510(k) · Cleared
ClearedVictorch Meditek's HCG Test Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victorch Meditek, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Dec 27, 2001 after a 50-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 27, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- DHA
- 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 DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 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 SureStep hCG Test 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 DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card device (also known as: VicTorch hCG Test Card) 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 Card devices…
Read the full statement (187 words)
The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card device (also known as: VicTorch hCG Test Card) 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 Card 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 Card devices are not intended for quantitative resuits, nor for over the counter (OTC) sales. VicTorch hCG Test Card 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 result.
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/K013678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013678: Victorch Meditek's HCG Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026