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K Number
K123703
Device Name
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
Manufacturer
HEALGEN SCIENTIFIC, LLC
Date Cleared
2013-04-10

(128 days)

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

The Healgen hCG One Step Pregnancy Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

The Healgen hCG One Step Pregnancy Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the Healgen hCG One Step Pregnancy Test Strip and Cassette. It confirms substantial equivalence to a predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication.

Therefore, I cannot fully answer your request with the input provided. However, I can infer some aspects based on common FDA requirements for such devices.

Here's what can and cannot be answered based on the provided text:

What can be extracted:

  • Device Name: Healgen hCG One Step Pregnancy Test Strip, Healgen hCG One Step Pregnancy Test Cassette
  • Indications for Use: Rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, for Over-The-Counter self-testing use.
  • Type of Test: In vitro diagnostic visual qualitative immunochromatographic assay.

What cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. It would be in the detailed device performance section of the 510(k) submission. Acceptance criteria for pregnancy tests typically include sensitivity (limit of detection, analytical sensitivity), accuracy (agreement with a reference method), and sometimes precision.
  2. Sample size used for the test set and the data provenance: Not available in this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. For an OTC pregnancy test, ground truth is usually based on a quantitative lab reference method for hCG.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not available.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Highly unlikely for a qualitative, visually read OTC pregnancy test. This type of study is more common for imaging devices or algorithms that interpret complex data. The performance would be assessed against a quantitative standard, not typically human readers.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a visual qualitative assay, meaning a human reads the result directly. It's not an algorithm.
  7. The type of ground truth used: For a pregnancy test, the ground truth for hCG detection is typically established by a quantitative laboratory method (e.g., quantitative serum or urine hCG assay) to determine the precise hCG concentration.
  8. The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" or "AI" that requires a training set in the conventional sense for a visual immunochromatographic assay.
  9. How the ground truth for the training set was established: Not applicable for the same reason as above.

To obtain this detailed information, one would need to review the actual 510(k) submission (if it's publicly available and unredacted) or scientific publications related to the device's validation.

§ 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.