510(k) · Cleared
ClearedInnovita HCG Pregnancy Rapid Combo Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovita (Tangshan) Biological Technology Co., Ltd. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Aug 2, 2024 as substantially equivalent to K203272 (Hangzhou AllTest Biotech Co., Ltd., 2022) after a 32-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Aug 2, 2024
- Review
- 32 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 deviceK241919 Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2024
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) | K241919 | Innovita HCG Pregnancy Rapid Combo Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024 | — |
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
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 4…uman chorionic Clinical Chemistry gonadotropin (HCG) test system 5. Predicate Devices: K203272, Alltest Pregnancy Rapid Combo Test Cassette 6. Intended Use The Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatog… | 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 22 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. 2024, 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?
Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241919: Innovita HCG Pregnancy Rapid Combo Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241919
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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