(153 days)
Not Found
No
The device description and performance studies indicate a traditional immunoassay for detecting hCG, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" and "Description of the training set, sample size, data source, and annotation protocol" sections are explicitly marked as "Not Found".
No.
The device is an in vitro diagnostic test designed to detect pregnancy by measuring hCG levels, not to treat or alleviate a medical condition.
Yes
The device is intended for the "qualitative, presumptive detection of human chorionin in human urine or serum specimens" and for "early detection of pregnancy," which are diagnostic purposes.
No
The device description clearly states it is a "rapid visual immunoassay" and comes in "Strip, Cassette" formats, indicating a physical test kit that measures hCG in urine or serum. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative, presumptive detection of human chorionin in human urine or serum specimens" and is "intended for use as an aid in early detection of pregnancy." This involves testing biological samples (urine and serum) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms it "measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum." This further reinforces the in vitro testing of biological samples.
- Care Setting: It's intended for "prescription use in clinical laboratories and point-of-care use settings," which are typical environments for IVD testing.
The core function of the device is to analyze biological samples in vitro to provide information about a person's health status (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings. The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
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
Not Found
Intended User / Care Setting
clinical laboratories and point-of-care use settings.
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
Negative serum or urine specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were measured in 10 replicates using 3 different lots for each format at three testing sites. Tests were performed by three different operators for each sample concentration at each site for 5 days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision/Reproducibility/Cut-Off Value
Study type: Precision/Reproducibility/Cut-Off Value
Sample size: 50 replicates per hCG concentration per site per product format
Key results:
- Serum Strip Format: Cut-off values of 10 mIU/mL for serum are established. At 0, 4, and 6 mIU/mL hCG, 100% negative results were observed. At 10, 12, 14, 16, 20, and 50 mIU/mL hCG, 100% positive results were observed. At 8 mIU/mL hCG, 48% negative and 52% positive results were observed.
- Serum Cassette Format: Cut-off values of 10 mIU/mL for serum are established. At 0, 4, and 6 mIU/mL hCG, 100% negative results were observed. At 10, 12, 14, 16, 20, and 50 mIU/mL hCG, 100% positive results were observed. At 8 mIU/mL hCG, 49.3% negative and 50.7% positive results were observed.
- Urine Strip Format: Cut-off values of 20 mIU/mL for urine are established. At 0, 5, 10, and 12 mIU/mL hCG, 100% negative results were observed. At 20, 24, 30, 50, and 100 mIU/mL hCG, 100% positive results were observed. At 16 mIU/mL hCG, 48.7% negative and 51.3% positive results were observed.
- Urine Cassette Format: Cut-off values of 20 mIU/mL for urine are established. At 0, 5, 10, and 12 mIU/mL hCG, 100% negative results were observed. At 20, 24, 30, 50, and 100 mIU/mL hCG, 100% positive results were observed. At 16 mIU/mL hCG, 47.3% negative and 52.7% positive results were observed.
Analytical Performance - Stability
Study type: Stability
Key results: Stable at 4-30°C for 24 months based on the accelerated stability study at 50°C and real time stability determination at both 4℃ and 30℃.
Analytical Performance - Specificity / Cross Reactivity
Study type: High Dose Effect
Key results: No hook effect was observed at high hCG concentrations ranging from 62,500 to 2,000,000 mIU/mL.
Study type: Effects of hCG ß-core fragment
Key results: No interference was observed for the devices except that false positive was observed above the 200 pmol/L ß -core fragment hCG.
Study type: Effects of glycoprotein LH, FSH and TSH
Key results: No interference was observed for the devices at LH concentrations up to 300 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL.
Analytical Performance - Interference
Study type: Exogenous compound interference
Key results: All data show that there is no interference for the listed compounds at the stated concentrations.
Analytical Performance - Effect of Urine Specified Gravity and Urine pH
Study type: Urine Specified Gravity and Urine pH effect
Key results: Data show that there is no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035 of tested urine samples.
Comparison Studies
Study type: Method comparison study
Sample size: 120 each urine or serum samples from 120 women
Key results: The study result shows that 100% agreement for all samples when comparing to the predicate device QuickVue+ One-Step hCG Combo test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance is described qualitatively, e.g., "100% agreement")
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2016
ASSURE TECH., INC. C/O JOE SHIA REGULATORY CONSULTANT 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877
Re: K152768
Trade/Device Name: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 12, 2016 Received: February 22, 2016
Dear Joe Shia:
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. 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.
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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. 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) K152768
Device Name
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
Indications for Use (Describe)
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
This product is intended for prescription use in clinical laboratories and point-of-care use settings.
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
This product is intended for prescription use in clinical laboratories and point-of-care use settings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
510(k) SUMMARY
| 1. Date: | February 23, 2016 |
|---|---|
| 2. Submitter: | Assure Tech. (Hangzhou) Co., Ltd. |
| 2nd. Floor, Building 1, No.10, Xiyuansan Road | |
| Hangzhou, China, 310030 | |
| 3. Contact person: | Joe Shia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite I | |
| Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Fax: 301-916-6213 | |
| Email:shiajl@yahoo.com | |
| 4. Device Name: | Assure Tech hCG Pregnancy Serum/Urine Combo Test |
| Cassette | |
| Assure Tech hCG Pregnancy Serum/Urine Combo Test | |
| Strip |
Classification: Class II
| Product
| Code | CFR # | Panel |
|---|---|---|
| JHI | 862.1155, Human chorionic | |
| gonadotropin (HCG) test system | Clinical Chemistry |
-
- Predicate Devices:
K973858, QuickVue+ One-Step hCG Combo test, Quidel Corporation
- Predicate Devices:
-
- Intended Use
The Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin in human urine or serum specimens to aid in early detection of pregnancy. This device is intended for prescription use in clinical laboratories and point-of-care use settings.
- Intended Use
-
- Device Description
Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) and the predicate device is provided in the following table.
- Substantial Equivalence Information
4
| Item | Device | Predicate |
|---|---|---|
| Intended Use | Rapid qualitative detection of | |
| hCG to aid in the early detection | ||
| of pregnancy. | Same | |
| Specimen | Urine or serum | Same |
| Principle | Lateral flow Sandwich | |
| Immunochromatographic Assay | Same | |
| Detection reagent | Colloidal gold | Same |
| Read time | Serum: 5 minutes | |
| Urine: 3 minutes | Same | |
| Usage | For prescription use | Same |
| Cut-Off Values | 10 mIU/mL for serum and | |
| 20 mIU/mL for urine | Same | |
| Configurations | Strip and cassette | Same |
| Storage | 4 – 30°C | Same |
| Reading Control Window | 1 window for result reading and | |
| control reading | 2 windows: Small Control Window and Large Read Result Window | |
| Read Result Window | No preprinted line on membrane | Pre-printed horizontal blue line on membrane |
| Positive result | 2 colored red/pinkish horizontal | |
| lines in control and test regions | Pink and blue plus sign | |
| in large Window, along | ||
| with a blue line in small | ||
| Window | ||
| Negative result | 1 colored line in control region | |
| only | Blue horizontal line in | |
| Large Window, along | ||
| with a blue line in small | ||
| Window |
9. Test Principle
It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti hCG polyclonal antibody) membrane. At analyte concentration above the target cut off, it produces a colored test line that indicates a positive result. When analyte concentration is below the cutoff, no colored band shows in the test region, indicating a negative result. No line in the "C" region indicates that the test is invalid.
-
- Performance Characteristics
5
Analytical Performance
a. Precision/Reproducibility/Cut-Off Value
Negative serum or urine specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were measured in 10 replicates using 3 different lots for each format at three testing sites. Tests were performed by three different operators for each sample concentration at each site for 5 days. Results are shown in the following tables.
| hCG
Concentration
| (mIU/mL) | - | Site 1 | + | - | Site 2 | + | - | Site 3 | + | - | Total result | + | % Negative | % Positive |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 | ||||
| 4 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 | ||||
| 6 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 | ||||
| 8 | 25 | 25 | 23 | 27 | 24 | 26 | 72 | 78 | 48% | 52% | ||||
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | ||||
| 12 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | ||||
| 14 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | ||||
| 16 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | ||||
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | ||||
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
Serum Strip format
Serum Cassette format
| hCG
Concentration
(mIU/mL) | Site 1 | | Site 2 | | Site 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|--------|----|--------|----|--------|----|--------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 4 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 6 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 8 | 24 | 26 | 25 | 25 | 25 | 25 | 74 | 76 | 49.3% | 50.7% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 12 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 14 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 16 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
Urine Strip format
| hCG
Concentration
(mIU/mL) | Site 1 | | Site 2 | | Site 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|--------|---|--------|---|--------|---|--------------|---|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
6
| 12 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
|---|---|---|---|---|---|---|---|---|---|---|
| 16 | 24 | 26 | 24 | 26 | 25 | 25 | 73 | 77 | 48.7% | 51.3% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 24 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 30 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
Urine Cassette format
| hCG
Concentration
(mIU/mL) | Site 1 | | Site 2 | | Site 3 | | Total result | | %
Negative | %
Positive |
|----------------------------------|--------|----|--------|----|--------|----|--------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 10 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 12 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0 |
| 16 | 25 | 25 | 24 | 26 | 22 | 28 | 71 | 79 | 47.3% | 52.7% |
| 20 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 24 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 30 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% |
Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are established.
b. Stability
Stable at 4-30°C for 24 months based on the accelerated stability study at 50°C and real time stability determination at both 4℃ and 30℃.
c. Specificity / Cross Reactivity
High Dose Effect
Negative urine (serum) male samples were spiked with varying high hCG concentrations ranging from 62,500 to 2000,000 mIU/mL. The spiked samples were tested by 3 different lots and 3 different operators. No hook effect was observed at these concentrations
Effects of hCG ß-core fragment
Negative and positive samples (5 and 10 mIU/mL hCG in serum; 10 and 20 mIU/mL hCG in urine) were spiked with various concentrations of ß -core fragment hCG (0 to2x10 pmol/L). These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. No interference was observed for these samples for the devices except that false positive was observed above the 200 pmol/L ß -core fragment hCG.
Effects of glycoprotein LH, FSH and TSH
7
Negative and positive samples (10 and 20 mIU/mL hCG for urine, and 5 and 10 mIU/mL hCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. No interference was observed for these samples for the devices at LH concentrations up to 300 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL.
d. Interference
To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG free and hCG positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table.
| 3 minutes for urine (5 minutes for serum) | 10 minutes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Interferents | Negative hCG | Positive hCG | Negative hCG | Positive hCG | ||||||||
| Lot | Lot | Lot | Lot | Lot | Lot | Lot | Lot | Lot | Lot | Lot | Lot | |
| 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| Acetaminophen (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Acetoacetic Acid (2000mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Asorbic Acid (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| B-hydroxybutyrate | ||||||||||||
| (2000mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Caffeine (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Ephedrine (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Gentisic Acid (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Phenylpropanolamine(20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Salicylic Acid (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Phenothiazine (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| EDTA (80mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Acetylsalicylic Acid | ||||||||||||
| (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Benzoylecgonine (10mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Cannabinol (10mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Codeine (6ug/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Ethanol (1.0%) | - | - | - | + | + | + | - | - | - | + | + | + |
| Methanol (10%) | - | - | - | + | + | + | - | - | - | + | + | + |
| Albumin (2000mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Glucose (2000mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Bilirubin (2mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Atropine (20mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Estriol-17-beta (1400ug/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
| Hemoglobin (2000mg/dL) | - | - | - | + | + | + | - | - | - | + | + | + |
8
| Pregnanediol (1500ug/dL) | - | - | - | + | + | + | - | - | + | + |
|---|---|---|---|---|---|---|---|---|---|---|
| Thiophene (20mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Ampicillin (20mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Tetracycline(20mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Cholesterol (250mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Triglyceride (500mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Lipoprotein (70mg/dl) | - | - | - | + | + | + | - | - | + | + |
| Ketone(20mg/dl) | - | - | - | + | + | + | - | - | + | + |
All data show that there is no interference for the listed compounds at the stated concentrations.
e. Effect of Urine Specified Gravity and Urine pH
Negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested at pH values from 4 to 9 or at density values ranging from 1.000 to1.035 using 3 different lots by 3 different operators. Data show that there is no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035 of tested urine samples.
2. Comparison Studies
A method comparison study was performed, comparing the results obtained from the Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette (Strip) to the results from predicate devices (QuickVue'). 120 each urine or serum samples were collected from 120 women (about half of them were pregnant, early stage at less than 5 weeks) from three testing sites. Samples were randomly collected at various times throughout the day. Ages ranged from 18 to 49 years. Samples were tested by six different health professionals with the proposed and the predicate devices at each site. Each person could only perform tests for one device format. For example, a person who tested the strips could not test the cassettes. Each person tested three different lots of the device and one predicate device at the same time, but not sequentially. Typical results are shown in the following tables.
Summary Results for Urine Strip
| New Device | Cleared device | + | - | |
|---|---|---|---|---|
| + | 60 | 0 | ||
| - | 0 | 60 |
Summary Results for Urine Cassette
| New Device | Cleared device | + | - |
|---|---|---|---|
| + | 60 | 0 | |
| - | 0 | 60 |
Summary Results for Serum Strip
| New Device | Cleared device | |
|---|---|---|
| + | - | |
| + | 60 | 0 |
| - | 0 | 60 |
Summary Results for Serum Cassette
9
| New Device | Cleared device | + | - |
|---|---|---|---|
| + | 60 | 0 | |
| - | 0 | 60 |
The study result shows that 100% agreement for all samples.
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- Clinical Studies
Not applicable
- Clinical Studies
-
11.Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) is substantially equivalent to the predicate.