510(k) · Cleared
ClearedUnimark HCG Combo Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotech Atlantic, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Oct 10, 2001 as substantially equivalent to K941090 (Biotech Atlantic, Inc., 1994) after a 15-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 10, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941090 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- This deviceK013194 Unimark HCG Combo Pregnancy TestBiotech Atlantic, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| 0 (this device) | K013194 | Unimark HCG Combo Pregnancy Test | Biotech Atlantic, Inc. | 2001 | — |
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 |
|---|---|---|---|
| * | K941090 | Unistep HCG Pregnancy Test StripSummary page 1…nancy Test Common Name: hCG Pregnancy Test Classification Name: Human Chorionic Gonadotropin (hCG) Test System C. Legally Marketed Device UniMark® hCG Pregnancy Test, K941090 D. Device Description UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elev… | 1994 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K941090.
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?
UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.
It is indicated for use in the early detection of pregnancy.
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/K013194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013194: Unimark HCG Combo Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013194
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026