510(k) · Cleared
ClearedActim Prom and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medix Biochemica · OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Cleared on Jan 25, 2007 as substantially equivalent to K030849 (N-Dia, Inc., 2004) after a 206-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 206 days
- Class
- Class I
- Product code
- OAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030849 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030849 Amnisure Fetal Membranes Rupture Test Model FMRT1N-Dia, Inc. · 2004 · Recalled
- This deviceK061886 Actim Prom and ControlsMedix Biochemica · 2007
- Descendant · cites it directly · 0 of its ownK123986 Actim PromAlere Scarborough, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK110605 Rom PlusClinical Innovations, LLC · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030849 | Amnisure Fetal Membranes Rupture Test Model FMRT1 | N-Dia, Inc. | 2004 | 1 |
| 0 (this device) | K061886 | Actim Prom and Controls | Medix Biochemica | 2007 | — |
| +1 | K123986 | Actim Prom | Alere Scarborough, Inc. | 2014 | 1 |
| +1 | K110605 | Rom Plus | Clinical Innovations, LLC | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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 OAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030849 | Amnisure Fetal Membranes Rupture Test Model FMRT1Summary page 1…Quality Control Material (Assayed and Unassayed) 3. Predicate Device AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc. K030849 4. Device Description The Actim PROM is a rapid test for detection of premature rupture of fetal membranes. The tes… | 2004 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OAM devicesOAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OAM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · OAM
Too few OAM 510(k)s in any year since 2007 to give a median.
Recalls per year · OAM
No recall names OAM since 2007.
Adverse event reports per year · OAM
3in 2021
MAUDE reports naming product code OAM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks…
Read the full statement (121 words)
The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed.
The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061886: Actim Prom and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061886
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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