(96 days)
Not Found
No
The summary describes a rapid visual test for hCG, which is a standard immunoassay technology and does not mention any AI/ML components.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is an early pregnancy test, which is a diagnostic tool, not a therapeutic one. It aids in the determination of pregnancy but does not treat or cure any condition.
Yes
The device is described as a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy, which falls under diagnostic purposes.
No
The device description clearly states it is a "rapid visual test" and a "test strip," which are physical components, not software. The predicate device is also a physical test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of hCG in urine to aid in the determination of pregnancy." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to provide diagnostic information.
- Device Description: The description reinforces that it's a "rapid visual test for the qualitative detection of hCG in urine," confirming the in vitro nature of the test.
- Predicate Device: The mention of a predicate device (K954029 Testpack Plus HCG Urine) which is also a pregnancy test, further indicates that this device falls under the category of IVDs regulated by the FDA.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Preg-Q early pregnancy test is a rapid visual test for Intended Use: the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over-the counter, central laboratory, and point of care hospital use.
Product codes (comma separated list FDA assigned to the subject device)
LCX, JHI
Device Description
Not Found
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
over-the-counter, central laboratory, and point of care hospital use.
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)
Testing Completed: Interference, Accuracy, Sensitivity, Specificity, Reading Time, OTC Comparison (N/A). Performance is stated as "Same" when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity. Key results are listed as "Same" when compared to the predicate device.
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.
Testpack Plus HCG Urine K954029
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
510(k) SUMMARY (as required by 807.92(c))
DEC 1 6 2002
Submitter of 510(k): YD Diagnostics 228-8Chamsil-Dong,Songapa-Gu Keuk-Dong A,Bldg.2F Seoul, 138-220, Korea
Contact Person: Contact Phone Number: Mr. J.M. Lee 82-2-2233-5687 1-800-365-6146
Date of Summary: June 1,2002
| Trade Name: | Preg-Q Early Pregnancy Test |
|---|---|
| Classification Name: | Radioimmunoassay,Human Chorionic Gonadotropin |
| Predicate Device: | Testpack Plus HCG Urine K954029 |
The Preg-Q early pregnancy test is a rapid visual test for Intended Use: the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over-the counter, central laboratory, and point of care hospital use..
Device Comparison:
| | Preg-Q Early
Pregnancy Test | Testpack Plus HCG
Urine |
|-------------------|--------------------------------|----------------------------|
| 510(k) | | K954029 |
| Testing Completed | Interference | Same |
| | Accuracy | Same |
| | Sensitivity | Same |
| | Specificity | Same |
| | Reading Time | Same |
| | OTC Comparison | N/A |
| Intended Use | Detection of hCG | Same |
| Intended Specimen | Urine | Same |
| Results | Qualitative | Qualitative |
| Test Time | 5 minutes | 5 minutes |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
YD Diagnostics c/o Mr. Arthur J. Ward RMS Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572
DEC 1 6 2002
K023027 Re:
Trade/Device Name: Preg-Q Early Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX, JHI Dated: October 28, 2002 Received: October 29, 2002
Dear Mr. Ward:
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).
2
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 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if knov
Preg-Q Early Pregnancy Test Device Name:
Indications For Use:
The Preg-Q hCG Early Pregnancy Test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. This test is for over- the-counter, central laboratory, and point of care hospital use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Crozer
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023027
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)