Skip to content

Beta-HCG Microtiter Pregnancy Test

by Modern Diagnostics, Inc.

510(k) K853258

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853258 Date1 Oct 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Beta-HCG Microtiter Pregnancy Test is a visual, prescription-use in vitro diagnostic device designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It functions as a pregnancy test by identifying the presence of the hormone hCG, which is produced during pregnancy, enabling early detection of gestation.

This device is supplied as a single-use, non-sterile reagent kit intended for use in clinical chemistry settings. It requires no special storage conditions beyond those specified in the accompanying instructions and is classified under FDA regulation 862.1155. The test has received FDA 510(k) clearance as substantially equivalent to a predicate device, with the advisory committee classification falling under Clinical Chemistry.

Other devices from Modern Diagnostics, Inc.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Beta-HCG Microtiter Pregnancy Test used for?

    This device is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples. HCG is a hormone produced during pregnancy, so the test helps confirm early gestation by identifying its presence. It is intended for use in clinical chemistry settings as a visual, prescription-only diagnostic tool.

  • How is the Beta-HCG Microtiter Pregnancy Test supplied and stored?

    The test is supplied as a single-use, non-sterile reagent kit. Storage requirements are standard and detailed in the accompanying instructions. Unlike sterile devices, it does not require specialized conditions like refrigeration or sterile packaging, making it practical for routine clinical use.

  • Is this test single-use or reusable?

    The Beta-HCG Microtiter Pregnancy Test is explicitly designed for single-use only. This ensures accuracy and reliability for each test, as reuse could compromise results due to potential contamination or degradation of the reagents over time.

  • What regulatory approval does this device hold?

    The Beta-HCG Microtiter Pregnancy Test has received FDA 510(k) clearance, meaning it has been determined to be substantially equivalent to a predicate device already on the market. This clearance falls under the Clinical Chemistry advisory committee classification and is classified under FDA regulation 862.1155.

  • Can this test be used outside of clinical chemistry labs?

    The test is specifically intended for use in clinical chemistry settings as outlined in its design and regulatory classification. While it is a visual test, its prescription-use classification and reliance on controlled laboratory conditions make it unsuitable for home or non-clinical use without proper medical supervision.