510(k) · Cleared
Recalled · Class II · 2026Acon HCG One Step Pregnancy Test Device (Urine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Dec 1, 1999 after a 58-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 1, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK993317 Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK123050 Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette…Nantong Biotechnology Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy…Hangzhou Clongene Biotech Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK212447 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK102760 Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical · 2011
Most influential descendants
Showing 4 of 4 · See all- K123050Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and…Nantong Biotechnology Co., Ltd. · 2013 · cites it directly2descendants
- K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Hangzhou Clongene Biotech Co., Ltd. · 2019 · 2 generations on1descendant
- K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022 · 3 generations on0descendants
- K102760Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993317 | Acon HCG One Step Pregnancy Test Device (Urine) | ACON Laboratories, Inc. | 1999 | — |
| +1 | K123050 | Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I… | Nantong Biotechnology Co., Ltd. | 2013 | — |
| +2 | K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test… | Hangzhou Clongene Biotech Co., Ltd. | 2019 | — |
| +3 | K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test… | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022 | — |
| +1 | K102760 | Atlas Home Pregnancy Test (Midstream Format) Model 70172001 | Atlas Medical | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3274-2026 | Device Design | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| Jan 21, 2013 | Class III | Z-1344-2013 | Labeling mix-ups | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123050 (Nantong Biotechnology Co., Ltd., 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993317: Acon HCG One Step Pregnancy Test Device (Urine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993317
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026