510(k) · Cleared
Recalled · Class II · 2020Rom Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, LLC · NQM Immunoassay For Detection Of Amniotic Fluid Protein (S).
Cleared on Nov 23, 2011 as substantially equivalent to K030849 (N-Dia, Inc., 2004) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 2004. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Nov 23, 2011
- Review
- 266 days
- Class
- Class I
- Product code
- NQM
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K030849 (2004). 5 ancestors in all, the oldest K914419 (1993). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK030849 Amnisure Fetal Membranes Rupture Test Model FMRT1N-Dia, Inc. · 2004 · Recalled
- 1 generation backK061886 Actim Prom and ControlsMedix Biochemica · 2007
- This deviceK110605 Rom PlusClinical Innovations, LLC · 2011
Class I recalls in this family
- K081767 Amnisure Fetal Membranes Rupture Test, Model…direct predicate · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030849 | Amnisure Fetal Membranes Rupture Test Model FMRT1 | N-Dia, Inc. | 2004 | 1 |
| −1 | K061886 | Actim Prom and Controls | Medix Biochemica | 2007 | — |
| 0 (this device) | K110605 | Rom Plus | Clinical Innovations, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (5)
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…y pH (Nonquantitative) Test System and Quality Control Material (Assayed and Unassayed) 3. Predicate Devices AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc.-k030849, k08 1767 Actim Prom and Controls Medix Biochemica -k06 1886 AmnioTest (pH swab) -k914419 AmniScreen (pH liner) - k071 100 4. De… | 2004 |
| * | K081767 | Amnisure Fetal Membranes Rupture Test, Model FMRT-1Summary page 1…quantitative) Test System and Quality Control Material (Assayed and Unassayed) 3. Predicate Devices AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc.-k030849, k08 1767 Actim Prom and Controls Medix Biochemica -k06 1886 AmnioTest (pH swab) -k914419 AmniScreen (pH liner) - k071 100 4. Device Descr… | 2009 |
| * | K061886 | Actim Prom and ControlsSummary page 1…ial (Assayed and Unassayed) 3. Predicate Devices AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc.-k030849, k08 1767 Actim Prom and Controls Medix Biochemica -k06 1886 AmnioTest (pH swab) -k914419 AmniScreen (pH liner) - k071 100 4. Device Description The ROMPlus is a rapid test for detection of… | 2007 |
| * | K914419 | Amniotest (TM)Summary page 1…Predicate Devices AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc.-k030849, k08 1767 Actim Prom and Controls Medix Biochemica -k06 1886 AmnioTest (pH swab) -k914419 AmniScreen (pH liner) - k071 100 4. Device Description The ROMPlus is a rapid test for detection of premature rupture of fetal m… | 1993 |
| * | K071100 | Amniscreen Home Detection Liner KitSummary page 1…(Rupture Of [fetal] Membranes) Test N-Dia, Inc.-k030849, k08 1767 Actim Prom and Controls Medix Biochemica -k06 1886 AmnioTest (pH swab) -k914419 AmniScreen (pH liner) - k071 100 4. Device Description The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is l… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2020 | Class II | Z-0541-2021 | Process change control | Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K081767Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K030849.
How does its category compare?
All NQM devicesNQM Immunoassay For Detection Of Amniotic Fluid Protein (S).: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NQM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NQM
Too few NQM 510(k)s in any year since 2007 to give a median.
Recalls per year · NQM
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQM
1in 2025
MAUDE reports naming product code NQM, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in-vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PPI12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in…
Read the full statement (124 words)
The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in-vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PPI12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms.
The ROM Plus Quality Control Kit monitors the performance of the ROM Plus Fetal Membranes Rupture Test for the purposes of external quality control. The lyophilized human positive protein control is an assayed control material for qualitative testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110605: Rom Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110605
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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