510(k) · Cleared
ClearedAssure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assure Tech. Co., Ltd. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Feb 24, 2016 as substantially equivalent to K973858 (Quidel Corp., 1997) after a 153-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Feb 24, 2016
- Review
- 153 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973858 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973858 Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-ComboQuidel Corp. · 1997
- This deviceK152768 Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure…Assure Tech. Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo | Quidel Corp. | 1997 | — |
| 0 (this device) | K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG… | Assure Tech. Co., Ltd. | 2016 | — |
| +1 | K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | Assure Tech., LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K973858 | Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-ComboSummary page 4…5, Human chorionic Clinical Chemistry gonadotropin (HCG) test system 5. Predicate Devices: K973858, QuickVue+ One-Step hCG Combo test, Quidel Corporation 6. Intended Use The Assure Tech hCG Pregnancy Serum/Urine Combo Test (… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | 2025 | 0 |
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. 2016, 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 Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette 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 is intended for prescription use in clinical laboratories and point-of-care use settings. The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual…
Read the full statement (114 words)
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette 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 is intended for prescription use in clinical laboratories and point-of-care use settings.
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip 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 is intended for prescription use in clinical laboratories and point-of-care use settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152768
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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