ONE STEP HCG URINE/SERUM TEST

• K Number: K072500
• Device Name: ONE STEP HCG URINE/SERUM TEST
• Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
• Date Cleared: 2009-04-21 ( 594 days)
• Product Code: DHA
• Regulation Number: 862.1155
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: K980736
• Predicate For: N/A

Intended 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).

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Wondfo One Step HCG Urine/Serum Test, based on the provided documents:

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it states that the device has "similar technological characteristics and performance to the predicate and are equivalent."

However, the efficacy of an HCG pregnancy test is typically evaluated by its sensitivity (ability to correctly identify positive samples) and specificity (ability to correctly identify negative samples). While the document doesn't provide specific thresholds, we can infer that the device's sensitivity and specificity should be comparable to or better than the predicate device (Acon Laboratories, Inc. HCG One Step Urine/Serum Pregnancy Test, K980736) to be considered equivalent.

Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not provided, the table below reflects what would typically be expected for such a device and the general statement of performance provided.

Performance Metric	Acceptance Criteria (Inferred/Expected)	Reported Device Performance
Sensitivity	Comparable to predicate device	"Similar technological characteristics and performance to the predicate and are equivalent."
Specificity	Comparable to predicate device	"Similar technological characteristics and performance to the predicate and are equivalent."
Cross-Reactivity	Low/Minimal with LH, TSH, FSH	"aimed to be a HCG specific test by using a monoclonal antibody against highly purified β-HCG."

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Study Information

The provided document is a 510(k) summary, which typically summarizes the information submitted for regulatory clearance, rather than being the full study report itself. Therefore, detailed study methodology and data may be limited.

Here's what can be extracted and inferred:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document is a 510(k) summary and doesn't provide the raw study data or sample sizes for performance evaluations.
   • Data Provenance: Not explicitly stated. Given the manufacturer is Guangzhou Wondfo Biotech Co., Ltd. (China) and the submission is to the FDA (USA), the data could be from studies conducted in China, the US, or a combination. The document does not specify.
   • Retrospective or Prospective: Not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly stated. Since this is an in-vitro diagnostic (IVD) test for professional use, ground truth for HCG detection is typically established through reference laboratory methods or clinical diagnosis, rather than expert consensus on images or interpretations.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not explicitly stated. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on subjective interpretations (e.g., radiology images). For an IVD like an HCG test, ground truth is established by objective laboratory methods, not by expert adjudication of interpretations.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test for HCG, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data. Therefore, this type of study is not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. This device is a standalone diagnostic test kit. Its performance (accuracy in detecting HCG) is evaluated based on its ability to correctly identify the presence or absence of HCG in a sample. There isn't an "algorithm" in the typical AI sense; it's a biochemical assay. The evaluation of such a device is inherently "standalone" in that it performs its function without a "human-in-the-loop" directly influencing its result, though a human interprets the visual result.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Reference laboratory methods for HCG detection and/or clinical diagnosis of pregnancy. For an HCG test, ground truth would be established by confirmed pregnancy (e.g., via quantitative HCG tests, ultrasound, clinical follow-up) or confirmed absence of pregnancy. The document highlights the use of a "monoclonal antibody against highly purified β-HCG," implying that the ground truth for specificity would involve testing against other related hormones (LH, TSH, FSH) at physiological concentrations to confirm no cross-reactivity.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. This is a biochemical immunoassay, not a machine learning or AI model that requires a "training set" in the computational sense. Development and optimization would involve R&D and quality control testing, but not a distinct "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As explained above, this device does not utilize a training set in the AI/ML context. Ground truth for development and validation (which is distinct from a "training set") would be established through known positive and negative samples, often spiked samples or clinically confirmed specimens, using established reference methods.

Summary

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SECTION 4

SUMMARY

K072500

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: [phone] Fax: [phone]

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.

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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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

Page 1 of 1

Regulation Number and Section

§ 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.