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FDA 510(k)

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

K-Number: K243573 · 2025-01-15

ApplicantAssure Tech., LLC
Decision Date2025-01-15
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream is a medical device manufactured by Assure Tech., LLC. It received FDA 510(k) clearance on 2025-01-15 under approval number K243573. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream?

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2025-01-15. It is manufactured by Assure Tech., LLC. The 510(k) number is K243573.

When was FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream approved by the FDA?

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2025-01-15, under approval number K243573.

What company makes FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream?

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream is manufactured by Assure Tech., LLC.

What is the FDA product code for FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream?

The FDA product code for FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream is LCX.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT07600398 ReDS-Guided Decongestion in Acute Heart Failure (ReDS-LATAM HF) ACTIVE_NOT_RECRUITING NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT05880381 Virtual Reality for Coping With Involuntary Early Pregnancy Loss COMPLETED NCT06645106 Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department RECRUITING

Related PubMed Literature

PMID: 40135040 Integrating Ethical Principles Into the Regulation of AI-Driven Medical Software. Cureus (2025)

Other Devices by Assure Tech., LLC

K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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