(241 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information for the Access SHBG device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Access SHBG) |
|---|---|
| Imprecision (Total CV%) | < 7% at concentrations > 2 nmol/L- Sample 1 (6.3 nmol/L): Total CV 5.4%- Sample 2 (38 nmol/L): Total CV 5.3%- Sample 3 (80 nmol/L): Total CV 5.5%- Sample 4 (171 nmol/L): Total CV 5.2%Estimated CV% based on polynomial regression across the assay range (2-180 nmol/L) is 5.3%. |
| Analytical Sensitivity (Limit of Blank - LoB) | 0.017 nmol/L |
| Analytical Sensitivity (Limit of Detection - LoD) | 0.33 nmol/L |
| Dilution Recovery (Linearity) | Sample 1 (206.58 nmol/L): 103% Mean RecoverySample 2 (35.81 nmol/L): 101% Mean RecoverySample 3 (2.90 nmol/L): 100% Mean Recovery |
| Method Comparison (Correlation to Predicate Device) | Correlation Coefficient (r²) = 0.94 (between Access SHBG and DPC Immulite SHBG) |
| Interference | No significant interference from tested compounds including triglycerides, protein, bilirubin, cortisol, hemoglobin, estradiol, testosterone, 5α-DHT, 11-Deoxycortisol, acetaminophen, acetylsalicylic acid, alpha-fetoprotein (AFP), heparin, ibuprofen, GAS6, laminin, multivitamin supplement, thyroglobulin (Tg), thyroxine-binding globulin (TBG), transferrin at relevant levels. |
| Cross-Reactivity | No significant cross-reactivity with 5a-dihydroxytestosterone, 11-deoxycotrisol, estradiol, GAS6, laminin, protein S, testosterone, alpha-fetoprotein, thyroglobulin, thyroxine-binding globulin, and transferrin. |
| Stability (Reagents, Calibrators, Controls) | 28 days after opening |
| Stability (Calibration Curve) | 28 days |
Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Imprecision Study: Four patient samples at varying SHBG levels were used. The study involved running these samples for 20 different days, completing 2 runs per day, resulting in 480 data points (n=480) for the mean calculation.
- Analytical Sensitivity (LoB & LoD): Specific sample numbers are not provided, but the statement indicates "lowest level sample where the beta-percentile (...) was 5% or less" was used for LoD, and LoB used a 97.5% upper confidence limit.
- Dilution Recovery: Three serum samples were used (206.58 nmol/L, 35.81 nmol/L, and 2.90 nmol/L).
- Methods Comparison: 158 values (samples or observations) were used. The range of observations was 5.7-184.5 nmol/L. The data provenance is not explicitly stated in terms of country of origin but implies human serum from "patient samples." It is implied to be prospective as it's a comparison of a new device against an existing one, likely conducted as part of the validation.
- Interferences & Cross-Reactivity: Not explicitly stated, but derived from studies based on CLSI EP7-A2 guidance, which typically involve spiking known interferents into patient or control samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This device is an in vitro diagnostic (IVD) immunoassay for quantitative determination of SHBG levels. The "ground truth" for such devices is typically established through reference methods, established predicate devices, or calibrated reference materials, not through expert consensus in the way a diagnostic imaging device would use radiologists. The methods comparison study used a "commercially available enzyme immunoassay system" (the DPC Immulite SHBG) as a comparator, which itself has an established analytical performance. No human experts are explicitly mentioned as establishing ground truth in this context.
4. Adjudication Method for the Test Set:
- Not applicable in the traditional sense for an immunoassay. Discrepancies in results would be investigated through re-testing, calibration checks, or instrument troubleshooting, rather than human expert adjudication of a diagnostic finding.
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:
- Not applicable. This device is an immunoassay for quantitative chemical analysis, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is a standalone device in the sense that it performs automated quantitative measurements. There is no "human-in-the-loop" for the direct measurement itself; the human interacts with the system by placing samples and interpreting the numerical results. The performance data presented (imprecision, sensitivity, linearity, method comparison) are inherently "standalone" performance metrics of the device.
7. The Type of Ground Truth Used:
- The ground truth for the method comparison study was established by the predicate device (DPC Immulite SHBG assay).
- For other analytical performance studies (imprecision, sensitivity, linearity, interference, cross-reactivity), the ground truth is established by known concentrations in control materials, spiked samples, or reference standards, based on established laboratory practices and CLSI guidelines.
8. The Sample Size for the Training Set:
- Not applicable for this type of immunoassay. These devices are typically developed and validated using analytical studies rather than machine learning "training sets." The calibration curve is established using calibrators with known concentrations, which are analogous to a very small "training set" for the device's internal measurement algorithm, but not in the sense of a large machine learning dataset. Five calibrator levels (S1-S5) plus S0 are used to establish the calibration curve.
9. How the Ground Truth for the Training Set Was Established:
- The "ground truth" for the calibrators (S1-S5) is established by using purified human SHBG at known concentrations, traced to the WHO 95/560 standard. This ensures accuracy and traceability of the quantitative measurements.
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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 Center1000 lake Hazeltine DriveChaska, MN 55318 |
|---|---|
| Contact Person: | Tyler FoutchRegulatory Affairs SpecialistPhone: 952.368.1653Fax: 952.368.7610 |
| Date Prepared: | August 18, 2009 |
| ReagentClassification 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 |
| CalibratorClassification 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 |
| ControlsClassification 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.
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| Intended Use: | The Access SHBG assay is a paramagnetic particle,chemiluminescent immunoassay for the quantitativedetermination of Sex Hormone Binding Globulin levels in humanserum and plasma using the Access Immunoassay Systems.The Access Sex Hormone Binding Globulin assay is indicatedfor use in the assessment of androgen disorders. |
|---|---|
| The Access SHBG Calibrators are intended to calibrate theAccess SHBG assay for the quantitative determination of SexHormone Binding Globulin levels in human serum and plasmausing the Access Immunoassay Systems. | |
| The Access SHBG QC is intended for monitoring systemperformance of the Access SHBG assay. | |
| Device Description: | The Access SHBG assay is a sequential two-stepimmunoenzymatic ("sandwich") assay. A sample is added to areaction vessel along with paramagnetic particles coated withanti-SHBG antibody. During incubation, the SHBG antigen inthe sample binds to the immobilized anti-SHBG antibody on thesolid phase. Alkaline phosphatase conjugated anti-SHBGantibody is then added and reacts with a different antigenic siteon the SHBG molecule. After incubation in a reaction vessel,materials bound to the solid phase are held in a magnetic fieldwhile unbound materials are washed away. Then, thechemiluminescent substrate Lumi-Phos 530 is added to thevessel and light generated by the reaction is measured with aluminometer. The light production is directly proportional to theconcentration of SHBG in the sample. The amount of analyte inthe sample is determined from a stored, multi-point calibrationcurve. |
Predicate Device:
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DPC Immulite SHBG" (K941797)
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** The IMMULITE SHBG assay and IMMULITE 2000 analyzer are registered trademarks of Siemens Healthcare Diagnostics.
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Reagents:
Similarities
| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
|---|---|---|
| Product Type | Immunoassay | Immunoassay |
| Intended Use | The Access SHBG assay is aparamagnetic particle,chemiluminescent immunoassay forthe quantitative determination of SexHormone Binding Globulin levels inhuman serum and plasma using theAccess Immunoassay Systems.The Access SHBG assay is indicatedfor use in the assessment androgendisorders. | For in vitro diagnostic use with theIMMULITE 2000 Analyzer-for thequantitative measurement of SHBG inserum, as an aid in the differentialdiagnosis of hirsutism. |
| Assay Format | Chemiluminescent, two-site sandwichimmunoassay | Chemiluminescent, two-site sandwichimmunoassay |
| 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 thecorrelation coefficient obtained was 0.94. | |
| Differences | ||
| Characteristics | Access SHBG Immunoassay ' | DPC Immulite SHBG (predicate) |
| Composition | Access Reagent PackWell R1a: Paramagnetic particlescoated with mouse monoclonal anti-SHBG, protein (bovine, mouse)buffered matrix, <0.1% sodium azide,0.1% ProClin.Well R1b: Mouse monoclonal anti-SHBG alkaline phosphate (bovine)conjugate, buffered matrix with protein(bovine). <0.1% sodium azide, 0.1%ProClin.Well R1c: TRIS buffer with <0.1%sodium azide and 0.1% ProClin 300. | SHBG Bead Pack200 beads, coated with monoclonalmurine anti-SHBG.SHBG Reagent Wedge11.5 mL alkaline phosphatase (bovine calfintestine) conjugated to polyclonal rabbitanti-SHBG antibody in buffer. |
| AnalyticalSensitivity | Limit of Blank 0.017 nmol/L.Limit of Detection 0.33 nmol/L | 0.2 nmol/L |
| Interferences | The Access SHBG assay utilized theCLSI EP7-A2 guidance evaluating ahigh and low patient sample spikedwith interferents at a high and lowlevels. The Access did not showsignificant interference withtriglycerides (Intralipid), protein(human serum albumin), bilirubin,cortisol, hemoglobin, estradiol,testosterone, 5α-DHT, 11-Deoxycortisol acetaminophen,acetylsalicylic acid, alpha-fetoprotein(AFP), heparin, ibuprofen, GAS6,laminin, multivitamin supplementthyroglobulin (Tg), thyroxine-bindingglobulin (TBG), transferrin at relevantlevels. | The DPC device exhibits no interferencewith 30 µL/mL of packed red blood cells,200 mg/L bilirubin, 100,000 ng/mLcortisol, 5 g/dL protein (human serumalbumin). 20.000 ng/mL testosterone,3,600 pg/mL estradiol, 20,000 ng/mL 5a-DHT, and 4000 ng/mL 11-Deoxycortisol. |
| Analytical Range | 0.33 nmol/L to ~200 nmol/L | 0.2 nmol/L to 180 nmol/L. |
| AnalyticalSpecificity | The Access SHBG assay utilized theCLSI EP7-A2 quidance evaluating ahigh and low patient sample spikedwith interferents at a high and lowlevels. The Access did not showsignificant cross-reactivity with 5a-dihydroxytestosterone, 11-deoxycotrisol, estradiol, GAS6,laminin, protein S, testosterone,alpha-fetoprotein, thyroglobulin,thyroxine-binding globulin, andtransferrin. | The DPC assay exhibits no cross-reactivity with 400 IU/mL alpha-fetoprotein, 300 ng/mL thyroglobulin, 193µL thyroxine-binding globulin, and 4mg/mL transferrin. |
| Expected Values | Males (20-50 years of age), 151subjects, mean 38.2 nmol/L; 95Percentile, 13.3-89.5 nmol/L. | Males, 122 subjects, mean 32 nmol/L; 95Percentile, 13-71 nmol/L. |
| Females (non-pregnant, 20-46 yearsof age), 141 subjects, mean 47.2nmol/L; 95 Percentile 18.2-135.5nmol/L.Females (post-menopausal 47-91years of age) 131 subjects, mean49.6 nmol/L; 95 Percentile, 16.8-125.2nmol/L. | Females (non-pregnant), 111 subjects,mean 51 nmol/L; 95 Percentile, 18-114nmol/L. |
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Beckman Coulter, Inc.
Access SHBG , 510(k) Summary
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Reagents:
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Access SHBG
OIVD 510(k) Submission: 510(k) Summary
Calibrators
Similarities
| Characteristics | Access SHBG Immunoassay | DPC IMMULITE SHBG (predicate) |
|---|---|---|
| Intended Use | The Access SHBG Calibrators areintended to calibrate the AccessSHBG assay for the quantitativedetermination of Sex HormoneBinding Globulin levels in humanserum and plasma using the AccessImmunoassay Systems. | IMMULITE Adjustors (Low, High) are usedfor calibrating the quantitative IMMULITESHBG assay on the IMMULITE 2000systems. |
Differences
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| Differences | ||
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| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
| CalibratorComponents | S0: Lyophilized buffered protein(bovine) matrix, <0.1% sodium azide,0.5% Proclin 300S1-S5: Lyophilized purified humanSHBG, protein (bovine) bufferedmatrix, at levels of approximately 3, 9,27, 80 and 200 nmol/L, with <0.1%sodium azide, 0.5% ProClin 300. | Two vials (Low and High) of lyophilizedSHBG in a nonhuman protein/buffermatrix. |
| Traceability | WHO 95/560 | DPC's IRMA-Count SHBG assay |
Beckman Coulter, Inc. Access SHBG
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Controls
Similarities
| Characteristics | Access SHBG Immumoassay | DPC IMMULITE SHBG (predicate) |
|---|---|---|
| Intended Use | The Access SHBG QC is intended formonitoring system performance of theAccess SHBG assay. | IMMULITE SHBG Controls are used formonitoring system performance of theIMMULITE SHBG assay. |
Differences
| Characteristics | Access SHBG Immumoassay | DPC Immulite SHBG (predicate) |
|---|---|---|
| CalibratorComponents | QC1: Lyophilized purified humanSHBG at a level of approximately 10nmol/L, protein (bovine) bufferedmatrix, <0.1% sodium azide, 0.5%ProClin 300.QC2: Lyophilized purified humanSHBG at a level of approximately 100nmol/L, protein (bovine) bufferedmatrix, <0.1% sodium azide, 0.5%ProClin 300. | Two vials (LSHC1, LSHC2) of lyophilizedSHBG in a nonhuman protein/buffermatrix. |
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Summary of Analytical Studies
Imprecision:
This assay exhibits a total imprecision of <7% at concentrations greater than 2nmol/L. 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 provided the following data, analyzed via analysis of variance (ANOVA).
| Mean(n=480) | Within-run | Total | |||
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| SampleID | (nmol/L) | SD | CV (%) | SD | CV (%) |
| 1 | 6.3 | 0.3 | 4.7 | 0.3 | 5.4 |
| 2 | 38 | 1.8 | 4.6 | 2.0 | 5.3 |
| 3 | 80 | 3.6 | 4.5 | 4.4 | 5.5 |
| 4 | 171 | 8.1 | 4.8 | 9.0 | 5.2 |
A polynomial regression of all imprecision data (4 samples spanning the range of the assay), provides an overall estimation of the imprecision. Data was further analyzed utilizing linear modeling plotting the log of the sample concentration by the log of the standard deviation, as shown in the following table, and determining the upper limit of 95% confidence interval of this regression fit.
| Dose (nmol/L) | Estimated CV% | Estimated SD |
|---|---|---|
| 2 | 5.3% | 0.11 |
| 5 | 5.3% | 0.27 |
| 10 | 5.3% | 0.53 |
| 15 | 5.3% | 0.79 |
| 25 | 5.3% | 1.32 |
| 40 | 5.3% | 2.11 |
| 60 | 5.3% | 3.17 |
| 80 | 5.3% | 4.22 |
| 100 | 5.3% | 5.27 |
| 150 | 5.3% | 7.89 |
| 180 | 5.3% | 9.47 |
Beckman Coulter, Inc. Access SHBG
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Analytical Sensitivity:
Limit of Blank (Analytical Sensitivity)
Limit of Blank (LoB) for Access SHBG was determined to be 0.017 nmol/L. LoB was tested using a protocol based on CLSI EP17-A. The 97.5% upper confidence limit of this estimate was determined as LoB.
Limit of Detection
Limit of Detection (LoD) of Access SHBG assay was determined to be 0.33 nmol/L, based on the lowest level sample where the beta-percentile (defined as the percentage of observations below LoB) was 5% or less. The LoD study was run under a protocol based on CLSI EP17-A.
Dilution Recovery (Linearity): Dilution recovery studies were performed by diluting three serum samples at 206.58 nmol/L (sample 1), 35.81 nmol/L (sample 2), and 2.90 nmol/L (sample 3) respectively, with Access Wash Buffer II. Sample mean recovery values were 103% Mean Recovery for sample 1. 101% Mean Recovery for sample 2. and 100% Mean Recovery for sample 3.
Methods Comparison (External Site):
A comparison of 158 values, with a range of observations of 5.7-184.5 nmol/L, using the Access SHBG assay on the UniCel Dxl 800 immunoassay system and a commercially available enzyme immunoassay system gave the following statistical data using Passing Bablok calculations:
- Intercept (95% Confidence Interval)= 1.84 (0.54-3.00) nmol/L ●
- Slope (95% Confidence Interval)= 1.09 (1.06-1.12) .
- Correlation Coefficient (r2)= 0.94 .
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Analytical Specificity: There was no significant interference from compounds tested based on EP7-A2. Compounds include Acetaminophen, Acetylsalicylic acid, Alpha-Fetoprotein (AFP), conjugated and unconjugated Bilirubin, Cortisol, 11-deoxycortisol, 5a-dihydroxytestosterone, Hemoglobin, Heparin, Human serum albumin (HSA), Ibuprofen, Estradiol, GAS6, Laminin, Multivitamin supplement, Protein S, Testosterone, Thyroglobulin (Tg), Thyroxine-binding Globulin (TBG), Transferrin, Triglycerides (Intralipid).
Additionally, there was no cross-reactivity for molecules tested based on EP7-A2. Molecules include Alpha-Fetoprotein, Cortisol, 5α-dihydroxytestosterone, 11-deoxycortisol, Estradiol, GAS6, Laminin, Protein S, Testosterone, Thyroglobulin (Tg), Thyroxine-binding Globulin (TBG), Transferrin.
Stability: SHBG reagents are stable for 28 days after opening, calibrators are stable for 28 days after opening, and controls are stable for 28 days after opening. The calibration curve is stable for 28 days.
Conclusion
As summarized above the Access SHBG, SHBG Calibrators, and SHBG QC on the Access Immunoassay Systems are substantially equivalent to the DPC Immulite SHBG assay for the measurement Sex Hormone Binding Globulin in serum or plasma. Substantial equivalence for the reagent and calibrators has been demonstrated as recommended by the FDA quidance 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 Assaved and Unassayed Quality Control Material" (Draft Guidance released for comment on February 3, 1999).
Beckman Coulter, Inc. Access SHBG
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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Beckman Coulter, Inc. c/o Mr. Tyler Foutch 1000 Lake Hazeltine Dr. Chaska, MN 55318-1084
AUG 2 7 2009
Re: K083867
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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§ 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.