(67 days)
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant.
This document is an FDA 510(k) clearance letter for "The Poly stat Serum/Urine hCG Test." As such, it does not contain the detailed study information requested in the prompt. FDA clearance letters primarily confirm that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it performs as safely and effectively.
Specifically, the letter states: "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... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
Therefore, I cannot extract the following information from this document:
- Table of acceptance criteria and reported device performance: This letter doesn't detail performance metrics or specific acceptance criteria.
- Sample sizes used for the test set and data provenance: No information on test set size or origin is provided.
- Number of experts used to establish ground truth and their qualifications: This is not discussed in the letter.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study results: No such study is mentioned or referenced.
- Standalone algorithm performance: This is a diagnostic test, not an AI algorithm, so this concept doesn't apply directly.
- Type of ground truth used: Not specified.
- Sample size for the training set: This refers to AI/machine learning models, which is not applicable here.
- How ground truth for the training set was established: This refers to AI/machine learning models, which is not applicable here.
The document only provides:
- Device Name: The Poly stat Serum/Urine hCG Test
- Regulation Number: 21 CFR 862.1155
- Regulation Name: Human chorionic gonadotropin (HCG) test system
- Regulatory Class: Class II
- Product Code: JHI
- Indications For Use: The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
To obtain the detailed study information requested, one would typically need to review the original 510(k) submission document itself, which contains the scientific data and performance studies, rather than just the FDA's clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 8 2003
Ms. Helen Landicho, RAC Director Regulatory Affairs Alidex, Inc. 12277 134th CT., N.E., #100 Redmond, WA 98052
Re: K030430
Trade/Device Name: The Poly stat Serum/Urine hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 5, 2003 Received: February 10, 2003
Dear Ms. Landicho:
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 (301) 594-3084. Also, please note 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 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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SECTION 12,0 INDICATIONS FOR USE STATEMENT
510(k) Number: K030430
Device Name: The Poly stat Serum/Urine hCG Test
Indications For Use:
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
R. Charles for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 0304 36 7 510(k) Number _
V Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Alidex, Inc.
§ 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.