510(k) · Cleared
ClearedChemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on May 30, 2013 as substantially equivalent to K990578 (Wyntek Diagnostics, Inc., 1999) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 30, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964461 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964461 One -Step Urine/Serum Combo Pregnancy Card TestTeco Diagnostics · 1997
- This deviceK123844 Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette…Chemtron Biotech, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964461 | One -Step Urine/Serum Combo Pregnancy Card Test | Teco Diagnostics | 1997 | — |
| 0 (this device) | K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and… | Chemtron Biotech, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K990578 | Osom Card II HCG-Urine Test, Model 102Summary page 4…510(k) k number IGenzyme Diagnostics OSOM' Card hCG Urine Test K990578 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test K964461 2. Comparison with predic… | 1999 |
| * | K964461 | One -Step Urine/Serum Combo Pregnancy Card TestSummary page 4…ard hCG Urine Test K990578 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test K964461 2. Comparison with predicate: The Chemntrue® hCG Pregnancy test device is similar to the predicate(s) with regard to the technol… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K990578.
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. 2013, 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 Chemntrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only. The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC). The Chemntrue® hCG Pregnancy…
Read the full statement (199 words)
The Chemntrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
The Chemntrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.
The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).
The Chemntrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only.
The test kits are for prescription use including professionals at physician's office laboratories (POLs) or Point-Of-Care site (POC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123844: Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123844
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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