510(k) · Cleared
ClearedCards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Nov 26, 1997 after a 48-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Nov 26, 1997
- Review
- 48 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK973858 Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-ComboQuidel Corp. · 1997
- Descendant · cites it directly · 1 of its ownK152768 Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure…Assure Tech. Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC · 2025
- Descendant · cites it directly · 0 of its ownK131166 Sofia (R) HCG FiaQuidel Corp. · 2013
Most influential descendants
Showing 3 of 3 · See all- K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…Assure Tech. Co., Ltd. · 2016 · cites it directly1descendant
- K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC · 2025 · 2 generations on0descendants
- K131166Sofia (R) HCG FiaQuidel Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo | Quidel Corp. | 1997 | — |
| +1 | K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG… | Assure Tech. Co., Ltd. | 2016 | — |
| +2 | K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | 2025 | — |
| +1 | K131166 | Sofia (R) HCG Fia | Quidel Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152768 (Assure Tech. Co., Ltd., 2016) has gone furthest, with 1 descendant 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?
The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ hCG-Combo) is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.
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/K973858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973858: Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973858
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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