(241 days)
Not Found
No
The device description details a standard immunoassay process based on chemical reactions and light measurement, with results determined from a stored calibration curve. There is no mention of AI or ML in the description, performance studies, or key metrics.
No
Explanation: This device is an in-vitro diagnostic (IVD) assay designed to quantitatively determine Sex Hormone Binding Globulin levels in human samples, which is used for the assessment of androgen disorders. It does not directly treat or prevent a disease, which is the definition of a therapeutic device.
Yes
The device is described as an "immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma" and is "indicated for use in the assessment of androgen disorders," which directly relates to diagnosing or assessing a medical condition.
No
The device description clearly outlines a physical immunoassay kit involving paramagnetic particles, antibodies, and chemiluminescent substrate, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma. This is a test performed on samples taken from the human body, but outside of the body (in vitro).
- Device Description: The description details an immunoassay process using paramagnetic particles and chemiluminescence to measure an analyte (SHBG) in a sample. This is a typical method used in in vitro diagnostic tests.
- Calibrators and QC: The mention of calibrators and quality control materials further supports its use in a laboratory setting for diagnostic testing.
- Performance Studies: The performance studies (Imprecision, Analytical Sensitivity, Dilution Recovery, Methods Comparison, Analytical Specificity, Stability) are all standard evaluations performed on IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K941797; DPC Immulite SHBG) which is also an immunoassay for SHBG, indicates that this device is intended to perform a similar diagnostic function.
All of these elements point to the Access SHBG assay being a device used to perform diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders.
The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.
Product codes (comma separated list FDA assigned to the subject device)
CDZ, JIT, JJX
Device Description
The Access SHBG assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-SHBG antibody. During incubation, the SHBG antigen in the sample binds to the immobilized anti-SHBG antibody on the solid phase. Alkaline phosphatase conjugated anti-SHBG antibody is then added and reacts with a different antigenic site on the SHBG molecule. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of SHBG in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.
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)
Imprecision:
The study consisted of four patient samples at varying SHBG levels, on three separate pack lots, in duplicate, running for 20 different days, completing 2 runs per day, over a period of 28 days on two Dxl 800 instruments. The assay exhibits a total imprecision of
§ 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
AUG 2 7 2009
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 510(k) number is: K083867
| Applicant: | Beckman Coulter, Inc.
Immunodiagnostics Development Center
1000 lake Hazeltine Drive
Chaska, MN 55318 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tyler Foutch
Regulatory Affairs Specialist
Phone: 952.368.1653
Fax: 952.368.7610 |
| Date Prepared: | August 18, 2009 |
| Reagent
Classification Name: | Radioimmunoassay, testosterones and dihydrotestosterone |
| Trade Name: | Access SHBG Reagent* |
| Device Classification: | 21 CFR 862.1680 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | CDZ |
| Calibrator
Classification Name: | Calibrator Secondary |
| Trade Name: | Access SHBG Calibrators* |
| Device Classification: | 21 CFR 862.1150 |
| Device Class: | Class II |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JIT |
| Controls
Classification Name: | Single (Specified) Analyte Controls (assayed and unassayed) |
| Trade Name: | Access SHBG QC* |
| Device Classification: | 21 CFR 862.1660 |
| Device Class: | Class I |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JJX |
- The Access SHBG assay and the Access UniCel Dxl 800 Immunoassay Analyzer are registered trademarks of Beckman Coulter, Inc.
Beckman Coulter, Inc. Access SHBG
.
1
ア
| Intended Use: | The Access SHBG assay is a paramagnetic particle,
chemiluminescent immunoassay for the quantitative
determination of Sex Hormone Binding Globulin levels in human
serum and plasma using the Access Immunoassay Systems.
The Access Sex Hormone Binding Globulin assay is indicated
for use in the assessment of androgen disorders. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Access SHBG Calibrators are intended to calibrate the
Access SHBG assay for the quantitative determination of Sex
Hormone Binding Globulin levels in human serum and plasma
using the Access Immunoassay Systems. |
| | The Access SHBG QC is intended for monitoring system
performance of the Access SHBG assay. |
| Device Description: | The Access SHBG assay is a sequential two-step
immunoenzymatic ("sandwich") assay. A sample is added to a
reaction vessel along with paramagnetic particles coated with
anti-SHBG antibody. During incubation, the SHBG antigen in
the sample binds to the immobilized anti-SHBG antibody on the
solid phase. Alkaline phosphatase conjugated anti-SHBG
antibody is then added and reacts with a different antigenic site
on the SHBG molecule. After incubation in a reaction vessel,
materials bound to the solid phase are held in a magnetic field
while unbound materials are washed away. Then, the
chemiluminescent substrate Lumi-Phos 530 is added to the
vessel and light generated by the reaction is measured with a
luminometer. The light production is directly proportional to the
concentration of SHBG in the sample. The amount of analyte in
the sample is determined from a stored, multi-point calibration
curve. |
Predicate Device:
.
DPC Immulite SHBG" (K941797)
:
** The IMMULITE SHBG assay and IMMULITE 2000 analyzer are registered trademarks of Siemens Healthcare Diagnostics.
ﺮ
·
Beckman Coulter, Inc. Access SHBG
.
,
2
.
.
Reagents:
Similarities
| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
|---|---|---|
| Product Type | Immunoassay | Immunoassay |
| Intended Use | The Access SHBG assay is a | |
| paramagnetic particle, | ||
| chemiluminescent immunoassay for | ||
| the quantitative determination of Sex | ||
| Hormone Binding Globulin levels in | ||
| human serum and plasma using the | ||
| Access Immunoassay Systems. | ||
| The Access SHBG assay is indicated | ||
| for use in the assessment androgen | ||
| disorders. | For in vitro diagnostic use with the | |
| IMMULITE 2000 Analyzer-for the | ||
| quantitative measurement of SHBG in | ||
| serum, as an aid in the differential | ||
| diagnosis of hirsutism. | ||
| Assay Format | Chemiluminescent, two-site sandwich | |
| immunoassay | Chemiluminescent, two-site sandwich | |
| immunoassay | ||
| Sample types | Human serum or plasma (heparin). | Human serum or plasma (heparin). |
| Method | Access SHBG was compared to the predicate device. | |
| Comparison | 158 samples ranging 5.7 nmol/L to 184.5 nmol/L were evaluated and the | |
| correlation coefficient obtained was 0.94. | ||
| Differences | ||
| Characteristics | Access SHBG Immunoassay ' | DPC Immulite SHBG (predicate) |
| Composition | Access Reagent Pack | |
| Well R1a: Paramagnetic particles | ||
| coated with mouse monoclonal anti- | ||
| SHBG, protein (bovine, mouse) | ||
| buffered matrix, Trade/Device Name: Access Sex Hormone Binding Globulin Reagent Regulation Number: 21 CFR § 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Code: CDZ, JIT, JJX Dated: July 20, 2009 Received: July 22, 2009 |
Dear Mr. Foutch:
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 of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H
Courtney C. Harper, Ph.D. Acting 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): K083867
Device Name: Access Sex Hormone Binding Globulin Reagent
For in vitro diagnostic use.
Indication For Use:
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders.
The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.
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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083867
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