(266 days)
No
The device description and performance studies indicate a lateral flow immunochromatographic test, which is a chemical reaction-based method, not an AI/ML technology. There are no mentions of AI, ML, or image processing.
No
This device is a diagnostic device used to detect rupture of fetal membranes, not a therapeutic device used for treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms," which is a diagnostic purpose.
No
The device description clearly outlines physical components like a sterile polyester swab, specimen extraction buffer solution, and a cassette with a lateral flow strip, indicating it is a hardware-based in vitro diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is for the "in vitro detection of amniotic fluid in vaginal secretions". "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs.
- Device Description: The description details a test that analyzes a biological sample (vaginal secretions) using a chemical process (immunochromatography) to detect specific substances (AFP and PP12). This is consistent with the nature of an IVD.
- Quality Control Kit: The mention of a "Quality Control Kit" for monitoring performance is also typical for IVDs, as quality control is essential for ensuring accurate results.
- Performance Studies: The description of performance studies, including analytical sensitivity, specificity, and clinical studies comparing the device to a clinical standard, are all standard evaluations for IVDs to demonstrate their accuracy and reliability.
- Predicate Devices: The listing of predicate devices, which are other legally marketed devices that are similar in intended use and technology, further confirms that this device falls within the category of IVDs. The predicate devices listed are also IVDs for detecting ROM.
In summary, the device's intended use, method of operation, quality control measures, performance evaluation, and comparison to predicate devices all clearly indicate that it is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 PP12 (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.
Product codes
NQM, JJX
Device Description
The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. ROM Plus is available in packages of 5 tests. Each individual test pack contains a sterile polyester swab. specimen extraction buffer solution in a plastic vial and a cassette with integral timer containing the lateral flow strip packed in a foil pouch with desiccant.
The ROM Plus Controls contain one vial each of negative, and positive controls, with integral reconstitution solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal secretions
Indicated Patient Age Range
pregnant women
Intended User / Care Setting
health care professionals; point-of-care and clinical laboratory settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A multi-center prospective observational study was performed. Clinicians performing ROM Plus testing were masked from the standard Clinical Assessment results. The clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine were used.12,16 because these are commonly used in clinical hospital protocol to evaluate ROM.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of nonclinical and clinical studies was conducted to assess the performance of the RQM Plus, These studies evaluated method comparison, repeatability, analytical sensitivity, analytical specificity and interfering substances.
- High Concentration ("High Dose Hook" effect) for the ROM Plus upper-detection . range, the PP12 and AFP were tested. Concentrations of PP12 were tested up to 400,000 ng/ml and AFP up to 200,000 ng/ml with positive visual results.
- For 100% of ROM Plus tests sampled, the lowest limit of detection (LOD) is 5 ne/ml for . PP12, and 150 ng/ml for AFP (these refer to concentrations in samples of vaginal secretions before dilution with the assay buffer).
- . Reproducibility was tested on different days at six levels of amniotic fluid spiked into a negative control. The assay was run on three lots of ROM Plus to determine the visual positive or negative results. Two low positives, two moderate positives and two high positives were run on three lots of ROM Plus on four different days. No difference in activity was observed.
- To determine interference and cross-reactivity of the assay, Tylenol, aspirin, and three . different bath products (Lever Soap, Noxzema cream, Pert Shampoo), were spiked into the low positive control at a final concentration of 0.1% without visual loss of activity. The same bath products were spiked into the negative-matrix control and shown to be negative. In addition, human semen, urine and blood were spiked into the low positive at a 10% final concentration without loss of activity. Human semen, urine and blood were also spiked into the negative-control matrix and shown to be negative. PP12 assay does not cross-react with IGFBP-2, IGFBP-3, and IGFBP-4 based on Western Blot results. ROM Plus was shown to be negative when tested with specimens that were positive for bacterial vaginosis and sexually transmitted diseases. All samples were pH>4.5.
A multi-center prospective observational study was performed. Total sample size for combined analysis was 264.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Combined:
Sens: 0.99 (CI: 0.96 to 1.00)
Spec: 0.75 (CI: 0.66 to 0.82)
PPV: 0.85 (CI: 0.79 to 0.90)
NPV: 0.99 (CI: 0.94 to 1.00)
≥ 37:
Sens: 0.99 (CI: 0.96 to 1.00)
Spec: 0.58 (CI: 0.46 to 0.71)
PPV: 0.84 (CI: 0.78 to 0.89)
NPV: 0.97 (CI: 0.85 to 0.99)
34-37 EGA:
Sens: 1.00 (CI: 0.82 to 1.00)
Spec: 0.85 (CI: 0.64 to 0.95)
PPV: 0.87 (CI: 0.65 to 0.95)
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
NOV 2 3 2011
510(k) Summary for the Clinical Innovations, LLC ROMPlus
- Applicant/Sponsor Clinical Innovations, LLC 747 W. 4170 S. Murray, Utah USA 84123 Contact Person: Wm. Dean Wallace, MD, PhD. Telephone: 801-268-8200 wdw@clinicalinnovations.com Date Prepared: November 7, 2011
2. Device Name
Proprietary Name: ROM Plus and ROM Plus Controls Common/Usual Name: Rupture Of Fetal Membranes (ROM) Rapid Diagnostic Test Classification Name: Urinary 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, K081767 Actim Prom and Controls Medix Biochemica -K061886 AmnioTest (pH swab) -K914419 AmniScreen (pH liner) - K071100
4. Device Description
The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. ROM Plus is available in packages of 5 tests. Each individual test pack contains a sterile polyester swab. specimen extraction buffer solution in a plastic vial and a cassette with integral timer containing the lateral flow strip packed in a foil pouch with desiccant.
The ROM Plus Controls contain one vial each of negative, and positive controls, with integral reconstitution solution.
Clinical Innovations, LLC 747 W. 4170 S. Murray, Utah USA 84123 5. Intended Use
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 PP12 (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.
1
6. Technological Characteristics and Substantial Equivalence
The RQM Plus and the predicate devices cited above are both qualitative, lateral flow immunochromatographic assays intended to aid in detecting rupture of fetal membranes in pregnant women. Detection of results is by visual inspection. The analytes detected by ROM Plus and AmniSure and ActimPROM tests are similar amniotic fluid proteins. ROM Plus uses antibodies to PP12 (IGFBP-1) and AFP (alpha feto-protein). The specimen collection and extraction, test procedure, and reading and interpretation of results is similar between the three devices. All devices are intended for use in point-of-care and clinical laboratory settings. The differences between the ROM Plus and the predicate devices do not impact the safety or effectiveness of the proposed ROM Plus products for their intended uses.
7. Performance Testing
A series of nonclinical and clinical studies was conducted to assess the performance of the RQM Plus, These studies evaluated method comparison, repeatability, analytical sensitivity, analytical specificity and interfering substances.
- High Concentration ("High Dose Hook" effect) for the ROM Plus upper-detection . range, the PP12 and AFP were tested. Concentrations of PP12 were tested up to 400,000 ng/ml and AFP up to 200,000 ng/ml with positive visual results.
- For 100% of ROM Plus tests sampled, the lowest limit of detection (LOD) is 5 ne/ml for . PP12, and 150 ng/ml for AFP (these refer to concentrations in samples of vaginal secretions before dilution with the assay buffer).
- . Reproducibility was tested on different days at six levels of amniotic fluid spiked into a negative control. The assay was run on three lots of ROM Plus to determine the visual positive or negative results. Two low positives, two moderate positives and two high positives were run on three lots of ROM Plus on four different days. No difference in activity was observed.
- To determine interference and cross-reactivity of the assay, Tylenol, aspirin, and three . different bath products (Lever Soap, Noxzema cream, Pert Shampoo), were spiked into the low positive control at a final concentration of 0.1% without visual loss of activity. The same bath products were spiked into the negative-matrix control and shown to be negative. In addition, human semen, urine and blood were spiked into the low positive at a 10% final concentration without loss of activity. Human semen, urine and blood were also spiked into the negative-control matrix and shown to be negative. PP12 assay does not cross-react with IGFBP-2, IGFBP-3, and IGFBP-4 based on Western Blot results. ROM Plus was shown to be negative when tested with specimens that were positive for bacterial vaginosis and sexually transmitted diseases. All samples were pH>4.5.
A multi-center prospective observational study was performed. Clinicians performing ROM Plus testing were masked from the standard Clinical Assessment results. The clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine were used.12,16 because these are commonly used in clinical hospital protocol to evaluate ROM. Corrections for ROM based on
2
subsequent patient chart review was nos used in this study for the detection of ruptured membranes.
Results are shown below:
| Combined | Clin-Assess | positive | negative | ≥ 37 | Clin-Assess | positive | negative |
|---|---|---|---|---|---|---|---|
| ROM Plus | positive | 153 | 28 | ROM Plus | positive | 125 | 23 |
| negative | 1 | 82 | negative | 1 | 33 | ||
| Total: 264 | Total: 182 | ||||||
| Sens | 0.99 | CI: 0.96 to 1.00 | Sens | 0.99 | CI: 0.96 to 1.00 | ||
| Spec | 0.75 | CI: 0.66 to 0.82 | Spec | 0.58 | CI: 0.46 to 0.71 | ||
| PPV | 0.85 | CI: 0.79 to 0.90 | PPV | 0.84 | CI: 0.78 to 0.89 | ||
| NPV | 0.99 | CI: 0.94 to 1.00 | NPV | 0.97 | CI: 0.85 to 0.99 | ||
| 34-37 EGA | Clin-Assess | positive | negative |