(262 days)
Not Found
No
The device description and performance studies detail a standard lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML for analysis or result determination. There is no mention of any computational analysis or algorithms.
No
The device is designed to detect the presence of hCG to aid in the early detection of pregnancy, which is a diagnostic function, not a therapeutic one. It does not treat or prevent a disease or condition.
Yes
Explanation: The device is designed to detect the presence of hCG hormone in urine to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device is a lateral flow immunoassay, which is a physical test strip/cassette/midstream that detects a chemical reaction. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy". This is a diagnostic purpose performed on a biological sample (urine) in vitro (outside the body).
- Device Description: The description details a "lateral flow immunoassay" which is a common technology used in IVD tests. It describes the components and how the test works by detecting a specific analyte (hCG) in the urine sample.
- Performance Studies: The document includes detailed descriptions of performance studies conducted on urine samples to evaluate the device's precision, sensitivity, detection limit, specificity, and interference. These are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device" (K043443 Wondfo One Step HCG Urine Pregnancy Test) is typical in regulatory submissions for IVD devices, where a new device is compared to a previously cleared device.
All of these elements strongly indicate that the ACCU NEWS One Step Pregnancy Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below:
The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region.
Test Result Interpretation:
Not Pregnant: No visible pink line appearing in the test region.
Pregnant: A visible pink line appearing in the test region.
Invalid: No visible line in control region, regardless if there is a visible line in the test region or not.
The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.
Strip Format
The Strip format is a test strip used by itself without any housing components. Urine specimen is collected in a cup and the sample pad is dipped into the urine directly.
Cassette Format
The Cassette format includes a test strip housed in a plastic cassette. Urine specimen is collected in a cup and a dropper is provided to transfer the urine specimen to the sample well of the cassette, wetting the sample pad to activate the test.
Midstream Format
The Midstream format includes a test strip housed in a plastic case with an absorbent tip contacting the sample pad of the test strip. When the absorbent tip is placed in a urine steam it draws urine specimen onto the sample pad of the test strip to activate the test.
All three formats are built on the basic test strip model containing 6 components as illustrated above. The strips used in the three different formats contains the same components except that the plastic adhesive backing card, absorbent pad and sample pad are in different sizes.
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
Not Found
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)
a. Read Time Window: 10 devices from each format (Strip, Cassette, and Midstream) were tested with each of the urine samples containing 0, 12.5, 18.75, 25, 50, and 100mIU/mL hCG. Data indicated that test result was most accurate when it was interpreted at 5 minutes.
b. Precision/Sensitivity:
- Three lots of devices for each format were used to test blind-labelled urine samples containing 0, 12.5, 18.75, 25, 50, and 100mIU/mL of hCG. All urine samples were calibrated against the hCG standard WHO 3td IS. The study was carried out at three sites (one internal site and two external sites representative of the intended use setting). Each site tested a unique lot of test device. For each format, at least 30 urine samples were tested for each concentration. Test result demonstrated that all three formats of ACCU NEWS™ One Step hCG Pregnancy Test were able to produce consistent and precise test results.
- Linearity/Assay reportable range: Not applicable. This is a qualitative test.
- Detection Limit: The Precision/Sensitivity study demonstrated that the detection limit for the test was 25 mIU/mL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The test is calibrated against reference material traceable to WHO International Standard 3rd edition. A shelf-life stability test of the device was performed in accelerated temperature at 60°C. The results support that the device was stable for 2 years when stored at 4-30°C.
d. Comparison Study: Urine samples were randomly collected from 250 female donors from three sites at various times throughout the day. About 50% of the donors were suspected to be pregnant. Donor age range was from 18 to 43. Healthcare professionals tested each urine sample with each format of ACCU NEWSTM One Step hCG Pregnancy Test and a predicate hCG test. Test results were compared. Test result demonstrated that test results from all three formats of the ACCU NEWS"M One Step hCG Pregnancy Test had 100% agreement with that of the predicate device.
e. Specificity: Specificity was determined by testing the ACCU NEWS™ One Step hCG Test with structurally related compounds spiked in negative urine samples and positive (hCG 25 mIU/mL) urine samples. The compounds analyzed were luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Five tests were performed for each compound. Result demonstrated that ACCU NEWSTM One Step hCG Test was not interfered by FSH, TSH, and LH at the levels of 1000mIU/mL, 1000µIU/mL, and 1000mIU/mL respectively. However, LH, FSH, and TSH may cause false negative readings at concentrations of >1000 mIU/mL, >1000 mIU/mL, and >1000 µIU/mL respectively.
f. Interference:
- Exogenous Compounds: To determine if some exogenous compounds would react and interfere with the ACCU NEWS™M One Step hCG Pregnancy Test, positive urine samples (hCG 25 mIU/mL) and negative urine samples were spiked with individual chemicals to specific concentrations. Each spiked urine sample was tested with five ACCU NEWS TM One Step hCG Pregnancy Test devices from each format. Results showed that ACCU NEWS™ One Step hCG Pregnancy Test was not interfered by the substances listed below at their specific concentrations.
- pH Study: To determine if different pH values in urine would have an effect on the ACCU NEWS™ One Step hCG Pregnancy Test, positive (hCG 25 mIU/mL) and negative urine samples with the following pH values: 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, and 9.0 were tested. Each urine sample was tested with three test devices from each format of the ACCU NEWS™M One Step hCG Test. Result showed that pH values 2.0-9.0 in urine did not interfere with the performance of the test.
- Specific Gravity: To determine if different specific gravity values in urine can affect the ACCU NEWSTM One Step hCG Pregnancy Test, positive (25 mIU/mL) and negative hCG urine samples with the following specific gravity levels: 1.003, 1.005, 1.010, 1.015, 1.020, and 1.030 were tested. Each urine sample was tested with three test devices from each format of the ACCU NEWS 110 One Step hCG Pregnancy Test. Result showed that the test functioned properly with no interference from these various specific gravity values in urine.
- High Dose/Hook Effect: To determine if high concentrations of hCG would cause false negative result on the ACCU NEWS™ One Step hCG Pregnancy Test. Urine samples spiked with 50, 100, 200, 300, and 500 IU/mL of hCG were tested with the device. Each urine sample was tested with three test devices from each format of the ACCU NEWSTM One Step hCG Pregnancy Tes. Result showed that the device did not exhibit high dose/hook effect for urine containing up to 500 IU/mL (or 500,000 mIU/mL) of hCG.
- hCG ß-core fragment: To determine the effects of ß-core hCG fragment on the ACCU NEWS™ One Step hCG Test, the device was tested with negative and positive (hCG 25mIU/mL) hCG urine samples spiked with ß-core hCG fragment at the concentrations of 20,000 pmol/L, 25,000 pmol/L, 50,000 pmol/L, 62,500 pmol/L, 100,000 pmol/L, 125,000 pmol/L, 250,000 pmol/L, 500,000 pmol/L and 1000.000 pmol/L. Result showed that ß-core hCG fragments did not interfere with the test result of the device at or below the concentration of 100,000pmol/L. However, at a concentration of >100,000 pmol/L. hCG ß-core Fragment may cause false negative reading.
g. Other Clinical Supportive Data: OTC lay-user Test Result: Urine samples were randomly collected from 250 female donors at three sites. About 50% of the donors were suspected to be pregnant. Donor age range was from 18 to 43. Donors were given all three formats of the ACCU NEWSTM One Step hCG Pregnancy Test to test the collected urine samples. The same urine samples were tested by healthcare professionals using the ACCU NEWSTM One Step hCG Pregnancy Test. The recorded test results from the lay users were compared with that from the healthcare professionals. Data showed 100% agreement between lay user results and professional result. This demonstrated that the device was easy enough to be used by untrained lay users. In addition, each participant was given an English questionnaire to assess the readability of the labeling. The result showed that lay users found the product instruction to be easy to understand and the device to be easy to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection limit: 25 mIU/mL
Comparison Study: 100% agreement between subject device and predicate device.
Precision Study Data (Sample size for each format and concentration is at least 30):
Strip, Cassette, and Midstream formats:
For 0 mIU/mL, 12.5 mIU/mL, and 18.75 mIU/mL hCG: 0 positive results, 30 negative results.
For 25 mIU/mL, 50 mIU/mL, and 100 mIU/mL hCG: 30 positive results, 0 negative results.
OTC Lay-User Test Result: 100% agreement between lay user results and professional results for all three formats (Strip, Cassette, Midstream).
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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2015
CORETESTS, INC. WEN LI REGULATORY AFFAIRS SPECIALIST 6190 YARROW DRIVE CARLSBAD CA 92011
Re: K150063
Trade/Device Name: ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS One Step hCG Pregnancy Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: August 14, 2015 Received: August 17, 2015
Dear Wen Li:
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 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
1
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 regulations (21 CFR Parts 801 and 809), 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/ResourcesforYou/Industry/default.htm. 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 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,
Katherine Serrano -S
For : 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) K150063
Device Name
ACCU NEWS One Step hCG Pregnancy Test Strip ACCU NEWS One Step hCG Pregnancy Test Cassette ACCU NEWS One Step hCG Pregnancy Test Midstream
Indications for Use (Describe)
ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------- |
|× Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510k Summary
A. Submitter Information
Coretests Inc. 6190 Yarrow Drive, Carlsbad, CA 92011, USA. Phone Number: 858-333-1122 Contact Person: Wen Li Summary Prepared on September 29th, 2015
B. Trade Name, common name, classification name
Trade Names: ACCU NEWSTM One Step hCG Pregnancy Test Strip, ACCU NEWS™ One Step hCG Pregnancy Test Cassette, and ACCU NEWS™ One Step hCG Pregnancy Test Midstream. Common Name: Qualitative Lateral Flow Immunoassay Classification: Class II Regulation Number: 21 CFR 862.1155 Human chorionic gonadotropin test system Product code: LCX Panel: Clinical Chemistry (75)
C. Predicate device
K043443 Wondfo One Step HCG Urine Pregnancy Test
D. Device description
ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below:
Image /page/3/Figure/9 description: The image shows a diagram of a lateral flow assay test strip. The test strip consists of several components, including a sample pad labeled as '1', a conjugate pad labeled as '2', and a nitrocellulose membrane labeled as '3'. The test strip also has a test line labeled as '4(a)', a control line labeled as '4(b)', an absorbent pad labeled as '5', and a plastic adhesive backing card labeled as '6'.
The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region.
4
Test Result Interpretation:
Not Pregnant: No visible pink line appearing in the test region.
Pregnant: A visible pink line appearing in the test region.
Invalid: No visible line in control region, regardless if there is a visible line in the test region or not.
The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.
Strip Format
The Strip format is a test strip used by itself without any housing components. Urine specimen is collected in a cup and the sample pad is dipped into the urine directly.
Cassette Format
The Cassette format includes a test strip housed in a plastic cassette. Urine specimen is collected in a cup and a dropper is provided to transfer the urine specimen to the sample well of the cassette, wetting the sample pad to activate the test.
Midstream Format
The Midstream format includes a test strip housed in a plastic case with an absorbent tip contacting the sample pad of the test strip. When the absorbent tip is placed in a urine steam it draws urine specimen onto the sample pad of the test strip to activate the test.
All three formats are built on the basic test strip model containing 6 components as illustrated above. The strips used in the three different formats contains the same components except that the plastic adhesive backing card, absorbent pad and sample pad are in different sizes. This is specified in the table below:
| Component | Strip | Cassette | Midstream | |
|---|---|---|---|---|
| Plastic Adhesive Backing Card | 300 x 80 mm | 300 x 60 mm | 300 x 85 mm | |
| Absorbent pad | 298×33 mm | 298x23 mm | 298x31mm | |
| Sample Pad | 300 x 24 mm | 300 x 20 mm | 300 x 40 mm |
E. Intended use
ACCU NEWSTM One Step Pregnancy Test Strip: The ACCU NEWS™ One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS™ One Step Pregnancy Test Cassette: The ACCU NEWS™ One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWSTM One Step Pregnancy Test Midstream: The ACCU NEWSTM One Step
5
Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
| Similarities | ||
|---|---|---|
| Feature | Subject Device | Predicate Device |
| Intended Use | It is intended for both | |
| professional and over-the- | ||
| counter use for qualitative | ||
| detection of hCG hormone in | ||
| urine to aid early detection of | ||
| pregnancy. | It is intended for both | |
| professional and over-the- | ||
| counter use for qualitative | ||
| detection of hCG hormone in | ||
| urine to aid early detection of | ||
| pregnancy. | ||
| Specimen Type | Urine | Urine |
| Technology | Lateral Flow Immunoassay | Lateral Flow Immunoassay |
| Basic Components | Test strip containing | |
| nitrocellulose membrane, | ||
| sample pad, alpha and beta | ||
| hCG antibodies | Test strip containing | |
| nitrocellulose membrane, | ||
| sample pad, alpha and beta hCG | ||
| antibodies | ||
| Detection Limit | 25 mIU/mL | 25 mIU/mL |
| Storage Temperature | 4-30°C | 4-30°C |
| Formats | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Traceability | WHO 3rd International | |
| Standard | WHO 3rd International Standard | |
| Differences | ||
| Feature | Subject Device | Predicate Device |
| Read Time | at 5 minutes | 3-5 minutes |
| High Dosage Hook | ||
| Effect | No high dosage hook effect | |
| for hCG up to 500,000 | ||
| mIU/mL | No high dosage hook effect for | |
| hCG up to 100,000 mIU/mL | ||
| Specificity | LH at 1000mIU/mL, FSH at | |
| 1000mIU/mL, and TSH at | ||
| 1000μIU/mL | LH at 300mIU/mL, FSH at 300 | |
| mIU/mL, and TSH at 1000 | ||
| mIU/mL | ||
| pH Interference | No interference for urine with | |
| pH 2-9 | No interference for urine with | |
| pH 4-9 | ||
| Specific Gravity | ||
| Interference | No interference for urine with | |
| Specific Gravity 1.003-1.030 | No interference for urine with | |
| Specific Gravity 1.000-1.050 |
- F. Summary of the technological characteristics of your device compared to the predicate device
G. Non-clinical performance data
a. Read Time Window
To determine the optimal time to interpret the test results of the ACCU NEWS™ One Step hCG Pregnancy Test, 10 devices from each format (Strip, Cassette, and Midstream) were tested with each of the urine samples containing 0, 12.5, 18.75, 25, 50, and 100mIU/mL hCG. Data indicated that test result was most accurate when it
6
was interpreted at 5 minutes.
b. Precision/Sensitivity
-
- Three lots of devices for each format were used to test blind-labelled urine samples containing 0, 12.5, 18.75, 25, 50, and 100mIU/mL of hCG. All urine samples were calibrated against the hCG standard WHO 3td IS. The study was carried out at three sites (one internal site and two external sites representative of the intended use setting). Each site tested a unique lot of test device. For each format, at least 30 urine samples were tested for each concentration.
| hCG conc. (mIU/mL) | Lot #1 | Lot #2 | Lot #3 | Total | ||||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | - | |
| 0 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 12.5 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 18.75 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 25 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 50 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 100 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
Table 1: Precision Study Data for Strip
| Table 2: Precision Study Data for Cassette | ||||||||
|---|---|---|---|---|---|---|---|---|
| hCG conc. (mIU/mL) | Lot #1 | Lot #2 | Lot #3 | Total | ||||
| + | - | + | - | + | - | + | - | |
| 0 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 12.5 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 18.75 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 25 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 50 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 100 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| + | - | + | - | + | - | + | - | |
|---|---|---|---|---|---|---|---|---|
| 0 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 12.5 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 18.75 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 25 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 50 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 100 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
Table 3: Precision Study Data for Midstream
| hCG conc. (mIU/mL) | Lot #1 | Lot #2 | Lot #3 | Total | ||||
|---|---|---|---|---|---|---|---|---|
| + | - | + | - | + | - | + | - | |
| 0 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 12.5 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 18.75 | 0 | 10 | 0 | 10 | 0 | 10 | 0 | 30 |
| 25 | 10 | 0 | 10 | 0 | 39 | 1 | 59 | 1 |
| 50 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
| 100 | 10 | 0 | 10 | 0 | 10 | 0 | 30 | 0 |
Test result demonstrated that all three formats of ACCU NEWS™ One Step hCG Pregnancy Test were able to produce consistent and precise test results.
-
- Linearity/Assay reportable range:
Not applicable. This is a qualitative test.
- Linearity/Assay reportable range:
-
- Detection Limit:
The Precision/Sensitivity study demonstrated that the detection limit for the test was 25 mIU/mL.
- Detection Limit:
7
Traceability, Stability, Expected values (controls, calibrators, or methods) C. The test is calibrated against reference material traceable to WHO International Standard 3rd edition.
A shelf-life stability test of the device was performed in accelerated temperature at 60°C. The results support that the device was stable for 2 years when stored at 4-30°C.
Comparison Study d.
Urine samples were randomly collected from 250 female donors from three sites at various times throughout the day. About 50% of the donors were suspected to be pregnant. Donor age range was from 18 to 43. Healthcare professionals tested each urine sample with each format of ACCU NEWSTM One Step hCG Pregnancy Test and a predicate hCG test. Test results were compared.
| Table 4. Data Summary for Comparison Study | |||||||
|---|---|---|---|---|---|---|---|
| Predicate | |||||||
| Device | |||||||
| Result | ACCU NEWS™ One Step hCG Pregnancy Test | ||||||
| Midstream | Cassette | Strips | |||||
| Positive | Negative | Positive | Negative | Positive | Negative | ||
| Positive | 124 | 0 | 124 | 0 | 124 | 0 | |
| Negative | 0 | 126 | 0 | 126 | 0 | 126 | |
| Total | 124 | 126 | 124 | 126 | 124 | 126 | |
| % Agreement | 100% | 100% | 100% |
Table 4: Data Summary for Comparison Study
Test result demonstrated that test results from all three formats of the ACCU NEWS"M One Step hCG Pregnancy Test had 100% agreement with that of the predicate device.
e. Specificity
Specificity was determined by testing the ACCU NEWS™ One Step hCG Test with structurally related compounds spiked in negative urine samples and positive (hCG 25 mIU/mL) urine samples. The compounds analyzed were luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Five tests were performed for each compound. Result demonstrated that ACCU NEWSTM One Step hCG Test was not interfered by FSH, TSH, and LH at the levels of 1000mIU/mL, 1000µIU/mL, and 1000mIU/mL respectively. However, LH, FSH, and TSH may cause false negative readings at concentrations of >1000 mIU/mL, >1000 mIU/mL, and >1000 µIU/mL respectively.
f. Interference
1. Exogenous Compounds
To determine if some exogenous compounds would react and interfere with the ACCU NEWS™M One Step hCG Pregnancy Test, positive urine samples (hCG 25 mIU/mL) and negative urine samples were spiked with individual chemicals to specific concentrations. Each spiked urine sample was tested with five ACCU NEWS TM One Step hCG Pregnancy Test devices from each format. Results showed that ACCU NEWS™ One Step hCG Pregnancy Test was not interfered
8
| Substance | Concentration |
|---|---|
| (1R,2S)-(-)-Ephedrine | 20 mg/dL |
| (1S,2R)-(+)-Ephedrine | 20 mg/dL |
| Acetylsalicylate Acid | 20 mg/dL |
| Albumin (Human) | 2000 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Acetaminophen | 20 mg/dL |
| Ampicillin | 5.3 mg/dL |
| Bilirubin | 2 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| Gentisic Acid | 20 mg/dL |
by the substances listed below at their specific concentrations.
Substance Concentration 2000 mg/dL Glucose Hemoglobin 250 mg/dL Ibuprofen 40 mg/dL Methadone 10 mg/dL Morphine 10 mg/dL 20 mg/dL Nicotine 1.5 mg/dL Tetracycline 20 mg/dL Acetone 20 mg/dL Phenylpropanolamine Salicylic acid 20 mg/dL Uric Acid 20 mg/dL DL-ß-Hydroxybutyric Acid 2000 mg/dL
2. pH Study
To determine if different pH values in urine would have an effect on the ACCU NEWS™ One Step hCG Pregnancy Test, positive (hCG 25 mIU/mL) and negative urine samples with the following pH values: 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, and 9.0 were tested. Each urine sample was tested with three test devices from each format of the ACCU NEWS™M One Step hCG Test. Result showed that pH values 2.0-9.0 in urine did not interfere with the performance of the test.
3. Specific Gravity
To determine if different specific gravity values in urine can affect the ACCU NEWSTM One Step hCG Pregnancy Test, positive (25 mIU/mL) and negative hCG urine samples with the following specific gravity levels: 1.003, 1.005, 1.010, 1.015, 1.020, and 1.030 were tested. Each urine sample was tested with three test devices from each format of the ACCU NEWS 110 One Step hCG Pregnancy Test. Result showed that the test functioned properly with no interference from these various specific gravity values in urine.
4. High Dose/Hook Effect
To determine if high concentrations of hCG would cause false negative result on the ACCU NEWS™ One Step hCG Pregnancy Test. Urine samples spiked with 50, 100, 200, 300, and 500 IU/mL of hCG were tested with the device. Each urine sample was tested with three test devices from each format of the ACCU NEWSTM One Step hCG Pregnancy Tes. Result showed that the device did not exhibit high dose/hook effect for urine containing up to 500 IU/mL (or 500,000 mIU/mL) of hCG.
5. hCG ß-core fragment
To determine the effects of ß-core hCG fragment on the ACCU NEWS™ One Step hCG Test, the device was tested with negative and positive (hCG 25mIU/mL) hCG urine samples spiked with ß-core hCG fragment at the concentrations of 20,000 pmol/L, 25,000 pmol/L, 50,000 pmol/L, 62,500 pmol/L, 100,000 pmol/L, 125,000 pmol/L, 250,000 pmol/L, 500,000 pmol/L
9
and 1000.000 pmol/L. Result showed that ß-core hCG fragments did not interfere with the test result of the device at or below the concentration of 100,000pmol/L. However, at a concentration of >100,000 pmol/L. hCG ß-core Fragment may cause false negative reading.
H. Clinical performance data
- a. Clinical Sensitivity: Not Applicable
- b. Clinical Specificity: Not Applicable
Other Clinical Supportive Data: ﻥ OTC lay-user Test Result
Urine samples were randomly collected from 250 female donors at three sites. About 50% of the donors were suspected to be pregnant. Donor age range was from 18 to 43. Donors were given all three formats of the ACCU NEWSTM One Step hCG Pregnancy Test to test the collected urine samples. The same urine samples were tested by healthcare professionals using the ACCU NEWSTM One Step hCG Pregnancy Test. The recorded test results from the lay users were compared with that from the healthcare professionals.
| ACCU NEWS™ One Step hCG Pregnancy Test Strip | |||
|---|---|---|---|
| Positive | Negative | ||
| Professional | |||
| Test Result | |||
| (Strip | |||
| Format) | Positive | 124 | 0 |
| Negative | 0 | 126 | |
| Total | 124 | 126 | |
| % Agreement | 100% |
Table 5: Data Summary of OTC Lay-User Test Result for Strip
Table 6: Data Summary of OTC Lay-User Test Result for Cassette
| ACCU NEWS™ Step hCG Pregnancy Test Cassette | |||
|---|---|---|---|
| Positive | Negative | ||
| Professional | |||
| Test Result | |||
| (Cassette | |||
| Format) | Positive | 124 | 0 |
| Negative | 0 | 126 | |
| Total | 124 | 126 | |
| % Agreement | 100% |
Table 7: Data Summary of OTC Lay-User Test Result for Midstream
| ACCU NEWS™ One Step hCG Pregnancy Test Midstream | |||
|---|---|---|---|
| Positive | Negative | ||
| Professional | |||
| Test Result | |||
| (Midstream | |||
| Format) | Positive | 124 | 0 |
| Negative | 0 | 126 | |
| Total | 124 | 126 | |
| % Agreement | 100% |
10
Data showed 100% agreement between lay user results and professional result. This demonstrated that the device was easy enough to be used by untrained lay users. In addition, each participant was given an English questionnaire to assess the readability of the labeling. The result showed that lay users found the product instruction to be easy to understand and the device to be easy to use.
I. Conclusion
The performance characteristics studies performed demonstrated substantial equivalency between ACCU NEWS™ One Step hCG Pregnancy Test and the predicate device.