Product code LCX— Clinical Chemistry
CLEARBLUE EASY
- Classification name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Total cleared
- 226
- First cleared
- Most recent
Market context for product code LCX
FDA has cleared devices under product code LCX between 1978 and 2025, filed by 120 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2013
- 2012
- 2011
- 2009
Top applicants under product code LCX
Recent clearances under product code LCX
1–100 of 226- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
- K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more
- K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
- K241978 — Shinetell Digital Pregnancy Test
- K240643 — MissLan® Early Detection Pregnancy Test Strip +2 more
- K232715 — Distinct® Digital Pregnancy Test
- K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
- K234152 — ACESO Early Pregnancy Test
- K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- K240025 — Clearblue® Early Detection Pregnancy Test
- K232864 — EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
- K230741 — Macro & Micro-Test HCG Pregnancy Test Midstream
- K230038 — MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
- K222305 — MissLan Digital Pregnancy Rapid Test
- K213379 — Clearblue ® Early Pregnancy Test
- K212418 — hCG One Step Pregnancy Test
- K213808 — Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
- K210341 — One Step Pregnancy Test
- K212447 — SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
- K200913 — Clearblue® Early Digital Pregnancy Test
- K203246 — Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
- K193318 — Distinct® Early Detection Pregnancy Test
- K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
- K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
- K192843 — INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
- K192123 — HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
- K182328 — VeriClear Digital Early Result Pregnancy Test
- K190705 — WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
- K181551 — DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
- K183097 — Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
- K180771 — Acro HCG Pregnancy Rapid Test
- K172627 — David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
- K173229 — Preview Digital Pregnancy Test
- K172512 — ACRO HCG Pregnancy Rapid Test
- K171136 — LIA Pregnancy Test
- K142754 — Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
- K150063 — One Step hCG Pregnancy Test
- K150022 — Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
- K132085 — ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
- K131236 — UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
- K123567 — FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
- K123436 — FIRST RESPONSE EARLY RESULT PREGNANCY TEST
- K131931 — CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
- K123703 — HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
- K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
- K123050 — EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
- K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
- K103487 — FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
- K102760 — ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
- K103574 — PREGNANCY ONE STEP RAPID TEST
- K110889 — IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
- K110433 — CLEARBLUE EASY PREGNANCY TEST
- K081150 — RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
- K083716 — FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
- K071930 — ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
- K062703 — ONE STEP HCG PREGNANCY TEST
- K062096 — KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
- K070054 — FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
- K053236 — DAVID PREGNANCY TEST (MIDSTREAM)
- K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
- K060825 — MULTI-USE ELECTRONIC PREGNANCY TEST
- K053452 — PURE-AID PREGNANCY TEST
- K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST
- K053138 — MYSET PREGNANCY TEST
- K060019 — ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
- K051963 — BE-CERTAIN PREGNANCY TEST
- K050305 — ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
- K050546 — ACON +/- MIDSTREAM PREGNANCY TEST
- K050930 — E.P.T. CERTAINTY PREGNANCY TEST
- K043231 — PROOF POSITIVE ELECTRONIC PREGNANCY TEST
- K043443 — ONE STEP HCG URINE PREGNANCY TEST
- K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
- K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT
- K042151 — ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
- K041748 — AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
- K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST
- K041273 — ONE-STEP PREGNANCY TEST
- K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST
- K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
- K033658 — E.P.T. PREGNANCY TEST
- K032992 — UNIMARK HOME PREGNANCY TEST DEVICE
- K033041 — ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
- K031798 — GOOD MORNING TEST
- K032939 — EPT CERTAINTY PREGNANCY TEST
- K032661 — ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
- K032510 — ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
- K032159 — CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
- K031271 — ONE-STEP PREGNANCY TEST
- K030659 — CLEARBLUE EASY DIGITAL PREGNANCY TEST
- K030533 — ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
- K023037 — MID STREAM PREGNANCY TEST
- K030258 — FIRST RESPONSE PREGNANCY TEST
- K023638 — CASSETTE/URINE HCG
- K023027 — PREG-Q EARLY PREGNANCY TEST
- K023699 — CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
- K023126 — AMEDITECH IMMUTEST HCG PREGANCY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.