510(k) · Cleared
ClearedInstant-View® hCG Combo II Cassette Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Sep 22, 2026 as substantially equivalent to K203272 (Hangzhou AllTest Biotech Co., Ltd., 2022) after a 77-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Sep 22, 2026
- Review
- 77 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020801 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK020801 Quickvue One-Step HCG-ComboQuidel Corp. · 2002
- 2 generations backK132834 Fastep S10 HCG Serum/Urine Combo TestPolymed Therapeutics, Inc. · 2014
- 1 generation backK203272 Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022
- This deviceK262299 Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020801 | Quickvue One-Step HCG-Combo | Quidel Corp. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | 2026 | — |
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 K203272 Alltest Pregnancy Rapid Combo Test Cassettescore 9.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K203272 | Alltest Pregnancy Rapid Combo Test CassetteSummary page 5…man chorionic Clinical Chemistry gonadotropin (HCG) test system 5. Predicate Device: K203272, Alltest Pregnancy Rapid Combo Test Cassette 6. Intended Use The Instant-View® hCG Combo II Cassette Test is a chromatographi… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K203272.
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. 2026, 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 Instant-View® hCG Combo II Cassette Test is a chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. It is for use as an aid in the early detection of pregnancy.
This test is for health care professional use only and not for self-testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262299 · printed Nov 4, 2026
Cite this page
510(k) Report. “K262299: Instant-View® hCG Combo II Cassette Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K262299
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026