Access SHBG
Device Facts
| Record ID | K233480 |
|---|---|
| Device Name | Access SHBG |
| Applicant | Beckman Coulter, Inc. |
| Product Code | CDZ · Clinical Chemistry |
| Decision Date | Feb 8, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1680 |
| Device Class | Class 1 |
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 SHBG assay is indicated for use in the assessment of androgen disorders.
Device Story
Access SHBG is a sequential two-site immunoenzymatic (sandwich) assay; utilizes paramagnetic particles and chemiluminescent detection. Input: human serum or plasma samples. Operation: performed on Dxl 9000 Access Immunoassay Analyzer in clinical laboratory settings by trained personnel. Device transforms sample analyte concentration into chemiluminescent signal proportional to SHBG levels. Output: quantitative SHBG concentration (nmol/L). Healthcare providers use results to assess androgen disorders; aids in clinical decision-making regarding hormonal health. Benefits: provides standardized, automated measurement of SHBG to support diagnostic evaluation.
Clinical Evidence
No clinical data. Bench testing only. Precision evaluated per CLSI EP05-A3 (N=80 per sample, total CV 2.6-4.6%). Linearity evaluated per CLSI EP06-Ed2 (0.33-200 nmol/L). Detection limits (LoB 0.005, LoD 0.01, LoQ 0.06 nmol/L) determined per CLSI EP17-A2. Method comparison (N=151) against predicate showed slope 1.01 and correlation R=1.00.
Technological Characteristics
Paramagnetic particle, chemiluminescent immunoassay; sequential two-site sandwich format. Analyte measured in human serum/plasma. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos Pro. Calibration: stored curve. Standards: CLSI EP05-A3, EP06-2nd Ed, EP17-A2, EP09c-A3.
Indications for Use
Indicated for the quantitative determination of Sex Hormone Binding Globulin (SHBG) in human serum and plasma to assist in the assessment of androgen disorders.
Regulatory Classification
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.
Predicate Devices
- Access Sex Hormone Binding Globulin Reagent (K083867)
Related Devices
- K143075 — ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set · Tosoh Bioscience, Inc. · Jul 2, 2015
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K233480
B Applicant
Beckman Coulter Inc.
C Proprietary and Established Names
Access SHBG
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CDZ | Class I, reserved | 21 CFR 862.1680 - Testosterone Test System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modified device
B Measurand:
Sex Hormone Binding Globulin (SHBG)
C Type of Test:
Quantitative immunoassay
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Indication(s) 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 SHBG assay is indicated for use in the assessment of androgen disorders.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro diagnostic use
D Special Instrument Requirements:
DxI 9000 Access Immunoassay Analyzer
IV Device/System Characteristics:
A Device Description:
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin (SHBG) levels in human serum and plasma (lithium heparin). The Access SHBG reagent pack is provided in the two assay packs containing 50 tests per pack for 100 tests. This reagent pack consists of the following reagents:
- R1a (3.25 mL): Paramagnetic particles coated with mouse monoclonal anti-SHBG, protein (bovine, mouse) buffered matrix, <0.1% sodium azide, 0.1% ProClin 300
- R1b (13.25 mL): Mouse monoclonal anti-SHBG alkaline phosphatase (bovine) conjugate, buffered matrix with protein (bovine), <0.1% sodium azide, 0.1% ProClin 300
- R1c (9.86 mL): TRIS buffer with <0.1% sodium azide and 0.1% ProClin 300
Other materials needed to run the assay, but not included in the kit, include: Access SHBG Calibrators, Quality Control (QC) materials, Lumi-Phos PRO, UniCel DxI Wash Buffer II, and Access Wash Buffer II (optional material for dilution).
B Principle of Operation:
The Access SHBG assay is a sequential two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with monoclonal anti-SHBG antibody and saline buffer with proteins. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A second monoclonal anti-SHBG antibody conjugated to alkaline phosphatase is added to the reaction vessel. After the second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate 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 analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
V Substantial Equivalence Information:
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A Predicate Device Name(s):
Access Sex Hormone Binding Globulin Reagent
B Predicate 510(k) Number(s):
K083867
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K233480 | K083867 |
| --- | --- | --- |
| Device Trade Name | Access SHBG | Access Sex Hormone Binding Globulin Reagent |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the quantitative determination of Sex Hormone Binding Globulin (SHBG) levels in human serum and plasma | Same |
| Technology | Two-step immunoenzymatic assay | Same |
| Format | Chemiluminescent | Same |
| Measuring Range | 0.33 – approximately 200 nmol/L (up to the highest calibrator) | Same |
| General Device Characteristic Differences | | |
| Instrument | DxI 9000 Access Immunoassay Analyzer | Access UniCel DxI 800 Immunoassay System |
| Substrate | Lumi-Phos Pro Substrate | Access Substrate |
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VI Standards/Guidance Documents Referenced:
Clinical & Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Third Edition
CLSI EP06-2nd Edition:- Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Repeatability (within-run) and within-laboratory (total) precision were evaluated in accordance with the CLSI Guideline EP05-A3. The study was run on three DxI 9000 Access Immunoassay Analyzers using three reagent lots and three calibrator lots. Five (5) serum samples with SHBG concentrations spanning the analytical measuring interval were assayed in duplicate in two runs per day over 20 days. Results from multiple lots were similar. The results from one representative lot are provided in the table below:
| Concentration (nmol/L) | | | Repeatability (Within-run) | | Between-run | | Between-day | | Within-Laboratory (Total) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 0.82 | 0.02 | 2.3 | 0.01 | 1.5 | 0.03 | 3.7 | 0.04 | 4.6 |
| Sample 2 | 80 | 18 | 0.3 | 1.4 | 0.2 | 1.4 | 0.4 | 1.9 | 0.5 | 2.7 |
| Sample 3 | 80 | 47 | 0.7 | 1.6 | 0.6 | 1.6 | 0.8 | 1.8 | 1.3 | 2.7 |
| Sample 4 | 80 | 90 | 1.4 | 1.5 | 1.4 | 1.5 | 1.7 | 1.9 | 2.6 | 2.9 |
| Sample 5 | 80 | 198 | 3.0 | 1.5 | 3.4 | 1.5 | 2.3 | 1.2 | 5.1 | 2.6 |
2. Linearity:
Studies were performed using serum samples across the assay measuring range to evaluate the linearity of the Access SHBG assay on the DxI 9000 Access Immunoassay Analyzer in accordance with the CLSI Guideline EP06-Ed2. The data was analyzed using a weighted linear regression model.
The results of these linearity studies support that the Access SHBG assay is linear on the DxI 9000 Access Immunoassay Analyzer throughout the proposed analytical measuring interval of $0.33\mathrm{nmol/L}$ – approximately $200\mathrm{nmol/L}$ (up to the highest calibrator).
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3. Analytical Specificity/Interference:
Previously established in K083867.
4. Assay Reportable Range:
See section VII.A.2 Linearity above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Access SHBG calibrators and controls are traceable to WHO 95/560 reference material.
6. Detection Limit:
Determination of the Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) were conducted in accordance with the CLSI guideline EP17-A2. The LoQ was defined as the lowest concentration of analyte which has within-laboratory imprecision less than or equal to 20% CV. Results are summarized below.
| LoB (nmol/L) | LoD (nmol/L) | LoQ (nmol/L) |
| --- | --- | --- |
| 0.005 | 0.01 | 0.06 |
7. Assay Cut-Off:
Not applicable
B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was performed comparing the Access SHBG assay on the DxI 9000 Access Immunoassay Analyzer to the Access SHBG assay on the Access 2 Immunoassay System using a protocol based on CLSI EP09c-A3. Patient samples falling within the analytical measuring interval of the comparator device were evaluated. A total of one hundred and fifty-one (151) samples were evaluated: 138 samples were individual native serum samples, 3 samples were individual native serum samples supplemented with SHBG antigen, 9 samples were pools of serum samples, and 1 was a serum sample depleted of antigen. The study was run on three DxI 9000 Access Immunoassay Analyzers and three Access 2 instruments with three reagent pack lots and three calibrator lots. The Passing-Bablok regression analysis results between the candidate device (dependent variable, y) and the comparator device (x, comparator), are shown below:
| N | Concentration Range (nmol/L) | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation Coefficient R |
| --- | --- | --- | --- | --- | --- | --- |
| 151 | 0.63 - 235 | 1.01 | 1.00-1.03 | -0.019 | -0.46 - 0.29 | 1.00 |
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2. **Matrix Comparison:**
Previously established in K083867.
**C Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable.
2. **Clinical Specificity:**
Not applicable.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
**D Clinical Cut-Off:**
Not applicable.
**E Expected Values/Reference Range:**
Previously established in K083867.
**VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
**IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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