Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCX — Predicate Candidate Screening
226 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
242 days90th percentile
226clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Ea | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 | 159 | 0 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 | 102 | 0 |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test | Assure Tech., LLC | 2025-02-13 | 28 | 0 |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 | 193 | 0 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregna | Assure Tech., LLC | 2025-01-15 | 57 | 0 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test | Andon Health Co, Ltd. | 2024-12-20 | 218 | 0 |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 | 255 | 0 |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 | 39 | 0 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Earl | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 | 106 | 0 |
| K232715 | Distinct® Digital Pregnancy Test | ACON Laboratories, Inc. | 2024-05-31 | 269 | 0 |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnanc | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 | 151 | 0 |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 2024-04-05 | 98 | 0 |
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 | 130 | 0 |
| K240025 | Clearblue® Early Detection Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 | 28 | 0 |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midst | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 | 133 | 0 |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023-10-13 | 210 | 0 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Ra | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 | 53 | 0 |
| K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 | 121 | 0 |
| K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-09-21 | 343 | 0 |
| K212418 | hCG One Step Pregnancy Test | Healstone Biotech, Inc. | 2022-06-30 | 331 | 0 |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Te | Co-Innovation Biotech Co., Ltd. | 2022-04-05 | 120 | 0 |
| K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022-03-10 | 398 | 0 |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022-02-18 | 197 | 0 |
| K200913 | Clearblue® Early Digital Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 | 494 | 2 |
| K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One S | Atlas Link Technology Co., Ltd. | 2021-08-04 | 273 | 0 |
| K193318 | Distinct® Early Detection Pregnancy Test | ACON Laboratories, Inc. | 2020-08-20 | 262 | 0 |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Tes | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-08-13 | 205 | 0 |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pre | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 | 29 | 0 |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregna | Innovita (Tangshan) Biological Technology Co., Ltd. | 2019-11-22 | 50 | 0 |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rap | Qingdao Hightop Biotech Co., Ltd. | 2019-09-05 | 30 | 0 |
| K182328 | VeriClear Digital Early Result Pregnancy Test | True Diagnostics, Inc. | 2019-05-15 | 261 | 0 |
| K190705 | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnan | Wholepower Biotech Co., Ltd. | 2019-04-15 | 27 | 0 |
| K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One | Runbio Biotech Co.,Ltd | 2019-02-22 | 254 | 0 |
| K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019-01-10 | 64 | 0 |
| K180771 | Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018-05-18 | 56 | 0 |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregn | Runbio Biotech Co.,Ltd | 2018-03-28 | 208 | 0 |
| K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018-03-12 | 159 | 0 |
| K172512 | ACRO HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018-02-02 | 165 | 0 |
| K171136 | LIA Pregnancy Test | Lia Diagnostics | 2017-11-20 | 217 | 0 |
| K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Te | Sugentech, Inc. | 2016-04-07 | 560 | 0 |
| K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | 2015-10-02 | 262 | 0 |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One S | Guangzhou Wondfo Biotech Co., Ltd. | 2015-08-07 | 213 | 0 |
| K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STE | Co-Innovation Biotech Co., Ltd. | 2013-11-12 | 130 | 0 |
| K131236 | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY | Ucp Biosciences, Inc. | 2013-11-07 | 190 | 0 |
| K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-09-10 | 294 | 0 |
| K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-08-26 | 292 | 2 |
| K131931 | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | Chemtron Biotech, Inc. | 2013-07-26 | 29 | 0 |
| K123703 | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE | Healgen Scientific,, LLC | 2013-04-10 | 128 | 3 |
| K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | Polymed Therapeutics, Inc. | 2013-03-14 | 174 | 0 |
| K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSE | Nantong Biotechnology Co., Ltd. | 2013-02-05 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda