(256 days)
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.
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.
The y.b.t. Pregnancy Test Strip and Cassette are immuno-chromatographic assays intended for the qualitative determination of hCG in human urine as an aid in early pregnancy detection.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for overall performance in a formal table; however, the Method Comparison and Precision sections demonstrate performance against expected outcomes, which serve as de facto acceptance criteria for this type of diagnostic device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Detect hCG at 25 mIU/ml and higher. | Confirmed with hCG standards (25, 50, 2500, and 500,000 mlU/ml) in urine calibrated against the WHO Third I.S. |
| Specificity | No interference from menopausal urine samples. | All 20 menopausal urine samples tested negative. |
| No interference from various common substances. | No interference from 16 specified substances at given concentrations when added to urine samples containing 0 mlU/ml and 25 mlU/ml hCG. | |
| No cross-reactivity with related glycoprotein hormones. | No interference from Luteinizing hormone, Follicle stimulating hormone, and Thyroid stimulating hormone at specified concentrations. | |
| Accuracy (Method Comparison) | 100% agreement with routine diagnostic method for positive and negative samples. | Positive agreement: 100% (60/60) Negative agreement (Specificity): 100% (60/60) |
| Intra-assay Precision | 100% correct results across replicates for 0, 25, and 250 mIU/ml hCG. | Eleven replicate assays performed with 0, 25, and 250 mIU/ml hCG specimens yielded 100% correct negative and positive results. |
| Inter-assay Precision | 100% correct results across different assays, lots, and times for 0, 25, and 250 mIU/ml hCG. | The same three specimens (0, 25, 250 mIU/ml hCG) analyzed in eleven independent assays with y.b.t. hCG Cards from three different lots over two months yielded 100% expected negative and positive results. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Specificity (Menopausal urine): 20 samples
- Method Comparison: 120 patient urine specimens (60 positive, 60 negative)
- Precision (Intra-assay & Inter-assay): For each test: 3 specimens (0, 25, 250 mIU/ml hCG)
- Data Provenance: The document does not explicitly state the country of origin for the patient urine specimens. The "Method Comparison" study was performed "at two certified hospital," but the location of these hospitals is not specified. The studies appear to be prospective for the experiments involving spiked samples and controlled conditions (specificity, precision). For the method comparison, it refers to "patient urine specimens confirmed with routine diagnostic method," suggesting these were retrospective or collected for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set.
- For the "Method Comparison," ground truth was established by "routine diagnostic method" performed by the "two certified hospital," implying diagnosis by healthcare professionals using established laboratory practices. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
- No specific adjudication method (like 2+1, 3+1, etc.) is described. The "Method Comparison" states that patient urine specimens were "confirmed with routine diagnostic method," suggesting a single, established diagnostic report served as the ground truth against which the y.b.t. pregnancy test results were compared.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test, not an imaging AI; therefore, human reader improvement with or without AI assistance is not applicable in this context. The comparator is the "routine diagnostic method" for confirming hCG.
6. Standalone (Algorithm Only) Performance
- This device is an IVD test, not a software algorithm. Its performance is inherent to the physical test strip/cassette and its chemical reactions, which are read directly for results. Therefore, the reported performance metrics (sensitivity, specificity, precision, method comparison) represent its standalone performance as a diagnostic device. There is no human-in-the-loop component in its fundamental operation or result interpretation that would distinguish "algorithm only" from "human-in-the-loop," as the human reading is an essential part of using the device.
7. Type of Ground Truth Used
- Sensitivity: Calibrated hCG standards (WHO Third I.S.).
- Specificity: Known negative menopausal urine samples, and urine samples spiked with known substances/hormones.
- Method Comparison: "Routine diagnostic method" from two certified hospitals, which would typically involve laboratory-based quantitative hCG assays or other established qualitative pregnancy tests.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or "validation set" in the context of machine learning or AI algorithm development. This device is a biochemical immunoassay. Its development would involve R&D and optimization, but not typically "training" in the AI sense.
9. How Ground Truth for the Training Set Was Established
- As the device is an immunoassay and not an AI algorithm, the concept of a "training set" and establishing ground truth for it in the AI context does not directly apply. The development of such devices involves extensive laboratory testing and optimization using characterized samples and reagents to ensure the assay performs as intended.
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KII2315
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510k Summary · :
APR 2 3 2012 1 1 1 1
| Submitted By: | NewScen Coast Bio-Pharmaceutical Co.,Ltd.No 65. 6th StreetTEDA, Tianjin, China, P.C: 300457Telephone: 86-22-25321648-867Fax: 86-22-25321647 |
|---|---|
| Submission Contact: | Chandravadan Patel, Ph.D. |
| Date Prepared: | Feb 23, 2012 |
| Device Trade Name: | y.b.t. Pregnancy Test Cassettey.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 immunochromatographic assay for the qualitativedetermination of HCG in human urine. The test isintended for use as an aid in the early detection ofpregnancy. |
| Physiologic Basis of the Test: | Human Chorionic Gonadotropin is a hormoneproduced 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 andcassette.Both of them are intended for prescriptionuse. Both of them have the same memebrane format,reagents and flow characteristics. Devices arepackaged one device per pouch with 1 devices perkit. |
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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 immunochromatographic assay for thequalitative determination of HCG inhuman urine. The test is intended foruse as an aid in the early detection ofpregnancy. | The Acon Pregnancy Test Strip is aone-step immunoassay for the qualitativedetection of HCG in Urine for the earlydetection of pregnancy. The test isintended for use by health careprofessionals. |
| 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 StripComponents | Test Line*Monoclonal Beta anti-hCG antibody isimmobilized in the test zone on thenitrocellulose membrane | Test Line*Monoclonal Beta anti-hCG antibody isimmobilized in the test zone on thenitrocellulose membrane |
| IndicatorMonoclonal Alpha anti-HCG antibodycoupled to red-colored gold particles isincorporated into the conjugate Pad | IndicatorMonoclonal Alpha anti-HCG antibodycoupled to red-colored gold particles isincorporated into the conjugate Pad | |
| Control Line*Goat anti-mouse antibody is spotted inthe control zone on the nitrocellulosemembrane. | Control Line*Goat anti-mouse antibody is spotted inthe control zone on the nitrocellulosemembrane. |
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 |
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| 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 |
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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.
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Conclusion:
The result of these studies demonstrate that y.b.t pregnancy test is substantially equivalent with the predicate Acon Pregnancy Test
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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.
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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
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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) -
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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
Page 1 of 2
§ 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.