(206 days)
Not Found
No
The device description and performance studies focus on immunochromatography and visual interpretation, with no mention of AI or ML.
No
The device is a diagnostic test for detecting rupture of fetal membranes, not a device that treats or prevents a disease or condition.
Yes
The device aids in the diagnosis of the rupture of fetal membranes (ROM) by detecting a specific marker in cervicovaginal secretions.
No
The device description clearly outlines physical components such as a sterile polyester swab, specimen extraction solution, and a dipstick, indicating it is a hardware-based test kit, not software only.
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" to "help diagnose the rupture of fetal membranes (ROM)". This involves testing a sample taken from the human body to provide information for diagnosis.
- Device Description: The description details a "rapid test for detection of premature rupture of fetal membranes" that uses "lateral flow immunochromatography". This is a common method used in IVD tests.
- Sample Type: The test uses "cervicovaginal secretions", which are biological samples from the human body.
- Professional Use: It is intended for "professional use", indicating it's used by healthcare professionals in a clinical setting.
- Controls: The inclusion of "Actim PROM Controls" for external quality control is typical for IVD devices to ensure the test is performing correctly.
- Predicate Device: The mention of a "Predicate Device" with a K number (K030849 AmniSure ROM Test) strongly suggests this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAM, JJX
Device Description
The Actim PROM is a rapid test for detection of premature rupture of fetal The test principle is lateral flow immunochromatography. Actim membranes. PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant.
The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervicovaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of nonclinical studies was conducted to assess the performance of the Actim PROM and Actim PROM Controls. These studies evaluated method comparison, repeatability, reproducibility, analytical sensitivity, analytical specificity and interfering substances. The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) Summary for the Medix Biochemica Actim PROM
1. Applicant/Sponsor
Medix Biochemica Asematie 13 02700 Kauniainen Finland
| Contact Person: | Heli Paloheimo |
|---|---|
| Telephone: | 358 9 547 680 |
Date Prepared: January 5, 2007
2. Device Name
| Proprietary Name: | Actim PROM and Actim PROM 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 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 The test principle is lateral flow immunochromatography. Actim membranes. PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant.
The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.
Page 1 of 2
JAN 2 5 2007
1
న. Intended Use
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.
6. Technological Characteristics and Substantial Equivalence
The Actim PROM and the predicate device 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 for both tests. The analytes detected by both the Actim PROM and AmniSure tests are thought to be very similar. The specimen collection and extraction, test procedure, and reading and interpretation of results is similar between the two devices. Both devices are intended for use in point-of-care and clinical laboratory settings.
The differences between the Actim PROM and the predicate device do not impact the safety or effectiveness of the proposed Actim PROM products for their intended uses.
7. Performance Testing
A series of nonclinical studies was conducted to assess the performance of the Actim PROM and Actim PROM Controls. These studies evaluated method comparison, repeatability, reproducibility, analytical sensitivity, analytical specificity and interfering substances. The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications.
2
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Cynthia Sinclair Medix Biochemica 49 Plain Street North Attelboro, MA 02760
Re: K061886
Trade/Device Name: Actim PROM Regulation Number: 21 CFR§862.1550 Regulation Name: Urinary pH (nonquantitative) test system. Regulatory Class: Class I Product Code: OAM, JJX Dated: November 29, 2006 Received: November 30, 2006
JAN 2 5 2007
Dear Ms. Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandijils and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 200).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Coopers, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061886
Device Name: Actim PROM
Indications for Use:
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.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
sign-Off
്ലം of In Vitro Diagnostic Devices · 'eation and Safety
12061886
Medix Biochemica Additional Information - K061886 January 5, 2007