(120 days)
K#030258
No
The device description mentions a microprocessor and specific algorithms for interpreting the reaction result, but there is no indication of AI or ML being used. The technology described is standard for digital diagnostic tests.
No.
The device is an in vitro diagnostic test for the detection of pregnancy, not a device used for treating or managing a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy."
No
The device description clearly states that the device is a physical test system with a plastic housing, chromatographic strip, electronic and optical components, a microprocessor, and a battery. While it has a digital display and algorithms, it is not solely software.
Yes, based on the provided text, the FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses."
- Explicit Statement in Device Description: The "Device Description" section also states: "The First Response Gold Digital Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user..."
- Nature of the Test: The device performs a test on a biological sample (urine) to detect a specific analyte (human chorionic gonadotropin - hCG) to diagnose a condition (pregnancy). This is the fundamental definition of an in vitro diagnostic test.
The text repeatedly and explicitly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses. The test is indicated for use from four days before the expected period, that is, five days before the missed period.
The First Response Gold Digital Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to five (5) days sooner than the day of the missed period (four (4) days before the day of the expected period). The test detects human chorionic gonadotropin in urine.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions on a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays the result of the immunochemical reactions on the Display Screen of the device in a manner similar to the predicate device.
The subject 510(k) device and its analog counterpart First Response Early Result Pregnancy Test (K#030258) utilize the identical immunochemical principles for the assay of hCG: an immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in that it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The digital version of the device incorporates into the stick housing electronic and optical components along with a microprocessor and specific algorithms capable of determining and correctly interpreting the reaction result and displaying a simple "YES+" or "-NO" on a Display Screen. The digital device is battery powered and will display the result for at least thirty minutes after completion of the reaction. All components are integrated and unitized into the stick housing.
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 user
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)
Not Found
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.
K#030258
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
| 3.0 510(k) SUMMARY | K070054 | |
|---|---|---|
| 3.1 Submitted by: | Church & Dwight Co., Inc | |
| 469 North Harrison Street | ||
| Princeton, NJ 08543 | ||
| 3.2 Contact Person: | Cynthia Davidson | |
| Manager, Regulatory Affairs | ||
| (609) 497-7479 | ||
| (609) 497-7179 FAX | MAY - 4 2007 | |
| 3.3 Date Prepared: | December 28, 2006 | |
| 3.4 Proprietary Name: | FIRST RESPONSE® GOLD™ Digital Pregnancy Test | |
| 3.5 Common Name: | At-home Pregnancy Test (OTC) | |
| 3.6 Classification Name: | Human chorionic gonadotropin (hCG) test system | |
| [21 CFR §862.1155] 75 LCX; Class II | ||
| 3.7 Predicate Device: | CLEAR BLUE® Easy Digital Pregnancy Test (Unipath | |
| Ltd., UK), K041404 |
3.8 Description of Device: The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions on a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays the result of the immunochemical reactions on the Display Screen of the device in a manner similar to the predicate device.
3.9 Intended Use and Indication for Use of the Device: The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses. The test is indicated for use from four days before the expected period, that is, five days before the missed period.
1
3.0 510(K) SUMMARY
3.10 Technological Characteristics: The subject 510(k) device and its analog counterpart First Response Early Result Pregnancy Test (K#030258) utilize the identical immunochemical principles for the assay of hCG: an immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in that it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The digital version of the device incorporates into the stick housing electronic and optical components along with a microprocessor and specific algorithms capable of determining and correctly interpreting the reaction result and displaying a simple "YES+" or "-NO" on a Display Screen. The digital device is battery powered and will display the result for at least thirty minutes after completion of the reaction. All components are integrated and unitized into the stick housing.
2
Image /page/2/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 lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Church & Dwight Co., Inc. c/o Ms. Cynthia Davidson Regulatory Affairs Manager 469 North Harrison Street Princeton, NJ 08543
MAY - 4 2007
Re: K070054
Trade/Device Name: FIRST RESPONSE® Gold™ Digital 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 11, 2007 Received: April 12, 2007
Dear Ms. Davidson:
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 (QS) regulation (21 CFR Part 820).
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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 (240) 276-0490. Also, please onte 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 tolling of (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopers, M.S., D.V.M.
Séan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
ADDIGATIONS FOR SECT SEPS FOR FECTORY.
| 510(k) Number: | K070054 |
|---|---|
| Device Name: | FIRST RESPONSE® GOLD™ Digital Pregnancy Test |
| Indications for Use: | The First Response Gold Digital Pregnancy Test is an in |
| vitro diagnostic test device intended for the early detection of | |
| pregnancy by the lay user up to five (5) days sooner than the | |
| day of the missed period (four (4) days before the day of the | |
| expected period). The test detects human chorionic | |
| gonadotropin in urine. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/ OR Over-the Counter Use X Part 21 CFR 801
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-On
Office of In Vit > Diagnostic Device ිvaluation and Safety
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