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Directaclone CG Slide Pregnancy Test

by Pacific Biotech, Inc. 510(k)

Active United States

510(k) K860945

Overview

The Directaclone CG Slide Pregnancy Test is an agglutination‑based in‑vitro diagnostic device that detects human chorionic gonadotropin (HCG) in plasma or urine for early pregnancy detection. It utilizes a slide format to provide a visual result indicating the presence of the placental hormone.

The test is cleared under FDA 510(k) (K860945) as a Class II device with a traditional clearance type and product code JHJ. It is supplied as a single‑use slide, intended for clinical chemistry laboratories, and is regulated as a human chorionic gonadotropin test system.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860945 Date2 May 1986ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Directaclone CG Slide Pregnancy Test used for?

    The Directaclone CG Slide Pregnancy Test is an agglutination-based in vitro diagnostic device designed to detect human chorionic gonadotropin (HCG) in plasma or urine specimens for the purpose of early pregnancy detection. It provides a visual result on a slide format to indicate the presence of the placental hormone HCG, which is produced during pregnancy. This test is intended for use in clinical chemistry laboratories where qualitative assessment of HCG levels is needed to support pregnancy diagnosis.

  • How is the Directaclone CG Slide Pregnancy Test supplied and is it reusable?

    The device is supplied as a single-use slide, meaning each test unit is intended for one application only and should not be reused. This design ensures test integrity and prevents cross-contamination between patient samples. As a single-use in vitro diagnostic, it is discarded after use according to standard laboratory biohazard waste procedures. Reuse is not recommended or supported by the device's design or labeling.

  • What regulatory pathway was used for the Directaclone CG Slide Pregnancy Test, and what class is it?

    The Directaclone CG Slide Pregnancy Test received regulatory clearance through the FDA 510(k) process under submission number K860945. It is classified as a Class II medical device, which indicates it requires special controls to ensure safety and effectiveness. The clearance was granted as a traditional 510(k) with a finding of substantial equivalence to a legally marketed predicate device. The product code assigned to this device is JHJ, which corresponds to agglutination-based human chorionic gonadotropin test systems.