(315 days)
One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories.
One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a human chorionic gonadotropin (HCG) pregnancy test. It does not contain information about acceptance criteria, device performance, or details of a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
Therefore, I cannot provide the requested information based on the given text.
The text only states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It defines the device's intended use and formats.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AI DE Diagnostic, Co., Ltd. C-Tech c/o Lin Wang, 1929 Woodberry Court Iowa City, IA 52246
JUL 2 3 2007
Re: K062703
Trade/Device Name: One Step HCG Urine Pregnancy Test Formats: Strip, Cassette and Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system. Regulatory Class: Class II Product Code: JHI, LCX Dated: June 07, 2007 Received: June 11, 2007
Dear Lin Wang:
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 1egally 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 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean 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
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AIDE DIAGNOSTIC CO. LTI
141 Zhuzhou Road, Qingdao High-Tech Industrial Park, Shandong, P. R. China Tel : 86-532-88606600 Fax : 86-532-8860665515-mail : aide@inddiagnostic.com
Statement of Indications for Use [21 CFR 801. 109]
510 (K) Number: K062703
Deice Trade Name: One Step HCG Urine Pregnancy Test Formats: Strip, Cassette and Midstream
Indications for Use:
One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories.
Dean Cooper, D.V.M.
Division Sign-Off
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use X (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
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AIDE DIAGNOSTIC CO. LTD
141 Zhuzhou Road, Qingdao High-Tech Industrial Park, Shandong, P. R. China Tel : 86-532-88606600 Fax : 86-532-88606655E-mail : aide@inddiagnostic.com
Statement of Indications for Use [21 CFR 801. 109]
JUL 2 3 2007
K062703 510 (K) Number:
Deice Trade Name: One Step HCG Serum/Urine Combo Pregnancy Test Formats: Strip and Cassette
Indications for Use:
One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.
Sean Cooper, D.V.M
Division Sign-Off
610(k) Kole 27103
OR
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
§ 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.