510(k) · Cleared
ClearedAcro HCG Pregnancy Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acro Biotech, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on May 18, 2018 as substantially equivalent to K172512 (Acro Biotech, Inc., 2018) after a 56-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 18, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914253 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK914253 Proclinic One Step Pregnancy TestVanguard Biomedical Corp. · 1991
- 2 generations backK960733 Ministick Pregnancy TestVanguard Biomedical Corp. · 1996
- 1 generation backK172512 ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc. · 2018
- This deviceK180771 Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914253 | Proclinic One Step Pregnancy Test | Vanguard Biomedical Corp. | 1991 | — |
| −2 | K960733 | Ministick Pregnancy Test | Vanguard Biomedical Corp. | 1996 | — |
| −1 | K172512 | ACRO HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018 | — |
| 0 (this device) | K180771 | Acro HCG Pregnancy Rapid Test | Acro Biotech, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K172512 | ACRO HCG Pregnancy Rapid TestSummary page 5…Glucose Monitoring System noted below. Name: ACRO HCG Pregnancy Rapid Test Device Company: ACRO Biotech, Inc. 510(K) Number: K172512 7. Comparison to Predicate Devices: The ACRO HCG Pregnancy Rapid Test is an identical device (with or without absorbent… | 2018 |
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 27 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
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. 2018, 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 ACRO hCG Pregnancy Rapid Test is for use by the over the counter consumers for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180771: Acro HCG Pregnancy Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180771
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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