(115 days)
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 determination 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.
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 sample pad there 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 performance to other legally marketed "home pregnancy test devices" that are in commercial distribution.
Here's a breakdown of the acceptance criteria and study information for the One Step HCG Urine Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its performance is comparable to already legally marketed devices.
However, based on the nature of a pregnancy test, the implied acceptance criteria would revolve around the accurate detection of HCG. The "reported device performance" in this context refers to the successful demonstration of performance similar to predicate devices, which allowed for substantial equivalence.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (as implied by Substantial Equivalence) |
|---|---|
| Detection of hCG (Sensitivity & Specificity) | Comparable to predicate devices (Unipath, Ltd, E.P.T. Pregnancy Test, etc.) in detecting elevated levels of human Chorionic Gonadotropin (hCG) in urine. |
| Reliability and Consistency | Similar to predicate devices in design, materials, and method of manufacture, indicating comparable reliability. |
| Ease of Use (for OTC) | Designed for non-professional, over-the-counter use, similar to predicate OTC pregnancy tests. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for performance studies. The 510(k) summary primarily focuses on regulatory equivalence rather than detailed clinical study results in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention the number of experts used or their qualifications for establishing ground truth in any performance study. This type of detail is typically found in the full study report, which is not included here.
4. Adjudication Method
The provided text does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this document. The focus is on the device's standalone performance in comparison to predicate devices, not on human reader performance with or without AI assistance. The device is a "One Step HCG Urine Pregnancy Test," implying a direct read of a test line, not an AI-assisted diagnostic.
6. Standalone (Algorithm Only) Performance Study
As this is a chemical/biochemical diagnostic test (HCG urine test) and not an AI-driven device, the concept of a "standalone (algorithm only)" performance study does not apply. The device itself is the "standalone" entity that performs the detection. The 510(k) process for such devices relies on demonstrating the accuracy of the chemical reaction and visual interpretation.
7. Type of Ground Truth Used
The type of ground truth used to evaluate the performance of this device would typically involve a reference laboratory method for detecting HCG, such as a quantitative blood HCG test or another highly accurate and validated urine HCG test method. The provided text does not explicitly state the specific ground truth method used in any underlying studies, but it is implied to be related to the "quantification" or "detection" of hCG.
8. Sample Size for the Training Set
The provided text does not mention any training set sample size. As this is a chemical diagnostic test that works based on a fixed biochemical reaction, there is no "training set" in the machine learning sense. The device's design and materials are optimized through development, not by training an algorithm on a data set.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an algorithm for this device, the question of how its ground truth was established does not apply. The performance of the test relies on the inherent chemical properties and design, which are validated against known HCG concentrations and clinical samples in studies.
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Exhibit 1 510(k) Summary
| 1 | 510(k) Summary | ||||
|---|---|---|---|---|---|
| Date of Summary Preparation: | May 17, 2004 | ||||
| 1.2 | Submitter: | Mr. Jason ZhouGuangzhou Wondfo Biotech Co., Ltd.WONDFO Scientech ParkSouth China University of TechnologyGuangzhou, Guangdong, PRC, 510641E-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.
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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.
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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).
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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
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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
§ 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.