510(k) · Cleared
ClearedVictorch HCG Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victorch Meditek, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Dec 27, 2001 after a 49-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 27, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | ABI's SureStrip™ hCG pregnancy rapid test devices Named without a submission number |
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.
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 VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also known as: VicTorch hCG Test Strip) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCl) assay for the early detection of pregnancy, providing a quick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mIU hCG/ml of human urine. VicTorch hCG Test Strip…
Read the full statement (187 words)
The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also known as: VicTorch hCG Test Strip) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCl) assay for the early detection of pregnancy, providing a quick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mIU hCG/ml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCl assay of hCG, a placental hormone that may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use only, and provide only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical resuit.
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/K013702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013702: Victorch HCG 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/K013702
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026