510(k) · Cleared
ClearedDAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Runbio Biotech Co.,Ltd · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Feb 22, 2019 as substantially equivalent to K123436 (Church & Dwight Co., Inc., 2013) after a 254-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Feb 22, 2019
- Review
- 254 days
- Class
- Class II
- Product code
- LCX
- 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 deviceK181551 DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step…Runbio Biotech Co.,Ltd · 2019
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) | K181551 | DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use… | Runbio Biotech Co.,Ltd | 2019 | — |
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 LCX? 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 LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 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 11…ubstantial Equivalence Information 1.Predicate Device Name(s)： Church & Dwight Co., Inc., FIRST RESPONSE Early Result Pregnancy Test 2.Predicate 510（K）Number(s): k123436 3. Comparison with predicate Similarities Item Pr… | 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 20 years and passes through 3 companies; a new generation was cleared every 5.5 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 LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, 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 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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. This product is intended for prescription use. DAVID One Step Prescription…
Read the full statement (374 words)
DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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.
This product is intended for prescription use.
DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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.
This product is intended for prescription use.
DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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.
This product is intended for over-the-counter use.
DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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.
This product is intended for over-the-counter use only.
DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases 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.
This product is intended for over-the-counter use.
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/K181551 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181551: DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181551
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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