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WH Accu Test Pregnancy Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012284

by W.h.p.m. Inc.

Identifiers

510(k) Number
K012284 FDA 510(k)
FDA Product Code
JHI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1155 FDA 510(k)
Regulation Number
862.1155 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The WH Accu Test Pregnancy Test is a visual, prescription-use pregnancy diagnostic device designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It functions as a lateral flow immunoassay, utilizing monoclonal-dye conjugate and polyclonal-solid phase antibodies to identify pregnancy biomarkers.

This single-use, non-sterile device is intended for laboratory professional use only and is classified as a Class II medical device under FDA regulations. Supplied in various lot-specific reference codes, it requires no special storage conditions beyond standard laboratory practices and is regulated under the FDA’s 510(k) clearance process (K012284).

Frequently asked questions

What is the primary purpose of the WH Accu Test Pregnancy Test and who should use it?

The WH Accu Test Pregnancy Test is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine, a key biomarker for pregnancy. It is intended exclusively for laboratory professionals—not for home or point-of-care use—and is classified as a prescription-use device. This means it requires professional interpretation and is not meant for self-diagnosis.

How is the WH Accu Test Pregnancy Test supplied, and what should I know about its storage?

The device is supplied in single-use units with lot-specific reference codes (e.g., 3013332582, 3006198300, etc.). It is non-sterile, so standard laboratory hygiene practices apply. No special storage conditions are required beyond typical laboratory environments—simply maintain it in a clean, dry space away from extreme temperatures or direct sunlight.

Is the WH Accu Test Pregnancy Test reusable, or is it designed for one-time use?

The WH Accu Test Pregnancy Test is explicitly labeled as a single-use device. After one test procedure, it should be discarded to ensure accuracy and prevent cross-contamination. Reuse is not recommended or supported by the manufacturer.

What regulatory pathway does the WH Accu Test Pregnancy Test follow, and how was its equivalence determined?

The device was cleared through the FDA’s 510(k) process (K012284), specifically under the Traditional pathway, and was determined to be substantially equivalent to a predicate device. The Clinical Chemistry (CH) Advisory Committee reviewed it, and its classification as a Class II device reflects its moderate risk level. The clearance was granted in 2001 based on scientific evidence of equivalence.

Are there multiple models or sizes available for the WH Accu Test Pregnancy Test, or is it a uniform product?

The WH Accu Test Pregnancy Test is not described as having varying sizes or models in the provided data. However, it is supplied across multiple lot-specific reference codes (over 100 listed), which may correspond to batch variations or packaging formats rather than distinct device configurations. All lots function identically for detecting hCG.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fertility Diagnostics Products - US - US — W.H.P.M., Inc.® Industry ..., Wh Accu Test One-step Urine/Serum Combo Pregnancy Test, WH ACCU TEST PREGNANCY TEST (K012284) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
W.h.p.m. Inc.
FDA Applicant
W.H.P.M., Inc.

Sources (1)

  • FDA 510(k) K012284 24 fields · synced Sep 19, 2026