Immunoassay for the in vitro quantitative determination sex hormone binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Device Description

A device for the measurement of human SHBG in serum or plasma.

AI/ML Overview

This document is a 510(k) summary for the Elecsys® SHBG Immunoassay by Roche Diagnostics Corporation, submitted to the FDA in 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device, the DPC Immulite SHBG. The information provided is characteristic of a medical device submission rather than a clinical study evaluating AI performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a modern AI-driven device are not present in this document. This submission is for an in-vitro diagnostic immunoassay, not an AI device.

Here's an analysis of the provided text based on your request, with a clear distinction for information that is not available from this document given its nature:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way one might for an AI device. Instead, it presents performance characteristics of the Elecsys SHBG Immunoassay and compares them to a predicate device to demonstrate substantial equivalence. The "reported device performance" refers to the characteristics of the Elecsys SHBG Immunoassay.

Feature	Elecsys SHBG Immunoassay Performance	DPC Immulite SHBG (predicate) Performance (for comparison)
Calibration Interval (E170/E2010)	After 1 month (same lot), After 7 days (same kit)	2 weeks
Calibration Interval (E1010)	With every reagent kit, After 7 days (20-25°C), After 3 days (25-32°C)	2 weeks
Sample Type	Human serum and Li-heparin plasma	Human serum
Reagent Stability (Unopened)	Up to stated expiration date at 2-8°C	7 days at 2-8°C; 2 months at -20°C
Reagent Stability (Opened)	12 weeks at 2-8°C (7 weeks on E170/2010, 4 weeks on E1010, up to 20 hours opened in total at 20-25° ambient temp)	7 days at 2-8°C; 2 months at -20°C
Expected Values (Males)	10-80 nmol/L	Central 95% 13-71 nmol/L; Median 32 nmol/L
Expected Values (Females)	20-130 nmol/L	Central 95% 18-114 nmol/L; Median 51 nmol/L
Measuring Range	0.350-200 nmol/L	0.2-180 nmol/L
Precision (E170, Within-run)	1.1-1.7 %CV from 14.9-219 nmol/L	4.1-7.7 %CV from 4.5-121 nmol/L
Precision (E170, Total)	1.8-4.0 %CV from 14.9-219 nmol/L	5.8-13 %CV from 6.0-105 nmol/L
Precision (E1010/2010, Within-run)	2.1-2.7 %CV from 14.1-204 nmol/L	(Not specified for predicate by instrument type)
Precision (E1010/2010, Total)	2.6-5.6 %CV from 14.1-204 nmol/L	(Not specified for predicate by instrument type)
Hook Effect	No high dose hook effect up to 1000 nmol/L	No high-dose hook effect up to 11,000 nmol/L
Analytical sensitivity (LDL)	0.35 nmol/L	0.2 nmol/L
Interference (Bilirubin)	No interference up to 60 mg/dL	No interference up to 200mg/L
Interference (Hemoglobin)	No interference up to 2.9 g/dL	No interference up to 10000 mg/dL
Interference (Intralipid)	No interference up to 2700 mg/dL	(Not specified for predicate)
Interference (Biotin)	No interference up to 60 ng/mL (warning for >5 mg/dL)	(Not specified for predicate)
Interference (Rheumatoid factor)	No interference up to 1160 IU/mL	(Not specified for predicate)
Interference (Pharmaceuticals)	No interference from 16 commonly used pharmaceuticals	(Not specified for predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. A 510(k) summary typically doesn't detail the specific sample sizes used for each performance characteristic study (e.g., precision, interference) or the demographic/provenance of the samples. These details would be in the full submission, but not summarized here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is an immunoassay measuring a biochemical marker, not an AI device interpreting images or other data requiring expert human-established ground truth. The "ground truth" for an immunoassay is typically established by comparing its measurements to a reference method or validated standard, not by expert consensus on interpretations.

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

This is not applicable for an immunoassay. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging with multiple readers.

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

This is not applicable. This document describes an immunoassay, not an AI system. Therefore, no MRMC study involving human readers and AI assistance would have been performed or reported.

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

This refers to the performance of the immunoassay device itself. The listed performance characteristics (precision, measuring range, analytical sensitivity, hook effect, interference) reflect the standalone performance of the Elecsys SHBG Immunoassay system (reagents + analyzer) as it would be used in a laboratory setting. Human intervention is involved in operating the analyzer and interpreting the quantitative results, but the "algorithm" equivalent is the chemical reaction and detection method within the instrument.

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

For an immunoassay, the "ground truth" for accuracy and calibration is typically established using:

Reference materials/standards: The document states "1st International Standard for SHBG NIBSC code 95/560" for traceability/standardization. This is the primary "ground truth" for ensuring the assay accurately measures SHBG.
Known concentrations: For studies like precision, known concentrations of SHBG are used.
Comparison to established/predicate methods: The entire 510(k) process is about demonstrating equivalence to an already legally marketed device (predicate), implying that the predicate's measurements serve as a comparative "truth"
Clinical correlation: The "Intended Use" and "Indications for Use" connect the measured SHBG levels to clinical conditions, but the direct ground truth for the measurement itself comes from reference standards.

8. The sample size for the training set

This information is not available as the concept of a "training set" in the context of machine learning/AI does not apply to this immunoassay. The development of an immunoassay involves optimization and validation using various samples, but these are not referred to as a "training set" in the AI sense.

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

This is not applicable for the same reasons as point 8.

Summary

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K 63/717

Elecsys® SHBG Immunoassay

Roche Diagnostics Corporation

SECTION III - 510k Summary

:・・

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Elecsys® SHBG Immunoassay Roche Diagnostics Corporation 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics Corporation name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Theresa M. Ambrose Date Prepared: May 28, 2003 の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 Device Name Proprietary name: Elecsys® SHBG Immunoassay System Common name: SHBG test Classification name: Testosterone test system Device A device for the measurement of human SHBG in serum or plasma. Description Intended use For the in vitro quantitative determination of sex hormone binding globulin in human serum and plasma. Indications for An aid in the diagnosis of androgen disorders including hirsuitism, Use virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations

AUG - 5 2003

K 031 717

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510(k) Summary, Continued

Substantial		The Elecsys SHBG Immunoassay is substantially equivalent to other devices
equivalence		legally marketed in the United States. We claim equivalence to the DPC
		Immulite SHBG cleared under K941797. Both products are intended for use
		in the quantitative determination of sex hormone binding globulin.

Substantial The following table compares the Roche Elecsys SHBG Immunoassay with equivalence the predicate device. comparison

Feature	Elecsys SHBGImmunoassay	DPC Immulite SHBG(predicate)
Intended Use	For the in-vitro quantitativedetermination of SHBG inserum and plasma.	For the quantitativemeasurement of SHBG, as anaid in the differentialdiagnosis of hirsuitism.
Indication for Use	An aid in the diagnosis ofandrogen disorders includinghirsuitism, virilization,polycystic ovarian syndrome,adrenogenital syndrome, andhyperandrogenism;the correct interpretation oftestosterone and estradiolconcentrations; investigationof the androgen-estrogenbalance in gonadal and sexualdysfunction; assessment ofthe peripheral effect ofhormones which regulateSHBG concentrations	For the quantitativemeasurement of SHBG as anaid in the differentialdiagnosis of hirsuitism.
Assay Protocol	ElectrochemiluminescentImmunoassay	ChemiluminescentImmunoassay
Traceability / Standardization	1st International Standard forSHBG NIBSC code 95/560	DPC's IRMA-Count SHBGassay
Feature	Elecsys SHBGImmunoassay	DPC Immulite SHBG(predicate)
Calibration Interval	E170/E2010After 1 month when using the same reagent lot After 7 days when using the same reagent kit E1010 With every reagent kit After 7 days (20-25°C) After 3 days (25-32°C)	2 weeks
Sample Type	Human serum and Li-heparin plasma	Human serum
Reagent Stability	Unopened Up to stated expiration date stored at 2-8°C Opened 12 weeks at 2-8° 7weeks on E170/ 2010 4 weeks on E1010 (20-25° ambient temp - up to 20 hours opened in total)	7 days at 2-8°C 2 months at -20°C
Calibrator	Elecsys SHBG CalSet	SHBG Adjustors
Controls	Elecsys PreciControlUniversal 1 and 2	SHBG Controls
Expected Values	Males: 10-80 nmol/LFemales: 20-130 nmol/L	Males: Central 95% 13-71 nmol/L; Median 32 nmol/LFemales: Central 95% 18-114 nmol/L; Median 51 nmol/L*
Instrument	Elecsys family of analyzers(Elecsys 1010, Elecsys 2010 and Elecsys E170MODULAR AnalyticsImmunoassay Analyzers)	IMMULITE Analyzers
Measuring Range	0.350-200 nmol/L	0.2-180 nmol/L
Feature	Elecsys SHBG Immunoassay	DPC Immulite SHBG(predicate)
Precision	E170Within-run 1.1- 1.7 %CV from 14.9 – 219 nmol/L Total 1.8- 4.0 % CV from 14.9 – 219 nmol/L E1010/2010 Within-run 2.1- 2.7 %CV from 14.1 – 204 nmol/L Total 2.6 - 5.6%CV from 14.1 – 204 nmol/L	Within-run 4.1-7.7 %CV from 4.5-121 nmol/L Total 5.8% - 13% CV from 6.0-105 nmol/L
Hook Effect	No high dose hook effect up to 1000 nmol/L	No high-dose hook effect up to 11,000 nmol/L
Analyticalsensitivity (LDL)	0.35 nmol/L	0.2 nmol/L

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Roche Diagnostics Corporation

Elecsys® SHBG Immunoassay

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510(k) Summary, Continued

The performance characteristics of the Elecsys SHBG Immunoassay and the Substantial equivalence predicate device are compared in the table below. performance characteristics

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ﻮ

Feature	Elecsys SHBG Immunoassay	DPC Immulite SHBG (predicate)
Limitations/Warnings/Precautions	No interference from bilirubin up to 60 mg/dL No interference from hemoglobin up to 2.9 g/dL No interference from Intralipid up to 2700 mg/dL No interference with biotin up to 60 ng/mL No interference from rheumatoid factor up to 1160 IU/mL No interference from 16 commonly used pharmaceuticals In patients receiving high biotin doses > 5 mg/dL, sample should not be taken until 8 hours after administration. Erroneous findings may be obtained in samples from patients who have been treated with monoclonal mouse antibodies In rare cases interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur	Lipemia may interfere Fibrin clots may cause erroneous results Results from hemolyzed specimens should be interpreted with caution No interference from packed red blood cells up to 30 uL/mL No interference from bilirubin up to 200mg/L No interference from hemoglobin up to 10000 mg/dL Heterophilic antibodies in human serum can react with assay components to cause interference. SHBG results should be interpreted in conjunction with measures of the hormones with which it binds, notably testosterone.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

AUG - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa M. Ambrose, Ph.D., FACB Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250

Re: K031717

Trade/Device Name: Elecsys® SHBG Immunoassay Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS, CDZ, JJY Dated: May 28, 2003 Received: June 3, 2003

Dear Dr. Ambrose:

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). 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.

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Page 2 –

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 Sutman

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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Elecsys® SHBG Immunoassay

Roche Diagnostics Corporation

Indications for Use Statement

510(k) Number (if known): N/A K/31717

Device Name:

Elecsys® SHBG Immunoassay

Indications For Use:

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Albert Sant

Division Sign-Off for: Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031717

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.