ACTIM PROM AND CONTROLS

K061886 · Medix Biochemica · OAM · Jan 25, 2007 · Clinical Chemistry

Device Facts

Record IDK061886
Device NameACTIM PROM AND CONTROLS
ApplicantMedix Biochemica
Product CodeOAM · Clinical Chemistry
Decision DateJan 25, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.1550
Device ClassClass 1

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.

Device Story

Actim PROM is a rapid, qualitative, lateral flow immunochromatographic test for detecting IGFBP-1, a marker for amniotic fluid, in cervicovaginal secretions. The device consists of a sterile polyester swab, specimen extraction solution, and a dipstick. Used in point-of-care and clinical laboratory settings by healthcare professionals. The clinician collects a cervicovaginal sample using the swab, extracts it, and applies it to the dipstick. Results are determined by visual inspection of the dipstick. The test aids in the clinical diagnosis of premature rupture of fetal membranes (ROM) in pregnant women. External controls are provided to verify test performance, including negative, low positive, and high positive results.

Clinical Evidence

Clinical performance supported by two published studies (Ragosch et al. 1996; Jain and Morris 1998) totaling 175 patients. Combined results: 100% sensitivity (95% CI: 94-100%) and 87% specificity (95% CI: 79.4-92.5%). PPV was 80% and NPV was 100%. Analytical performance included precision/reproducibility testing, analytical sensitivity (detection limit ~25 µg/L), and specificity testing showing no cross-reactivity with IGFBP-2 through -6 or interference from common vaginal products, semen, blood, or urine.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: sterile polyester swab, phosphate buffer extraction solution (with BSA, protease inhibitor, preservative), and dipstick with two mouse monoclonal antibodies to human IGFBP-1. Qualitative visual readout. Point-of-care/lab use. No instrumentation required. Controls are lyophilized human IGFBP-1 in buffered protein matrix.

Indications for Use

Indicated for professional use in pregnant women >34 weeks gestation presenting with signs or symptoms of rupture of fetal membranes (ROM) to detect IGFBP-1 in cervicovaginal secretions.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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<br>Test | | Classification Name: | Urinary pH (Nonquantitative) Test System and<br>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
Innolitics
510(k) Summary
Decision Summary
Classification Order
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