ten (10) sample concentrations that span the assay measuring range were prepared and assayed per CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures.

S=10 samples (dilutions)

Concentration = (C1V1 + C10V10)/(V1+V10)

| | C1 | V1 | C10 | V10 | Calculated
Concentration | Observed
Concentration | Recovery |
|----|-------|-------|-------|-------|-----------------------------|---------------------------|----------|
| | pg/ml | ml | pg/ml | ml | pg/ml | pg/ml | % |
| 1 | | | | * | 5.5 | 5.2 | 94.5 |
| 2 | 5.2 | 0.889 | 631.5 | 0.111 | 74.7 | 76.3 | 102.1 |
| 3 | 5.2 | 0.778 | 631.5 | 0.222 | 144.2 | 153.6 | 106.5 |
| 4 | 5.2 | 0.667 | 631.5 | 0.333 | 213.8 | 216.1 | 101.1 |
| 5 | 5.2 | 0.556 | 631.5 | 0.444 | 283.3 | 275.3 | 97.2 |
| 6 | 5.2 | 0.444 | 631.5 | 0.556 | 353.4 | 323.6 | 91.6 |
| 7 | 5.2 | 0.333 | 631.5 | 0.667 | 422.9 | 401.8 | 95.0 |
| 8 | 5.2 | 0.222 | 631.5 | 0.778 | 492.5 | 461.7 | 93.8 |
| 9 | 5.2 | 0.111 | 631.5 | 0.889 | 562.0 | 561.4 | 99.9 |
| 10 | | | | * | 650.0 | 631.5 | 97.2 |

Targets of low and high sample concentrations.

The results demonstrate that the assay is linear from 5.5 - 650.0 pg/mL. (Y=0.9597x + 3.335, R2 = 0.99685)

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c. Recovery

Seven (7) saliva samples containing different levels of endogenous testosterone were spiked with known
quantities of testosterone and assayed.

| Sample | Endogenous
(pg/ml) | Added
(pg/ml) | Expected
(pg/ml) | Observed
(pg/ml) | Recovery
(%) |
|--------|-----------------------|------------------|---------------------|---------------------|-----------------|
| 1 | 10.000 | 7.813 | 17.813 | 19.400 | 108.9 |
| 2 | 19.000 | 15.625 | 34.625 | 36.300 | 104.8 |
| 3 | 27.600 | 31.250 | 58.850 | 54.500 | 92.6 |
| 4 | 28.200 | 62.500 | 90.700 | 95.100 | 104.9 |
| 5 | 9.800 | 125.000 | 134.800 | 127.900 | 94.9 |
| 6 | 103.700 | 250.000 | 353.700 | 346.800 | 98.0 |
| 7 | 38.600 | 500.000 | 538.600 | 497.600 | 92.4 |

d. Manual Dilution

A 1:10 sample manual dilution study was performed utilizing six (6) samples to verify the accuracy of the dilution procedure with a dilution factor of 10. The following table indicates the summary of results:

| Subject | Observed
Endogenous
Value
(pg/mL) | Testosterone
Spiked
(pg/mL) | Expected
Value
(pg/mL) | Observed
1:10 diluted
Value
(pg/mL) | Applied
Factor 10
(pg/mL) | Recovery
(%) |
|---------|--------------------------------------------|-----------------------------------|------------------------------|----------------------------------------------|---------------------------------|-----------------|
| AL-209 | 346.7 | 0 | 346.7 | 33.3 | 333 | 96.0 |
| AL-210 | 274.3 | 0 | 274.3 | 26.5 | 265 | 96.6 |
| *AL-225 | 133.1 | 500 | 633.1 | 67.2 | 672 | 106.1 |
| AL-227 | 229.5 | 0 | 229.5 | 22.7 | 227 | 98.9 |
| *AL-228 | 100 | 750 | 850 | 93.1 | 931 | 109.5 |
| *AL-247 | 125.8 | 1000 | 1125.8 | 121.3 | 1213 | 107.7 |

Spiked samples.

4. Reagent Stability/Sample Stability/Expected Values

The long term stability study for reagents stored at 2 - 8° C is currently on-going; however, at the time of this executive summary report the expiration date supported by the results obtained on the stability study is 4 months from the manufacturing date when the reagents are stored at 2 - 8° C. As the stability study progresses, the expiration date will be upgraded accordingly.

a. Open Vial Stability

Condition	Stability	Storage Temperature
Open vial stability	31 days	2 - 8°C
Working Testosterone-HRP Conjugate solution	31 days	2 - 8°C
Diluted working testosterone stock calibrator	31 days	2 - 8°C
Diluted working testosterone stock control	31 days	2 - 8°C

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b.Sample Stability

| Storage | 20-28°C | 37°C | 2-8°C | ≤-15°C
(7 freeze/thaw cycles) | ≤-15°C
(Long term) |
|-----------|--------------|--------------|--------------|----------------------------------|-----------------------|
| Stability | Up to 7 days | Up to 7 days | Up to 7 days | Up to 7 days | Up to 180 days |

Sample Shipping, Handling and Storage Conditions Stability C.

The samples were shipped to a location outside the testing site on 7/2/14 and returned to the testing site on 7/11/14 representing a total of 9 days in transit; thereafter, the samples were stored at 2-8℃, 20-28°C, 37°C and ≤-15°C for 7 days and tested after 3 days and 7 days. Based on the results obtained, it appears that the samples retained their physical integrity and testosterone levels remained unaffected for 9 days in transit and up to 7 days when stored at the stated temperatures.

| Storage | 2-8°C and
room
temperature
during transit | 20-28°C | 37°C | 2-8°C |