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K Number
K050930
Device Name
E.P.T. CERTAINTY PREGNANCY TEST
Manufacturer
UNIPATH LTD.
Date Cleared
2005-05-12

(28 days)

Product Code
LCX
Regulation Number
862.1155
Type
Special
Panel
CH
Reference & Predicate Devices
K050750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

e.p.t CertaintyTM Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.

Device Description

Not Found

AI/ML Overview

The provided text does not contain specific information about the acceptance criteria and the study that proves the device meets those criteria. It is a 510(k) clearance letter from the FDA for the 'e.p.t CertaintyTM Pregnancy Test'.

The document includes:

  • Device Name: e.p.t CertaintyTM Pregnancy Test
  • Regulation Number: 21 CFR 862.1155 (Human chorionic gonadotropin (HCG) test system)
  • Regulatory Class: Class II
  • Product Code: LCX
  • Indications For Use: Over-the-counter urine hCG test for the detection of pregnancy, indicated for use from the first day of the expected period and thereafter, and also from three days before the expected period.
  • 510(k) Number: K050750

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

To obtain this information, one would typically need to review the full 510(k) submission summary or associated clinical study reports, which are not provided in this document.

§ 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.