(30 days)
Immunoassay for in vitro diagnostic use in hospital, physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in urine for the early confirmation of pregnancy.
Not Found
I am sorry, but the provided text does not contain the detailed information needed to fill out all the sections of your request about acceptance criteria and study particulars for the BioSign™ hCG-One Step Pregnancy Test. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not typically include the nitty-gritty details of the studies conducted to demonstrate performance.
Here's what I can and cannot extract from the given text:
Information I CANNOT extract from the document:
- Acceptance Criteria Table and Reported Device Performance: This document does not specify exact acceptance criteria or detailed performance metrics like sensitivity, specificity, accuracy, or reported values from a study.
- Sample Size (Test Set) and Data Provenance: This information is not present.
- Number of Experts and Qualifications: Not mentioned in this regulatory letter.
- Adjudication Method: Not specified.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study and its results are not discussed.
- Standalone Performance: While the device is "one-step," the specific details of a standalone performance study with metrics are not included.
- Type of Ground Truth Used: The method for establishing ground truth (e.g., pathology, expert consensus) is not detailed.
- Sample Size (Training Set): Not provided.
- How Ground Truth for Training Set was Established: Not provided.
What I can infer/extract at a high level:
- Device Name: BioSign™ hCG-One Step Pregnancy Test
- Indications for Use: Immunoassay for in vitro diagnostic use in hospitals and physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) for the early confirmation of pregnancy.
- Ground Truth (Indirect Inference): For a pregnancy test, the ground truth would typically be established by a reference method for hCG detection (e.g., a laboratory quantitative hCG assay) or confirmed clinical pregnancy outcomes, but the document doesn't explicitly state which was used.
- Regulatory Context: This is a 510(k) premarket notification, indicating the device was cleared based on substantial equivalence to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics, or if different, that the differences do not raise new questions of safety or effectiveness. Performance data would have been submitted to support this claim, but those details are not in this letter.
To get the information you requested, you would typically need to refer to the 510(k) submission summary or detailed performance data submitted by Princeton BioMeditech Corporation to the FDA, which is not part of this clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 1997
Jemo Kanq, Ph.D. Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139
Re : K974425 BioSign™ hCG-One Step Pregnancy Test Regulatory Class: II Product Code: DHA Dated: November 20, 1997 Received: November 21, 1997
Dear Dr. Kang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 reclassified in accordance 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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 regulations.
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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 Sitman
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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Page_ 1__of_1
510(k) Number (if known):_ K 9 7 442 5
Device Name:BioSing hCG-_One_Step_Pregnancy Test
Indications For Use: Immunoassay for in vitro diagnostic use in hospital, Immunoassay for In vicro araysicians' offices for the qualitative detection of Human Chorionic the quarteaerve account of the early confirmation of pregnancy.
//McClewals for the Attorney
(Division Sign-Off) Division of Clinical Laboratory 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use_X Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
o
§ 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.