(379 days)
Not Found
No
The device is a visually interpreted, qualitative immunoassay rapid test based on lateral flow technology. The description focuses on the chemical and physical interactions of antibodies and latex particles, with no mention of computational analysis, algorithms, or learning processes. The interpretation is visual, not automated or based on AI/ML.
No.
The device is a diagnostic test used to detect the rupture of fetal membranes, not to treat a condition or restore a function.
Yes
The device is described as aiding in the "diagnosis of premature rupture of fetal membranes" and is intended to "help diagnose the rupture of fetal membranes (ROM)". This aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical lateral flow immunoassay test strip with components like a sample/conjugate pad, membrane, absorbent pad, and plastic films. This indicates a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of amniotic fluid in cervicovaginal secretions during pregnancy" and is used "to help diagnose the rupture of fetal membranes (ROM)". This involves testing a sample taken from the body to provide information about a medical condition.
- Device Description: The description details a "qualitative immunoassay rapid test" that detects a specific protein (IGFBP-1) in a "vaginal sample". This is a classic description of an in vitro diagnostic test.
- Sample Type: The test uses "cervicovaginal secretions," which are biological samples taken from the body.
- Testing Location: The test is intended for "point of care and clinical laboratory settings," which are typical environments for IVD testing.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women ≥29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.
Product codes (comma separated list FDA assigned to the subject device)
OAM
Device Description
The Actim PROM test is a rapid test to aid in diagnosis of premature rupture of fetal membranes in pregnant women who present with signs, symptoms or complaints suggestive of RQM. The test is based on lateral flow immunoassav. It utilizes two monoclonal antibodies to human IGFBP-1. One of the two antibodies is bound to blue latex particles (detecting antibody). The other antibody is immobilized as a test line on the membrane (catching antibody). The test strip (dipstick) is composed of the sample/conjugate pad, the membrane with test and control lines, and the absorbent pad assembled between plastic films. The upper film contains a test window. When the sample area of the dipstick is placed in an extracted sample, the dipstick absorbs liquid, which starts to flow up the dipstick. If the sample contains IGFBP-1 it binds to the antibody labeled with latex particles. The particles are carried by the liquid flow, and if IGFBP-1 is bound to them, they bind to the catching antibody. A blue line (test line) will appear in the result area if the concentration of IGFBP-1 in the sample exceeds the detection limit of the test. A second blue line, the control line, confirms correct operator performance of the test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervicovaginal secretions
Indicated Patient Age Range
pregnant women ≥29 weeks gestation
Intended User / Care Setting
prescription use in 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 total of 222 pregnant women presenting with signs/symptoms suggestive of ROM were evaluated using the Actim PROM test and compared to results obtained from conventional criteria. Subjects were considered clinically positive for PROM if amniotic fluid was seen leaking from the cervical os upon diagnostic speculum examination, or if two of the three following clinical signs were positive: visual pooling of fluid in the posterior fornix, positive nitrazine test or microscopic evidence of ferning. Actim PROM test performance was established relative to clinical diagnosis as determined by the conventional clinical criteria identified above.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study: The clinical performance of the Actim PROM test was established in a multi-center, prospective clinical study conducted at six US clinical sites over an 18 month period. A total of 222 pregnant women presenting with signs/symptoms suggestive of ROM were evaluated using the Actim PROM test and compared to results obtained from conventional criteria.
Results:
≥ 29 weeks (Without Speculum), N=222: Sensitivity 90.1% (100/111) (95% CI: 83.1-94.4%), Specificity 91.0% (101/111) (95% CI: 84.2-95.0%)
≥ 29 weeks (With Speculum), N=220: Sensitivity 95.5% (105/110) (95% CI: 89.8-98.0%), Specificity 86.4% (95/110) (95% Cl: 78.7-91.6%)
≥ 29 to 34 weeks (Without Speculum), N=97: Sensitivity 95.7% (44/46) (95% CI: 85.5-98.8%), Specificity 96.1% (49/51) (95% CI: 86.8-98.9%)
≥ 29 to 34 weeks (With Speculum), N=96: Sensitivity 95.7% (44/46) (95% CI: 85.8-98.8%), Specificity 90.0% (45/50) (95% CI: 78.6-95.7%)
Repeatability: A panel of specimens consisting of samples of different IGFBP-1 concentration levels was evaluated for intra-assay precision. The samples were tested with 10 replicates during the same day using three different lots of the Actim PROM test. Repeatable results were obtained.
Reproducibility: A study of the Actim PROM test was conducted at three separate sites using panels of blind coded specimens containing negative (0ug/) of IGFBP-1), high negative (5ug/l of IGFBP-1), moderate negative (12.5ug/l of IGFBP-1), low positive (20ug/l of IGFBP-1), moderate positive (25ug/l of IGFBP-1), and high positive (30, 50, and 100ug/l of IGFBP-1) specimens. Test operators (n=9) tested each level multiple times over a period of five days. A total of 360 tests were performed (120 per site) with a total of 45 tests per sample. The overall reproducibility of the Actim PROM test is 97% (350/360) with no significant differences within runs (replicates tested by one operator), between runs (five different days), between sites (three sites) or between operators (nine operators).
Analytical Sensitivity: The analytical sensitivity (detection limit) of the Actim PROM test was identified by evaluating different concentrations of IGFBP-1 in extracted sample on three different lots of the Actim PROM test. Two different operators each interpreted ten devices run at each concentration under various lighting conditions for a total of 60 determinations per level. The Actim PROM test limit of detection (100% positive) is approximately 25 ug/L of IGFBP-1 in extracted sample. The measuring range of the Actim PROM test is approximately 25-500,000 ug/L in extracted sample. It should be noted that positive results could be observed for extracted samples with IGFBP-1 at
§ 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K123986
The primary purpose of this 510(k) submission is to expand the intended use claims to support use of the Actim PROM test in pregnant women greater than or equal to (≥) 29 weeks gestational age and use of vaginal swab samples collected without the use of a speculum in addition to the current sample type, swabs collected with the use of a speculum.
To establish substantial equivalence to the predicate, the Actim PROM test was compared to the previously cleared version of the Actim PROM test (510(k) K061886).
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 Establishment Registration Number: 1221359
CONTACT PERSON .
Angela Drysdale, VP Regulatory & Clinical Affairs - Infectious Disease Phone: (207)-730-5737 Fax: (207)-730-5717 Angela.drysdale@alere.com
DATE PREPARED
January 7, 2014
TRADE NAME
Actim PROM
COMMON NAME
Rupture of Fetal Membranes (ROM) Rapid Diagnostic Test
CLASSIFICATION NAME
Urinary pH (non-quantitative) Test System (per 21 CFR 862.1550)
CLASSIFICATION Class I
PRODUCT CODE OAM
PANEL Clinical Chemistry
PREDICATE DEVICE Actim PROM (510(k) K061886)
1
DEVICE DESCRIPTION
The Actim PROM test is a rapid test to aid in diagnosis of premature rupture of fetal membranes in pregnant women who present with signs, symptoms or complaints suggestive of RQM. The test is based on lateral flow immunoassav. It utilizes two monoclonal antibodies to human IGFBP-1. One of the two antibodies is bound to blue latex particles (detecting antibody). The other antibody is immobilized as a test line on the membrane (catching antibody). The test strip (dipstick) is composed of the sample/conjugate pad, the membrane with test and control lines, and the absorbent pad assembled between plastic films. The upper film contains a test window. When the sample area of the dipstick is placed in an extracted sample, the dipstick absorbs liquid, which starts to flow up the dipstick. If the sample contains IGFBP-1 it binds to the antibody labeled with latex particles. The particles are carried by the liquid flow, and if IGFBP-1 is bound to them, they bind to the catching antibody. A blue line (test line) will appear in the result area if the concentration of IGFBP-1 in the sample exceeds the detection limit of the test. A second blue line, the control line, confirms correct operator performance of the test.
INTENDED USE
The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of ammiotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women ≥29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.
TECHNOLOGICAL CHARACTERISTICS
The Actim PROM test is a qualitative, lateral flow immunoassay intended to aid in the detection of ruptured fetal membranes in pregnant women. Detection of results is by visual inspection. The Actim PROM test is intended for use in the point-of-care and clinical laboratory setting.
There have been no changes made to the Actim PROM test. The device is physically the same as the current, 510/k) cleared Actim PROM test. The purpose of this submission is to expand the indication for use claims to include use of the device in pregnant women ≥29 weeks gestational age and to allow use of the device with vaginal swabs collected without use of a speculum.
PERFORMANCE SUMMARY
CLINICAL STUDY
The clinical performance of the Actim PROM test was established in a multi-center, prospective clinical study conducted at six US clinical sites over an 18 month period. A total of 222 pregnant women presenting with signs/symptoms suggestive of ROM were evaluated using the Actim PROM test and compared to results obtained from conventional criteria. Subjects were considered clinically positive for PROM if amniotic fluid was seen leaking from the cervical os upon diagnostic speculum examination, or if two of the three following clinical signs were positive: visual pooling of fluid in the posterior fornix, positive nitrazine test or microscopic evidence of ferning. Actim PROM test performance was established relative to clinical diagnosis as determined by the conventional clinical criteria identified above.
Actim PROM test performance by sample type and gestational age versus clinical diagnosis, including 95% Confidence Intervals (CI), is presented below.
2
Table 1: Actim PROM Test Performance vs. Clinical Diagnosis - Overall Results - ≥ 29 Weeks Gestational Age
| | N | Sensitivity
(95% Confidence Intervals) | Specificity
(95% Confidence Intervals) |
|----------------------------------|------|-------------------------------------------|-------------------------------------------|
| ≥ 29 weeks
(Without Speculum) | 222 | 90.1% (100/111)
(95% CI: 83.1-94.4%) | 91.0% (101/111)
(95% CI: 84.2-95.0%) |
| ≥ 29 weeks
(With Speculum) | 220* | 95.5% (105/110)
(95% CI: 89.8-98.0%) | 86.4% (95/110)
(95% Cl: 78.7-91.6%) |
*2 invalid test results (control lines were not visible) were not included in the analysis for sample collected with speculum.
Performance of the Actim PROM test was analyzed based on a patient's gestational age at the time of sample collection.
Table 2: Actim PROM Test Performance vs. Clinical Diagnosis – ≥ 29 to 34 Weeks Gestational Age
| N | Sensitivity | Specificity | |
|---|---|---|---|
| (95% Confidence Intervals) | (95% Confidence Intervals) | ||
| ≥ 29 to 34 weeks | |||
| (Without Speculum) | 97 | 95.7% (44/46) | 96.1% (49/51) |
| (95% CI: 85.5-98.8%) | (95% CI: 86.8-98.9%) | ||
| ≥ 29 to 34 weeks | |||
| (With Speculum) | 96* | 95.7% (44/46) | 90.0% (45/50) |
| (95% CI: 85.8-98.8%) | (95% CI: 78.6-95.7%) |
*1 invalid test result (control line was not visible) was not included in the analysis for sample collected with speculum.
ANALYTICAL STUDIES
REPEATABILITY
A panel of specimens consisting of samples of different IGFBP-1 concentration levels was evaluated for intra-assay precision. The samples were tested with 10 replicates during the same day using three different lots of the Actim PROM test. Repeatable results were obtained.
REPRODUCIBILITY
A study of the Actim PROM test was conducted at three separate sites using panels of blind coded specimens containing negative (0ug/) of IGFBP-1), high negative (5ug/l of IGFBP-1), moderate negative (12.5ug/l of IGFBP-1), low positive (20ug/l of IGFBP-1), moderate positive (25ug/l of IGFBP-1), and high positive (30, 50, and 100ug/l of IGFBP-1) specimens. Test operators (n=9) tested each level multiple times over a period of five days. A total of 360 tests were performed (120 per site) with a total of 45 tests per sample. The overall reproducibility of the Actim PROM test is 97% (350/360) with no significant differences within runs (replicates tested by one operator), between runs (five different days), between sites (three sites) or between operators (nine operators).
ANALYTICAL SENSITIVITY
The analytical sensitivity (detection limit) of the Actim PROM test was identified by evaluating different concentrations of IGFBP-1 in extracted sample on three different lots of the Actim PROM test. Two different operators each interpreted ten devices run at each concentration under various lighting conditions for a total of 60 determinations per level. The Actim PROM test limit of detection (100% positive) is approximately 25 ug/L of IGFBP-1 in extracted sample. The measuring range of the Actim PROM test is approximately 25-500,000 ug/L in extracted sample. It should be noted that positive results could be observed for extracted samples with IGFBP-1 at 29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123986
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