(56 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 l Jse.
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 study details for the One-Step Pregnancy Test, based on the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, the study aimed to demonstrate "substantial equivalence" to a predicate device, for which "100% performance" appears to be the implied acceptance.
| Performance Metric | Implied Acceptance Criteria (relative to predicate) | Reported Device Performance |
|---|---|---|
| Sensitivity | Substantially Equivalent (ideally 100%) | 100% |
| Specificity | Substantially Equivalent (ideally 100%) | 100% |
| Agreement | Substantially Equivalent (ideally 100%) | 100% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the document. The wording "A clinical trial was done" and "These data clearly demonstrate..." suggests a sufficient sample size was used to achieve 100% agreement, sensitivity, and specificity, but the exact number of participants or samples is not provided.
- Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies a prospective collection of data comparing the device to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not explicitly stated.
- Qualifications: The ground truth was "confirmed by physical examination and/or ultrasound." This implies that licensed medical professionals (e.g., physicians, sonographers) were involved in establishing the ground truth, but their specific number, experience level, or specialty are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The ground truth was based on "physical examination and/or ultrasound," which implies an independent clinical assessment rather than a consensus among multiple readers of the device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not done. The study compared the device's performance to another FDA-cleared pregnancy test and confirmed its results with clinical outcomes, not by evaluating human readers' interpretation with and without AI assistance.
6. Standalone Performance Study:
- Was a standalone study done? Yes, the performance data provided (Sensitivity, Specificity, Agreement) reflects the standalone performance of the One-Step Pregnancy Test. The device itself produced the results, which were then compared to the predicate device and clinical ground truth. The statement "Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals" also points to testing the device's standalone usability.
7. Type of Ground Truth Used:
- Ground Truth Type: Clinical outcomes data. Specifically, "All pregnancy results were confirmed by physical examination and/or ultrasound."
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a biochemical assay (lateral flow immunoassay), not an AI/machine learning model, so there is no training set in the conventional sense. The device's performance is inherently based on its chemical/biological design and manufacturing, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The "ground truth" for developing and validating the assay's ability to detect hCG would have come from established biochemical principles, spiked samples with known hCG concentrations, and clinical samples with confirmed pregnancy status.
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JUN 1 7 2003
510k Submission One-Step Pregnancy Test Amerisource Pharmacal, Inc.
Page 20 of 39
510 (K) SUMMARY
Date of Summary: April 17, 2003
Product Name:
One-Step Pregnancy Test
Sponsor:
Amerisource Pharmacal, Inc. 8306 Wilshire Blvd. #774 Beverly Hills, CA 90211
Correspondent:
MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Devices:
Product: Wh Accutest Pregnancy Test Manufactured by: W.H.P.M., Inc.
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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510k Submission One-Step Pregnancy Test Amerisource Pharmacal, Inc.
Page 22 of 39
Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals.
Amerisource Inc. confirms that any/all data provided in this submission may be released upon request.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 7 2003
Amerisource Pharmacal, Inc.
JUN 17 2003
c/o Ms. Fran White Regulatory Consultant MDC ASSOCIATES 163 Cabot Street Beverly, MA 01915
A
Re: K031271
Trade/Device Name: One-Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: April 17, 2003 Received: May 12, 2003
Dear Ms. White:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec 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, or questions 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.
Sincercly yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director 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 Amerisource Pharmacal, Inc.
Page 23 of 39
d.
/
| 510(k) Number: (if known) | K03127 |
|---|---|
| Device Name: One-Step Pregnancy Test |
Indication 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 l Jse.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over The Counter Use(Optional Format 1-2-96) ✓ |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------------------------------------------------------------------------- |
Division Sign-Off
Qian Cooper
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031271
§ 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.