(39 days)
The WH Accu Test™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory Professional Use Only. This device is not for use in the Over the Counter market.
The WH Accu Test™ 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 WH Accu Test ™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The WH Accu Test™ Pregnancy Test will be sold for professional use only.
The WH Accu Test™ Pregnancy Test is a qualitative assay designed to detect human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection, intended for professional laboratory use.
Here's an analysis of its performance and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= 95%"). Instead, it compares the device's performance directly against a legally marketed predicate device (Fisher SURE VUE) and demonstrates equivalency. The reported performance is based on achieving 100% agreement with this predicate.
| Metric | Reported Device Performance (WH Accu Test™) |
|---|---|
| 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 test set. It mentions a "clinical trial" but does not provide details on the number of urine samples or patients involved. The data provenance (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document states that a "trained Laboratory Technician performed testing in a CLIA registered laboratory." It does not specify the number of technicians or their detailed qualifications (e.g., years of experience). The ground truth was established by comparing the WH Accu Test™ to the predicate device, Fisher SURE VUE.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method such as 2+1 or 3+1. The performance data is presented as a direct comparison and agreement with the predicate device (Fisher SURE VUE).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focused on the performance of the device itself compared to a predicate device, rather than the improvement of human readers with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Performance Data" section details the sensitivity, specificity, and agreement of the WH Accu Test™ as a standalone device, compared to the Fisher SURE VUE. This demonstrates the algorithm's (or in this case, the test's) performance without human interpretation as the variable. The test is designed to provide a visual positive or negative result.
7. Type of Ground Truth Used:
The ground truth for the test set was established using a predicate device (Fisher SURE VUE), a commonly used pregnancy test. This is an example of using a "comparator" or "reference method" as the ground truth.
8. Sample Size for the Training Set:
The document does not provide any information about a "training set" or its sample size. This type of in-vitro diagnostic device (lateral flow immunoassay) typically does not involve a machine learning model that requires a distinct training set in the conventional sense. The test's performance is inherent in its chemical and biological components.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the method for establishing its ground truth is not applicable.
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AUG 2 8 2001
510k Submission WH ACCU TEST W.H.P.M. Inc.
Page 18 of 31
510 (K) SUMMARY
Date of Summary: July 18, 2001
Product Name:
WH Accu Test™ Pregnancy Test
Sponsor:
W.H.P.M. Inc 2540 Corporate Place Suite B107 Monterey Park, CA 91754
Correspondent:
MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Devices:
Product: SURE VUE Manufactured by: Fisher Diagnostics
PRODUCT DESCRIPTION:
The WH Accu Test™ 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 WH Accu Test ™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The WH Accu Test™ Pregnancy Test will be sold for professional use only.
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INTENDED USE:
The WH Accu Test™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory Professional Use Only.
SUMMARY OF TECHNOLOGY:
The WH Accu Test™ Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine portion of the device, the antibody-dye conjugate binds to the hCG forming an antibodyantigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose 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 WH Accu Test™ Pregnancy Test. These data clearly demonstrate that the performance of the WH Accu Test™ Pregnancy Test by W.H.P.M. Inc. is substantially equivalent to the Fisher SURE VUE.
| Sensitivity = | 100% |
|---|---|
| Specificity = | 100% |
| Agreement = | 100% |
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510k Submission WH ACCU TEST W.H.P.M. Inc.
Page 20 of 31
STATEMENT OF SAFETY AND EFFICACY:
The WH Accu Test™ Pregnancy Test when compared with another commonly used pregnancy test (Fisher SURE VUE) demonstrated 100% performance.
These data clearly demonstrate the safety and efficacy of the WH Accu Test™ Pregnancy Test and further confirm the accuracy, sensitivity and specificity of this product, when compared to a substantially equivalent device currently being sold for professional use. A trained Laboratory Technician performed testing in a CLIA registered laboratory.
W.H.P.M. 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 & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle. The logo is black and white.
AUG 2 8 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
W.H.P.M., Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K012284
Trade/Device Name: WH Accu Test ™ Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulatory Class: II Product Code: JHI Dated: July 18, 2001 Received: July 20, 2001
Dear Ms. White:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Submission – Request for Additional Information K012284 WH Accu Test Pregnancy Test W.H.P.M. Inc.
Page 6 of 11
Device Name: The WH Accu Test™ Pregnancy Test
Indication for Use:
The WH Accu Test™ Pregnancy Test is a test for the qualitative determination of human cho will roonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory Professional Use Only. This device is not for use in the Over the Counter market.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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) |
|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ---- | -------------------------------------------------- |
Kesia Alexander Spi Jean Couper
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K012284 |
|---|---|
| --------------- | --------- |
§ 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.