HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Device Facts
| Record ID | K240242 |
|---|---|
| Device Name | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
| Applicant | Anhui Deepblue Medical Technology Co., Ltd. |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Oct 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Indications for Use
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the quantitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for the over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
Device Story
Rapid chromatographic immunoassay for qualitative hCG detection in urine; utilizes monoclonal hCG antibodies and colloidal gold tracer. Specimen migrates via capillary action; positive results indicated by red line at test region; control line confirms procedural validity. Available in strip, cassette, and midstream formats. Intended for over-the-counter home use by lay users. Results provide early pregnancy indication; positive results require clinical confirmation by healthcare providers for medical decision-making.
Clinical Evidence
Bench testing only. Precision studies (single-site/single-day, single-site/multi-day, multi-site) performed with 60-900 replicates per concentration (0-100 mIU/mL). Interference testing (endogenous/exogenous substances, pH, specific gravity, β-core fragment) showed no interference. Method comparison study (n=300) and lay-user study (n=300) demonstrated 100% agreement with professional testing using the predicate device.
Technological Characteristics
Lateral flow sandwich immunochromatographic assay. Components: nitrocellulose membrane with anti-rat-α-hCG monoclonal antibody test line; glass fiber pad with gold nanoparticle-conjugated anti-rat-β-hCG monoclonal antibody; goat anti-mouse polyclonal control line. Formats: strip, cassette (with dropper/cup), or midstream (plastic housing). No electronic components; visual readout.
Indications for Use
Indicated for qualitative detection of hCG in urine to aid early pregnancy detection. Intended for over-the-counter, home use by women of childbearing age.
Regulatory Classification
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
Predicate Devices
- hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (K200133)
Related Devices
- K041748 — AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) · Azog, Inc. · Aug 9, 2004
- K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream · Assure Tech., LLC · Jan 15, 2025
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K240242
B Applicant
Anhui DEEPBLUE Medical Technology Co. LTD.
C Proprietary and Established Names
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCX | Class II | 21 CFR 862.1155 - Human Chorionic Gonadotropin | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Human Chorionic Gonadotropin (hCG)
C Type of Test:
Qualitative chromatographic immunoassay
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K240242 - Page 2 of 13
# III Intended Use/Indications for Use:
## A Intended Use(s):
See Indications for Use below.
## B Indication(s) for Use:
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use.
Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the quantitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for the over-the-counter use.
Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
## C Special Conditions for Use Statement(s):
OTC - Over The Counter
The device is intended for home-use only and not intended for clinical-care settings.
## D Special Instrument Requirements:
None
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K240242 - Page 3 of 13
## IV Device/System Characteristics:
### A Device Description:
The test comes in three test formats (strip, cassette, and midstream) named HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold), respectively. The test strip format is packaged as a single test strip sealed in a desiccated aluminum pouch with instructions for use. The midstream format is a test strip assembled in a plastic housing with an absorbent tip and is packaged as a single test sealed in a desiccated aluminum pouch with instructions for use. The cassette format is the test strip assembled in a plastic cassette and is packaged as a single test with a dropper, a collection container, and instructions for use.
### B Principle of Operation:
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) are qualitative, lateral flow sandwich immunochromatographic assays for the in vitro detection of human chorionic gonadotropin (hCG) in urine. Each test reagent strip consists of an anti-rat-α-hCG monoclonal antibody coated test line on the nitrocellulose membrane and a dried glass fiber membrane pad containing an anti-rat-β-hCG monoclonal antibody labeled with gold nanoparticle conjugate. The control antibodies are goat anti-mouse polyclonal antibody coated at the quality control region on the nitrocellulose membrane.
To use the strip format of the test, the user dips the sample pad into urine collected in a collection cup for at least 10 seconds. To use the cassette format, the user applies 3 full drops of urine specimen to the specimen well on the cassette. To use the midstream format, the user applies a specimen by keeping the absorbent tip in a urine midstream for at least five (5) seconds.
After application of the urine specimen, the test result is shown in the result window and read visually after 5 minutes of urine application. Two distinct colored lines, one in the test zone and another in the control zone indicate a positive test result (pregnant). Absence of a colored line in the test zone and only a colored line in the control zone indicates a negative test result (not pregnant). Absence of a colored line in the control zone, even in the presence of a colored line in the test zone, indicates an invalid test result.
### V Substantial Equivalence Information:
#### A Predicate Device Name(s):
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
#### B Predicate 510(k) Number(s):
K200133
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K240242 | K200133 |
| --- | --- | --- |
| Device Trade Name | HCG Home Use Pregnancy Test Strip (Colloidal Gold) | hCG Urine Test Strip |
| | HCG Home Use Pregnancy Test Cassette (Colloidal Gold) | hCG Urine Test Cassette |
| | HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | hCG Urine Test Midstream |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. | Same |
| Specimen | Urine | Same |
| Methodology | Chromatographic immunoassay | Same |
| Analytical Sensitivity | 25 mIU/mL | Same |
| General Device Characteristic Differences | | |
| Specific Gravity Interference | No interference in urine with specific gravity 1.000 -1.035 | No interference in urine with specific gravity 1.000 -1.039 |
| High Dosage Hook Effect | No high dosage hook effect for hCG up to 1,000,000 mIU/mL | No high dosage hook effect for hCG up to 850,000 mIU/mL |
VI Standards/Guidance Documents Referenced:
Clinical Laboratory Standard Institute (CLSI) EP07: Interference Testing in Clinical Chemistry, 3rd edition.
CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents.
CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; 3rd edition
K240242 - Page 4 of 13
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VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Single-Site/Single-Day Precision Study
A precision study was performed using a pooled negative female urine sample spiked with hCG (traceable to the 5th WHO IS) to obtain samples with hCG concentration of 0, 12.5, 18.75, 25, 50, and 100 mIU/mL. Each sample was tested using 3 lots of HCG Home Use Pregnancy Test Cassette (Colloidal Gold), 3 lots of HCG Home Use Pregnancy Test Strip (Colloidal Gold) and 3 lots of HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Each sample was tested in replicates of 20 per lot of device format at 1 site on 1 day by 3 different operators. A total of 60 replicates were performed per test format per hCG concentration. Summary of results are presented in the following tables.
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| hCG concentration(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 12.5 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 18.75 | 12 | 8 | 11 | 9 | 12 | 8 | 35 | 25 | 58.33 | 41.67 |
| 25 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 50 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 100 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| hCG concentration(mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 12.5 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 18.75 | 11 | 9 | 12 | 8 | 12 | 8 | 35 | 25 | 58.33 | 41.67 |
| 25 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 50 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 100 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
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HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| hCG concentration (mIU/mL) | Lot 7 | | Lot 8 | | Lot 9 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 12.5 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 18.75 | 11 | 9 | 12 | 8 | 12 | 8 | 35 | 25 | 58.33 | 41.67 |
| 25 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 50 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 100 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
# Single-Site/Multi-Day Precision Study
A multi-day precision study was performed using a pooled negative female urine sample spiked with hCG (traceable to the $5^{\text{th}}$ WHO IS) to obtain samples with hCG concentration of 0, 12.5, 18.75, 25, 50, and $100\mathrm{mIU / mL}$ . Each sample was tested using 3 lots of HCG Home Use Pregnancy Test Cassette (Colloidal Gold), 3 lots of HCG Home Use Pregnancy Test Strip (Colloidal Gold) and 3 lots of HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Each sample was tested in 20 replicates per run, 2 runs per day over the course of 5 days per lot per device test format. A total of 600 replicates per sampling method per hCG concentration. The table below summarized the precision data for each test format.
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| hCG concentration (mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 12.5 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 18.75 | 115 | 85 | 111 | 89 | 114 | 86 | 340 | 260 | 56.67 | 43.33 |
| 25 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 50 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 100 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| hCG concentration (mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 12.5 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 18.75 | 113 | 87 | 113 | 87 | 112 | 88 | 338 | 262 | 56.33 | 43.67 |
| 25 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 50 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 100 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
K240242 - Page 6 of 13
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HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| hCG concentration (mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 12.5 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 18.75 | 118 | 82 | 113 | 87 | 114 | 86 | 345 | 255 | 57.5 | 42.5 |
| 25 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 50 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 100 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
## Multi-Site Precision Study
A multi-site precision study was performed using pooled negative female urine sample spiked with hCG (traceable to the 5th WHO IS) to obtain samples with hCG concentration of 0, 12.5, 18.75, 25, 50, and 100 mIU/mL. Each sample was tested using 3 lots of HCG Home Use Pregnancy Test Cassette (Colloidal Gold), 3 lots of HCG Home Use Pregnancy Test Strip (Colloidal Gold) and 3 lots of HCG Home Use Pregnancy Test Midstream (Colloidal Gold) at 3 sites. At each site, each sample was tested in 10 replicates per run, 2 runs per day over the course of 5 days per lot per device test format. All lots were tested at each site for each test format and a total of 900 replicates per test format per hCG concentration were obtained at 3 sites together. The table below summarized the precision data for each test format.
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| hCG concentration (mIU/mL) | Site 1 (Lot 1, Lot 2, Lot 3) | | Site 2 (Lot 1, Lot2, Lot 3) | | Site 3 (Lot 1, Lot 2, Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 12.5 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 18.75 | 150 | 150 | 150 | 150 | 150 | 150 | 450 | 450 | 50 | 50 |
| 25 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 50 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 100 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
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HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| hCG concentration (mIU/mL) | Site 1 (Lot4, Lot5, Lot6) | | Site 2 (Lot4, Lot5, Lot6) | | Site 3 (Lot4, Lot5, Lot6) | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 12.5 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 18.75 | 150 | 150 | 150 | 150 | 140 | 160 | 440 | 460 | 51.11 | 48.89 |
| 25 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 50 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 100 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| hCG concentration (mIU/mL) | Site 1 (Lot7, Lot8, Lot9) | | Site 2 (Lot7, Lot8, Lot9) | | Site 3 (Lot7, Lot8, Lot9) | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 12.5 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 | 0 |
| 18.75 | 170 | 130 | 150 | 150 | 140 | 160 | 480 | 420 | 53.53 | 46.67 |
| 25 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 50 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
| 100 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100 |
2. Linearity:
Linearity is not applicable since this is a qualitative test.
3. Analytical Specificity/Interference:
Interference from exogenous and endogenous substances:
A study was performed to evaluate potential interference from certain exogenous and endogenous substances for the HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold). A urine pool from non-pregnant females was used to prepare samples with hCG levels of $0\mathrm{mIU / mL}$, $10\mathrm{mIU / mL}$ and $25\mathrm{mIU / mL}$, which were then spiked with potentially interfering substances at the concentrations listed below. Samples were tested in replicates of 5 per lot using 3 lots of each device format. The results demonstrated no interferences at the concentrations shown in the table below.
K240242 - Page 8 of 13
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| Potential Interferent | Highest Concentration Tested that demonstrated no interference |
| --- | --- |
| **Endogenous Interferents** | |
| Albumin | 2000 mg/dL |
| Bilirubin | 2mg/dL |
| Ethanol | 1% |
| Glucose | 2000 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Ketone | >80 mg/dL |
| Protein | 5.65 mmol/L |
| Erythrocytes | >250/μL |
| Leukocyte | >500/μL |
| Uric acid | 450 mmol/L |
| **Exogenous Interferents** | |
| Ascorbic acid | 20 mg/dL |
| Acetaminophen | 20 mg/dL |
| Aspirin | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| β hydroxybutyrate | 2000 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| EDTA | 80 mg/dL |
| Ephedrine | 20 mg/dL |
| Folic acid | 800 μg/mL |
| Phenylpropanolamine | 20 mg/dL |
| Pheothiazine | 20 mg/dL |
| Thiophene | 20 mg/dL |
| Vitamin B1 | 800 μg/mL |
**Cross-Reactivity of Structurally Related Compounds:**
A study was performed to evaluate the potential cross-reactivity from luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH) on the HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices. Urine specimens from non-pregnant females were pooled and used to prepare samples with hCG levels of 0 mIU/mL, 12.5 mIU/mL and 25 mIU/mL. Then hCG samples were spiked with each cross-reactants at the following concentrations: 500 mIU/mL LH, 1000 mIU/mL FSH and 1 mIU/mL TSH. The samples were tested in replicates of 5 per lot using 3 lots of each device format. The results demonstrated no cross reactivity with LH at 500 mIU/mL, FSH at 1000 mIU/mL and TSH at 1 mIU/mL in either negative or positive urine samples.
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## Effects of hCG β-core fragment:
A study was performed to evaluate the effect of hCG β-core fragment on the HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices. Negative female urine samples (0 mIU/mL) and negative samples spiked with hCG to levels of 10 mIU/mL and 25 mIU/mL were spiked with hCG β-core fragment at concentrations of 125,000, 250,000, 500,000 and 1,000,000 pmol/mL. The samples were tested in replicates of 10 per lot using three lots of each device format. The results demonstrated that the candidate devices are not affected by concentrations of hCG β-core fragment up to 1,000,000 pmol/mL.
## Effects of Urine pH:
A study was performed to evaluate the effects of pH on the HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices. Negative female urine samples (0 mIU/mL) and negative samples spiked with hCG to levels of 10 mIU/mL and 25 mIU/mL were adjusted to have pH values of 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0. The negative and positive hCG samples with the different pH levels were tested in replicates of 10 per lot using 3 lots of each device. The results demonstrated that changes in pH ranging from 3.0 to 9.0 do not interfere with either negative or positive results from the devices.
## Effects of Urine Specific Gravity:
A study was performed to evaluate the effects of urine specific gravity HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices. Negative female urine samples (0 mIU/mL) and negative samples spiked with hCG to levels of 10 mIU/mL and 25 mIU/mL were adjusted to have urine specific gravities of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The negative and positive hCG samples with the different urine gravity levels were tested in replicates of 10 per lot using 3 lots of each device format. The results demonstrated that changes in urine specific gravity from 1.000 to 1.035 do not interfere with either negative or positive results from the devices.
## Hook Effect:
A study was performed to evaluate the high dose hook effect on HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices. Negative female urine samples were spiked with hCG at concentrations of 5000, 10,000, 100,000, 500,000, 650,000, 850,000, 950,000 and 1,000,000 mIU/mL. The samples were tested in replicates of 30 using three device lots per test format. The results demonstrated that no hook effect was observed at hCG concentration up to 1,000,000 mIU/mL.
## 4. Assay Reportable Range:
Not applicable
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Strip (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) devices are calibrated against reference material traceable to WHO International Standard 5th edition (NIBSC code 07/364)
6. Detection Limit:
The detection limit was determined in the precision study (see Section VII.A.1 above)
7. Assay Cut-Off:
The device’s cut-off is 25 mIU/mL., See Precision/Reproducibility (Section VII.A.1) section above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
A total of 300 urine samples were collected from women whose ages ranged from 18 to 48 years, who presented to the clinics for pregnancy testing. Approximately half of the 300 women were suspected to be pregnant and most of them were in the early stage of pregnancy (less than 5 weeks). The samples were masked and randomized prior to testing by professionals using 1 lot of the candidate devices and a single lot of the predicate device. One hundred (100) samples were tested using the HCG Home Use Pregnancy Test Cassette (Colloidal Gold), 100 samples were tested using the HCG Home Use Pregnancy Test Strip (Colloidal Gold, and 100 samples were tested using HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Summary results are presented in the tables below.
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| Candidate Device | Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | |
| Cassette | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| Candidate Device | Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | | Negative |
| Test Strip | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
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| Candidate Device | Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | |
| Midstream | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
An additional method comparison study was performed in which 100 people tested their own sample for each test format. One false positive result was observed using the cassette format of the device when results were compared to the predicate. Limiting statements have been added to the labeling to indicate that false positives are possible when using this device.
2. Matrix Comparison:
Not Applicable. The device is intended for urine samples only.
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):
A lay user study was conducted at 3 sites with 300 volunteers with diverse educational and occupational backgrounds who were between the age of 18 and 48. This included 100 lay users using the HCG Home Use Pregnancy Test Cassette (Colloidal Gold) at site 1, 100 lay-users using the HCG Home Use Pregnancy Test Strip (Colloidal Gold) at site 2, and 100 lay-users using the HCG Home Use Pregnancy Test Midstream (Colloidal Gold) at site 3. Lay users collected their own sample, and these samples were split into two groups, one group was for the lay-user testing, and the other was for the professional testing. All samples were masked and randomized prior to professional testing. Each lay user tested her own urine sample with only one test method on the candidate device following the instructions on the package insert. The same sample was tested by the professional using the predicate device. Then the results of lay-user tests were compared to results reported by a laboratory professional. The data shows that the agreement between lay-user results and professional results was 100% (below):
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| Cassette | Professional User Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | | Negative |
| Lay-User | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
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{12}
HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| Test Strip | Professional User Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | | Negative |
| Lay-User | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| Midstream | Professional User Predicate Device | | Total | |
| --- | --- | --- | --- | --- |
| | | Positive | | Negative |
| Lay-User | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| | Total | 50 | 50 | 100 |
Each lay person was given a questionnaire that was completed at the end of the study. The questionnaire results indicated that lay-users found the tests easy to use, the results clear and easy to read, and the instructions for use easy to understand.
D Clinical Cut-Off:
Not applicable
E Expected Values/Reference Range:
Not applicable
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.
K240242 - Page 13 of 13
