(172 days)
Not Found
Not Found
No
The device description details a standard immunochromatographic assay for detecting hCG, which relies on chemical reactions and visual interpretation of lines, not AI/ML algorithms. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML-based devices.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is an in vitro diagnostic (IVD) device used to diagnose pregnancy, not treat any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy." The "Device Description" also labels it as a "Class II in vitro diagnostic medical device product."
No
The device description clearly outlines a physical test stick with an absorbent tip, reagents, and a chromatographic strip, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is an "aid in the early diagnosis of pregnancy" by detecting hCG in urine. This is a diagnostic purpose.
- Device Description: The description clearly states that it is a "Class II in vitro diagnostic medical device product."
- Mechanism: The device functions by detecting a substance (hCG) in a biological sample (urine) using an immunochromatographic assay. This is a common method for in vitro diagnostics.
- Purpose: The test provides information about a person's physiological state (pregnant or not pregnant) based on the analysis of a sample outside the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The First Response® 1-Step Pregnancy Test is a simple-to-use 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay consumers / at-home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
First Response® 1-Step Pregnancy Test
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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July 1, 1999 Page 2
DEC 2 1 1999
510(k) SUMMARY II.
| Submitted By: | Carter-Wallace
Carter Products Division
P.O. Box 1001, Half Acre Road
Cranbury, 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.
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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 |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |