(261 days)
No
The device uses a microprocessor and algorithms to interpret the results of an immunochromatographic assay and display them digitally. While this involves processing, the description does not indicate the use of AI or ML techniques for learning or adapting based on data. The algorithms appear to be fixed rules for interpreting the optical signal from the assay.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It does not directly treat or prevent a disease or condition.
Yes
Explanation: The device is described as aiding in the "early detection of pregnancy" by "qualitative detection of human chorionic gonadotropin (hCG) in urine." This process of detecting a medical condition (pregnancy) based on a biological marker (hCG) qualifies it as a diagnostic device.
No
The device description explicitly states that the device incorporates electronic and optical components along with a microprocessor and specific algorithms into a plastic housing. This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information.
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes "immunochemical principles" and "colloidal gold as a direct label" to detect hCG. These are all techniques commonly used in IVD tests.
- Sample Type: The device analyzes urine, which is a biological specimen.
- Purpose: The purpose is to aid in the early detection of pregnancy, which is a diagnostic purpose.
The fact that it has a digital display and incorporates electronic components does not change its fundamental nature as an IVD. It is still performing an in vitro analysis of a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
VeriClear™ Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The VeriClear™ hCG Early Result Pregnancy Test utilize the identical immunochemical principles for the detection of hCG in the urine as in K172257. It is a device intended for use by the lay user in the early detection of pregnancy by way of a series of immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in which it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The VeriClear™ Digital Early Result Pregnancy Test device incorporates electronic and optical components along with a microprocessor and specific algorithms into the plastic housing. VeriClear™ Digital Early Result Pregnancy Test is capable of correctly determining and interpreting the test results correctly, and shows the results as "YES+" (Pregnancy), "NO-" (Non-pregnancy) or "?" (Error) on a display. The VeriClear™ Digital Early Result Pregnancy Test is powered by battery and the testing results will be displayed on the screen until the battery is used up.
All components are integrated and unitized into the plastic housing.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
Lay user
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)
Analytical performance:
- Precision/Reproducibility:
- Within-lot precision: A study was performed using human urine samples spiked with hCG (0 mIU/ml, 3 mIU/ml, 5 mIU/ml, 8.5 mIU/ml, 10 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml). 20 replicates for each level of standard were obtained from one lot by a single operator.
- Inter-lot precision: A study was performed using three different lots of devices over five consecutive days by five different operators. For each day, each lot, and each operator, 2 replicates per run were performed for each standard level (0 mIU/ml, 3 mIU/ml, 5 mIU/ml, 8.5 mIU/ml, 10 mIU/ml, 50 mIU/ml, 50 mIU/ml, and 100 mIU/ml) using both simulated stream and dipping methods. A total of 150 replicate data points were obtained using all three lots.
- Key results: At 8.5 mIU/ml, the overall positivity rate across all operators was 69%. At 10 mIU/ml and above, 100% positive results were observed.
- High dose hook effect study: Negative urine samples were spiked with hCG up to 450,000 mIU/ml and tested in 2 replicates per lot using two lots of devices. No hook effect was observed.
- Traceability: The tests are calibrated against the WHO 4th International Standards for hCG.
- Stability: A 24-month shelf life was claimed for devices stored in sealed foil pouches at 39-86 °F (4-30 °C).
- Detection limits (sensitivity): An analytical sensitivity study used negative human urine samples spiked with hCG (0, 3.0, 5.0, 7.0, 7.5, 8.5, 9.0, 10, 12.5, 15 and 25 mIU/ml). A total of 45 replicates (3 operators x 3 days x 5 replicates per run) were obtained for each lot at each hCG level, using both dipping and simulated stream methods. The lowest concentration yielding 100% positive results was 10 mIU/ml.
- Analytical specificity:
- Structure non-related compounds: Potential interference from compounds like Acetaminophen, Acetylsalicylic acid, Human serum Albumin, Ampicillin, Ascorbic acid, Atropine, Caffeine, Cortisol, EDTA, Phenylpropanolamine, Ephedrine, Gentisic acid, Glucose, Tetracycline, Uric acid, Bilirubin, Ethanol, and Salicylic Acid was evaluated by spiking into negative and 10mIU/ml hCG positive urine samples. Each sample was tested using 2 different lots in 5 replicates per lot. No interference was observed.
- Structure-related compounds: Cross-reactivity with hLH (1000 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 μIU/ml) was assessed in negative and 10 mIU/ml hCG positive urine. No cross-reactivity was observed.
- Effect of urine pH: Urine pH was adjusted from 4 to 9. The results demonstrated that varying ranges of pH did not interfere with the test performance.
- Effect of urine specific gravity: Urine samples with specific gravity from 1.003 to 1.030 were tested. The results demonstrated that specific gravity did not affect the expected accuracy.
- Effect of hCG ß-core fragment: hCG free and hCG standard samples (5 mIU/ml, 10 mIU/ml, 25 mIU/ml, 20,000 mIU/ml) were spiked with hCG ß-core fragment at concentrations up to 408,000 pmol/L. All devices yielded correct results.
Comparison studies:
- Method comparison with predicate device: Urine samples from 366 women (215 suspected pregnant) were collected at physician offices. Samples were masked and randomized. All samples were tested by two healthcare professionals using two different lots of the device (one for simulated stream, one for dipping).
- Key results: For both simulated stream and dipping methods, the device showed 215 positive and 151 negative results, matching the predicate device.
Clinical Studies:
- Detection of hCG in Early Pregnancy Clinical Samples: 616 urine samples were collected from 56 women (25 to 43 years old) who planned to become pregnant. Urine was collected from day -9 to day +1 relative to their expected period.
- Key results: The device detected hCG positive in 69% of samples from five days before the expected menstrual period and 100% of samples from one day before the expected menstrual period.
Lay User Study:
- Sample size: 109 female subjects (18 to 63 years old) with diverse backgrounds participated.
- Training: Lay users were only provided with the package insert.
- Key results: Comparison results between lay users and professional users showed 100% agreement for pregnant (9/9) and non-pregnant (100/100) urine samples for both simulated stream and dipping methods. Lay users also tested 4 blind hCG urine samples (3.0 mIU/ml, 7.5 mIU/ml, 8.5 mIU/ml, and 10 mIU/ml). Agreement percentage between lay user and professional user interpretation was 100% for all hCG levels and both methods. A questionnaire confirmed that consumers found the test easy to use and understood the labeling.
Specificity Study to Determine False-Positive Result Rate:
- Sample size: 320 subjects (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal).
- Protocol: All urine samples were tested with three lots of the device and quantitatively analyzed for hCG level with a Microwell Quantitative hCG test.
- Key results: No false positives were observed from VeriClear™ Digital Early Result Pregnancy Test in any age group (0/100 for pre-menopausal, 0/100 for peri-menopausal, 0/100 for post-menopausal).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical Sensitivity: 10 mIU/ml (lowest concentration yielding 100% positive results)
- Overall % Positive in precision study: 0% for 0, 3, 5 mIU/ml hCG; 69% for 8.5 mIU/ml hCG; 100% for 10, 25, 50, 100 mIU/ml hCG.
- Early Pregnancy Detection Rate: 0% at -9/-8 days relative to EMP, 12% at -7 days, 41% at -6 days, 69% at -5 days, 94% at -4 days, 98% at -3/-2 days, 100% at -1, 0, +1 days.
- Lay user vs. Professional user agreement: 100% agreement for positive and negative samples, and for specific hCG levels tested.
- False-Positive Result Rate: 0% (0/320 subjects) across all age groups tested.
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.
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/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
May 15, 2019
True Diagnostics, Inc. % Jinjie Hu, Principle Consultant Axteria BioMed Consulting Inc. 8040 Cobble Creek Circle Potomac, MD 20854
Re: K182328
Trade/Device Name: VeriClear™ Digital Early Result Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: April 5, 2019 Received: April 5, 2019
Dear Jinjie Hu:
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.htm); 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182328
Device Name VeriClear Digital Early Result Pregnancy Test
Indications for Use (Describe)
VeriClear Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K182328
510(k) Submission For VeriClear™ Digital Early Result Pregnancy Test True Diagnostics, Inc.
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
SUBMITTER:
| True Diagnostics, Inc. |
|---|
| 2782 Loker Ave. West |
| Carlsbad, CA 92010 |
- Contact person: Jinjie Hu, Axteria BioMed Consulting Inc. 8040 Cobble Creek Circle Potomac, MD 20854 Tel: 1-(301)814-4985 Email: jinjiehu@axteriabiomed.com
| Purpose of Submission: | To obtain a substantial equivalence for the VeriClear™ Digital Early Result Pregnancy Test |
|---|---|
| ------------------------ | -------------------------------------------------------------------------------------------- |
4
510(k) Number: K182328
- A. Purpose for Submission: New Device
- B. Measure: Human Chorionic Gonadotropin (hCG)
C. Type of Test: Qualitative chromatographic immunoassay
- D. Applicant: True Diagnostics, Inc. U.S.A
E. Proprietary and Established Names: VeriClear™ Digital Early Result Pregnancy Test
F. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1155 Human Chorionic Gonadotropin (hCG) test System
-
- Classification: Class II
-
- Product Code: LCX: hCG, Over the Counter
-
- Panel: Chemistry (75)
5
G. Intended Use:
-
- Intended use(s): See Indication for use below.
-
- Indication(s) for use:
VeriClear™ Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
-
- Special condition for use statement(s): This device is intended for over-the-counter (OTC) use.
-
- Special instrument requirements: None
H. Device Description:
The VeriClear™ hCG Early Result Pregnancy Test utilize the identical immunochemical principles for the detection of hCG in the urine as in K172257. It is a device intended for use by the lay user in the early detection of pregnancy by way of a series of immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in which it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The VeriClear™ Digital Early Result Pregnancy Test device incorporates electronic and optical components along with a microprocessor and specific algorithms into the plastic housing. VeriClear™ Digital Early Result Pregnancy Test is capable of correctly determining and interpreting the test results correctly, and shows the results as "YES+" (Pregnancy), "NO-" (Non-pregnancy) or "?" (Error) on a display. The VeriClear™ Digital Early Result Pregnancy Test is powered by battery and the testing results will be displayed on the screen until the battery is used up.
All components are integrated and unitized into the plastic housing.
I. Substantial Equivalence Information:
-
- Predicate device name(s):
Church & Dwight Co., FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
- Predicate device name(s):
-
- Predicate K number(s):
6
K123567
3. Comparison with predicate
| Feature | Proposed Device
Pending | Predicate Device
K123567 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Similarities | | |
| Intended Use | Qualitative detection of hCG for an aid in early
detection of pregnancy. | Same |
| Target User | Over-the-counter | Same |
| Test Principle | Lateral flow qualitative immunochromatographic assay
with digital display for the result | Same |
| Electronic
components | Microprocessor with specific circuitry and algorithms;
LCD read out with batteries as power source | Same |
| Early detection
claim | Detection of pregnancy as early as 5 days before the
expected period or as early as 6 days before the day of
the missed period. | Same |
| Sample Matrix | Urine | Same |
| Traceability | WHO 4th International Standards for hCG | Same |
| Analytical
Sensitivity | 10 mIU/ml | Same |
| Time to Result | 3 minutes | Same |
| Sample
Application | Stream and Dipping Methods | Same |
| Sampling Time | 5 seconds in urine stream
5 seconds in cup (Dipping) | Same |
| Device Format | Single Use | Same |
| Differences | | |
| hCG Isoforms
Detected | Intact hCG
Hyperglycosylated hCG
hCG β-subunit | Intact hCG
Hyperglycosylated
hCG
hCG β-subunit |
7
| Test Result | Digital Read Out, result show as Yes, No or Invalid | Visual read, result
show control line, test
line |
| ------------- | ----------------------------------------------------- | -------------------------------------------------------- |
|---|
J. Standard/Guidance Document referenced (if applicable):
None referenced 。
K. Test Principle:
The VeriClear™ Digital Early Result Pregnancy Test uses the same test principle as used in the analog counterpart device - VeriClear™ hCG Early Result Pregnancy Test (K172257). The VeriClear™ Digital Early Result Pregnancy Test detects the presence of hCG in a urine sample of a pregnant woman by way of a series of immunochemical reactions via component reagents striped onto a chromatographic strip in a plastic housing.
A digital component integrated with the test strip reads and displays the result of the immunochemical reaction on an LCD (Liquid Crystal Display) screen of the device.
The test is performed by placing the absorbent collection tip into the urine stream for 5 seconds, or alternatively, by fully immersing the collection tip in a urine sample collected in a urine cup for 5 seconds. After urine is applied to The VeriClear™ Digital Early Result Pregnancy Test, the clock symbol starts blinking in about 30 seconds, which indicates the test has already started. The test result is shown on the LCD screen within 3 minutes. A "YES+" test result indicates the pregnancy hormone (hCG) was detected (Pregnant) and "NO-" test result indicates that no hCG was detected (Not pregnant).
L. Performance Characteristics (if/when applicable):
The sensitivity, precision, specificity, interference, method comparison, clinical early detection, clinical specificity and storage stability studies were tested and verified with the proposed devices. Software validation and reader reliable was performed specifically to ensure the performance of VeriClear™ Digital hCG Reader electronic read-out result. The VeriClear™ Digital hCG Reader meets the safety and EMC requirements of IEC/EN61010-1: 2001, IEC/EN61010-2-101: 2002, EN61326; 2006 and IEC61000-4-2.
A lay user study was conducted to evaluate two application methods (stream and dipping) and the easiness of use by following the instructions. The results demonstrate that the instruction manual of VeriClear™ Digital Early Result Pregnancy Test is understandable and clear enough for lay user, and the devices are easy to operate by following the instruction.
1. Analytical performance:
- a. Precision/Reproducibility:
8
A precision study was performed using human urine samples spiked with hCG, traceable to the 4th WHO International Standard to obtain samples with hCG concentrations of 0 mIU/ml, 3 mIU/ml, 8.5 mIU/ml, 10 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml.
A within-lot precision test was performed using one lot of the VeriClear™ Digital Early Result Pregnancy Test. The test was performed in one day by a single operator. A total of 20 replicates for each level of standard (0 mIU/ml, 3 mIU/ml, 5 mIU/ml, 8.5 mIU/ml, 10 mIU/ml, 25 mIU/ml, 50 mIU/ml, and 100 mIU/ml) were obtained.
An inter-lot precision test was performed using three different lots of VeriClear™ Digital Early Result Pregnancy Test devices. The tests were performed over a course of five consecutive days by five different operators. On each day, and with each lot, each operator performed 2 replicates per run for each level of standard (0 mIU/ml, 3 mIU/ml. 5 mIU/ml. 8.5 mIU/ml. 10 mIU/ml. 50 mIU/ml. 50 mIU/ml. and 100 mIU/ml) using both simulated stream and dipping methods. A total of 150 replicate data points were obtained using all three lots.
| HCG Standards
(mIU/ml) | Total #
of Test | VeriClear™ Digital Early Result Pregnancy Test Device
Lot 1
Simulated Stream | | | Dipping | | |
|---------------------------|--------------------|------------------------------------------------------------------------------------|----------|---------|----------|----------|---------|
| | | Negative | Positive | P/Total | Negative | Positive | P/Total |
| 0 | 20 | 10 | 0 | 0/10 | 10 | 0 | 0/10 |
| 3.0 | 20 | 10 | 0 | 0/10 | 10 | 0 | 0/10 |
| 5.0 | 20 | 10 | 0 | 0/10 | 10 | 0 | 0/10 |
| 8.5 | 20 | 3 | 7 | 7/10 | 3 | 7 | 7/10 |
| 10 | 20 | 0 | 10 | 10/10 | 0 | 10 | 10/10 |
| 25 | 20 | 0 | 10 | 10/10 | 0 | 10 | 10/10 |
| 50 | 20 | 0 | 10 | 10/10 | 0 | 10 | 10/10 |
| 100 | 20 | 0 | 10 | 10/10 | 0 | 10 | 10/10 |
Within-Lot Reproducibility of VeriClear™ Digital Early Result Pregnancy Test Device
Inter-Lot Reproducibility of VeriClear™ Digital Early Result Pregnancy Test Device (Simulated Stream Method)
| HCG Standards (mIU/ml) | Total # of Test | Observed Results Lot 1 | Observed Results Lot 2 | Observed Results Lot 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| P (+) | N (-) | P/Total | P (+) | N (-) | P/Total | P (+) | N (-) | P/Total | ||
| 0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
9
| 3.0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
|---|---|---|---|---|---|---|---|---|---|---|
| 5.0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
| 8.5 | 150 | 35 | 15 | 35/50 | 34 | 16 | 34/50 | 35 | 15 | 35/50 |
| 10 | 150 | 50 | 0 | 50/50 | 50 | 0 | 50/50 | 50 | 0 | 50/50 |
| 25 | 150 | 50 | 0 | 50/50 | 50 | 0 | 50/50 | 50 | 0 | 50/50 |
| 50 | 150 | 50 | 0 | 50/50 | 50 | 0 | 50/50 | 50 | 0 | 50/50 |
| 100 | 150 | 50 | 0 | 50/50 | 50 | 0 | 50/50 | 50 | 0 | 50/50 |
Inter-Lot Reproducibility of VeriClear™ Digital Early Result Pregnancy Test Device (Dipping Method)
| HCG
Standards
(mIU/ml) | Total
of Test | VeriClear TM Digital Early Result Pregnancy Test Device
(Dip Method)
Observed Results Lot 1 | | | Observed Results Lot 2 | | | Observed Results Lot 3 | | |
|------------------------------|--------------------|---------------------------------------------------------------------------------------------------|----------|---------|------------------------|----------|---------|------------------------|----------|---------|
| | | P
(+) | N
(-) | P/Total | P
(+) | N
(-) | P/Total | P
(+) | N
(-) | P/Total |
| 0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
| 3.0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
| 5.0 | 150 | 0 | 50 | 0/50 | 0 | 50 | 0/50 | 0 | 50 | 0/50 |
| 8.5 | 150 | 34 | 16 | 34/50 | 35 | 15 | 35/50 | 34 | 16 | 34/50 |
| 10 | 150 | 50 | 0 | 50/50 | 15 | 0 | 50/50 | 50 | 0 | 50/50 |
| 25 | 150 | 50 | 0 | 50/50 | 15 | 0 | 50/50 | 50 | 0 | 50/50 |
| 50 | 150 | 50 | 0 | 50/50 | 15 | 0 | 50/50 | 50 | 0 | 50/50 |
| 100 | 150 | 50 | 0 | 50/50 | 15 | 0 | 50/50 | 50 | 0 | 50/50 |
Precision Study Result Summary- Operators
| hCG level
(mIU/ml) | Operator
1 | Operator
2 | Operator
3 | Operator
4 | Operator
5 | Over all %
Positive |
|-----------------------|---------------|---------------|---------------|---------------|---------------|------------------------|
| 0 | 0/60 | 0/60 | 0/60 | 0/60 | 0/60 | 0 % |
| 3 | 0/60 | 0/60 | 0/60 | 0/60 | 0/60 | 0 % |
| 5 | 0/60 | 0/60 | 0/60 | 0/60 | 0/60 | 0 % |
| 8.5 | 42/60 | 42/60 | 42/60 | 40/60 | 41/60 | 69% |
| 10 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 100% |
| 25 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 100% |
| 50 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 100% |
| 100 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 100% |
10
-
b. Linearity/assay reportable range:
Not applicable. This is a qualitative device. -
c. High dose hook effect study:
Negative urine samples were spiked with hCG stock solution to a final concentration up to 450,000 mIU/ml, and then tested in 2 replicate per lot using two lots of devices. The results demonstrated that no hook effect was observed at hCG concentrations up to 450,000 mIU/ml. -
d. Traceability:
The tests are calibrated against the WHO 4th International Standards for hCG. -
e. Stability:
Testing protocol and acceptance criteria used to support the shelf life were reviewed and found to be acceptable. The sponsor claimed a 24-month shelf life of the devices stored in the sealed foil pouches at 39-86 °F (4-30 °C). -
f. Detection limits (sensitivity):
An analytical sensitivity study was performed using negative human urine samples spiked with hCG traceable to the WHO 4th international standard for hCG to obtain final concentrations of 0, 3.0, 5.0, 7.0, 7.5,8.5, 9.0, 10, 12.5, 15 and 25 mIU/ml. A total of 45 replicate (3 operators x 3 days x 5 replicates per run) data points were obtained for each lot at each level of hCG sample being tested, using both dipping and simulated stream methods.
The results are summarized in the following table.
| hCG Standards
| Conc. (mIU/ml) | # of positive result /# of total test | |||
|---|---|---|---|---|
| Lot 1 | ||||
| Stream | Lot 2 | |||
| Dipping | Lot 3 | |||
| Dipping | % Positive | |||
| 0 | 0/15 | 0/15 | 0/15 | 0 % |
| 3.0 | 0/15 | 0/15 | 0/15 | 0 % |
| 5.0 | 0/15 | 0/15 | 0/15 | 0 % |
| 7.0 | 3/15 | 3/15 | 3/15 | 20 % |
| 7.5 | 8/15 | 8/15 | 8/15 | 53.3 % |
| 8.5 | 10/15 | 10/15 | 11/15 | 68.9 % |
| 9.0 | 15/15 | 14/15 | 14/15 | 95.6 % |
| 10.0 | 15/15 | 15/15 | 15/15 | 100 % |
| 12.5 | 15/15 | 15/15 | 15/15 | 100 % |
| 15.0 | 15/15 | 15/15 | 15/15 | 100 % |
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| CALLA
1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1
1 C / 1 C
| 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 | |||
|---|---|---|---|
| ل 1 ال 1 | |||
| ل 1 ال 1 | |||
| نال ال ال ال ال ال ال ال ال ال ال ال ال الملك المنتج المنتجات المنتجات المنتجات المحافظ المنتجات المحافظة المنتقل المنتقل المنتقل المنتقل المنتجات المحافظة المنتجات المحافظة | |||
| ل 1 ال 1 | 100 % |
The results demonstrate that the analytical sensitivity of the VeriClear™ Digital Early Result Pregnancy Test (the lowest concentration yielding 100 % positive results) is 10 mIU/ml.
g. Analytical specificity
Structure non-related compounds
To evaluate potential interference from certain exogenous compounds, each interfering substance was prepared at 100X concentration bulk and spiked into negative urine and positive urine samples (containing 10mIU/ml hCG). Each spiked urine sample was mixed and to make sure a homogeneous solution before testing. Each sample was tested using 2 different lots of the testing kits.
Each sample was tested in 5 replicate per lot using two lots of devices. No interference effect was observed at the concentration tested.
The results are demonstrated below.
| Interferent | Concentration at which no significant interference was observed |
|---|---|
| Acetaminophen | 20 mg/dl |
| Acetylsalicylic acid | 20 mg/dl |
| Human serum Albumin | 2000 mg/dl |
| Ampicillin | 20 mg/dl |
| Ascorbic acid | 20 mg/dl |
| Atropine | 20 mg/dl |
| Caffeine | 20 mg/dl |
| Cortisol | 200 ng/dl |
| EDTA | 80 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Ephedrine | 20 mg/dL |
| Gentisic acid | 20 mg/dl |
| Glucose | 2000 mg/dl |
| Tetracycline | 20 mg/dl |
| Uric acid | 10 mg/dl |
| Bilirubin | 20 mg/dL |
| Ethanol | 0.1 % |
| Salicylic Acid | 20 mg/dL |
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Structure-related compounds:
Negative and positive urine contain 10 mIU/ml hCG were spiked with various concentrations of the following potential cross reactants: hLH, hFSH, and hTSH. The samples were tested by two operators using two lots of the test kits. No cross reactivity was observed at the concentrations tested below.
| Reactant | Concentration at which no significant
interference was observed |
|----------|--------------------------------------------------------------------|
| hLH | 1000 mIU/ml |
| hFSH | 1000 mIU/ml |
| hTSH | 1000 μIU/ml |
Effect of urine pH
Effects of urine pH were performed by adjusting urine pool to a pH range from 4 to 9 in 1 pH unit increment. The samples with spiked hCG concentrations or non-spiked hCG of different pH unit were tested by using VeriClear™ Digital Early Result Pregnancy Test Device. The results demonstrate that varying ranges of pH (from 4 to 9) does not interfere with the performance of the test.
Effect of urine specific gravity:
Effect of specific gravity of urine was determined by using across the specific gravity hCG-free urine samples of normal (1.030) to low (1.003). Each urine sample was spiked with hCG stock solution to a final concentration of 10 mIU/ml. The VeriClear™ Digital Early Result Pregnancy Test devices were tested in duplicate using the two negative and spiked urine samples. The results demonstrated that specific gravity ranges from 1.003 to 1.030 did not affect the expected results or accuracy of the result.
Effect of hCG ß-core fragment:
Both hCG free and hCG standard samples (5 mIU/ml, 10 mIU/ml, 25 mIU/ml, 20,000 mIU/ml) were spiked with hCG ß-core fragment at concentrations of 51,000 pmol/L, 102,000 pmol/L, 204,000 pmol/L and 408,000 pmol/L. All the interference tests have been performed on two lots of VeriClear™ Digital Early Result Pregnancy Test devices. All devices yielded correct results with hCG ß-core fragment concentration up to 408,000 pmol/L.
h. Assay cutoff
See detection limits section.
The results demonstrate that the analytical sensitivity of the VeriClear™ Digital Early
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Result Pregnancy Test (the lowest concentration vielding 100 % positive results) is 10 mIU/ml.
2. Comparison studies:
- a. Method comparison with predicate device:
Urine samples were collected from 366 women at physician offices for pregnancy testing and 215 of them were suspected to be pregnant. All samples were randomly collected at various time throughout the day. Ages of these women ranged from 19 to 41 years. Samples were masked and randomized by people who did not participate in the testing. All samples were tested by two different health care professionals. Each person tested with two different lots of device at same time. One lot was used by for simulated stream method; another lot was used for dipping method.
The results are summarized in the table below.
| First Response Digital Early Result Pregnancy Test | ||||
|---|---|---|---|---|
| VeriClear™ Digital | ||||
| Early Result Pregnancy | ||||
| Test (Simulated Stream | ||||
| Method) | Positive | Negative | Total | |
| Positive | 215 | 0 | 215 | |
| Negative | 0 | 151 | 151 | |
| Total | 215 | 151 | 366 |
| This Nosponsy Pightar Latty Noom I Tvghally Too | ||||
|---|---|---|---|---|
| VeriClear™ Digital | Positive | Negative | Total | |
| Early Result Pregnancy | Positive | 215 | 215 | |
| Test (Dipping Method) | Negative | 0 | 151 | 151 |
| Total | 215 | 151 | 366 |
b. Matrix comparison:
Not Applicable. The device is intended for urine samples only.
3. Clinical Studies:
-
Clinical Sensitivity: a.
Not Applicable. -
Clinical Specificity: b.
Not Applicable. -
Other clinical supportive data (when a. and b. are not applicable): C.
4. Detection of hCG in Early Pregnancy Clinical Samples
A total of 616 urine samples were collected from 56 different women of 25 to 43 years old, who planned to become pregnant. These women were followed throughout their
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conception cycles with urine collected from day -9 to day +1 of their expected period. The VeriClear™ Digital Early Result Pregnancy Test device detected hCG positive in 69% of samples from five days before the expected menstrual period and 100% of samples from one day before the expected menstrual period.
| Day in cycle | hCG Positive Ratio (%) | Overall Pregnancy | |
|---|---|---|---|
| relative to | |||
| EMP | Simulated | ||
| Stream | Dipping | Detection Rate (%) | |
| -9 days | 0% | 0% | 0% |
| -8 days | 0% | 0% | 0% |
| -7 days | 12% | 12% | 12% |
| -6 days | 41% | 41% | 41% |
| -5 days | 69% | 69% | 69% |
| -4 days | 94% | 94% | 94% |
| -3 days | 98% | 98% | 98% |
| -2 days | 98% | 98% | 98% |
| -1 days | 100% | 100% | 100% |
| 0 days | 100% | 100% | 100% |
| +1 days | 100% | 100% | 100% |
The Early Pregnancy detection results are summarized below:
5. Lay User Study
The purpose of this study is to demonstrate that the intended users is able to safely and correctly perform the VeriClear™ Digital Early Result Pregnancy Test using their own urine and with the provided hCG control according to the Instruction for Use. A total of 109 female subjects with diverse educational and professional backgrounds and ages (between 18 to 63 years old) participated in the study. Lay users were only provided with the package insert prior to performing the study.
The comparison results between lay user and professional user are listed below:
| Pregnancy | Lay user vs. Professional user | |
|---|---|---|
| Result | Simulated Stream | Dipping |
| Pregnant | 9/9 (100%) | 9/9 (100%) |
| Non-pregnant | 100/100 (100%) | 100/100 (100%) |
| Total | 109/109 (100%) | 109/109(100%) |
Besides testing their own urine samples, lay users also tested 4 blind hCG urine samples at hCG concentrations of 3.0 mIU/ml, 7.5 mIU/ml, 8.5 mIU/ml and 10 mIU/ml. A total of 109 samples were tested by using the VeriClear™ Digital Early Result Pregnancy Test at hCG each level. Among the 109 devices tested at each hCG level, 50 of them were tested in simulated stream method, while 59 were tested in dipping method. The test results
15
collected by lay user using VeriClear™ Digital Early Result Pregnancy Test device were also interpreted by the professional.
The results are summarized below:
| | Lay user vs. Professional user
Simulate Stream Method | | | Dipping Method | | |
|---------------|----------------------------------------------------------|----------------------|----------------------------|------------------|----------------------|----------------------------|
| hCG
mIU/ml | Positive Results | | Percentage of
Agreement | Positive Results | | Percentage of
Agreement |
| | Lay user | Professional
user | | Lay user | Professional
user | |
| 3 | 0 | 0 | 100% | 0 | 0 | 100% |
| 7.5 | 24 | 24 | 100% | 28 | 28 | 100% |
| 8.5 | 35 | 35 | 100% | 41 | 41 | 100% |
| 10 | 50 | 50 | 100% | 59 | 59 | 100% |
All the lay users participated in the study were given a questionnaire to rate how well they understand the instruction in the package insert. A Flesch-Kincaid reading analysis was performed to determine if the package insert content is appropriate for a reading Grade level of 5.5. The result of the questionnaire reflects that the consumers found the test easy to use and they did not have trouble understanding the labeling or interpreting results.
6. Specificity Study to Determine False-Positive Result Rate
A study was performed to determine the incidence of false positive test results from VeriClear™ Digital Early Result Pregnancy Test among non-pregnant women 15-41 years of age (pre-menopausal), 42-55 years of age (peri-menopausal) and >55 year of age (post- menopausal). A total of 320 subjects provided urine samples including 100 premenopausal patients, 111 peri-menopausal patients, and 109 post-menopausal patients. All 320 urine samples were tested with three lots of VeriClear™ Digital Early Result Pregnancy Test devices and quantitatively analyzed for hCG level of each subject with Microwell Quantitative hCG test. Positive test results on VeriClear™ Digital Early Result Pregnancy Test device or hCG levels > 5.00 mIU/ml measured by Microwell Quantitative hCG test were referred to clinical confirmation of pregnancy. The results are summarized in table below:
| Age Group | Urine specimens (n) | VeriClear™ Digital Early Result Pregnancy Test | Microwell Elisa Quantitative hCG Test | ||
|---|---|---|---|---|---|
| Positive Ratio (%) | Approx. Mean Concentration Concentration Range | ||||
| Pre-menopausal (15-41 years) | 100 | 0/100 (0%) | 1.04 mIU/ml 0.00-2.50 mIU/ml |
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| Peri-menopausal
(42-55 years) | 111 | 0/100 (0%) | 1.16 mIU/ml | 0.45–2.00
mIU/ml |
|----------------------------------|-----|------------|-------------|---------------------|
| Post-menopausal
(>55 years) | 109 | 0/100 (0%) | 1.11 mIU/ml | 0.57–2.26
mIU/ml |
7. Clinical Cut-off
Not applicable
8. Expected value/ Reference Range:
Not applicable