(172 days)
The First Response® 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® I-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as three days before the expected period.
The First Response®1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The acceptance criteria for the First Response® 1-Step Pregnancy Test and the studies proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Consumer accuracy in reading low levels of hCG | Evaluated in a performance study |
| Ability of lay consumers to perform the test and interpret the result | Evaluated in a performance study |
| Ability to understand the package insert, including use before the expected period | Evaluated in a quantitative market research study |
| Clinical sensitivity using samples collected prior to missed menses | Evaluated and confirmed in a laboratory study |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text for individual studies.
- Data Provenance: Not explicitly stated, but the studies were conducted by Carter-Wallace, Inc., in the United States.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable as the ground truth was established through laboratory testing for clinical sensitivity and consumer studies for user performance and comprehension, rather than expert consensus on diagnostic images or conditions.
4. Adjudication Method
- Not applicable for the types of studies described. Clinical sensitivity would rely on laboratory reference methods, and consumer studies would involve direct observation and survey results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on the device's standalone performance and consumer interaction rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance studies were done. The text describes a laboratory study to evaluate and confirm the clinical sensitivity of the First Response® 1-Step Pregnancy Test using samples collected prior to missed menses. This assesses the device's ability to detect hCG independently. Additionally, consumer accuracy in reading low levels of hCG suggests a standalone assessment of the device's output interpretation by users.
7. Type of Ground Truth Used
- Clinical Sensitivity: Likely laboratory reference methods for hCG detection (e.g., quantitative serum hCG assays) or established clinical diagnosis of pregnancy.
- Consumer Accuracy/Performance/Comprehension: Actual presence or absence of hCG in urine samples (for accuracy) and direct observation or survey responses regarding user actions and understanding.
8. Sample Size for the Training Set
- Not applicable. This device is an in-vitro diagnostic test, not an AI or machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
July 1, 1999 Page 2
DEC 2 1 1999
510(k) SUMMARY II.
| Submitted By: | Carter-WallaceCarter Products DivisionP.O. Box 1001, Half Acre RoadCranbury, New Jersey 08512-0181(609) 655-6000 |
|---|---|
| Contact Person: | Maureen Garner |
| Date Prepared: | July 1, 1999 |
| Proprietary Name: | First Response® 1-Step Pregnancy |
| Common Name: | At-Home Pregnancy Test |
| Classification Name: | Human chorionic gonadotropin (hCG) test system |
| Predicate Device: | First Response® 1-Step Pregnancy Test |
Description of the Device: The First Response®1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
Intended Use of the Device: The First Response® 1-Step Pregnancy Test is a simple-touse at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of pregnancy. The directions for use for the First Response® 1-Step Pregnancy Test state that the test can be used as early as three days before the expected menses.
{1}------------------------------------------------
II. 510(k) SUMMARY (cont'd) III.
Technological Characteristics: The First Response® 1-Step Pregnancy Test utilizes a plastic stick with an absorbent tip which protrudes from the end of the device and collects and delivers the urine to reagents on the chromatographic strip contained within the device. The test product detects hCG, the hormone produced during pregnancy, by utilizing a double antibody immunochromatographic assay and uses a direct label to visualize the immunoreaction indicating the presence of hCG. The test uses colloidal gold, which upon agglutination produces a pink/purple color and also utilizes a third complexing reaction (between biotin and streptavidin) to produce an easy-to-read test result.
The performance studies conducted included the evaluation of consumer accuracy in reading low levels of hCG using the First Response® 1-Step Pregnancy Test and the ability of lay consumers to perform the test and interpret the result. A quantitative market research study was performed to evaluate consumers' ability to understand the package insert, which indicates that the test can be used before the expected period. A laboratory study was performed to evaluate and confirm the clinical sensitivity of the First Response® 1-Step Pregnancy Test using samples collected prior to missed menses.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 1999
Ms. Maureen N. Garner Manager, Regulatory Affairs Carter-Wallace, Inc. Half Acre Road P.O. Box 1001 Cranbury, New Jersey 08512-0181
Re: K992232
Trade Name: First Response® 1-Step Pregnancy Test Regulatory Class: II Product Code: LCX Dated: October 4, 1999 Received: October 5, 1999
Dear Ms. Garner:
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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
{3}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT VI.
5992232 510(k) Number:
First Response® 1-Step Pregnancy Test Device Name:
The First Response® 1-Step Pregnancy Test is an at-home Indications For Use: pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® I-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as three days before the expected period.
ﮯ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronica Meluer for Jla Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K992332/A4 |
|---|---|
| --------------- | ------------ |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
§ 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.