FDA product code JHI: Visual, Pregnancy Hcg, Prescription Use
JHI is the FDA product code for visual, pregnancy hcg, prescription use. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. FDA has cleared 375 510(k) submissions under JHI, 2 in the last five years, from 155 different applicants. The average 510(k) review took 70 days (median 55); 32 days on average over the last three years. FDA has posted 47 recalls for JHI devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JHI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 149 |
| 2018 | 1 | 240 |
| 2022 | 1 | 451 |
| 2024 | 1 | 32 |
Compare with all 510(k) review times · Search every JHI clearance
Top JHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quidel Corp. | 19 | 2013-08-02 |
| Abbott Laboratories | 15 | 1997-02-20 |
| Hybritech, Inc. | 14 | 1987-06-03 |
| Pacific Biotech, Inc. | 13 | 1989-11-13 |
| Leeco Diagnostics, Inc. | 10 | 1988-03-15 |
150 more applicants have JHI clearances. See the full list in Caduvo.
Most recent JHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241919 | Innovita (Tangshan) Biological Technology Co., Ltd. | Innovita HCG Pregnancy Rapid Combo Test | 2024-08-02 | 32 |
| K203272 | Hangzhou AllTest Biotech Co., Ltd. | Alltest Pregnancy Rapid Combo Test Cassette | 2022-01-31 | 451 |
| K172322 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Total hCG (ThCG) | 2018-03-29 | 240 |
| K172257 | True Diagnostics, Inc. | 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) | 2017-12-22 | 149 |
| K152768 | Assure Tech. Co., Ltd. | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip | 2016-02-24 | 153 |
Recalls for JHI devices
47 product recalls in 28 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code JHI?
JHI is the FDA product code for visual, pregnancy hcg, prescription use. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is JHI?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHI?
Across 375 cleared submissions the average was 70 days from receipt to decision (median 55).
Which companies have the most JHI clearances?
Quidel Corp. (19); Abbott Laboratories (15); Hybritech, Inc. (14); Pacific Biotech, Inc. (13); Leeco Diagnostics, Inc. (10).
Have JHI devices been recalled?
Yes: 47 product recalls across 28 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JHI
- Run a recall and safety report across every JHI manufacturer
- Watch product code JHI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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