(256 days)
Not Found
No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI/ML or related concepts like image processing, training sets, or complex algorithms.
No
The device is a qualitative test to aid in the early detection of pregnancy, not for treating any condition.
Yes
The device is an "immunochromatographic assay for the qualitative determination of HCG in human urine," and is "intended for use as an aid in the early detection of pregnancy." This function, along with its ability to "detect hCG in urine at concentration of 25 mIU/ml and higher" and its mention of "Method Comparison" with "routine diagnostic method," clearly indicates its role in disease detection or diagnosis.
No
The device description clearly states it is an immunochromatographic assay available in strip and cassette formats, which are physical hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of HCG in human urine." This involves testing a biological sample (urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Device Description: The description mentions it's an "immunochromatographic assay," which is a common type of in vitro test.
- Performance Studies: The performance studies detail testing with urine specimens and analyzing the results, which is characteristic of IVD testing.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to provide information for diagnosis, monitoring, or screening. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The y.b.t. Pregnancy Test is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
The test is available in two formats: strip and cassette.Both of them are intended for prescription use. Both of them have the same memebrane format, reagents and flow characteristics. Devices are packaged one device per pouch with 1 devices per kit.
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)
SENSITIVITY
The test will detect hCG in urine at concentration of 25 mIU/ml and higher. This sensitivity level has been confirmed with hCG standards (25, 50, 2500, and 500,000 mlU/ml) in urine calibrated against the WHO Third I.S.. Occasionally, specimens containing less than 25 mIU/ml hCG can give positive results.
SPECIFICITY
Menopausal urine samples
A study was performed using urine specimens from 20 postmenopausal women. Urine of postmenopausal women can interfere with pregnancy testing due to elevated concentrations of gonadotropic hormone structurally similar to hCG. All 20 samples tested negative with the y.b.t. hCG Card.
Potentially interfering substances
The following substances did not interfere with hCG testing using y.b.t. hCG Card when added to urine samples containing 0 mlU/ml and 25 mlU/ml hCG:
Acetaminophen 20mg/dl, Ascorbic acid 20mg/dl, Acetylsalicylic acid 20mg/dl, Ampicilline 20mg/dl, Atropine 20mg/dl, Caffeine 20mg/ml, Cortisol 200ng/ml, Albumin 2,000mg/dl, DHEAS 500ng/ml, Estradiol (E-2) 25ng/ml, Estriol (E-3) 25ng/ml, Gentisic acid 20mg/dl, Glucose 2,000mg/dl, Tetracycline 20mg/dl, Uric acid 10mg/dl, Bilirubin 1000mg/dl, Hemoglobin 1mg/dl.
Cross reactive glycoprotein hormones
The following hormones structurally related to hCG did not interfere with hCG testing using the y.b.t. hCG Card when added to urine specimens at the concentrations indicated below:
Luteinizing hormone 100-1000 mIU/ml, Follicle stimulating hormone 100-1,000 mlU/ml, Tyroid stimulating hormone 100-1,000 mlU/ml.
Method Comparison
60 positive and 60 negative patient urine specimens confirmed with routine diagnostic method were tested against y.b.t pregnancy test strip at two certified hospital. The results showed 100% consistence.
PRECISION
Intra-assay
In the study, eleven replicate assays were performed with each of three specimens containing 0, 25, and 250 mlU/ml hCG. Correct negative and positive results were registered in 100% of the assays.
Inter-assay
The study involved the same three specimens containing 0, 25, and 250 mlU/ml hCG. The samples were analyzed in eleven independent assays with y.b.t. hCG Card originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
STORAGE AND STABILITY
Store Y.b.t. Preganacy Test Strip at temperature ranges 2-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze. Use the strip immediately once the sealed pouch is opened.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/ml
Specificity: 100% (based on method comparison for negative agreement)
Positive agreement: (60+0)/60=100%
Negative agreement: Specificity: (60+60)/(60+60)=100%
Intra-assay: 100% correct negative and positive results
Inter-assay: 100% expected negative and positive results
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.
ACON™ hCG One Step Pregnancy Test Strip (Urine) (K993203)
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
KII2315
l
510k Summary · :
APR 2 3 2012 1 1 1 1
| Submitted By: | NewScen Coast Bio-Pharmaceutical Co.,Ltd.
No 65. 6th Street
TEDA, Tianjin, China, P.C: 300457
Telephone: 86-22-25321648-867
Fax: 86-22-25321647 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Chandravadan Patel, Ph.D. |
| Date Prepared: | Feb 23, 2012 |
| Device Trade Name: | y.b.t. Pregnancy Test Cassette
y.b.t. Pregnancy Test Strip |
| Common Name: | Urine Pregnancy Test |
| Predicate Device: | ACON™ hCG One Step Pregnancy Test Strip (Urine)
(K993203) |
| Product Code: | JHI |
| Device Classification / Name: | 21 CFR§862.1155 / Human Chorionic Gonadotropin
(hCG) Test System, Class II |
| Intended Use: | The y.b.t. Pregnancy Test is an immuno
chromatographic assay for the qualitative
determination of HCG in human urine. The test is
intended for use as an aid in the early detection of
pregnancy. |
| Physiologic Basis of the Test: | Human Chorionic Gonadotropin is a hormone
produced by the placenta shortly after implantation.
Since hCG is present in the urine of pregnant women,
it is an excellent marker for confirming pregnancy. |
| Device Description: | The test is available in two formats: strip and
cassette.Both of them are intended for prescription
use. Both of them have the same memebrane format,
reagents and flow characteristics. Devices are
packaged one device per pouch with 1 devices per
kit. |
. T
1
Device Comparison
| Features | NewScen y.b.t Pregnancy Test
(Proposed) | Acon Pregnancy Test Strip
(K993203) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The y.b.t. Pregnancy Test is an immuno
chromatographic assay for the
qualitative determination of HCG in
human urine. The test is intended for
use as an aid in the early detection of
pregnancy. | The Acon Pregnancy Test Strip is a
one-step immunoassay for the qualitative
detection of HCG in Urine for the early
detection of pregnancy. The test is
intended for use by health care
professionals. |
| Analyte | Human Chorionic Gonadotropin | Human Chorionic Gonadotropin |
| Specimen | Urine | Urine or serum |
| Format | Lateral-flow immunoassay | Lateral-flow immunoassay (strip) |
| Total steps | 1 | 1 |
| Read Time | 5 minutes | 3 or 5 minutes |
| Sensitivity | 25 mIU/ml | 25 mIU/ml |
| Test | Red procedural control line | Red procedural control line |
| Interpretation | Pink-to-red line | Pink-to-red line |
| Test Strip
Components | Test Line*
Monoclonal Beta anti-hCG antibody is
immobilized in the test zone on the
nitrocellulose membrane | Test Line*
Monoclonal Beta anti-hCG antibody is
immobilized in the test zone on the
nitrocellulose membrane |
| | Indicator
Monoclonal Alpha anti-HCG antibody
coupled to red-colored gold particles is
incorporated into the conjugate Pad | Indicator
Monoclonal Alpha anti-HCG antibody
coupled to red-colored gold particles is
incorporated into the conjugate Pad |
| | Control Line*
Goat anti-mouse antibody is spotted in
the control zone on the nitrocellulose
membrane. | Control Line*
Goat anti-mouse antibody is spotted in
the control zone on the nitrocellulose
membrane. |
Table 1. Device Comparison of NewScen y.b.t Pregnancy Test and Acon Pregnancy Test
*Note : The monoclonal antibodies used for the Test Line and the Indicator in the y.b.t Pregnancy Test are identical to those used in the predicate Acon Pregnancy Test Strip. The components that generate the Control Line are also identical.
Table 2. Components Comparison of y.b.t HCG Strip and y.b.t HCG Cassette
| Features | Y.b.t Pregnancy Test (Cassette) | Y.b.t Pregnancy Test (Strip) |
|---|---|---|
| Antibody | T-line: mouse anti HCG-Beta, Clone # 9008 | Same |
| C-line: goat anti mouse IgG, | Same | |
| Conjugation, Mouse anti HCG-Alpha, Clone # 9001 | Same |
2
2
| Specimen pad | Non-woven cloth | Same |
|---|---|---|
| Conjugate Gold Pad | Non-woven cloth, Conjugate gold | Same |
| NC membrane | Nitrocellulose membrane | Same |
| Absorbent pad | Absorbent paper | Same |
| PVC baseplate | PVC plate | Same |
| Buffer | PBS | Same |
| Cassette | No | Cassette |
| Colorful paper | Colorful Paper | No |
| Max line | Colorful Paper | No |
Summary of Performance Data:
SESITIVITY
The test will detect hCG in urine at concentration of 25 mIU/ml and higher. This sensitivity level has been confirmed with hCG standards (25, 50, 2500, and 500,000 mlU/ml) in urine calibrated against the WHO Third I.S.. Occasionally, specimens containing less than 25 mIU/ml hCG can give positive results.
SPECIFICITY
Menopausal urine samples
A study was performed using urine specimens from 20 postmenopausal women. Urine of postmenopausal women can interfere with pregnancy testing due to elevated concentrations of gonadotropic hormone structurally similar to hCG. All 20 samples tested negative with the y.b.t. hCG Card.
Potentially interfering substances
The following substances did not interfere with hCG testing using y.b.t. hCG Card when added to urine samples containing 0 mlU/ml and 25 mlU/ml hCG:
| Acetaminophen | 20mg/dl | Ascorbic acid | 20mg/dl |
|---|---|---|---|
| Acetylsalicylic acid | 20mg/dl | Ampicilline | 20mg/dl |
| Atropine | 20mg/dl | Caffeine | 20mg/ml |
| Cortisol | 200ng/ml | Albumin | 2,000mg/dl |
| DHEAS | 500ng/ml | Estradiol (E-2) | 25ng/ml |
| Estriol (E-3) | 25ng/ml | Gentisic acid | 20mg/dl |
| Glucose | 2,000mg/dl | Tetracycline | 20mg/dl |
| Uric acid | 10mg/dl | Bilirubin | 1000mg/dl |
| Hemoglobin | 1mg/dl |
3
3
Cross reactive glycoprotein hormones
The following hormones structurally related to hCG did not interfere with hCG testing using the y.b.t. hCG Card when added to urine specimens at the concentrations indicated below:
· Luteinizing hormone 100-1000 mIU/ml,
Follicle stimulating hormone 100-1,000 mlU/ml
Tyroid stimulating hormone 100-1,000 mlU/ml
Method Comparison
60 positive and 60 negative patient urine specimens confirmed with routine diagnostic method were tested against y.b.t pregnancy test strip at two certified hospital. The results showed 100% consistence.
| Positive Urine | Negative Urine | Total | |
|---|---|---|---|
| y.b.t (+) | 60 | 0 | 60 |
| y.b.t (-) | 0 | 60 | 60 |
| Total | 60 | 60 | 120 |
Positive agreement: (60+0)/60=100% Negative agreement:: Specificity: (60+60)/(60+60)=100%
PRECISION
Intra-assay
In the study, eleven replicate assays were performed with each of three specimens containing 0, 25, and 250 mlU/ml hCG. Correct negative and positive results were registered in 100% of the assays.
Inter-assay
The study involved the same three specimens containing 0, 25, and 250 mlU/ml hCG. The samples were analyzed in eleven independent assays with y.b.t. hCG Card originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
STORAGE AND STABILITY
Store Y.b.t. Preganacy Test Strip at temperature ranges 2-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze. Use the strip immediately once the sealed pouch is opened.
4
Conclusion:
The result of these studies demonstrate that y.b.t pregnancy test is substantially equivalent with the predicate Acon Pregnancy Test
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with flowing lines. The symbol is positioned to the right of the text.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NewScen Coast Bio-Pharmaceutical Co., Ltd c/o Chandravadan Patel, Ph.D. 2117 Claney Ct. Simi Valley, CA 93065
10903 New Hampshire Avenue Silver Spring, MD 20993
APR 2 3 2012
Re: K112315
Trade/Device Name: y.b.t. Pregnancy Test Strip; y.b.t. Pregnancy Test Cassette
Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: Class II Product Code: JHI Dated: April 9, 2012 Received: April 16, 2012
Dear Dr. Patel:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K112315
Device Name:__ The y.b.t Pregnancy Test Strip
Indications for Use:
The y.b.t. Pregnancy Test Strip is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy.
Prescription Use ×
Over-The-Counter Use AND/OR
(Part 21 CFR801 Subpart D)
(21 CFR801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices(OIVD)
Rch
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 112315 510(k) -
7
Indications for Use
510(k) Number (if known): K112315
Device Name: The y.b.t Pregnancy Test Cassette
Indications for Use:
The y.b.t. Pregnancy Test Cassette is an immunochromatographic assay for the qualitative determination of HCG in human urine. The test is intended for use as an aid in the early detection of pregnancy.
Prescription Use ×
Over-The-Counter Use AND/OR
(Part 21 CFR801 Subpart D)
(21 CFR801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices(OIVD)
Qlum
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)____ | ( 2 3 \ 5
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