Answer At-Home Pregnancy Test Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K802660 ↗

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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• Brand Name 1-Step Pregnancy Test-May Be Marketed Under First Response, Answer, or Other Brand Names

  Class II

  FDA 510(k) K962183 Active Cleared 10 Jul 1996

See all devices from Armkel, LLC →

• How does the Answer At-Home Pregnancy Test Kit work, and what does it detect in urine?

  The Answer At-Home Pregnancy Test Kit detects the presence of human chorionic gonadotropin (hCG), a hormone produced during pregnancy, using an agglutination method. This qualitative test provides a simple yes-or-no result indicating whether hCG is present in the urine, which can confirm pregnancy status.

• Is this pregnancy test kit meant for clinical use, or is it designed for home testing?

  This kit is explicitly designed for over-the-counter, at-home use by individuals seeking to determine pregnancy status without clinical supervision. It does not require medical oversight or professional administration.

• What storage conditions are required for the Answer At-Home Pregnancy Test Kit?

  The kit does not require special storage conditions beyond what is recommended on the packaging. It is a single-use, non-sterile device, so it should be stored according to the manufacturer’s instructions to maintain its intended performance.

• Is this pregnancy test reusable, or is it intended for one-time use?

  The Answer At-Home Pregnancy Test Kit is explicitly labeled as a single-use device. Each kit is intended for one test only and should not be reused.

• What regulatory pathway was followed for FDA clearance of this pregnancy test kit?

  The device was cleared through the FDA’s 510(k) pathway, specifically under Traditional Review with a Substantively Equivalent (SESE) determination by the Clinical Chemistry (CH) Advisory Committee. It was classified as a Class II device under product code JHJ and is legally marketed as equivalent to predecessors.