(138 days)
No
The description details a standard chemiluminescent immunoassay and analyzer, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
This device is an in vitro diagnostic (IVD) device used for quantitative determination of Sex Hormone Binding Globulin, which aids in the diagnosis of androgen disorders, but it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as an aid in the diagnosis of androgen disorders."
No
The device description clearly outlines a chemiluminescent immunoassay involving physical reagents (monoclonal antibodies, paramagnetic particles, chemiluminogenic substrate mixture), a reaction sequence at a controlled temperature, and measurement by a photomultiplier tube in a physical analyzer (FastPack® Analyzer). This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma". It also states it's "intended for use as an aid in the diagnosis of androgen disorders." This clearly indicates it's used to test human samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a laboratory-based immunoassay process involving patient samples (serum and plasma), reagents, and an analyzer to measure a specific analyte (SHBG). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes detailed performance studies (Precision, Limits of blank/detection/quantitation, Linearity, Interferences, Serum and plasma equivalence, Expected Values/Reference Intervals, Method Comparison) which are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K083867) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
- Intended User / Care Setting: "Professional use" in a laboratory or clinical setting is typical for IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
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.
Product codes
CDZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Males 13-50 years, Males >= 50 years, Females 12-46 years, Females > 46 years
Intended User / Care Setting
Professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
- Study Type: Evaluated following CLSI EP5-A3 guidance.
- Sample Size: Seven serum patient samples with concentrations of ~5 to ~150 nmol/L SHBG, each 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, yielding 240 replicate determinations of each sample.
- Key Results: Within-run, between-run, between-day, and total imprecision were calculated using a fully nested 2-way random factor analysis of variance (ANOVA) model.
- Reagent lot 1, analyzer 1, calibrator lot 1:
- Sample 1 (mean 4.85 nmol/L): Total %CV 7.06
- Sample 2 (mean 12.56 nmol/L): Total %CV 4.82
- Sample 3 (mean 25.59 nmol/L): Total %CV 5.46
- Sample 4 (mean 59.49 nmol/L): Total %CV 6.16
- Sample 5 (mean 91.33 nmol/L): Total %CV 6.56
- Sample 6 (mean 102.26 nmol/L): Total %CV 6.95
- Sample 7 (mean 154.79 nmol/L): Total %CV 3.21
- Reagent lot 2, analyzer 2, calibrator lot 2:
- Sample 1 (mean 5.02 nmol/L): Total %CV 5.83
- Sample 2 (mean 16.74 nmol/L): Total %CV 8.65
- Sample 3 (mean 29.97 nmol/L): Total %CV 8.51
- Sample 4 (mean 63.53 nmol/L): Total %CV 8.15
- Sample 5 (mean 94.47 nmol/L): Total %CV 10.66
- Sample 6 (mean 107.81 nmol/L): Total %CV 11.53
- Sample 7 (mean 150.43 nmol/L): Total %CV 5.04
- Reagent lot 3, analyzer 3, calibrator lot 3:
- Sample 1 (mean 4.90 nmol/L): Total %CV 4.7
- Sample 2 (mean 14.26 nmol/L): Total %CV 6.67
- Sample 3 (mean 25.47 nmol/L): Total %CV 9.10
- Sample 4 (mean 58.56 nmol/L): Total %CV 9.93
- Sample 5 (mean 91.40 nmol/L): Total %CV 12.05
- Sample 6 (mean 105.25 nmol/L): Total %CV 8.61
- Sample 7 (mean 148.44 nmol/L): Total %CV 4.0
- Reagent lot 1, analyzer 1, calibrator lot 1:
Limits of Blank, Detection, and Quantitation Study:
- Study Type: Determined according to CLSI EP17-A2.
- Sample Size: 180 replicate determinations of a blank sample for LOB; 180 replicate determinations of four low level samples for LOD.
- Key Results:
- LOB: 0.08 nmol/L SHBG.
- LOD: 0.20 nmol/L SHBG.
- LOQ: 0.80 nmol/L SHBG (lowest sample providing 50 years: 13.0 - 86.4 nmol/L
- Females 12-46 years: 9.2 - 134.4 nmol/L
- Females > 46 years: 12.2 - 121.2 nmol/L
Method Comparison Study:
- Study Type: Comparison of FastPack® IP Sex Hormone Binding Globulin Immunoassay results to the predicate method.
- Sample Size: 158 human serum samples.
- Key Results: Correlated well with the predicate method.
- Range of observations: 5.7 – 176.0 nmol/L
- R: 0.985
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Key metrics reported are precision (%CV), LOB, LOD, LOQ, linearity, interference recovery, bias, slope, y-intercept, and correlation coefficients (R, R2).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.
0
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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.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------- | -------------------------------------------------------- |
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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 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.