(79 days)
One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.
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The provided text is a 510(k) premarket notification approval letter for a medical device called "One Step HCG Pregnancy Test 2000 mIU / mL." This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information needed to answer the specific questions about acceptance criteria and device performance as typically found in a clinical study report.
Therefore, I cannot provide a comprehensive answer to your request based on the given input. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Details on standalone algorithm performance.
- Type of ground truth used (beyond implying a "determination of human chorionic gonadotropin (HCG) concentration").
- Sample size for the training set.
- How ground truth for the training set was established.
The document states the device is a "qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL to aid in the detection of pregnancy." This implies that the device's performance would be evaluated based on its accuracy (sensitivity and specificity) in detecting HCG at or above the 2000 mIU/mL threshold against a known reference method or clinical outcome, but the specific study details are not present.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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DEC 16 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jason Peng Regulatory Affairs Manager IND Diagnostic Inc. 1629 Fosters Way Delta, BC V3M 6S7 Canada
Re: K052694
Trade/Device Name: One Step HCG Pregnancy Test 2000 mlU / mL Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 22, 2005 Received: September 28, 2005
Dear Mr. Peng:
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. 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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Indications for Use
510(k) Number (if known): K052694
One Step HCG Pregnancy Test 2000 mIU / mL Device Name:
One Step HCG Pregnancy Test 2000 mIU / mL is a Indications For Use: qualitative, two sites sandwich immunoassay test device for the determination of human chorionic designed gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Devices (OIVD)
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052694
§ 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.