510(k) · Cleared
ClearedFastep S10 HCG Serum/Urine Combo Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymed Therapeutics, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Jan 9, 2014 as substantially equivalent to K020801 (Quidel Corp., 2002) after a 121-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Jan 9, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020801 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020801 Quickvue One-Step HCG-ComboQuidel Corp. · 2002
- This deviceK132834 Fastep S10 HCG Serum/Urine Combo TestPolymed Therapeutics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK203272 Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK262299 Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241919 Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022 · cites it directly2descendants
- K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026 · 2 generations on0descendants
- K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020801 | Quickvue One-Step HCG-Combo | Quidel Corp. | 2002 | — |
| 0 (this device) | K132834 | Fastep S10 HCG Serum/Urine Combo Test | Polymed Therapeutics, Inc. | 2014 | — |
| +1 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022 | — |
| +2 | K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | 2026 | — |
| +2 | K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020801 | Quickvue One-Step HCG-ComboSummary page 1…, Human chorionic Ciia hmsr __________ gonadotropin_(HCG)_test system _____________ 5. Predicate Devices: K020801, QuickVue One-Step hCG Combo test Quidel Corporation 6. Intended Use The Fastep SbO hCG Serum/Urine Combo Test is a r… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | 2022 | 2 |
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?
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. 2014, this device’s year, is highlighted.
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 Fastep SI10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the
qualitative, presumptive detection of human chorionic gonadotropin in human urine or
serum specimens. This kit is intended for use as an aid in early detection of pregnancy.
This product isonly intended for prescription use in clinical laboratories and is not
intended for point-of-care use settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132834: Fastep S10 HCG Serum/Urine Combo Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132834
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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