(302 days)
k#031717
Not Found
No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device's operation or data analysis.
No
This device is an in vitro diagnostic assay intended to aid in the diagnosis of androgen disorders by quantitatively determining SHBG. It does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" states that the assay "is intended for use as an aid in the diagnosis of androgen disorders."
No
The device is an in vitro diagnostic (IVD) assay that utilizes reagents and hardware (ARCHITECT i System) to perform a chemiluminescent immunoassay. The description focuses on the chemical and physical processes of the assay, not on software functionality as the primary component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is for the "quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma" and is "intended for use as an aid in the diagnosis of androgen disorders." This clearly indicates it's used to test human samples in vitro (outside the body) for diagnostic purposes.
- Controls: The description of the controls states "For in vitro diagnostic use."
- Device Description: The description details a laboratory-based immunoassay process using human serum and plasma samples.
- Intended User/Care Setting: The intended user is listed as "Clinical Laboratories," which is a typical setting for IVD testing.
N/A
Intended Use / Indications for Use
The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System.
The ARCHITECT SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The ARCHITECT® SHBG Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
ARCHITECT® SHBG Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
CDZ, JIT, JJX
Device Description
The ARCHITECT SHBG assay is a two-step immunoassay to determine the presence of SHBG in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-SHBG coated paramagnetic microparticles are combined. SHBG present in the sample binds to anti-SHBG coated microparticles. After washing, the SHBG binds to the anti-SHBG acridinium-labeled conjugate that is added in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of SHBG in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of SHBG in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT SHBG calibration.
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
Clinical Laboratories
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)
The ARCHITECT® SHBG assay is substantially equivalent to the Elecsys® SHBG assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
The ARCHITECT® SHBG assay demonstrated substantially equivalent performance to the Elecsys® SHBG indicated by a method comparison with a correlation coefficient of 0.98.
Method Comparison: ARCHITECT SHBG was compared to the predicate device. 626 specimens ranging 6.5 nmol/L to 1072.0 nmol/L were evaluated and the correlation coefficient obtained was 0.98.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.1 nmol / L
Analytical Specificity: Non detectable cross-reactivities were found for: AFP, cortisol, 11-Deoxycortisol, Estradiol, testosterone, 5-dihydrotestosterone, TG, TBG and transferrin.
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.
k#031717
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
SHBG
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of CFR
The Assigned 510(k) Number is: __
Preparation date: February 21st, 2006
Applicant Name:
Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Llica d'Amunt Barcelona, Spain 08186
Device Name:
Reagent
Classification Name: Radioimmunoassay, testosterones and dihydrotestosterone Trade Name: ARCHITECT® SHBG Device Classification: 21 CFR 862 1680 Device Class: Class I Classification Panel: Clinical Chemistry Product Code: CDZ
Calibrators
Classification Name: Calibrator, Secondary Trade Name: ARCHITECT® SHBG Calibrators Device Classification: 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: ARCHITECT® SHBG Controls Device Classification: 862.1660 Device Class: Class I Classification Panel: Clinical Chemistry Product Code: JJX
ldentification of Predicate Device:
Elecsys® SHBG Immunoassay System (Roche, k#031717)
1
Intended Use of Device:
The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System.
The ARCHITECT® SHBG Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
The ARCHITECT® SHBG Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
Description of Device:
The ARCHITECT SHBG assay is a two-step immunoassay to determine the presence of SHBG in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-SHBG coated paramagnetic microparticles are combined. SHBG present in the sample binds to anti-SHBG coated microparticles. After washing, the SHBG binds to the anti-SHBG acridinium-labeled conjugate that is added in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of SHBG in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of SHBG in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT SHBG calibration.
Comparison of Technological Characteristics:
The ARCHITECT® SHBG assay is a chemiluminiscent microparticle immunoassay (CMIA) method for the quantitative determination of the SHBG in human serum or plasma.
Summary of Non-Clinical Performance:
The ARCHITECT® SHBG assay is substantially equivalent to the Elecsys® SHBG assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT® SHBG assay demonstrated substantially equivalent performance to the Elecsys® SHBG indicated by a method comparison with a correlation coefficient of 0.98.
ARCHITECT SHBG February, 2006
510(k) Summarv
2
Reagents:
・
| Similarities: | ||
|---|---|---|
| Characteristics | Device | Predicate |
| Product Type | Immunoassay | Immunoassay |
| Methodology | Chemiluminescent Microparticle | |
| Immunoassay (CMIA) | Chemiluminescence a solid | |
| phase enzyme immunoassay | ||
| Intended Use | The ARCHITECT® SHBG assay | |
| is a chemiluminescent | ||
| microparticle immunoassay | ||
| (CMIA) for the quantitative | ||
| determination of sex hormone | ||
| binding globulin (SHBG) in | ||
| human serum and plasma on | ||
| the ARCHITECT / System. | Immunoassay for the in vitro | |
| quantitative determination of sex | ||
| hormone-binding globulin in | ||
| human serum and plasma. The | ||
| ECLIA is intended for use on the | ||
| Roche Elecsys® 1010/2010 and | ||
| MODULAR ANALYTICS E170 | ||
| (Elecsys module) immunoassay | ||
| analyzers. | ||
| Where Used | Clinical Laboratories | Clinical Laboratories |
| Assay Protocol | Two-step direct sandwich | |
| immunoassay | Sandwich principle | |
| Specimen Type | Human serum or plasma | |
| (Lithium Heparin, Sodium | ||
| Heparin, Ammonium Heparin, | ||
| Potassium EDTA) | Human Serum and Lithium | |
| Heparin Plasma | ||
| Interpretation of Results | Standard Curve | Standard Curve |
| Interferences | Non significant interferences | |
| with: | ||
| Hemoglobin, bilirubin, | ||
| triglycerides, protein | Non significant interferences | |
| with: | ||
| Bilirubin, hemolysis, lipemia, | ||
| biotin | ||
| Measuring Range | 0.1 – 250 nmol / L | 0.350 - 200 nmol / L |
| Analytical Sensitivity | 0.1 nmol / L | 0.35 nmol / L |
| Analytical Specificity | Non detectable cross- | |
| reactivities were found for: | ||
| AFP, cortisol, 11-Deoxycortisol, | ||
| Estradiol, testosterone, 5- | ||
| dihydrotestosterone, TG, TBG | ||
| and transferrin. | Non detectable cross- | |
| reactivities were found for: | ||
| AFP, CBG, DHT, estradiol, | ||
| fibrinogen, human IgA, human | ||
| IgG, plasminogen, TBG, | ||
| testosterone, TG, transferrin | ||
| and TSH. | ||
| Method Comparison | ARCHITECT SHBG was compared to the predicate device. | |
| 626 specimens ranging 6.5 nmol/L to 1072.0 nmol/L were | ||
| evaluated and the correlation coefficient obtained was 0.98. |
.
.
.
3
Differences:
| Characteristics | Device | Predicate |
|---|---|---|
| Platform | ARCHITECT / System | ROCHE Elecsys® 1010/1020 |
| Analyzer and MODULAR | ||
| ANALYTICS E170 | ||
| Components | Microparticles | Microparticles |
| 1or 4 Bottle(s) (6.6 mL each) | 1 bottle of 6.5mL. | |
| Anti-SHBG(mouse monoclonal) | ||
| coated microparticles in TRIS | ||
| buffer. | ||
| Preservative: sodium azide. | Streptavidin-coated | |
| microparticles, 0.72 mg/mL; | ||
| binding capacity: 470 ng | ||
| biotin/mg microparticles. | ||
| Preservative. | ||
| Conjugate | R1 - Anti-SHBG-Ab~biotin - | |
| 1or 4 Bottle(s) (5.9 mL each) | 1 bottle (10.0 mL) | |
| Anti-SHBG(mouse,monoclonal) | ||
| acridinium-labeled conjugate in | ||
| phosphate buffer with protein | ||
| (mouse, bovine) stabilizer. | ||
| Preservative: sodium azide. | Biotinylated monoclonal anti- | |
| SHBG antibody (mouse) 1.25 | ||
| mg/L; phosphate buffer 100 | ||
| mmol/L, pH 7.2. | ||
| Preservative. | ||
| Assay Diluent | R2 - Anti-SHBG-Ab~Ru | |
| 1or 4 Bottle(s) (8.0 mL each) | 1 bottle, 10 mL | |
| SHBG Assay Diluent containing | ||
| phosphate buffer with protein | ||
| (mouse,bovine) stabilizer. | ||
| Preservative: sodium azide. | Monoclonal anti-SHBG | |
| antibody (mouse) labeled with | ||
| ruthenium complex 1.25 mg/L; | ||
| phosphate buffer 100mmol/L, | ||
| pH 7.2. Preservative |
.
:
:
4
Calibrators:
Similarities: Predicate Characteristics Device ARCHITECT® Elecsys® SHBG CalSet is used
for calibrating the quantitative Intended Use The SHBG Calibrators for the are Elecsys SHBG assay on the calibration of the ARCHITECT i Elecsys immunoassay systems. System when used for the quantitative determination of SHBG in human serum and plasma. Against the first International Traceable to the WHO Standardization/Traceability Standard for SHBG from the Standard Material NIBSC National Institute for Biological CODE: 95/560. Standards and Control (NIBSC) code 95/560.
Differences:
| Characteristics | Device | Predicate |
|---|---|---|
| Calibrator Components | 6 Bottles (2.0 mL each) of | |
| ARCHITECT SHBG | ||
| Calibrators. Calibrator A | ||
| contains phosphate buffered | ||
| saline with protein (goat) | ||
| stabilizer. Calibrators B to F | ||
| contain SHBG in phosphate | ||
| buffered saline with protein | ||
| (goat) stabilizer. Preservatives: | ||
| sodium azide and ProClin® 300. | SHBG Cal1 and Cal2 (1.0 mL | |
| each) The concentration of | ||
| SHBG Cal1 is approximately | ||
| 0.0 nmol/L; SHBG Cal2 | ||
| contains approximately 40 | ||
| nmol/L human SHBG in a | ||
| human serum matrix. | ||
| Calibrator Concentrations | CAL A - 0.0 nmol/L | |
| CAL B - 2.0 nmol/L | ||
| CAL C - 6.0 nmol/L | ||
| CAL D - 25.0 nmol/L | ||
| CAL E - 125.0 nmol/L | ||
| CAL F - 250.0 nmol/L | 0.0 and 40 nmol/L | |
| Matrix | Purified Human SHBG in a | |
| phosphate buffered saline | Lyophilized equine serum (cal1) | |
| and human serum (cal2). Both | ||
| containing SHBG. |
ARCHITECT SHBG February, 2006
510(k) Summary
5
Controls:
| Similarities: | ||
|---|---|---|
| Characteristics | Device | Predicate |
| Intended Use | The ARCHITECT® SHBG | |
| Controls are for the verification | ||
| of the accuracy and precision of | ||
| the ARCHITECT i System | ||
| when used for the quantitative | ||
| determination of SHBG in | ||
| human serum and plasma. | Elecsys® PreciControl Universal | |
| is used for quality control of | ||
| Elecsys immunoassay on the | ||
| Elecsys immunoassay systems. | ||
| Methodology | Chemiluminescent | |
| Microparticle Immunoassay | ||
| (CMIA) | Chemiluminescence a solid | |
| phase enzyme immunoassay | ||
| Matrix | Purified Human SHBG in buffer | SHBG human serum in buffer |
Differences:
| Characteristics | Device | Predicate |
|---|---|---|
| Control Components | 3 Bottles (4.0 mL each) of | |
| ARCHITECT SHBG Controls | ||
| contain SHBG (human, | ||
| purified) in phosphate buffered | ||
| saline with protein (goat) | ||
| stabilizer. Preservatives: | ||
| sodium azide and ProClin® |
- | SHBG Controls (LSHC1,
LSHC2)
Two vials of lyophilized SHBG
in a nonhuman protein/buffer
matrix. |
| Control Concentrations | Low – 9.0 nmol/L
Medium – 25.0 nmol/L
High – 150.0 nmol/L | Target values and
concentration range are
indicated in a value sheet. |
Conclusion:
As summarized above the ARCHITECT® SHBG Reagents, Calibrators (A-F) and Controls (Low, Medium and High) are substantially equivalent to the ROCHE Elecsys® SHBG Reagents, Calibrators and Controls. Substantial equivalence for the reagents and calibrators has been demonstrated as recommended by the FDA guidance for Industry "Format for Traditional and Abbreviated 510(k)s" (Issued on: August 12, 2005) and for controls as recommended by the FDA Guidance for Industry "Points to Consider Document on Assayed and Unassayed Quality Control Material" (Draft Guidance released for comment on February 3, 1999).
ARCHITECT SHBG February, 2006
510(k) Summary
6
Image /page/6/Picture/0 description: The image is a seal for the Department of Health & Human Services in the USA. The seal is circular and contains the department's logo. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Joan Guixer Quality Assurance and Regulatory Affairs Director Biokit S.A. Can Malè s/n Llissa d'Amunt, Barcelona, 08186 Spain
JAN 2 3 2007
K060818 Re: Trade/Device Name: ARCHITECT® SHBG Reagents, Calibrators (A-F) and ARCHITECT® SHBG Controls (Low, Medium, High) Regulation Number: 21 CFR§ 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved Product Code: CDZ, JIT, JJX Dated: December 20, 2006 Received: December 26, 2006
Dear Mr. Guixer:
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).
7
Page 2 -
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 vour 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
510(k) Number (if known): K060818
Device Name: ARCHITECT® SHBG REAGENTS, CALIBRATORS (A-F) and ARCHITECT® SHBG CONTROLS (LOW, MEDIUM, HIGH)
Indications for Use:
Reagents
The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System.
The ARCHITECT SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
Calibrators
The ARCHITECT® SHBG Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
Controls
ARCHITECT® SHBG Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
For in vitro diagnostic use.
Prescription Use × (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
AC
rision Sign-Off
fire of In Vitro Diagnostic Device valuation and Safety
060818