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Sas One Step Pregnancy

FDA 510(k)

Class II (US FDA 510(k))

510(k) K926204

by Sa Scientific, Inc.

Identifiers

510(k) Number
K926204 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)

SAS ONE STEP PREGNANCY is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is a rapid, visual, in vitro diagnostic test for qualitative hCG detection in urine.

This test is for professional use only. It is supplied as a prescription use device and has received FDA 510(k) clearance under K926204. The device is classified under regulation number 862.1155 and product code JHI, with a device class of 2.

Frequently asked questions

What is SAS ONE STEP PREGNANCY used for?

SAS ONE STEP PREGNANCY is used for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is a rapid, visual, in vitro diagnostic test designed for professional use only.

How is SAS ONE STEP PREGNANCY supplied and is it sterile or single-use?

The device is supplied as a prescription use device for professional use. While the data does not specify sterility or single-use details, it is formatted as a rapid visual test, which typically implies single-use application in clinical settings.

What regulatory pathway was used for SAS ONE STEP PREGNANCY and what is its classification?

SAS ONE STEP PREGNANCY received FDA 510(k) clearance under K926204 and is classified as a Class II device under regulation number 862.1155 with product code JHI, falling under the Clinical Chemistry specialty.

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: SAS ONE-STEP PREGNANCY (K990741) - FDA 510 (k), SAS ONE-STEP PREGNANCY (K990741) — FDA 510 (k) | Innolitics, SAS ONE STEP PREGNANCY (K926204) — FDA 510 (k) | Innolitics, SAS One-Step Pregnancy - MedEquip Directory, SAS ONE-STEP PREGNANCY (K990741) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K926204 24 fields · synced Oct 1, 2026