(175 days)
Not Found
No
The device description details a standard immunochemical reaction on a chromatographic strip, with results read visually by the user. There is no mention of computational analysis, algorithms, or any technology typically associated with AI/ML.
No.
The device is a diagnostic test that detects pregnancy, not a device used for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is an "in vitro diagnostic home use test device intended for the early detection of pregnancy." The "Device Description" also refers to it as a "screening device intended for early detection of pregnancy".
No
The device description clearly outlines a physical test strip within a plastic housing that utilizes immunochemical reactions to detect hCG in urine. This involves hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy." This is the most direct confirmation.
- Device Description: The description details how the device works by detecting hCG in urine through "immunochemical reactions via component reagents that are striped onto a chromatographic strip." This process of analyzing a biological sample (urine) outside of the body to diagnose a condition (pregnancy) is the core definition of an in vitro diagnostic.
- Target: The device detects "human chorionic gonadotropin (hCG)," which is a biological marker found in a bodily fluid (urine).
Therefore, based on the intended use, the method of operation, and the target being a biological marker in a sample, the FIRST RESPONSE® Early Result Pregnancy Test clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period).
This test is only intended for individual use at home. It is not intended for use in a healthcare setting.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 6 days before the missed period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period.
Important note regarding positive results:
Because this test detects very low levels of hCG, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).
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
individual use at home. It is not intended for use in a healthcare setting.
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)
A consumer study confirmed professional testing and verified the device performance characteristics with early pregnancy urines demonstrating that the results of the test can be accurately read and interpreted by consumers as early as 6 days before the missed period.
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.
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.
0
683716
510(k) Summary
| Submitted by: | Church & Dwight Co., Inc.
469 North Harrison Street
Princeton, NJ 08543 | JUN - 8 2009 |
|----------------------|---------------------------------------------------------------------------------------|--------------|
| Contact Person: | Stephen C. Kolakowsky
Director, Regulatory Affairs | |
| Date Prepared: | December 12, 2008; Revised June 5, 2009 | |
| Proprietary Name: | FIRST RESPONSE® Early Result Pregnancy Test | |
| Common Name: | At-home Pregnancy Test | |
| Classification Name: | Human chorionic gonadotropin (hCG) test system
[21 CFR §862.1155] 75 LCX; Class II | |
| Predicate Device: | FIRST RESPONSE® Early Result Pregnancy Test
510(k) #K030258 and#K992232 | |
Description of Device: The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).
Intended Use of the Device: The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period).
This test is only intended for individual use at home. It is not intended for use in a healthcare setting.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 6 days before the missed period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period.
Important note regarding positive results:
Because this test detects very low levels of hCG, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
1
Technological Characteristics: The modified 510(k)-subject device does not represent a change in technology, only an enhancement, and thus is substantially equivalent to the predicate device. The 510(k)-subject device and the predicate device are essentially identical. They differ in that the 510(k)-subject device has been modified to use a different size gold particle and a modified streptavidin to achieve an increased analytical and clinical sensitivity, and thus, the ability to detect the presence of hCG earlier in pregnancy, viz., six (6) days rather than five (5) days before the day of the missed period. The labeling claim and directions for use relative to the time of use prior to the expected period that the test may be used have been correspondingly modified. A consumer study confirmed professional testing and verified the device performance characteristics with early pregnancy urines demonstrating that the results of the test can be accurately read and interpreted by consumers as early as 6 days before the missed period. The device housing has also been modified to be more user-friendly.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Church & Dwight Co., Inc. c/o Stephen C. Kolakowsky, Director Regulatory Affairs 469 North Harrison Street Princeton, NJ 08543
JUN - 8 2009
Re: K083716
Trade/Device Name: FIRST RESPONSE® Early Result 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 23, 2009 Received: April 24, 2009
Dear Mr. Kolakowsky:
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 device 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 (OS) regulation (21 CFR Part 820).
3
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
A.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): K083716
Device Name: FIRST RESPONSE® Early Result Pregnancy Test
Indication For Use:
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCC), in some cases, as early as 6 days before the missed period (5 days before the expected period).
This test is only intended for individual use at home. It is not in a healthcare setting.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 6 days before the missed period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period.
Important note regarding positive results:
Because this test detects very low levels of hCC, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083716