(49 days)
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No
The description details a traditional latex slide agglutination test, which is a chemical reaction-based method and does not involve AI/ML.
No
This device is a diagnostic tool used to detect pregnancy, not to treat or cure a disease or condition.
Yes
The device is described as an aid in "early diagnosis of pregnancy," which directly indicates a diagnostic purpose.
No
The device description clearly states it is a "rapid direct color enhanced latex slide agglutination test," which is a physical laboratory test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy". This involves testing a biological sample (presumably urine or serum, though not explicitly stated, it's implied by the nature of a pregnancy test) in vitro (outside the body).
- Purpose: The purpose is to be used as an "aid in the early diagnosis of pregnancy". This is a diagnostic purpose.
- Method: It uses a "latex slide agglutination test", which is a common method for in vitro diagnostic tests.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to provide information for diagnosis, monitoring, or screening. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The PREGNACOL™ PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.
Product codes
JHJ
Device Description
PREGNACOL™ PREGNANCY TEST
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical and hospital laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Mycock Laboratory Director Immunostics, Inc. 3505 Sunset Avenue Ocean, New Jersey 07712 - ----
AUG 2 9 1997
Re : K972606/S1 Immunostics, Inc., Pregnacol™ Pregnancy Test Trade Name: Regulatory Class: II Product Code: JHJ Dated: August 7, 1997 Received: August 11, 1997
Dear Mr. Mycock:
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 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 (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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFK 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 action. In addition, FDA may publish further announcements 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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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Quality Microbiological, Serological and Immunological Reagents
K972600 510(k) Number (if known):
Device Name:_
PREGNACOL™PREGNANCY TEST
Indications for Use: . . . . .
The PREGNACOL PREGNANCY TEST is a rapid direct color enhanced latex slide agglutination test for the qualitative and semiquanitative detection of elevated levels of human chorionic gonadotropin (hCG) associated with pregnancy and is to be used as an aid in the early diagnosis of pregnancy. This test is to be used in clinical and hospital laboratories and is not for Doctor office use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
OR
Over-the-Counter Use_
(Division Sign-Off) | |
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Division of Clinical Laboratory Devices | |
510(k) Number | K972606 |
3505 Sunset Avenue, Ocean, New Jersey 07712 • 732-918-0770 • FAX 732-918-0618
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