(8 days)
The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The-Counter Use.
The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.
Here's a breakdown of the acceptance criteria and the study details for the One-Step Pregnancy Test:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sensitivity | 100% |
| Specificity | 100% |
| Agreement | 100% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical trial.
The data provenance is a "clinical trial" comparing the One-Step Pregnancy Test to an FDA-cleared product (Stanbio True 20 One-Step Pregnancy Test). The document does not specify the country of origin or whether the data was retrospective or prospective, though a "clinical trial" generally implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used. However, it states that "All pregnancy results were confirmed by physical examination and/or ultrasound." This implies that medical professionals (likely physicians or sonographers) were involved in establishing the ground truth, but their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that "All pregnancy results were confirmed by physical examination and/or ultrasound," suggesting a direct verification method rather than a multi-reader, consensus-based one for the initial test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study compares the performance of the device against a predicate device, and the ground truth was established by physical examination and/or ultrasound, not by human readers interpreting the test results with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The "One-Step Pregnancy Test" is a diagnostic device that provides a direct result (presence or absence of a color band), not an AI algorithm that assists a human reader. The performance metrics (sensitivity, specificity, agreement) reflect the device's ability to accurately detect hCG on its own.
7. The Type of Ground Truth Used
The ground truth used was outcomes data and clinical assessment, specifically "physical examination and/or ultrasound."
8. The Sample Size for the Training Set
The document does not mention details about a "training set" as it refers to a medical device for in-vitro diagnostic use, not an AI/machine learning model that typically requires separate training and test sets. The performance data presented is likely from a clinical validation study rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" for an AI algorithm, this question is not directly applicable. For the clinical trial, the ground truth was established by "physical examination and/or ultrasound."
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MAY 2 0 2004
KÖ41273
Page 20 of 38
510 (K) SUMMARY
Date of Summary: May 10, 2004
Product Name:
One-Step Pregnancy Test
Sponsor:
WHPM, Inc. 9440 Telstar, Inc. El Monte, CA 91731
Correspondent:
MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Devices:
Product: Amerisource One Step Pregnancy Test Manufactured by: W.H.P.M., Inc.
1988 - 1
PRODUCT DESCRIPTION:
The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.
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INTENDED USE:
The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine. for the early detection of pregnancy. For Over-The-Counter Use.
SUMMARY OF TECHNOLOGY:
The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pinkrose color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.
PERFORMANCE DATA:
A clinical trial was done to compare the performance of the One-Step Pregnancy Test to a FDA cleared product. These data clearly demonstrate the performance of the One-Step Pregnancy Test by Amerisource is substantially equivalent to a commercially available FDA cleared pregnancy test: Stanbio True 20 One-Step Pregnancy Test
| Sensitivity = | 100% |
|---|---|
| Specificity = | 100% |
| Agreement = | 100% |
STATEMENT OF SAFETY AND EFFICACY:
The One-Step Pregnancy Test when compared with another commonly used pregnancy test (Stanbio True) demonstrated 100% performance.
All pregnancy results were confirmed by physical examination and/or ultrasound.
These data clearly demonstrate the safety and efficacy of the One-Step Pregnancy Test and further confirm that the accuracy, sensitivity and specificity of this product when compared to a substantially equivalent device currently being sold.
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Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals.
W.H.P.M. confirms that any/all data provided in this submission may be released upon request.
:
1
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 0 2004
W.H.P.M., Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
K041273 Trade/Device Name: One- Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chronic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 11, 2004 Received: May 12, 2004
Dear Ms. White:
Re:
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 devicc 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); and good manufacturing practice requirements as set forth in the quality systems (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 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 information about the application of labeling requirements to your device, rr you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jann M. Cooper, MS, DVM.
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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510k Submission One-Step Pregnancy Test WHPM, Inc.
Page 23 of 38
Indications for Use
510(k) Number (if known): K041273
Device Name: One-Step Pregnancy Test
Indications for Use:
The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The -Counter Use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Page __ of ________________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041273
§ 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.