Product code JHI: 510(k) clearances and predicates
Product code JHI covers Instant-View® hCG Combo II Cassette Test. FDA lists 376 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
376 clearances on file under product code JHI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 0 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 1 |
Recent clearances
Newest JHI clearances in the FDA index, with applicant and decision date:
- K262299, Instant-View® hCG Combo II Cassette Test, applicant Alfa Scientific Designs, Inc., decided 2026-09-22. FDA record
- K241919, Innovita HCG Pregnancy Rapid Combo Test, applicant Innovita (Tangshan) Biological Technology Co., Ltd., decided 2024-08-02. FDA record
- K203272, Alltest Pregnancy Rapid Combo Test Cassette, applicant Hangzhou AllTest Biotech Co., Ltd., decided 2022-01-31. FDA record
- K172322, Atellica IM Total hCG (ThCG), applicant Siemens Healthcare Diagnostics, Inc., decided 2018-03-29. FDA record
- K172257, TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format), applicant True Diagnostics, Inc., decided 2017-12-22. FDA record
- K152768, Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip, applicant Assure Tech. Co., Ltd., decided 2016-02-24. FDA record
- K130456, WUNDER PREGNANCY TEST, applicant James Nguyen, decided 2014-04-08. FDA record
- K132834, FASTEP S10 HCG SERUM/URINE COMBO TEST, applicant Polymed Therapeutics, Inc., decided 2014-01-09. 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 Innovita HCG Pregnancy Rapid Combo Test, Alltest Pregnancy Rapid Combo Test Cassette. Watch new JHI 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 JHI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JHI clearances include Instant-View® hCG Combo II Cassette Test.
How many 510(k) clearances use product code JHI?
376 at the time this page was generated, from openFDA records.
How do I find a predicate device under JHI?
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 JHI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.