Product code LCX: 510(k) clearances and predicates
Product code LCX covers MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test. FDA lists 226 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
226 clearances on file under product code LCX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 2 |
| 2024 | 10 |
| 2025 | 5 |
| 2026 so far | 0 |
Recent clearances
Newest LCX clearances in the FDA index, with applicant and decision date:
- K251040, MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test, applicant Guangzhou Decheng Biotechnology Co., Ltd., decided 2025-09-09. FDA record
- K251053, Shinetell PlusTM Digital Early Pregnancy Test, applicant Hangzhou AllTest Biotech Co., Ltd., decided 2025-07-15. FDA record
- K250117, FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette, applicant Assure Tech., LLC, decided 2025-02-13. FDA record
- K242135, Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream, applicant Nanjing Synthgene Medical Technology Co., Ltd., decided 2025-01-31. FDA record
- K243573, FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream, applicant Assure Tech., LLC, decided 2025-01-15. FDA record
- K241394, iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip, applicant Andon Health Co, Ltd., decided 2024-12-20. FDA record
- 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), applicant Anhui Deepblue Medical Technology Co., Ltd., decided 2024-10-11. FDA record
- K241978, Shinetell Digital Pregnancy Test, applicant Hangzhou AllTest Biotech Co., Ltd., decided 2024-08-13. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Shinetell PlusTM Digital Early Pregnancy Test, FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette. Watch new LCX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LCX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LCX clearances include MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test.
How many 510(k) clearances use product code LCX?
226 at the time this page was generated, from openFDA records.
How do I find a predicate device under LCX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LCX clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for LCX, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free LCX brief
Tell us where to send it. No card required.
You are on the list.
We will email your free LCX brief shortly. LCX is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.