510(k) · Cleared
Recalled · Class II · 2023First Response Early Result Pregnancy Test (Otc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Church & Dwight Co., Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Jun 8, 2009 as substantially equivalent to K030258 (Armkel, LLC, 2003) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1999. 17 later devices descend from it. It has been recalled once.
- Decided
- Jun 8, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- LCX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992232 (1999). 3 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 1 generation backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- This deviceK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009
- Descendant · cites it directly · 13 of its ownK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG…Guangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK123567 First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK213379 Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK251040 MissLan® Early Detection Digital Pregnancy Test; MissLan® Early…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K123436First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · cites it directly13descendants
- K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test…Guangzhou Wondfo Biotech Co., Ltd. · 2015 · 2 generations on6descendants
- K123567First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 2013 · cites it directly2descendants
- K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022 · 2 generations on1descendant
- K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…Guangzhou Decheng Biotechnology Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −1 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| 0 (this device) | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | — |
| +1 | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | 2 |
| +2 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K123567 | First Response Gold Digital Pregnancy Test | Church & Dwight Co., Inc. | 2013 | — |
| +2 | K213379 | Clearblue ® Early Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022 | — |
| +3 | K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K030258 | First Response Pregnancy Test | 2003 |
| * | K992232 | First Response 1-Step PregnancySummary page 1…[21 CFR §862.1155] 75 LCX; Class II Predicate Device: FIRST RESPONSE® Early Result Pregnancy Test 5io(k) #Ko30258 and#K992232 Description of Device: The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is… | 1999 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2023 | Class II | Z-1350-2023 | No Marketing Application | Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123436 (Church & Dwight Co., Inc., 2013) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K030258.
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. 2009, 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?
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period). This test is only intended for individual use at home. It is not intended for use in a healthcare setting. Important note regarding negative results: Some pregnant women…
Read the full statement (180 words)
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period).
This test is only intended for individual use at home. It is not intended for use in a healthcare setting.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 6 days before the missed period. If you test negative before your missed period, but think you may still be pregnant, you should re-test again a few days after your missed period.
Important note regarding positive results:
Because this test detects very low levels of hCG, there is a small chance that this test will give positive results even if you are not pregnant. Chances of this are greater for women nearing age 40 and older.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083716: First Response Early Result Pregnancy Test (Otc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083716
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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