(114 days)
Not Found
No
The summary describes a standard immunoassay for measuring SHBG levels and does not mention any AI or ML components. The performance studies focus on analytical metrics typical of immunoassays.
No.
This device is an immunoassay intended for the in vitro quantitative determination of sex hormone-binding globulin, used as an aid in the diagnosis of androgen disorders. It measures a substance in the body but does not treat any condition.
Yes
The device is explicitly stated as an "Immunoassay for the in vitro quantitative determination of 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." The phrase "aid in the diagnosis" clearly indicates its diagnostic purpose.
No
The device description explicitly states it is an "Immunoassay" and is intended for use on "Elecsys and cobas e immunoassay analyzers," which are hardware devices. The performance studies also describe analytical characteristics of a physical assay.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of sex hormone-binding globulin in human serum and plasma." The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Purpose: The intended use also states it's "intended for use as an aid in the diagnosis of androgen disorders." This indicates the device is used to provide information for diagnostic purposes.
- Sample Type: The device measures SHBG in "human serum and plasma," which are biological samples typically analyzed in a laboratory setting.
- Technology: It uses an "electrochemiluminescence immunoassay 'ECLIA'," which is a common technology used in IVD tests.
- Device Description: The description confirms it's a "device for the measurement of human SHBG in serum or plasma," reinforcing its role in analyzing biological samples.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of 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. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CDZ
Device Description
A device for the measurement of human SHBG in serum or plasma.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A comparison of the Elecsys SHBG assay (y) with a commercially available SHBG assay (x) using clinical samples gave the following correlation: n = 109, Min =11.2 nmol/L, Max = 155 nmol/L.
Passing/Bablok: Slope 1.17, Intercept -3.26, Tau / r 0.909.
Linear Regression: Slope 1.15, Intercept -1.82, Tau / r 0.981.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: E170/ e601 Within run 1.1 – 1.7% CV from 14.9 - 219 nmol/L, Total 1.8 - 4.0% CV from 14.9 -219 nmol/L.
Analytical Sensitivity: Limit of Blank (LoB): 0.500 nmol/L, Limit of Detection (LoD): 0.800 nmol/L, Limit of Quantitation (LoQ): 2.00 nmol/L.
Hook Effect: There is no high-dose hook effect at SHBG concentrations up to 1000 nmol/L.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
JAN 2 0 2011
K10 2814
| Introduction | According to the requirements of 21 CFR 807.92, the following
information provides sufficient detail to understand the basis for a
determination of substantial equivalence. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
Name,
Address,
Contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
Contact person: Kelly French
Phone: (317) 521-3208
Fax: (317) 521-2324
Email: kelly.french@roche.com
Secondary contact: Stephanie Greeman
Phone: (317) 521-2458
Fax: (317) 521-2324
Email: stephanie.greeman@roche.com
Date Prepared: September 23, 2010 |
| Device Name | Proprietary names: Elecsys® SHBG Immunoassay System
Common name: SHBG test
Classification name: Radioimmunoassay, Testosterones and
Dihydrotestosterone |
1
| Device Description | A device for the measurement of human SHBG in serum or plasma. |
|---|---|
| Substantial Equivalence | The Elecsys SHBG Test System is substantially equivalent to other devices legally marketed in the United States. We claim equivalency to the currently marketed Elecsys SHBG Test System (K031717). |
Continued on next page
2
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
| Premarket Notification, Traditional 510(k) for | ||
|---|---|---|
| Elecsys SHBG Assay | ||
| Immunoassay Comparison | ||
| Feature | Predicate Device: Elecsys SHBG | |
| Assay (K031717) | Elecsys SHBG Assay | |
| General Assay Features | ||
| Intended | ||
| Use/ | ||
| Indications | ||
| for Use | Immunoassay for the in vitro | |
| quantitative determination of sex | ||
| hormone-binding globulin in human | ||
| serum and plasma. | Same | |
| The electrochemiluminescence | ||
| immunoassay “ECLIA” is intended | ||
| for use on Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Assay | ||
| Protocol | Sandwich assay | Same |
| Detection | ||
| Protocol | Electrochemiluminescent | |
| Immunoassay | Same | |
| Application | 18 Minute | Same |
| Instrument | ||
| Platform | Roche Elecsys 1010, 2010/cobas e | |
| 411 and MODULAR ANALYTICS | ||
| E170/cobas e 601 | Same with the exception of the | |
| removal of the Elecsys 1010 | ||
| analyzer | ||
| Sample | ||
| Volume | 10 µL | Same |
| Sample | ||
| Type | Human serum and plasma treated with | |
| lithium heparin. | Same | |
| Traceability | The Elecsys SHBG assay has been | |
| standardized against the 1st | ||
| International Standard for SHBG, | ||
| NIBSC code 95/560. | Same | |
| Calibrator | Elecsys SHBG CalSet | Same |
| Immunoassay Comparison | ||
| Feature | Predicate Device: Elecsys SHGB Assay (K031717) | Elecsys SHBG Assay |
| General Assay Features | ||
| Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: |
MODULAR ANALYTICS E170, Elecsys 2010 and cobas e analyzers:
After 1 month (28 days) when using the same reagent lot After 7 days (when using the same reagent kit on the analyzer) Elecsys 1010 analyzer: With every reagent kit After 7 days (ambient temperature 20-25 °C) After 3 days (ambient temperature 25-32 °C) | Same with the exception of the removal of the Elecsys 1010 analyzer. |
| Controls | Elecsys PreciControl Universal 1 and 2 | Same |
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4
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) | Elecsys SHBG Assay |
| General assay features | ||
| Reagent | ||
| Stability/ | ||
| Storage | Store at 2-8 °C. Store the Elecsys SHBG reagent kit upright in order to ensure complete availability of the microparticles during automatic mixing prior to use. |
Stability:
Unopened at 2-8 °C—up to the stated expiration date
After opening at 2-8 °C—12 weeks
On MODULAR ANALYTICS E170 and cobas e 601—7 weeks
On Elecsys2010 and cobas e 411—7 weeks
On Elecsys 1010- 4 weeks (stored alternately in the refrigerator and on the analyzer – ambient temperature 20-25 °C; up to 20 hours opened in total) | Same with the exception of the removal of the Elecsys 1010 analyzer. |
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| Feature | Predicate Device: Elecsys SHBG Assay (K031717) | Elecsys SHBG Assay | ||||
|---|---|---|---|---|---|---|
| Measuring Range | 0.350-200 nmol/L | 0.800 -200 nmol/L | ||||
| Expected Values | Males: 10-80 nmol/L | |||||
| Females, non-pregnant: 20-130 nmol/L | Reference ranges for the SHBG (nmol/L) | |||||
| N | Median | 5th Perc | 95th perc | |||
| Males 20-49 years | 136 | 33.5 | 16.5 | 55.9 | ||
| Males ≥ 50 years | 78 | 40.8 | 19.3 | 76.4 | ||
| Females 21-49 years | 89 | 64.3 | 24.6 | 122 | ||
| Females ≥ 50 years | 71 | 57.4 | 17.3 | 125 |
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| Feature | Immunoassay Comparison | ||||
|---|---|---|---|---|---|
| Predicate Device: Elecsys | |||||
| SHBG Assay (K031717) | |||||
| (18 Minute) | Elecsys SHBG Assay | ||||
| Expected | |||||
| Values | |||||
| cont. | Labeled Performance Characteristics | ||||
| Reference ranges for Testosterone II (nmol/L) | |||||
| N | Median | 5th | |||
| Perc | 95th | ||||
| perc | |||||
| Males | |||||
| 20-49 | |||||
| years | 136 | 18.6 | 8.64 | 29.0 | |
| Males | |||||
| ≥ 50 | |||||
| years | 78 | 16.5 | 6.68 | 25.7 | |
| Females | |||||
| 21-49 | |||||
| years | 89 | 0.941 | 0.290 | 1.67 | |
| Females | |||||
| ≥ 50 | |||||
| years | 71 | 0.563 | 0.101 | 1.42 | |
| Calculation for obtaining FTI (or FAI): | |||||
| %FTI = (Testosterone (nmol/L) ÷ SHBG (nmol/L)) x 100 | |||||
| Reference ranges for Free Testosterone Index (FTI) / | |||||
| Free Androgen Index (FAI) (nmol/L) | |||||
| N | Median | 5th | |||
| Perc | 95th | ||||
| perc | |||||
| Males | |||||
| 20-49 | |||||
| years | 136 | 57.2 | 35.0 | 92.6 | |
| Males | |||||
| ≥ 50 | |||||
| years | 78 | 38.2 | 24.3 | 72.1 | |
| Females | |||||
| 21-49 | |||||
| years | 89 | 1.53 | 0.297 | 5.62 | |
| Females | |||||
| ≥ 50 | |||||
| years | 71 | 1.15 | 0.187 | 3.63 |
Continued on next page
510(k) Summary, continued
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) (18 Minute) | Elecsys SHBG Assay |
| Labeled Performance Characteristics | ||
| Precision | E1010/ 2010/ 411 | |
| 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 E170/ e601 Within run 1.1 – 1.7% CV from 14.9 - 219 nmol/L Total 1.8 - 4.0% CV from 14.9 -219 nmol/L | Same with the exception of the removal of the Elecsys 1010 analyzer. | |
| Analytical | ||
| Sensitivity | Limit Detection Level (LDL): | |
| 0.35 nmol/L | Limit of Blank (LoB): 0.500 nmol/L | |
| Limit of Detection (LoD): 0.800 nmol/L | ||
| Limit of Quantitation (LoQ): 2.00 nmol/L | ||
| Hook Effect | There is no high-dose hook effect at SHBG concentrations up to 1000 nmol/L | Same |
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Elecsys SHBG Assay (K031717) (18 Minute) | Elecsys SHBG Assay |
| Labeled Performance Characteristics | ||
| Limitations | The assay is unaffected by: | |
| Hemoglobin If you should have questions or require further information, please do not hesitate to contact me. |
· Phone: (317) 521-3208 · FAX: (317) 521-2324 kelly.french@roche.com
Sincerely,
Kelly French, RN, BSN, RAC Regulatory Affairs Consultant US Regulatory Submissions Roche Diagnostics Corporation
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416 -
JAN 20 201
Re: K102814 Trade Name: Elecsys SHBG Regulation Number: 21 CFR §862.1680 Regulation Name: Radioimmunoassay, testosterone and dihydrotestosterone Regulatory Class: Class I, reserved Product Codes: CDZ Dated: December 15, 2010 Received: December 16, 2010
Dear Ms. French:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): .
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K102814
Device Name: Elecsys SHBG
Indication For Use:
Immunoassay for the in vitro quantitative determination of 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. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102814