The dbc CAN-fTE-260 EiAsy™ Free Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Free Testosterone in human serum. This assay is intended for in vitro diagnostic use only. Measurement of Free Testosterone are used in the diagnosis in male sex hormones (androgens) and in females hirsutism (excessive hair) and virilisation (masculinization).

Device Description

The free Testosterone Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96 wells per kit). The antigen Testosterone 3 carboxymethyl oxime is conjugated to an enzyme namely horse radish peroxidase. The standards are prepared in human serum matrix and all other reagents within the kit namely assay buffer, wash buffer concentrate, substrate tetramet hytbenzidine (TMB) and stopping solution. 50 ul of patient serum , control serum and each standard are added to each well. 100 ul of conjugate solution is again added to each well. The incubation time is 37°C for 60 minutes. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 100 ul of substrate TMB is added to each well and allowed to incubate for 10 - 15 minutes at 37°C. 50 ul of stopping solution is added into each well and the colour becomes yellow. The plate is read within 20 minutes in a microtiter plate reader at 450 nm.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information:

The document describes the dbc Free Testosterone by Enzymeimmunoassay (EiA) device and its comparison to a predicate device, the Diagnostics Products Corporation (DPC) COAT-A-Count Free Testosterone kit.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The primary performance metric presented is the correlation coefficient (r) between the new device and the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (DPC COAT-A-Count Free Testosterone kit)	Correlation (r) = 0.8908
Sensitivity	Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices"
Specificity	Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices"
Intra-assay precision	Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices"
Inter-assay precision	Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices"
Same intended use	Yes: "Direct determination of Free Testosterone by enzymeimmunoassay (Elisa) in human serum."
Same characteristics (antigen/antibody)	Yes
Similar methodology, reagents, materials, control serum	Yes

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 61 human serum samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). It is a retrospective comparison as the samples were tested on both devices to demonstrate equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device (in-vitro diagnostic assay for a biomarker). The "ground truth" is established by the predicate device's measurement. There's no mention of expert review of the results in the context of establishing ground truth.
Adjudication method for the test set:
- Not applicable. This is a quantitative measurement comparison between two devices, not a diagnostic interpretation by multiple readers.
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. This is an immunoassay kit, not an AI-powered diagnostic imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance data (correlation, sensitivity, specificity, precision) refer to the standalone performance of the dbc EiA kit compared to the predicate device. As an in-vitro diagnostic, it operates as a standalone measurement tool.
The type of ground truth used:
- Predicate device comparison: The performance is established by comparing the results of the new device to those obtained from a legally marketed and established predicate device (DPC COAT-A-Count Free Testosterone kit). The predicate device's measurements serve as the reference for "ground truth" in demonstrating equivalence.
The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning or AI. For an immunoassay, the development and optimization (which could be considered analogous to training) would involve optimizing reagents, protocols, and validating against known standards or reference materials. This document focuses on the validation against the predicate device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI sense. Ground truth for immunoassay development (if one were to use the term) would typically involve NIST (National Institute of Standards and Technology) traceable reference materials, reference methods (e.g., mass spectrometry), or highly characterized patient samples where the analyte concentration is known through established techniques. This information is not detailed in the provided text.

Summary

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Page 2

AUG 1 8 2003

K030730

dbc - DIAGNOSTICS BIOCHEM CANADA INC.

1020 Hargrieve Road, London, Ontario, Canada NGE 1P5 e-mail dbclabs@bellnet.ca Tel/Fax (519) 681-8731

G. R. Dumont M.D., M.Sc. A.J. Desrosters, D.Sc.M.Sc. J. U. Larvea, Ph. D. M.Sc.

DATE: July 2, 2003

Dr. G. R. Dumont Contact Person: Tel (519) 681-8731

19. 510 K Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510K number is K030730
The classification name of the device: Enzyme immunoassay for free testosterone
Classification number 862.1680
Proprietary name: Free Testosterone by Enzymeimmunoassay (EiA) Class I
Use of the device: Direct determination of Free Testosterone by enzymeimmunoassay (Elisa) in human serum. It is an in-vitro diagnostic kit
The predicate device's name and address of which we claim equivalence: Diagnostics Products Corporation, (DPC), 5700 West 96 Street, Los Angeles, CA, 900159597

COAT-A-Count Free Testosterone kit Cat. No. TKTF1 (100 tubes) and TKFT2 (200 tubes) 510(K) K844423

The free Testosterone Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96 wells per kit). The antigen Testosterone 3 carboxymethyl oxime

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is conjugated to an enzyme namely horse radish peroxidase. The standards are prepared in human serum matrix and all other reagents within the kit namely assay buffer, wash buffer concentrate, substrate tetramethytbenzidine (TMB) and stopping solution. 50 ul of patient serum , control serum and each standard are added to each well. 100 ul of conjugate solution is again added to each well. The incubation time is 37°C for 60 minutes. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 100 ul of substrate TMB is added to each well and allowed to incubate for 10 - 15 minutes at 37°C. 50 ul of stopping solution is added into each well and the colour becomes yellow. The plate is read within 20 minutes in a microtiter plate reader at 450 nm.

8. Substantial equivalence:

The DBC In-vitro diagnostic device namely free Testosterone by enzymeimmunoassay (EiA) has the same intended use as current device on the market referred to "predicate device".
The dbc In-vitro diagnostic device namely free Testosterone has the same characteristics as predicate device namely antigen/antibody.
The dbc results obtained of a number of human serum samples substantial equivalent to the predicate device. The results need not be exactly the same but a correlation of equivalence is necessary in this case r=0.8908
The dbc free testosterone reflect the same equivalence as the predicate devices which can be found in our results of performance characteristics namely, sensitivity, specificity, Intra and Inter assay precision and the results of 61 human serumsamples
dbc free testosterone intended use, methodology, reagents materials and control serum necessary to perform the test are similar to the predicate device.
Our 510K presentation demonstrates substantial equivalence to predicate device in regards:

· intended use
· performance
· material
· effectiveness
· standards
· control

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a logo with a circular border containing text, and an abstract symbol in the center. The text around the border is partially visible and appears to be in all caps. The central symbol consists of four curved lines that converge on the right side, resembling a stylized bird in flight. The image is in black and white.

AUG 1 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

G.R. Dumont, M.D., M.Sc. Director of Laboratories Diagnostics Biochem Canada, Inc. 1020 Hargrieve Road London, Ontario CANADA N6E 1P5

Re: K030730

Trade/Device Name: EiAsy 110 Free Testosterone EiA Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I Product Code: CDZ Dated: May 28, 2003 Received: May 29, 2003

Dear Dr. Dumont:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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18. Statements of Indication for Use

K630730 510K number

Device Name: EiAsyTM Free Testosterone EiA

Indication for Use:

Prescription USE..............................................................................................................................................................

Over-The-Counter Use .........

(Per 21 CFR 801.109

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K030736

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.