(96 days)
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.
The Preg-Q early pregnancy test is a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy.
The provided text describes the "Preg-Q Early Pregnancy Test," a rapid visual test for the qualitative detection of hCG in urine to aid in the determination of pregnancy. The submission is a 510(k) premarket notification, indicating it's a new device seeking to prove substantial equivalence to a legally marketed predicate device.
However, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics for the Preg-Q Early Pregnancy Test. The "Device Comparison" table only lists the types of testing completed (Interference, Accuracy, Sensitivity, Specificity, Reading Time, OTC Comparison) and indicates they are "Same" as the predicate device (Testpack Plus HCG Urine K954029), but it does not provide the actual quantitative acceptance criteria or reported performance results from these tests.
Therefore, I cannot fully answer your request based on the provided input. I can only infer what types of studies were likely performed based on the "Testing Completed" section.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document only states that testing was completed for "Interference," "Accuracy," "Sensitivity," "Specificity," and "Reading Time" and that these were "Same" as the predicate device, but no actual numerical criteria or performance values are given. | Not provided in the document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The device is for qualitative detection of hCG in urine, which typically uses laboratory reference methods or expert interpretation of clinical signs/symptoms for ground truth, but the details are not provided.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not applicable. This is a rapid visual pregnancy test, not an AI-assisted diagnostic tool involving human readers interpreting outputs.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "Preg-Q Early Pregnancy Test" is described as a "rapid visual test" for "over-the-counter, central laboratory, and point of care hospital use." This implies a standalone diagnostic performance by the test device itself, without an algorithm or human-in-the-loop AI assistance. However, the specific results of this standalone performance are not detailed.
7. The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. For a pregnancy test, ground truth typically involves confirmation by other established laboratory tests (e.g., quantitative hCG assays), clinical examination, or follow-up. The document does not specify which was used.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable, as this device does not appear to involve machine learning or a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Ground Truth (Training Set): Not applicable, as this device does not appear to involve machine learning or a training set.
In summary, the provided 510(k) summary is very high-level and focuses on the device's intended use and comparison to a predicate device. It lacks the detailed study results and acceptance criteria that would typically be found in a more comprehensive clinical study report.
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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 EarlyPregnancy Test | Testpack Plus HCGUrine | |
|---|---|---|
| 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 |
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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).
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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
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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)
§ 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.