(594 days)
Not Found
No
The description details a standard immunochromatographic assay (lateral flow test) for detecting HCG. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The technology described is purely biochemical and relies on antibody-antigen binding for detection.
No.
The device is an in-vitro diagnostic test used for the early detection of pregnancy, which aids in diagnosis rather than providing direct therapy or treatment.
Yes
The text explicitly states "Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test".
No
The device description clearly indicates it is an immunochromatograph assay using a lateral flow system, which is a physical test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "in-vitro diagnostic test".
- Nature of the Test: The test determines the presence of human chorionic gonadotropin (HCG) in human serum or urine. This is a biological sample taken from the body and tested outside of the body, which is the definition of an in vitro test.
- Purpose: The purpose is to "aid in the early detection of pregnancy," which is a diagnostic purpose.
- Device Description: The description details an "Immunochromatograph assay," which is a common method used in IVD tests.
- Intended User: It is intended for "professional use only (Clinical Laboratory Use)," which is typical for many IVD devices.
All of these factors clearly indicate that the Wondfo One Step HCG Urine/Serum Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The One Step HCG Urine/Serum Test is used for the qualitative determination of HCG which appears in urine or serum for early detection of pregnancy. They are intended for professional use.
Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).
Product codes (comma separated list FDA assigned to the subject device)
DHA
Device Description
Assay Principle: Human Chorionic Gonadotropin (HCG) is one of the glycoproteins secreted by the placenta. It contains a-and β-subunits. The a-subunit of HCG shows cross-reactions with LH, TSH and FSH, because of similarities in the amino acid sequences. However, the β-subunit of HCG is specific, and shows the lowest cross reactions in assays. The antibodies, which were used before in HCG detection, were directed against the whole HCG molecule, and therefore regularly presented cross reactions with LH and TSH. Wondfo One Step HCG Urine/Serum Test is aimed to be a HCG specific test by using a monoclonal antibody against highly purified β-HCG. Immunochromatograph assay for hCG using a lateral flow, one step system for the qualitative detection of hCG in human urine/serum. Each assay uses a monoclonal antibody-dye congugate from mouse against β-HCG with gold chloride and fixed a-HCG antibody conjugate and anti-mouse IgG polyclonal antibody in membriance
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
professional use
professional use only (Clinical Laboratory Use)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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SECTION 4
SUMMARY
Submitter's name: Address:
Phone:
Name of contact person:
Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 00-86-20-871-1274-8668
APR 2 1 2009
Howard Mann SHERBO ASSOCIATES 8903 Spruce Mill Drive . Yardley, PA 19067 Phone: 215-369-3705 Fax: 215-369-5246
Date the summary was prepared:
August 28, 2007
Name of the device: Trade or proprietary name: Common or usual name:
One Step HCG Urine/Serum Test One Step HCG Urine/Serum Test HCG Urine/Serum Test
Classification: All are Class II medical devices with the following product code and Code of Federal Regulation references:
Product Code CFR # DHA 862.1155
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. HCG One Step Urine/Serum Pregnancy Test, K980736.
Description of the device:
Assay Principle: Human Chorionic Gonadotropin (HCG) is one of the glycoproteins secreted by the placenta. It contains a-and ß-subunits. The a-subunit of HCG shows cross-reactions with LH, TSH and FSH, because of similarities in the amino acid sequences. However, the Bsubunit of HCG is specific, and shows the lowest cross reactions in assays. The antibodies, which were used before in HCG detection, were directed against the whole HCG molecule, and therefore regularly presented cross reactions with LH and TSH. Wondfo One Step HCG Urine/Serum Test is aimed to be a HCG specific test by using a monoclonal antibody against highly purified B-HCG. Immunochromatograph assay for hCG using a lateral flow, one step system for the qualitative detection of hCG in human urine/serum. Each assay uses a monoclonal antibody-dye congugate from mouse against β-HCG with gold chloride and fixed a-HCG antibody conjugate and anti-mouse IgG polyclonal antibody in membriance
Intended use of the device:
The One Step HCG Urine/Serum Test is used for the qualitative determination of HCG which appears in urine or serum for early detection of pregnancy. They are intended for professional use .
Summary of the technological characteristics of our device compared to the predicate device:
The Wondfo Biotech Co., Ltd. One Step HCG Urine/Serum Test have similar technological characteristics and performance to the predicate and are equivalent.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Guangzhou Wondfo Biotech Co., Ltd. c/o Mr. Howard Mann Official Correspondent Sherbo Associates 8903 Spruce Mill Drive Yardley, PA 19067.
APR 2 1 2009
Re: K072500
Trade/Device Name: Wondfo One Step HCG Urine/Serum Test Regulation Number: 21 CFR §862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System. Regulatory Class: Class II Product Code: DHA Dated: January 15, 2009 Received: January 21, 2009
Dear Mr. Mann:
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 either class II (Special Controls) or class III (PMA), 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 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
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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.
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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Courthey C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number (if known): K072500
Device Name: Wondfo One Step HCG Urine/Serum Test
Indication For Use:
Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).
Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kin2500
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