(55 days)
The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.
Not Found
The provided document does not contain enough information to complete the requested table and answer the questions regarding acceptance criteria and study details.
This document is a 510(k) clearance letter from the FDA for a device called "Maxie hCG Urine." It confirms that the device has been found substantially equivalent to a legally marketed predicate device. While it states the "Indications For Use" and the "cut off concentration of 20 mIU/ml" for early detection of pregnancy, it does not include:
- Specific acceptance criteria: The document doesn't outline a table of performance metrics (e.g., sensitivity, specificity, accuracy) that the device needed to meet.
- Study details: There is no mention of the study conducted to demonstrate the device's performance, including:
- Reported device performance values.
- Sample size (test or training set).
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC or standalone study details.
- Type of ground truth used.
- Training set information.
To provide the requested information, a separate study report or detailed submission document to the FDA would be necessary.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, with three wavy lines extending from the figure's head. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A."
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 2003
Ms. Martha Mazurek President Mainline Technology Inc. 3985 Research Park Drive Ann Arbor, MI 48108
K031445 Trade/Device Name: Maxie hCG Urine Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: April 3, 2003 Received: May 7, 2003
Dear Ms. Mazurek:
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 Putman
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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Ver/ 3 - 4/24/96
Applicant: Mainline Technology, Inc.
510(k) Number (if known):
Device Name: Maxie hCG Urine
Indications For Use:
The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and ﻨﺘ laboratory use.
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031445
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Over-the-Counter Use
Prescription Use
§ 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.