510(k) · Cleared
ClearedTrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
True Diagnostics, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Dec 22, 2017 as substantially equivalent to K123436 (Church & Dwight Co., Inc., 2013) after a 149-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 22, 2017
- Review
- 149 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992232 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 3 generations backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- 2 generations backK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- 1 generation backK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
- This deviceK172257 TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX…True Diagnostics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −3 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| −2 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| −1 | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | 2 |
| 0 (this device) | K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early… | True Diagnostics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K123436 | First Response Early Result Pregnancy TestSummary page 8…ence Information: 1. Predicate device name(s): Church & Dwight Co., FIRST RESPONSE Early Result Pregnancy Test 2. Predicate K number(s): K123436 3. Comparison with predicate… | 2013 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 5 other devices also cite its predicate K123436.
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. 2017, 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?
TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Format) is rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative result: Some pregnant women will not be able to detect hCG in…
Read the full statement (345 words)
TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Format) is rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative result:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test against a few days after you missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decision about future medical care.
VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Format) is rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative result:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test against a few days after you missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decision about future medical care.
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/K172257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172257: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172257
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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