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Home Access Hepatitis C Check Test

by Pwn Health Chicago, LLC

PMA P980046

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P980046↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP980046 Date28 Apr 1999ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0150-2007 FDA Unclassified (pre-2012) initiated 6 Oct 2006 on shared PMA P980046

    Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Home Access Hepatitis C Check and Hepatitis C Check Express
Generic Name
Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use
PMA Number
FDA Product Code
QRO
Advisory Committee
Microbiology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an immunoassay for the detection of antibody to Hepatitis C Virus (HCV), classified under microbiology diagnostics. It is designed for over-the-counter use to screen adults aged 18 and older for potential exposure to HCV, including historical risks such as blood transfusions or organ transplants prior to 1992, intravenous drug use, or contact with infected needles or individuals.

The test is intended for home use and involves collecting a dried blood spot specimen via finger-stick. Supplied as a single-use diagnostic kit, it requires no sterile environment and is approved under FDA_PMA (P980046). Storage and handling instructions are specified in the accompanying documentation, ensuring proper use and interpretation of results by the end user.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What age group is this test designed for, and what types of exposure risks does it screen for?

    This test is designed for adults aged 18 and older. It screens for potential exposure to Hepatitis C Virus (HCV) through historical risks such as blood transfusions or organ transplants before 1992, intravenous drug use, or contact with infected needles or individuals. It helps identify individuals who may have been exposed to HCV, allowing for early awareness and potential follow-up testing.

  • How is the specimen collected for this test, and is a sterile environment required?

    The specimen is collected via a dried blood spot obtained through a finger-stick. No sterile environment is required for this procedure, making it suitable for home use. The test kit is designed to simplify the collection process for the end user.

  • Is this test intended for single-use only, and how should it be stored?

    Yes, this test is supplied as a single-use diagnostic kit. Storage and handling instructions are provided in the accompanying documentation to ensure proper use and interpretation of results. Always follow the manufacturer’s guidelines for storage to maintain the test’s integrity.

  • What regulatory pathway was followed for this device, and what does that mean for its use?

    This device was approved under the FDA’s Premarket Approval (PMA) pathway, specifically with PMA number P980046. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use, which is home-based screening for HCV antibody in adults aged 18 and older. The approval confirms the test’s compliance with regulatory standards for over-the-counter diagnostic use.