(17 days)
RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab.
The test is a visual one step, in vitro assay.
The provided document is a 510(k) clearance letter from the FDA for the "RapidHCG Pregnancy Test." This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a product's 510(k) submission or a clinical study report. The letter is an official notification that the device has been found substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results from this document. The document only confirms the device's name ("RapidHCG Pregnancy Test"), its intended use (qualitative detection of hCG in human urine to diagnose pregnancy in hospital and clinical lab settings), its regulatory class (Class II), and its product code (JHI).
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1898
Charles Yu . President Rapid Diagnostics, Inc. 837 Cowan Road Burlingaime, California 94010
K981770 Re: RapidHCG Pregnancy Test Requlatory Class: II Product Code: JHI Dated: May 15, 1998 May 19, 1998 Received:
Dear Mr. Yu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marros is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realed Bevroo imenandance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __ K981770
Device Name: RapidHCG Pregnancy Test
Indications For Use:
RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab. _
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 1298/770
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.