(115 days)
Not Found
No
The description details a simple lateral flow immunoassay (test strip) for qualitative determination of hCG, which is a chemical reaction and does not involve AI/ML. There is no mention of any computational analysis or algorithms.
No.
This device is an in vitro diagnostic (IVD) test used to determine pregnancy, not to treat or alleviate a medical condition.
Yes
The device is intended for the "qualitative determination of elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy," which is a diagnostic purpose.
No
The device description clearly states it consists of a physical test strip with a sample pad, control region, and test region, indicating it is a hardware-based medical device.
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 elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." This involves testing a biological sample (urine) outside of the body to diagnose a condition (pregnancy).
- Device Description: While the description is simple, it describes a test strip designed to interact with a biological sample (urine) to produce a result.
- Nature of the Test: The test detects hCG, a hormone present in urine during pregnancy. This is a classic example of an in vitro diagnostic test.
The fact that it's intended for both professional and over-the-counter use further confirms its nature as an IVD, as IVDs can be designed for various user types and settings.
N/A
Intended Use / Indications for Use
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative detection of elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.
Product codes (comma separated list FDA assigned to the subject device)
LCX, JHI
Device Description
The device consists of a single test strip with one end designated for dipping, and control and test regions in the middle. At one end of the strip is a line with arrows indicating which end of the strip should not be dipped below this line.
The One Step HCG Urine Pregnancy Test device is similar in design, materials and method of operation to other hCG urine tests presently in commercial distribution.
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
non-professional, over-the-counter use and for professional and 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.
K033658, K032992, K033041, K031798
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
Exhibit 1 510(k) Summary
| 1 | 510(k) Summary | ||||
|---|---|---|---|---|---|
| Date of Summary Preparation: | May 17, 2004 | ||||
| 1.2 | Submitter: | Mr. Jason Zhou | |||
| Guangzhou Wondfo Biotech Co., Ltd. | |||||
| WONDFO Scientech Park | |||||
| South China University of Technology | |||||
| Guangzhou, Guangdong, PRC, 510641 | |||||
| E-mail: jason@wondfo.com.cn | |||||
| 1.3 | Trade Name: | One Step HCG Urine Pregnancy Test |
- Classification Name, Product Code, Class, Classification Reference: 1.4
| Classification Name | Common Name | Product Code | Class | 21CFR § |
|---|---|---|---|---|
| Kit, test, pregnancy, hcg, over the counter | Pregnancy Test | LCX | II | 862.1155 |
| Kit, test, pregnancy, hcg, professional and laboratory use | Pregnancy Test | JHI | II | 862.1155 |
-
Standards/Special Controls: 1.5
None -
Indications for Use: 1.6
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnany Test is The Guangzhou Wondlo Blocen Co., Ltd. Cho Sep of Corporasional use for the intended for non-professional, over-the-counter ass all-al-connectionic Gonadotropin (hCG) qualitative fut in the determination of pregnancy.
The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare I ne One Stop in its use and for Over-the-Counter use.
Device Description: 1.7
The device consists of a single test strip with one end designated for dipping, and ontrol The device consists of a single test sup whil one arows indicating which end of and test regions in the middle. At one cha of the samplar hat the strip should not be dipped below this line.
The One Step HCG Urine Pregnancy Test device is similar in design, materials and The One Step HCG Orme Tregiancy "Fost dones" is and in commercial distribution.
1
Substantially Equivalent Commercially Available Devices: 1.8
The One Step HCG Urine Pregnancy Test device is substantially equivalent to the The One Step HCC Orme Fregnaticy rest device to indications for use, device design, predicts, and method of manufacture:
Unipath, Ltd, E.P.T. Pregnancy Test - K033658 Unipath, Ltd, E.P.T. Freghancy Test - Rose over Test Device - K032992
Biotech Atlantic, Inc., Unimark Home Pregnancy Test Device - Kest Biotech Atlantic, Inc., Onlinark Home Pregnancy Test Development
Acon Laboratories, Inc., Acon Quick-Check II Home Pregnancy Test Strip --K033041 K033041
Standard Diagnostics, Inc., Good Morning Test - K031798
The predicate devices are commercially available and marketed Class II devices indicated The predicate devices are commercially avainter use and for professional use for the for use for non-professional, belevated levels of human Chorionic Gonadotropin (hCG) qualitative identified determination of pregnancy.
-
Substantial Equivalence Comparison: 1.9
See Section 5: Comparison Chart. -
Indications and Contraindications: 1.10
Relative indications and contraindications for the Guangzhou Worldfo Biotech Co., Ltd.
Contrally and Relative indications and contraindications for the Stangence - 1 similar
One Step HCG Urine Pregnancy Test and commercially available devices for similar intended uses are the same.
Conclusion: 1.11
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and In accordance with the Federal Food, Drug and Cosment , Guangzhou Wondfor based on the information provided in this provide no HCC Urine Pregnancy Test, is
Biotech Co., Ltd concludes that the new devices davices described herein. Biotech Co., Ltd concludes mat the new device, One Beep X B = = = = = =
safe, effective and substantially equivalent to the predicate device as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
APR 7 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Guangzhou Wondfo Biotech Co., Ltd. c/o Mr. Howard Mann Sherbo Associates 8903 Spruce Mill Drive Yardley, PA 19067
K043443 Re:
Trade/Device Name: One Step HCG Urine Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: 21 OF Roconic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: February 26, 2005 Received: February 28, 2005
Dear Mr. Mann:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section of the device is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decembined the arrest soredicate devices marketed in interstate for use stated in the encrosure) to regally manced predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food commerce prior to May 28, 1970, the channell and start of the Federal Food, Drug, devices that have been reclassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premaining of the Act . and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, saojeet to the generals for annual registration, listing of general controls provisions of the Fect morado required in against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (SCC above) into c. Existing major regulations affecting your device in editions a it may be subject to such additional controls. "Disting migrises" on and 10 895. In addition, FDA can be found in Title 21, Code of I each in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fillat I DA s issualles of a substition with other requirements of the Act that FDA has made a decertifications administered by other Federal agencies. You must be or any Federal statutes and regulations administered by the registration and listing (21 comply with an the Act 3 requirements, mo and 809); and good manufacturing practice CFR Part 807), labeling (21 CF R F R Lists over ms (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your bection 510(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket notification: "The PDT Intamig cification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, of k If you desire specific information acount in apparation, please contact the Office of In
or questions on the promotion and advertising of your device, please contact the Offi or questions on the promotion and Safety at (240)276-0484. Also, please note the Pliro Diagliostic Device Livatiation and Sales to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may onant outer general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
EXHIBIT B
Indications for Use Statement
Indications for Use
510(k) Number (if known):
One Step HCG Urine Pregnancy Test Device Name:
Indications for Use:
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is I he Guangzilou Wondto Dioloen Oo., Etar Silver Stores on the professional and laboratory
intended for non-professional, over-the-counter use and for professional and laborat intended for non-professional, over the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.
Prescription Use_ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagno
510(k) K043443