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K Number
K972606
Device Name
PREGNACOL PREGNANCY TEST
Manufacturer
IMMUNOSTICS, INC.
Date Cleared
1997-08-29

(49 days)

Product Code
JHJ
Regulation Number
862.1155
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for the Immunostics, Inc., Pregnacol™ Pregnancy Test. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.

The letter explicitly states:

  • "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..."
  • "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."

This kind of communication from the FDA confirms market clearance based on substantial equivalence, but it does not typically include the underlying scientific studies, acceptance criteria, or performance data details that were submitted by the manufacturer in their 510(k) submission.

To get the information you are requesting, you would need to access the actual 510(k) submission document (K972606) from the FDA, which is usually found in their public database or through a Freedom of Information Act (FOIA) request.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done
  6. If a standalone performance was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

Based solely on the provided text.

§ 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.