Who is the manufacturer of FastPack IP Sex Hormone Binding Globulin Immunoassay?

Qualigen, Inc. filed the 510(k) submission for FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521).

What is the FDA product code for FastPack IP Sex Hormone Binding Globulin Immunoassay?

CDZ. It is classified under 21 CFR 862.1680 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for FastPack IP Sex Hormone Binding Globulin Immunoassay?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FastPack IP Sex Hormone Binding Globulin Immunoassay?

Beckman Coulter Access Sex Hormone Binding Globulin Reagent (k083867).

Who can help prepare an FDA 510(k) submission like FastPack IP Sex Hormone Binding Globulin Immunoassay?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FastPack IP Sex Hormone Binding Globulin Immunoassay

K182521 · Qualigen, Inc. · CDZ · Jan 29, 2019 · Clinical Chemistry

Device Facts

Record ID	K182521
Device Name	FastPack IP Sex Hormone Binding Globulin Immunoassay
Applicant	Qualigen, Inc.
Product Code	CDZ · Clinical Chemistry
Decision Date	Jan 29, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1680
Device Class	Class 1

Intended Use

FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

Device Story

FastPack® IP SHBG is a quantitative chemiluminescent immunoassay for human serum and plasma; used on FastPack® Analyzer. Device utilizes disposable reagent pack containing paramagnetic particles coated with streptavidin-monoclonal anti-SHBG antibody and alkaline phosphatase-labeled anti-SHBG antibody. Principle of operation: two-site sandwich immunoassay; SHBG in sample forms sandwich complex with antibodies; chemiluminogenic substrate added; chemiluminescence signal measured is directly proportional to SHBG concentration. Used in professional laboratory settings; operated by trained personnel. Output provides quantitative SHBG concentration to aid clinicians in diagnosing androgen disorders.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A3 (N=240 replicates per sample). Linearity (0.80–174 nmol/L) per CLSI EP6-A. LOB (0.08 nmol/L), LOD (0.20 nmol/L), and LOQ (0.80 nmol/L) per CLSI EP17-A2. Interference and cross-reactivity testing performed for various endogenous substances. Method comparison against predicate (N=158) yielded R=0.985, slope=0.993, y-intercept=-0.614 nmol/L. Serum/plasma equivalence confirmed (N=54). Reference intervals established for males and females across age partitions.

Technological Characteristics

Sandwich immunoassay using monoclonal anti-SHBG antibodies. Signal phase: ALP-conjugated antibody. Capture phase: biotinylated antibody on streptavidin-coated paramagnetic particles. Detection: chemiluminescence via indoxyl-3-phosphate and lucigenin. Reaction temperature: 37 ± 0.5 °C. Automated processing on FastPack® Analyzer. Traceable to WHO 082/266 reference material. Storage: 2-8 °C.

Indications for Use

Indicated for the quantitative determination of Sex Hormone Binding Globulin (SHBG) in human serum and plasma as an aid in the diagnosis of androgen disorders in adult and adolescent populations.

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

Beckman Coulter Access Sex Hormone Binding Globulin Reagent (k083867)

Related Devices

K083867 — ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND · Beckman Coulter, Inc. · Aug 27, 2009
K233480 — Access SHBG · Beckman Coulter, Inc. · Feb 8, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 29, 2019 Qualigen, Inc. Wajdi Abdul-Ahad Vice President, Assay Development 2042 Corte Del Nogal Carlsbad. CA 92011 Re: K182521 Trade/Device Name: FastPack IP Sex Hormone Binding Globulin Immunoassay Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I. reserved Product Code: CDZ Dated: December 20, 2018 Received: December 26, 2018 Dear Wajdi Abdul-Ahad: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/5 description: The image shows the name "Kellie B. Kelm -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and easy to read. Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182521 Device Name FastPack® IP Sex Hormone Binding Globulin Immunoassay Indications for Use (Describe) FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Type of Use (Select one or both, as applicable) | <div>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |---------------------------------------------------------|--------------------------------------------------------| |---------------------------------------------------------|--------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY This 510(k) Summary information is submitted in accordance with the requirements of 21 CFR § 807.92. ### 510(k) Number: K182521 ### Submitter: Qualigen, Inc. 2042 Corte Del Nogal, Suite B Carlsbad, CA 92011 | Telephone: | (760) 918-9165 | |------------|----------------| | Facsimile: | (760) 918-9127 | ## Contact Person: Wajdi Abdul-Ahad PhD Vice President, Assay Development Telephone: (760) 918-9165 x234 Facsimile: (760) 918-9127 Email: wabdul-ahad@qualigeninc.com ### Device Identification | Trade Names: | FastPack® IP Sex Hormone Binding Globulin Immunoassay | |-----------------------|------------------------------------------------------------------| | Common Names: | Sex Hormone Binding Globulin Assay | | Classification names: | Immunological Test Systems | | Classifications: | Class I, reserved (assay) | | Panel: | Chemistry (75) | | Product Codes: | CDZ – SHBG Assay | | Regulation Numbers: | 21 CFR § 862.1680 - Testosterone test system - Class I, reserved | {4}------------------------------------------------ ### Devices to Which Substantial Equivalence is Claimed Access Sex Hormone Binding Globulin assay Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 K083867 ### Device Description The FastPack® IP Sex Hormone Binding Globulin Immunoassay employs a sandwich immunoassay principle. Endogenous SHBG in a patient sample, calibrator, or control is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-SHBG antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-SHBG antibody linked to biotin will bind to streptavidin coated paramagnetic particles (PMP). After incubation, washing steps (using a Tris buffer containing detergents) occur to separate bound from unbound anti-SHBG monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield N-methylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of SHBG in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light. ## Intended Use FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. {5}------------------------------------------------ ### Comparison of new device to predicate device | CHARACTERISTIC | Qualigen FastPack® IP Sex Hormone Binding Globulin Immunoassay | Beckman Coulter Sex Hormone Binding Globulin K083867 | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | FastPack® IP SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack® System. The FastPack® IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. | 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. | | Assay format | Paramagnetic particle, chemiluminescent, two-site sandwich immunoassay employing specific monoclonal antibodies | Same | | Assay procedure | Automated | Same | | Components | Mouse monoclonal antibody against SHBG in the capture phase and a mouse monoclonal anti- SHBG antibody conjugated to alkaline phosphatase in the signal phase. | Same | | Sample Type | Serum or lithium-heparin plasma | Same | | Sample Preparation | Standard processing for serum or plasma | Same | | Interpretation of Results | Standard Curve | Same | | Reagent Storage Temperature | 2-8 °C | Same | | Testing Environment | Professional use | Same | | | | | | Precision (% CV) | Within-run: ≤ 10% Between-run: ≤ 8% Between-day: ≤ 8% | ≤ 5.5% | | Linearity | Assay linear from LOQ (0.80 nmol/L) to 174 nmol/L | Assay linear from 0.33 - 200 nmol/L | | Interfering Substances/Specificity | No interference with acetaminophen (10 mg/dL), acetylsalicylic acid (80 mg/dL), alpha-fetoprotein (500 µg/L), conjugated bilirubin (40 mg/dL), unconjugated bilirubin (30 mg/dL), d-biotin (0.2 mg/dL), cortisol (10 mg/dL), 11- deoxycortisol (0.5 mg/dL), 5-α- dihydrotestosterone (2 mg/dL), hemoglobin (1.0 g/dL), heparin (10,000 U/dL), human serum albumin (8 g/dL), ibuprofen (600 mg/dL), estradiol (4 mg/dL), GAS6 (250 µg/L), laminin (6000 µg/L), Protein S (30 mg/L), testosterone (2.5 mg/dL), thyroglobulin (300 µg/L), thyroxine-binding globulin (20 mg/dL), transferrin (0.5 g/dL), and triglycerides/Intralipid (1000 mg/dL) | No interferences at similar concentrations of the same substances | | Comparative Testing vs Established Methods | FastPack® vs. Access N = 158 Range of observations: 5.7 to 176.0 nmol/L Passing-Bablok regression: Slope (95% CI): 0.993 (0.967- 1.019) y (95% CI): -0.614 (-2.21 to 0.982) R = 0.985 R2 = 0.971 | Beckman Access vs. Immulite N = 158 Range of observations: 5.7 – 184.5 nmol/L Deming regression: Slope (95% CI): 1.09 (1.06– 1.12) y (95% CI): 1.84 (0.54 – 3.00) R2 = 0.94 | | Expected Values/Reference Intervals | Males (13-50 years): 9.4-61.8 Males (≥ 50 years): 13.0-86.4 Females (12-46 years): 9.2-134.4 Females (> 46 years): 12.2-121.2 | Males (20-50 years): 13.3-89.5 nmol/L Females (20-49 years): 18.2- 135.5 nmol/L Post-menopausal females (≥50 years): 16.8-125.2 nmol/L | | Globulin | | | | CHARACTERISTIC | Qualigen FastPack® IP Sex Hormone Binding Globulin Immunoassay | Beckman Coulter Sex Hormone Binding Globulin K083867 | | Approximate assay time | 8 minutes | ~28 minutes (first result) | | Traceability | Traceable to the WHO 082/266 reference which serves as the Primary Reference Material | Traceable to the WHO 95/560 reference | ### Similarities between FastPack® and Beckman Coulter Access 2 Assays {6}------------------------------------------------ {7}------------------------------------------------ # Differences between FastPack® and Beckman Access Sex Hormone Binding {8}------------------------------------------------ ### Performance Summary ### Precision Precision was evaluated following the CLSI EP5-A3 guidance. Seven serum patient samples with concentrations of ~ 5 to ~ 150 nmol/L SHBG were tested in duplicate determinations in each of two runs per day on each of three FastPack® reagent lots, one FastPack® analyzer per reagent lot (total of three Analyzers), one FastPack® Calibrator per reagent lot (total of three Calibrator lots) over a period of 20 non-consecutive days to yield 240 replicate determinations of each sample. Within-run, between-run, between-day, and total imprecision were calculated using a fully nested 2-way random factor analysis of variance (ANOVA) model. The following three tables present the results by combination of reagent lot, analyzer, and calibrator lot: | | | Within-Run | | Between-Run | | Between-Day | | Total | | |--------|-------------|------------|------|-------------|------|-------------|------|-------|------| | Sample | Mean nmol/L | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 4.85 | 0.27 | 5.55 | 0.00 | 0.00 | 0.21 | 4.37 | 0.34 | 7.06 | | 2 | 12.56 | 0.60 | 4.82 | 0.68 | 5.46 | 0.28 | 2.19 | 0.60 | 4.82 | | 3 | 25.59 | 1.40 | 5.46 | 1.83 | 7.14 | 0.87 | 3.40 | 1.40 | 5.46 | | 4 | 59.49 | 3.67 | 6.16 | 1.80 | 3.03 | 2.95 | 4.96 | 3.67 | 6.16 | | 5 | 91.33 | 5.99 | 6.56 | 7.12 | 7.79 | 0.00 | 0.00 | 5.99 | 6.56 | | 6 | 102.26 | 7.11 | 6.95 | 3.85 | 3.76 | 4.76 | 4.66 | 7.11 | 6.95 | | 7 | 154.79 | 4.24 | 2.74 | 0.62 | 0.40 | 2.51 | 1.62 | 4.96 | 3.21 | Reagent lot 1, analyzer 1, calibrator lot 1 ### Reagent lot 2, analyzer 2, calibrator lot 2 | | | Within-Run | | Between-Run | | Between-Day | | Total | | |--------|-------------|------------|------|-------------|------|-------------|------|-------|-------| | Sample | Mean nmol/L | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 5.02 | 4.88 | 4.88 | 0.00 | 0.00 | 0.16 | 3.20 | 0.29 | 5.83 | | 2 | 16.74 | 0.74 | 4.40 | 0.89 | 5.29 | 0.88 | 5.24 | 1.45 | 8.65 | | 3 | 29.97 | 1.58 | 5.27 | 1.97 | 6.56 | 0.37 | 1.25 | 2.55 | 8.51 | | 4 | 63.53 | 2.99 | 4.71 | 3.36 | 5.29 | 2.57 | 4.04 | 5.18 | 8.15 | | 5 | 94.47 | 7.31 | 7.74 | 5.33 | 5.64 | 4.44 | 4.70 | 10.07 | 10.66 | | 6 | 107.81 | 8.31 | 7.70 | 4.59 | 4.26 | 8.03 | 7.44 | 12.43 | 11.53 | | 7 | 150.43 | 4.16 | 4.16 | 0.00 | 0.00 | 4.28 | 2.85 | 7.58 | 5.04 | | | | Reagent lot 3, analyzer 3, calibrator lot 3 | |--|--|---------------------------------------------| |--|--|---------------------------------------------| | | | Within-Run | | Between-Run | | Between-Day | | Total | | |--------|-------------|------------|------|-------------|------|-------------|------|-------|-------| | Sample | Mean nmol/L | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 4.90 | 0.21 | 4.2 | 0.0 | 0.0 | 0.1 | 2.0 | 0.2 | 4.7 | | 2 | 14.26 | 0.67 | 4.69 | 0.51 | 3.56 | 0.45 | 3.13 | 0.95 | 6.67 | | 3 | 25.47 | 1.22 | 4.78 | 1.75 | 6.86 | 0.91 | 3.58 | 2.32 | 9.10 | | 4 | 58.56 | 3.30 | 5.64 | 4.22 | 7.21 | 2.25 | 3.85 | 5.81 | 9.93 | | 5 | 91.40 | 8.78 | 9.60 | 3.70 | 4.05 | 5.53 | 6.05 | 11.02 | 12.05 | | 6 | 105.25 | 7.42 | 7.05 | 5.21 | 4.95 | 0.00 | 0.00 | 9.07 | 8.61 | | 7 | 148.44 | 5.04 | 3.4 | 0.8 | 0.5 | 3.0 | 2.0 | 5.9 | 4.0 | {9}------------------------------------------------ ### Limits of blank, detection, and quantitation The limit of blank (LOB, the highest measurement likely to be observed for a blank sample), limit of detection (LOD, the lowest amount of analyte in a sample that can be detected with type I and II error rates set to 5%), and limit of quantitation (LOQ, the lowest amount of analyte in a sample that can be reliably detected) were determined according to CLSI EP17-A2 for the FastPack® IP Sex Hormone Binding Globulin Immunoassay. In this study, the limit of blank was determined from 180 replicate determinations of a blank sample tested on six different FastPack® analyzers using three reagent lots. Raw RLUs from the assays were converted to apparent nmol/L based on the calibration curve for each assay. The LOB was determined as the 171.5th rank of the sorted distribution of values. This value was 0.08 nmol/L SHBG. The LOD was estimated from 180 replicate determinations of four low level samples. Per the CLSI EP17-A2 guideline, the parametric LOD calculation was utilized and the LOD was 0.20 nmol/L SHBG. The LOO was determined as the lowest sample which provided < 20% CV the value was 0.80 nmol/L SHBG. ### Linearity Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approved Guideline. A high patient sample was intermixed with a low sample to generate 11 concentration levels each tested in quadruplicate determinations. Linear results were compared to 2nd and 3rd order polynomial fits against a pre-specified allowable error. The linearity range was found to extend from the LOQ (0.80 nmol/L) to 174 nmol/L. ### Interferences The effect of endogenous interferences on quantification of SHBG was investigated by preparation of two serum samples with differing SHBG concentrations (a low and high) with known concentrations of conjugated bilirubin, unconjugated bilirubin, hemoglobin, lipids, and d-biotin. The value obtained for the sample with each interfering substance was compared to the value obtained for the sample without the interfering substance and the percentage recovery in nmol/L SHBG determined. These compounds did not show interference at the levels indicated in the following table. Higher levels may cause interference. {10}------------------------------------------------ | Compound | Highest level demonstrating no interference | |------------------------|---------------------------------------------| | Conjugated Bilirubin | 40 mg/dL | | Unconjugated Bilirubin | 30 mg/dL | | Hemoglobin | 1.0 g/dL | | Lipid | 1000 mg/dL | | d-Biotin | 0.2 mg/dL | The effect of potentially cross-reacting substances on quantification of SHBG was investigated. Again, two serum samples with differing SHBG concentrations (a low and high) with known concentrations of spiked cross-reactants were prepared. The value obtained for the sample with each potentially cross-reacting substance was compared to the value obtained for the sample without the substance and the percentage recovery in nmol/L SHBG determined. These compounds did not show cross-reactivity at the levels indicated in the following table. Higher levels may cause cross-reaction. | Compound | Highest level demonstrating no cross-reaction | |-------------------------------------|-----------------------------------------------| | Transferrin | 0.5 g/dL | | Heparin | 10,000 U/dL | | Low Molecular Weight Heparin (LMWH) | 0.6 U/dL | | Ibuprofen | 60 mg/dL | | Human Albumin | Endogenous in samples + 8.0 g/dL | | Human IgG | 1.0 g/dL | | Thyroxine Binding Globulin (TBG) | 20 mg/dL | | Thyroglobulin | 300 µg/L | | Testosterone | 2.5 mg/dL | | Laminin | 6,000 µg/L | | GAS6 | 250 µg/L | | Protein S | 30 mg/L | | Estradiol | 4.0 mg/dL | | 11-deoxycortisol | 0.5 mg/dL | | 5α-dihydrotestosterone | 2.0 mg/dL | | Cortisol | 10 mg/dL | | AFP | 500 µg/L | | Acetaminophen | 10 mg/dL | | Acetylsalicylic acid | 80 mg/dL | Rheumatoid factor at up to 1000 IU/mL and human anti-mouse IgG at up to 4 µg/mL do not cross-react in the FastPack® IP Sex Hormone Binding Globulin Immunoassay. {11}------------------------------------------------ Additionally, six known heterophile samples did not generate detectable interference in the assay. ### Serum and plasma equivalence Blood collections were obtained from 54 volunteers and processed in parallel to serum and lithium-heparin plasma. Measurements in the FastPack® IP Sex Hormone Binding Globulin Immunoassay were compared via Passing-Bablok regression and indicated equivalence between the matrices. | Parameter | Result | |-----------------------------------|-----------------------------------------------------------| | N compared | 54 | | Range of observations, nmol/L | Serum: 5.7 – 174.5 Lithium-Heparin Plasma: 7.1 – 175.1 | | Absolute bias, nmol/L | 1.117 | | % Bias | 1.928 | | Passing Bablok regression results | | | Slope (95% CI) | 0.960 (0.920-1.00) | | y-intercept (95% CI) | 1.859 (-0.89 to 4.61) | | R | 0.990 | | R2 | 0.979 | # Expected Values/Reference Intervals Serum samples from N=613 male (n=304) and female (n=309) apparently healthy individuals with no known pre-existing endocrine disorders were acquired and assayed in singlet determinations. Analysis of the data relied upon determination of the nonparametric 2.5th-97.5th (central 95%) percentiles of the distributions within four reference partitions. The FastPack® IP Sex Hormone Binding Globulin reference intervals are defined below: | Partition | N | Median (nmol/L) | Reference Interval (nmol/L) | |-----------------------|-----|-----------------|-----------------------------| | Males 13 - 50 years | 149 | 26.6 | 9.4 - 61.8 | | Males > 50 years | 155 | 35.9 | 13.0 - 86.4 | | Females 12 - 46 years | 151 | 39.6 | 9.2 - 134.4 | | Females > 46 years | 158 | 49.8 | 12.2 - 121.2 | ## Method Comparison Human serum samples were tested with the FastPack® IP Sex Hormone Binding Globulin Immunoassay and the obtained results were compared to the predicate method. A total of {12}------------------------------------------------ 158 samples ranging from 5.7 – 176.0 nmol/L were tested in both assays. The FastPack® IP Sex Hormone Binding Globulin Immunoassay correlated well with the predicate method with correlation coefficient (R) of 0.985, slope = 0.993, and y-intercept = -0.614 nmol/L. | Parameter | Result | |----------------------|-------------------------| | Slope (95% CI) | 0.993 (0.967-1.019) | | y-intercept (95% CI) | -0.614 (-2.21 to 0.982) | | R2 (95% CI) | 0.971 | | R (95% CI) | 0.985 | ## SUMMARY The information provided in this pre-market notification indicates that the FastPack® IP Sex Hormone Binding Globulin Immunoassay is substantially equivalent to the stated predicate device. The information further indicates that the FastPack® IP Sex Hormone Binding Globulin Immunoassay is safe and effective for its stated intended use.