IDS-iSYS Free Testosterone
Device Facts
| Record ID | K240865 |
|---|---|
| Device Name | IDS-iSYS Free Testosterone |
| Applicant | Immunodiagnostic Systems Limited |
| Product Code | CDZ · Clinical Chemistry |
| Decision Date | Oct 23, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1680 |
| Device Class | Class 1 |
Indications for Use
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and androgenital syndromes.
Device Story
IDS-iSYS Free Testosterone is an in vitro diagnostic assay for quantitative measurement of free testosterone in human serum or plasma. The device utilizes a competitive immunoassay principle on the IDS-iSYS Multi-Discipline Automated System. The reagent cartridge contains magnetic particles coated with streptavidin, biotinylated monoclonal anti-testosterone antibody, and testosterone labeled with an acridinium ester derivative. The system performs automated chemiluminescent detection. Used in clinical laboratories by trained personnel; results assist physicians in diagnosing and managing androgen-related conditions like hypogonadism, hirsutism, and virilization. The device provides quantitative values that inform clinical decision-making regarding hormone therapy or further diagnostic investigation.
Clinical Evidence
Bench testing only. Performance validated per CLSI guidelines. Precision (repeatability/reproducibility) evaluated with CVs generally <10%. Linearity established from 0.12 to 68.12 pg/mL. Analytical specificity (cross-reactivity) and interference (including biotin up to 500 ng/mL) showed no significant bias (≤±10%). Method comparison against a commercial ELISA (N=241) yielded a slope of 1.02 and correlation coefficient (r) of 0.98. Matrix equivalence confirmed for serum, SST, and various plasma types (K2 EDTA, Li/Na Heparin).
Technological Characteristics
Competitive immunoassay using chemiluminescence detection. Reagents: magnetic particles (streptavidin-coated), biotinylated monoclonal anti-testosterone antibody, acridinium ester-labeled testosterone. Form factor: reagent cartridge for automated IDS-iSYS system. Connectivity: integrated with IDS-iSYS platform. Software: automated system control. Sterilization: not applicable (reagent kit).
Indications for Use
Indicated for quantitative determination of free testosterone in human serum or plasma to aid in diagnosis and treatment of androgen-related disorders, including primary/secondary hypogonadism, impotence, hirsutism, and virilization in males and females.
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
- Free Testosterone AccuBind® ELISA Test System (k181017)
Related Devices
- K120009 — TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) · Abbott Laboratories · Sep 11, 2012
- K223405 — Access Testosterone · Beckman Coulter, Inc. · Jan 13, 2023
- K190121 — IDS SHBG · Immunodiagnostic Systems , Ltd. · Jun 17, 2019
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
K240865
B Applicant
Immunodiagnostic Systems Limited
C Proprietary and Established Names
IDS-iSYS Free Testosterone
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:
New Device
B Measurand:
Testosterone (free)
C Type of Test:
Quantitative, Enzyme Immunoassay (EIA)
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and androgenital syndromes.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
IDS-iSYS Multi-Discipline Automated Analyzer
IV Device/System Characteristics:
A Device Description:
The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains:
- Magnetic particles coated with Streptavidin in a buffer containing preservative, one bottle, 2.5 mL.
- Monoclonal anti-testosterone labelled with biotin, in a buffer containing preservative, one bottle, 7.5 mL
- Testosterone labelled with an acridinium ester derivative, in a buffer containing protein and preservative, one bottle, 3.5 mL
B Principle of Operation:
The IDS-iSYS Free Testosterone test system uses a competitive enzyme immunoassay technology. 20 µL of patient sample or calibrators are incubated with the biotinylated monoclonal anti- testosterone antibody, an acridinium labeled testosterone conjugate and streptavidin labeled magnetic particles. The magnetic particles are captured using a magnet and a wash step is performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of analyte in the original sample.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Free Testosterone AccuBind ELISA Test System
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B Predicate 510(k) Number(s):
K181017
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K240865 | K181017 |
| --- | --- | --- |
| Device Trade Name | IDS-iSYS Free Testosterone | Free Testosterone AccuBind ELISA Test System |
| General Device Characteristic Similarities | | |
| Intended Use | Quantitative determination of Free Testosterone | Same |
| Test Principle | Competitive immunoassay | Same |
| General Device Characteristic Differences | | |
| Sample Type | Human serum or plasma | Human serum |
| Detection Method | Chemiluminescence | Microplate colorimetric reader |
| Measuring Range | 0.40 – 60 pg/mL | 0.11 – 60 pg/mL |
# 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 EP07-A3 Interference Testing in Clinical Chemistry.
CLSI EP37 1st Edition: Supplemental Tables for Interference Testing in Clinical Chemistry
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition
CLSI C28-A3: Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory
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CLSI EP35 1st Edition: Assessment of Equivalence for Suitability of Specimen Types for Medical Laboratory Measurement Procedures
CLSI EP32-R (Formerly X05-R): Metrological Traceability and Its Implementation; A Report
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
### 1. Precision/Reproducibility:
Precision studies were conducted in accordance with the CLSI Guideline EP05-A3.
A precision study was conducted to estimate repeatability and within-laboratory precision. Ten serum samples with testosterone concentrations spanning the analytical measuring interval were assayed in duplicate in two runs per day over 20 days using one reagent lot on one IDS-iSYS Multi-Discipline Automated Analyzer. A total of 80 replicates per sample were measured. The results are provided in the table below:
| Sample | Concentration (pg/mL) | Repeatability | | Within Laboratory | |
| --- | --- | --- | --- | --- | --- |
| | | SD | CV | SD | CV |
| S1 | 0.67 | 0.05 | 7.0% | 0.07 | 9.9% |
| S2 | 1.15 | 0.05 | 4.3% | 0.06 | 5.2% |
| S3 | 1.19 | 0.04 | 3.0% | 0.06 | 5.0% |
| S4 | 3.75 | 0.06 | 1.7% | 0.12 | 3.3% |
| S5 | 9.17 | 0.20 | 2.2% | 0.27 | 2.9% |
| S6 | 10.78 | 0.15 | 1.4% | 0.39 | 3.7% |
| S7 | 19.71 | 0.28 | 1.4% | 0.44 | 2.3% |
| S8 | 32.18 | 0.77 | 2.4% | 1.03 | 3.2% |
| S9 | 43.37 | 0.76 | 1.8% | 1.45 | 3.3% |
| S10 | 56.04 | 1.24 | 2.2% | 1.90 | 3.4% |
A reproducibility study was conducted in which nine (9) human serum samples with testosterone concentrations spanning the analytical measuring interval were tested by one operator using three reagent lots on one IDS-iSYS Multi-Discipline Automated Analyzer. Each sample was tested in replicates of 5 per run, 1 run per day for 5 days for a total of 75 replicates per sample. The results are provided in the table below:
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| Sample | Concentration (pg/mL) | Reproducibility | |
| --- | --- | --- | --- |
| | | SD | CV |
| S1 | 1.2 | 0.09 | 7.8% |
| S2 | 1.3 | 0.07 | 5.8% |
| S3 | 3.7 | 0.15 | 4.1% |
| S4 | 9.3 | 0.44 | 4.7% |
| S5 | 10.9 | 0.46 | 4.2% |
| S6 | 20.1 | 0.89 | 4.4% |
| S7 | 33.1 | 2.85 | 8.6% |
| S8 | 45.4 | 2.36 | 5.2% |
| S9 | 58.9 | 2.80 | 4.7% |
A reproducibility study was conducted in which nine (9) human serum samples with testosterone concentrations spanning the analytical measuring interval were tested using one reagent lot on three instruments (IDS-iSYS Multi-Discipline Automated Analyzer) at 3 sites by 3 operators (one operator per instrument/site). Each sample was tested in replicates of 5 per run, 1 run per day for 5 days for a total of 75 replicates per sample. The results are provided in the table below:
| Sample | Concentration (pg/mL) | Reproducibility | |
| --- | --- | --- | --- |
| | | SD | CV |
| S1 | 1.2 | 0.13 | 11.1% |
| S2 | 1.3 | 0.08 | 6.5% |
| S3 | 3.8 | 0.17 | 4.5% |
| S4 | 9.2 | 0.35 | 3.8% |
| S5 | 10.8 | 0.44 | 4.1% |
| S6 | 19.8 | 0.83 | 4.2% |
| S7 | 32.6 | 1.82 | 5.6% |
| S8 | 44.4 | 1.94 | 4.4% |
| S9 | 57.9 | 2.24 | 3.9% |
2. Linearity:
A study was performed based on the CLSI Guideline EP06-Ed2. Three dilution series spanning the analytical measuring interval were prepared by mixing high and low serum samples pools. All dilution levels were assayed in replicates of four. Linearity was evaluated using linear regression analysis. The deviation from linearity did not exceed $-6.6\%$ for samples with free testosterone concentrations from the LoQ to $68.21~\mathrm{pg / mL}$ .
The combined linear regression for all 3 dilution series was as follows: $\mathrm{Y} = 1.00\mathrm{x} - 0.04;\mathrm{R} = 1.00$
The results from the linearity study support an analytical measuring interval of $0.40 - 60\mathrm{pg / mL}$
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# 3. Analytical Specificity/Interference:
Interference and cross-reactivity studies were conducted following the CLSI EP7-Ed3 guideline.
## Interference:
Aliquots from pools of human serum with free testosterone concentrations of 1.0 pg/mL or 45 pg/mL were spiked with potentially interfering substances. The samples were assayed, and the free testosterone concentrations of the spiked samples were compared to control samples without interferent. No significant interference (≤±10% bias) was observed when the interfering substances were tested at the following concentrations:
| Substance | Highest concentration at which no significant interference was observed |
| --- | --- |
| Acetylsalicylic Acid | 1.67 mmol/L |
| Acetaminophen | 1030 μmol/L |
| Bilirubin (Conjugated) | 40 mg/dL |
| Bilirubin (Unconjugated) | 40 mg/dL |
| Human Anti Mouse Antibody (HAMA) | 1000 ng/dL |
| Hemoglobin | 300 mg/dL |
| Ibuprofen | 1060 μmol/L |
| Total Protein | 10 g/dL |
| Salicylic Acid | 2.07 mmol/L |
| Triglycerides | 1500 mg/dL |
| Rheumatoid Factor (RhF) | 1500 IU/mL |
To evaluate the candidate device’s susceptibility to biotin interference, biotin was spiked into serum samples containing different concentrations of free testosterone (approximately 1.5 pg/mL, 20 pg/mL, or 45 pg/mL). Samples were assayed in multiple replicates. The sponsor defined no significant interference as ≤10% bias. The results are summarized below.
| % Bias for Samples Containing Various Concentration of Biotin | | | | | |
| --- | --- | --- | --- | --- | --- |
| Testosterone Concentration | Biotin Concentration (ng/mL) | | | | |
| | 250 | 500 | 750 | 870 | 1750 |
| 1.5 pg/mL | 5.4% | -10% | 11% | -6% | 61% |
| 20 pg/mL | 6.0% | -9% | 8% | NT | NT |
| 45 pg/mL | 9.0% | -10% | 16% | 33% | 64% |
NT = Not Tested
The sponsor has included the following limitations in the labeling:
- Specimens that contain biotin at a concentration of 500 ng/mL demonstrate a less than or equal to ±10% change in results. Biotin concentrations greater than this may lead to falsely elevated results for patient samples. The recommended adult daily dietary intake for biotin is 30 μg/day. Over the counter dietary supplements promoted for use in hair, skin and nail health may contain 5-10 mg of biotin. Pharmacokinetic studies in healthy adults have
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shown that ingesting 5 mg of biotin can result in serum levels as high as 73 ng/mL. In rare cases, subjects are prescribed up to 300 mg of biotin per day for therapeutic applications, resulting in serum biotin levels as high as 1,160 ng/mL.
- The lowest Total Protein level that does not significantly interfere (≤±10% bias) with IDS Free Testosterone assay is 10 g/dL.
- The lowest Hemoglobin level that does not significantly interfere (≤±10% bias) with the assay is 300 mg/dL. Visual hemolysis in the sample is typically already seen in samples with hemoglobin concentration of 50 mg/dL or greater. Visibly hemolyzed samples must not be used with IDS Free Testosterone assay.
- Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.
## Cross-Reactivity:
A cross-reactivity study was performed to evaluate the following substances. Aliquots from pools of human serum with a free testosterone concentration of 1.0 pg/mL or 15 pg/mL were spiked with potentially cross-reactive substances. The samples were assayed and the resulting percent cross-reactivity was calculated using the following formula:
$$
\% \text{ Cross Reactivity} = 100 \times (\text{Average "spike" concentration} - \text{Average "blank concentration}) / \text{Spike concentration}
$$
Results are shown in the table below:
| Cross-reactant | Test Concentration (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| 11-Deoxycortisol | 100,000 | < 0.01% |
| DHEA | 1000; 50000 | < 0.01% |
| Aldosterone | 3000 | < 0.01% |
| Cortisol | 1000 | < 0.01% |
| Androstenedione | 100 | 0.018% |
| 17α-Ethinilestradiol | 500 | < 0.01% |
| Androsterone | 500 | < 0.01% |
| Dihydrotestosterone | 500 | < 0.01% |
| Epitestosterone | 500 | < 0.01% |
| Norgestrel | 1000 | < 0.01% |
| Cortisone | 2000 | < 0.01% |
| Danazol | 1000 | < 0.01% |
| Estriol | 100 | < 0.01% |
| Testosterone propionate | 100 | < 0.01% |
| Prednisone | 1000 | < 0.01% |
| Oxymetholone | 10,000 | < 0.01% |
| Estradiol | 1000 | < 0.01% |
| 5α-Androstane-3β,17β-diol | 1000 | < 0.01% |
| Ethisterone | 1000 | < 0.01% |
| 11-β-Hydroxytestosterone | 1000 | < 0.01% |
| Prednisolone | 1000 | < 0.01% |
| Estrone | 1000 | < 0.01% |
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| Cross-reactant | Test Concentration (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Pregnenolone | 5000 | < 0.01% |
| Progesterone | 1000 | < 0.01% |
| 11-Ketotestosterone | 100 | 0.016% |
| Cyproterone | 2000 | < 0.01% |
| Dexamethasone | 2000 | < 0.01% |
| 17aOH-Progesterone | 500 | < 0.01% |
| Methyltestosterone | 100 | 0.039% |
| 17α-Estradiol | 1000 | < 0.01% |
| 17-Hydroxypregnenolone | 1000 | < 0.01% |
| Estriol 3-glucuronide | 1000 | < 0.01% |
| 3-EstriolSulfate | 1000 | < 0.01% |
| D-5-Androstene-3β,17β-diol | 1000 | < 0.01% |
| Amitriptyl HCI | 1000 | < 0.01% |
| Clomiphene Citrate | 1000 | < 0.01% |
| Corticosterone | 1000 | < 0.01% |
| Cyproterone acetate | 1000 | < 0.01% |
| DHEA-S | 100000 | < 0.01% |
| Desogestrel | 100 | < 0.01% |
| Ethynodiol | 1000 | < 0.01% |
| Ethynodiol diacetate | 50 | < 0.01% |
| Flunisolide | 1000 | < 0.01% |
| Fluoxymesterone | 1000 | < 0.01% |
| Lynestrenol | 1000 | < 0.01% |
| Medoxyprogesterone acetate | 1000 | < 0.01% |
| Mestranol | 1000 | < 0.01% |
| Norethindrone | 50 | < 0.01% |
| Norethinodrone acetate | 50 | < 0.01% |
| Norgestimate | 1000 | < 0.01% |
| Norethynodrel | 50 | < 0.01% |
| Salbutamol | 1000 | < 0.01% |
| Spironolactone | 1000 | < 0.01% |
| Stanozolol | 1000 | < 0.01% |
| Testosterone Cypionate | 12 | < 0.01% |
| Testosterone enanthate | 100 | < 0.01% |
| Testosterone SO4 | 1000 | < 0.01% |
| Testosterone Undecanoate | 12 | < 0.01% |
| Triamcinolone | 50 | < 0.01% |
4. Assay Reportable Range:
The sponsor claims a range of 0.40-60 pg/mL.
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The IDS-iSYS Free Testosterone assay is traceable to an internal reference material which is traceable to another commercially available assay.
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.
Limit of Blank (LoB)
For determination of LoB, four analyte-free samples were measured in replicates of 5 using 3 reagent lots over 5 days for a total of 60 replicates per reagent lot on one IDS-iSYS Multi-Discipline Automated Analyzer. LoB was calculated according to the parametric function as described in CLSI EP17-A2.
Limit of Detection (LoD)
For determination of LoD, seven serum samples with low-analyte concentrations were measured in replicates of 5 across 3 reagent lots over 3 days for a total of 105 replicates per reagent lot on one IDS-iSYS Multi-Discipline Automated Analyzer. LoD was calculated according to CLSI EP17-A2.
Limit of Quantitation (LoQ)
For the determination of LoQ, seven serum samples were measured in replicates of 5 across 3 reagent lots over 3 days for a total of 105 replicates per reagent lot on one IDS-iSYS Multi-Discipline Automated Analyzer. The LoQ was defined as the concentration of analyte which has imprecision less than 20% CV.
The summary results for LoB, LoD and LoQ are shown below.
| Limits of Detection | Free Testosterone Concentration |
| --- | --- |
| LoB | 0.08 pg/mL |
| LoD | 0.17 pg/mL |
| LoQ | 0.40 pg/mL |
7. Assay Cut-Off:
Not applicable
B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was performed comparing the IDS-iSYS Free Testosterone assay to the predicate device, using a protocol based on CLSI EP09c-A3. A total of 241 (220 native and 21 contrived) human serum samples with free testosterone concentrations ranging from 0.276 to 50.35 pg/mL (as measured by the predicate device) were evaluated with the candidate and predicate devices. The Passing-Bablok regression analysis results between the
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candidate device (dependent variable, y) and the comparator device (x, comparator), are shown below:
| N | Concentration Range (pg/mL)* | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation Coefficient (r) |
| --- | --- | --- | --- | --- | --- | --- |
| 241 | 00.41-55.98 | 1.02 | 0.97 – 1.06 | -0.02 | -0.26 – 0.07 | 0.98 |
*As measured by the candidate device
## 2. Matrix Comparison:
A matrix comparison study was conducted using 40 matched serum (without additives), serum gel separator tubes (SST) and plasma (K₂ EDTA, Lithium Heparin, and Sodium Heparin) samples with concentrations ranging from 0.40 to 58.45 pg/mL. The samples were tested in duplicate using one reagent lot, but only the first replicate was used for data analysis. The Passing-Bablok regression analysis was performed. The summary results are shown below.
| Tube type | N | Slope | Intercept | Correlation coefficient r |
| --- | --- | --- | --- | --- |
| SST | 40 | 0.96 | 0.08 | 1.00 |
| K₂ EDTA | 40 | 0.97 | 0.08 | 0.99 |
| Li Heparin | 40 | 0.97 | 0.03 | 0.99 |
| Na Heparin | 40 | 0.97 | 0.00 | 0.99 |
The results demonstrate equivalency between serum, serum gel separator tubes (SST) and plasma (K₂ EDTA, Lithium Heparin, and Sodium Heparin) sample matrices.
## 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
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# E Expected Values/Reference Range:
A reference interval study was performed for the IDS Free Testosterone assay in accordance with CLSI EP28-A3c guideline. A total of 563 adult serum samples were collected from apparently healthy individuals. The sample groups tested consisted of:
- 309 adult males between 21 and 77 years of age
- 254 adult females between 21 and 77 years of age
The data were analyzed to generate a nonparametric 95% reference interval using the 2.5th and 97.5th percentiles as reference limits. The resulting reference interval is summarized in the following table:
| Males | 21 to 39 years | 40 to 59 years | ≥ 60 years |
| --- | --- | --- | --- |
| N of subjects | 129 | 138 | 42 |
| Median (pg/mL) | 12.36 | 8.70 | 7.78 |
| Observed Range (pg/mL)
(2.5th to 97.5th percentile) | 4.91 to 21.64 | 3.73 to 14.96 | 2.25 to 11.37 |
| Females | 21 to 39 years | 40 to 59 years | ≥ 60 years |
| --- | --- | --- | --- |
| N of subjects | 130 | 57 | 67 |
| Median (pg/mL) | 1.13 | 0.71 | 0.89 |
| Observed Range (pg/mL)
(2.5th to 97.5th percentile) | 0.46 to 2.20 | 0.40 to 1.74 | 0.42 to 2.20 |
# Other Supportive Information
The sponsor evaluated whether the conjugate binds to SHBG (sex hormone binding globulin). Charcoal-stripped human serum was spiked with SHBG at concentrations ranging from 6.25 to 200 µg/mL and then assayed. All concentrations tested exhibited less than or equal to 7% binding.
# 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.
